Product Range Vaccines For Live Stock

Transcription

1 Product Range Vaccines For Live Stock Canine Vaccines Animal Health Formulations INDIAN IMMUNOLOGICALS LIMITED Human Health Vaccines 1. Raksha 2. Raksha Monovalent 3. Raksha Bivalent 4. Raksha Trivalent 5. Raksha Ovac 6. Raksha Ovac Monovalent 7. Raksha Ovac Bivalent 8. Raksha Ovac Trivalent 9. Raksha Biovac 10. Raksharab 11. Raksha - SP 12. Raksha HS 13. Raksha BQ 14. Raksha HS+BQ 15. Rakshavac-T 16. Raksha Anthrax 1. Raksharab 2. Megavac-6 3. Megavac-P (Inact) 4. Megavac-CC 1. Ivectin 2. Vetalben 2.5% 3. Vetalben 10% 4. Vetalben T 5. Vetalben Vetalben Vetalben Forte 8. Vetfen 9. Vetfen - B 10. Prazital 11. Prazital Plus 12. Levaxinide 13. Rafonide 14. Trichloben 15. Prozal 16. Trepanol 17. Tikkil Powder 22. Gyroflox Inj. 23. Gyroflox tab. 24. Gyroflox 10% 25. Inimox 26. G-cin Inj. 27. Sulfamin 28. Vetylosin 5% Inj. 29. Lithiomony 30. Inigesic 31. Nimovet 32. Pesurea Bolus 33. Calgonate 34. Miphocal 35. Bovoplex - CC 36. Mastect 37. Xylaxin 38. Trophovet 1. Abhayrab (B.P.) 2. Abhay RIG 3. Abhay-Vac 3 4. Abhay-M 5. Abhay-M (I.P.) 6. Elovac-B 7. Abhay-X 8. Abhay-DAG 9. Abhay-TAG 17. Bruvax 18. Tikkil Solution 18. Bruvax REV1 19. Raksha ET 20. Raksha PPR 19. Oxytetracycline 5% Inj. 20. Tetroxin - DS 21. Tetroxin - LA

2 Raksha (FOOT AND MOUTH DISEASE VACCINE BP (Vet)) Raksha FMD(Foot and Mouth Disease) vaccine is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep and goats. Raksha FMD vaccine is manufactured by Indian Immunologicals with the process know-how obtained from the Wellcome Foundation Ltd. U.K., the pioneers and world leaders in FMD research, control and vaccine production. Raksha FMD vaccine contains tissue culture inactivated FMD virus strains O, A, C and Asia-1 adsorbed on Aluminium hydroxide and Saponin added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously through an area of clean, dry skin with precautions taken against contamination. The chest wall behind the shoulder or the dewlap are the recommended sites for inoculation. DOSAGE Cattle, Buffaloes and Calves : 3 ml & Sheep and Goats : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age. Booster : 2 to 4 weeks after primary vaccination. Revaccination : Every 6 months thereafter. Primovaccinates irrespective of age should receive two doses initially. This should be followed by every 6 months thereafter. SIDE EFFECTS Generally no significant side effects are noticed after vaccination. However, in a few cases a small swelling may develop at the site of inoculation, which usually subsides within a few days. The body temperature generally remains normal. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha FMD vaccine is available in polypropylene bottles of 10 doses (30 ml) & 100 doses (300 ml). CAUTION Raksha FMD vaccine is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha FMD vaccine is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha FMD vaccine from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. Aqueous or Oil adjuvant vaccines, monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

3 Raksha Monovalent (FOOT AND MOUTH DISEASE VACCINE BP (Vet)) Raksha Monovalent FMD (Foot and Mouth Disease) vaccine is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep and goats. Raksha FMD vaccine is manufactured by Indian Immunologicals with the process know-how obtained from the Wellcome Foundation Ltd. U.K., the pioneers and world leaders in FMD research, control and vaccine production. Raksha Monovalent FMD vaccine contains tissue culture inactivated FMD virus strain O1 Manisa (monovalent) adsorbed on Aluminium hydroxide and Saponin added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously through an area of clean, dry skin with precautions taken against contamination. The chest wall behind the shoulder or the dewlap are the recommended sites for inoculation. DOSAGE Cattle, Buffaloes and Calves Sheep and Goats : 2 ml : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter. Primovaccinates irrespective of age should receive two doses initially. This should be followed by every 6 months thereafter. SIDE EFFECTS Generally no significant side effects are noticed after vaccination. However, in a few cases a small swelling may develop at the site of inoculation, which usually subsides within a few days. The body temperature generally remains normal. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha - Monovalent FMD Vaccine is available in polypropylene vials of 30 ml (15 Cattle doses and 30 Sheep doses), 100 ml (50 cattle doses and 100 sheep doses) and 200 ml (100 cattle doses and 200 Sheep doses). CAUTION Raksha Monovalent FMD vaccine is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/ stockists, no responsibility following their use can be accepted. Raksha Monovalent FMD vaccine is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Monovalent FMD vaccine from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. Aqueous or Oil adjuvant vaccines, monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

4 Raksha Bivalent (FOOT AND MOUTH DISEASE VACCINE BP (Vet.)) Raksha FMD (Foot and Mouth Disease) vaccine is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep and goats. Raksha FMD vaccine is manufactured by Indian Immunologicals with the process know-how obtained from the Wellcome Foundation Ltd. U.K., the pioneers and world leaders in FMD research, control and vaccine production. Raksha Bivalent FMD vaccine contains tissue culture inactivated FMD virus strain O and A (bivalent) adsorbed on Aluminium hydroxide and Saponin added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously through an area of clean, dry skin with precautions taken against contamination. The chest wall behind the shoulder or the dewlap are the recommended sites for inoculation. DOSAGE Cattle, Buffaloes and Calves : 3 ml Sheep and Goats : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter. Primovaccinates irrespective of age should receive two doses initially. This should be followed by every 6 months thereafter. SIDE EFFECTS Generally no significant side effects are noticed after vaccination. However, in a few cases a small swelling may develop at the site of inoculation, which usually subsides within a few days. The body temperature generally remains normal. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha Bivalent FMD vaccine is available in 300ml bottles. CAUTION Raksha Bivalent FMD vaccine is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/ stockists, no responsibility following their use can be accepted. Raksha Bivalent FMD vaccine is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Bivalent FMD vaccine from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. Aqueous or Oil adjuvant vaccines, monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

5 Raksha Trivalent (FOOT AND MOUTH DISEASE VACCINE BP (Vet)) Raksha Trivalent FMD (Foot and Mouth Disease) vaccine is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep and goats. Raksha FMD vaccine is manufactured by Indian Immunologicals with the process know-how obtained from the Wellcome Foundation Ltd. U.K., the pioneers and world leaders in FMD research, control and vaccine production. Raksha Trivalent FMD vaccine contains tissue culture inactivated FMD virus strains O, A and Asia-1 adsorbed on Aluminium hydroxide and Saponin added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously through an area of clean, dry skin with precautions taken against contamination. The chest wall behind the shoulder or the dewlap are the recommended sites for inoculation. DOSAGE Cattle, Buffaloes and Calves Sheep and Goats : 3 ml : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age. Booster : 2 to 4 weeks after primary vaccination. Revaccination : Every 6 months thereafter. Primovaccinates irrespective of age should receive two doses initially. This should be followed by every 6 months thereafter. SIDE EFFECTS Generally no significant side effects are noticed after vaccination. However, in a few cases a small swelling may develop at the site of inoculation, which usually subsides within a few days. The body temperature generally remains normal. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha Trivalent FMD vaccine is available in 300 ml polypropylene bottles. CAUTION Raksha Trivalent FMD vaccine is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/ stockists, no responsibility following their use can be accepted. Raksha Trivalent FMD vaccine is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Trivalent FMD vaccine from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. Aqueous or Oil adjuvant vaccines, monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

6 Raksha-Ovac (FOOT AND MOUTH DISEASE OIL ADJUVANT VACCINE BP (Vet)) Raksha - Ovac (FMD Oil Adjuvant vaccine) is a unique Double Emulsion Oil Adjuvant Vaccine and is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep, goats and pigs. Raksha FMD Oil Adjuvant vaccine contains tissue culture virus strains O, A, C and Asia-1 and inactivated with Aziridine compound. Mineral oil is added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously or intramuscularly through an area of clean, dry skin with precautions taken against contamination. DOSAGE Cattle, Buffaloes, Calves and Pigs Sheep and Goats : 2 ml : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Primary vaccination : 2 months of age (Pigs). Booster : 9 months after primary vaccination (Cattle/buffaloes/Sheep and Goats). Revaccination : Every 12 months thereafter (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter (Pigs). SIDE EFFECTS As with all vaccines, hypersensitivity may occasionally occur. Adrenalin is the appropriate treatment. However, treatment is seldom required and spontaneous recovery generally follows rapidly. In case of food animals local carcass blemish at the site of intramuscular injection may necessitate slight trimming of the carcass. This can be minimized by vaccinating at least two months before slaughter. Injection of mineral oil into humans can produce serious localised reactions and special care should be taken to avoid accidental inoculation. If it happens, medical attention should be sought at once. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha - OVAC vaccine is available in multiple dose bottles of 30 ml (15 doses) and 100 ml (50 doses) Packs. CAUTION Raksha - OVAC is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha - OVAC is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha - OVAC from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. FMD Oil adjuvant vaccines of monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

7 Raksha-Ovac Monovalent (MONOVALENT FOOT AND MOUTH DISEASE OIL ADJUVANT VACCINE BP (Vet)) Raksha - Ovac (FMD Oil Adjuvant vaccine) is a unique Double Emulsion Oil Adjuvant Vaccine and is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep, goats and pigs. Raksha Ovac Monovalent FMD Oil Adjuvant vaccine contains tissue culture virus strain O (Monovalent) and inactivated with Aziridine compound. Mineral oil is added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously or intramuscularly through an area of clean, dry skin with precautions taken against contamination. DOSAGE Cattle, Buffaloes, Calves, Pigs : 2 ml Sheep and Goats : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Primary vaccination : 2 months of age (Pigs). Booster : 9 months after primary vaccination (Cattle/buffaloes/Sheep and Goats). Revaccination : Every 12 months thereafter (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter (Pigs). SIDE EFFECTS As with all vaccines, hypersensitivity may occasionally occur. Adrenalin is the appropriate treatment. However, treatment is seldom required and spontaneous recovery generally follows rapidly. In case of food animals local carcass blemish at the site of intramuscular injection may necessitate slight trimming of the carcass. This can be minimized by vaccinating at least two months before slaughter. Injection of mineral oil into humans can produce serious localised reactions and special care should be taken to avoid accidental inoculation. If it happens, medical attention should be sought at once. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha Ovac Monovalent vaccine is available in 30 ml, 50 ml & 100 ml (50 dose) vials. CAUTION Raksha Ovac Monovalent is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha Ovac Monovalent is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Ovac Monovalent from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. SHELF LIFE 24 months. FMD Oil adjuvant vaccines of monovalent, bivalent, trivalent, quadrivalent or any other combination incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

8 Raksha-Ovac Bivalent (FOOT AND MOUTH DISEASE OIL ADJUVANT VACCINE BP (Vet)) Raksha - Ovac (FMD Oil Adjuvant vaccine) is a unique Double Emulsion Oil Adjuvant Vaccine and is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep, goats and pigs. Raksha Ovac Bivalent FMD Oil Adjuvant vaccine contains tissue culture virus strain O and A (Bivalent) and inactivated with Aziridine compound. Mineral oil is added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously or intramuscularly through an area of clean, dry skin with precautions taken against contamination. DOSAGE Cattle, Buffaloes, Calves, Pigs : 2 ml Sheep and Goats : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Primary vaccination : 2 months of age (Pigs). Booster : 9 months after primary vaccination (Cattle/buffaloes/Sheep and Goats). Revaccination : Every 12 months thereafter (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter (Pigs). SIDE EFFECTS As with all vaccines, hypersensitivity may occasionally occur. Adrenalin is the appropriate treatment. However, treatment is seldom required and spontaneous recovery generally follows rapidly. In case of food animals local carcass blemish at the site of intramuscular injection may necessitate slight trimming of the carcass. This can be minimized by vaccinating at least two months before slaughter. Injection of mineral oil into humans can produce serious localised reactions and special care should be taken to avoid accidental inoculation. If it happens, medical attention should be sought at once. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha Ovac Bivalent vaccine is available in 30 ml, 100 ml (50 dose) vials. CAUTION Raksha Ovac Bivalent is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha Ovac Bivalent is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Ovac Bivalent from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. SHELF LIFE 24 months. FMD Oil adjuvant vaccines of monovalent, bivalent, trivalent, quadrivalent or any other combination incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

9 Raksha-Ovac Trivalent (FOOT AND MOUTH DISEASE OIL ADJUVANT VACCINE BP (Vet)) Raksha - Ovac (FMD Oil Adjuvant vaccine) is a unique Double Emulsion Oil Adjuvant Vaccine and is recommended for prophylactic vaccination against Foot and Mouth Disease in cattle, buffaloes, sheep, goats and pigs. Raksha - Ovac Trivalent (FMD Oil Adjuvant vaccine) contains tissue culture virus strains, O, A, Asia-1, and inactivated with Aziridine compound. Mineral oil is added as an adjuvant. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected subcutaneously or intramuscularly through an area of clean, dry skin with precautions taken against contamination. DOSAGE Cattle, Buffaloes, Calves and Pigs : 2 ml Sheep and Goats : 1 ml VACCINATION REGIMEN Primary vaccination : 4 months of age (Cattle, Buffaloes, Sheep and Goats). Primary vaccination : 2 months of age (Pigs). Booster : 9 months after primary vaccination (Cattle/buffaloes/Sheep and Goats). Revaccination : Every 12 months thereafter (Cattle, Buffaloes, Sheep and Goats). Revaccination : Every 6 months thereafter (Pigs). SIDE EFFECTS As with all vaccines, hypersensitivity may occasionally occur. Adrenalin is the appropriate treatment. However, treatment is seldom required and spontaneous recovery generally follows rapidly. In case of food animals local carcass blemish at the site of intramuscular injection may necessitate slight trimming of the carcass. This can be minimized by vaccinating at least two months before slaughter. Injection of mineral oil into humans can produce serious localised reactions and special care should be taken to avoid accidental inoculation. If it happens, medical attention should be sought at once. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 o C and 8 C. Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha - Ovac Trivalent vaccine is available in 100 ml Packs. CAUTION Raksha - Ovac Trivalent is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha - Ovac Trivalent is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha - Ovac Trivalent from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day s operations. FMD Oil adjuvant vaccines of monovalent, bivalent, trivalent, quadrivalent or any other valency incorporating the most relevant strains of epidemiological significance can be manufactured as per customer s choice.

10 Raksha Biovac (FOOT AND MOUTH DISEASE + HAEMORRHAGIC SEPTICAEMIA VACCINE) Raksha - Biovac (FMD + HS Oil adjuvant vaccine) is a unique Double Emulsion Oil Adjuvant Vaccine and is recommended for prophylactic vaccination against Foot and Mouth Disease & Haemorrhagic Septicaemia in cattle, buffaloes. Raksha Biovac FMD Oil Adjuvant vaccine contains FMD virus inactivated antigens against strains ''O, A and Asia - 1'' (inactivated with Aziridine compound) and inactivated Pasteurella multocida culture (inactivated with Formaldehyde). Mineral oil is added as an adjuvant. Thiomersal 0.01% W/V added as preservative. The vaccine vial should be kept cold until used and each vial should be well shaken before contents are withdrawn. Syringes and needles must be sterilized before use. The vaccine should be injected intramuscularly through an area of clean, dry skin with precautions taken against contamination, at mid neck region. Directions Dosage Primary vaccination (PV) Booster / First revaccination Revaccination Cattle / Buffaloes / Calves 3ml 4 months of age 9 months after PV Annual SIDE EFFECTS Generally no significant side effects are noticed after vaccination. However, in a few cases small swelling may develop at the site of inoculation which usually subsides within a few days. The body temperature remains normal. In rare cases hypersensitivity may occur, immediate treatment with Antihistamine is advocated. Adrenalin is the appropriate treatment. Accidental inoculation of oil vaccine by intravenous route results in allergic reaction. Anti-histamine is the choice of drug incase of such allergic reactions. CAUTION Raksha Biovac is thoroughly tested before issue. As subsequent handling and administration are not controlled by the manufacturers or distributors/stockists, no responsibility following their use can be accepted. Raksha Biovac is issued subject to this condition. Under field conditions it is extremely difficult to avoid the accidental introduction of bacteria when withdrawing doses of Raksha Biovac from the containers. Part-used bottles of vaccine should therefore be discarded at the end of the day's operations. Injection of mineral oil into humans can produce serious localized reactions and special care should be taken to avoid accidental inoculation. If it happens, medical attention should be sought at once. NOT FOR HUMAN USE. FOR ANIMAL TREATMENT ONLY SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 o C and 8 o C, Antigenicity of the vaccine deteriorates if the temperature is allowed to rise above this range, the rate of deterioration depending on both temperature and time. At no stage should the vaccine be frozen. Raksha Biovac vaccine is available in 30ml polypropylene vials.

11 Raksharab (Rabies Veterinary Vaccine BP (Vet)) Raksharab is recommended for immunization of dogs and other domestic animals against rabies for prophylactic use. Raksharab Vaccine contains inactivated rabies virus with a potency > 1.0 I.U. per dose. The virus is propagated in BHK-21 Cell line, inactivated with an aziridine compound and concentrated. Aluminium hydroxide is added as an adjuvant. 1 ml. Subcutaneously / intramuscularly. PROPHYLACTIC USE Age - 3 months and above. IMMUNITY Immunity is conferred for 36 months. However, annual vaccination is recommended in endemic areas. PRECAUTIONS Shake well before use. Vaccinate only healthy animals. Malnutrition, helminth infestation, administration of immunosuppressive agents (like Corticosteroids, Radiation-therapy etc.) will interfere with immune response to the vaccine. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. Occasionally a transient, palpable nodule may occur at the site of injection. SRAGE AND TRANSPORT Store and transport the vaccine between 2 C and 8 C till use. At no stage should the vaccine be allowed to freeze. SHELF LIFE 36 months from the date of manufacture, when stored at recommended storage conditions. Single dose vial Multidose vial containing 5 doses Multidose vial containing 10 doses : 1 ml : 5 ml : 10 ml

12 Raksha-SP (SHEEP POX CELL CULTURE VACCINE) Raksha - SP (Sheep Pox) vaccine is recommended for prophylactic vaccination against Sheep Pox sheep. Raksha - SP vaccine contains live attenuated sheep pox virus grown on primary lamb testicle cell culture and freeze dried. The virus is comprised of Romanian strain which is the most effective and superior strain. The vaccine presented as a freeze dried preparation in vials. Vaccine diluent vials of 50 ml are supplied for reconstituting freeze dried material. Chill the diluent prior to reconstitution. Transfer a small aliquot of chilled diluent to vials containing the freeze-dried preparation. Mix well to ensure uniform suspension. Transfer the suspension to considering diluent vial and mix well. Intramuscular injection at mid neck or thigh region. DOSAGE Sheep : 1 ml reconstituted vaccine. VACCINATION REGIMEN Suitable age for vaccination is 3 months. It is advisable to vaccinate after lambing season or during onset of breeding season. CAUTION Not for human use. For animal treatment only. Keep reconstituted vaccine on ice. Use reconstituted vaccine immediately. Part use of vial and storing in deep freeze or refrigerator is not recommended. Avoid vaccination of animals in advanced stage of pregnancy. In rare cases hypersensitivity may occur, immediate treatment with antihistaminics is advocated. SHELF LIFE When stored between 2 C to 8 C, the vaccine retains its potency for a period of Two years. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 and 8 C. The diluent should be stored in a cool and dark place. Raksha - SP vaccine is available in 50 dose glass vials. Diluent : 50 ml in polypropylene vials.

13 Raksha-HS ( Haemorrhagic Septicaemia Vaccine ) Raksha-HS is recommended for prophylactic vaccination against Haemorrhagic Septicaemia in cattle and buffaloes. Raksha-HS vaccine contains formalin inactivated culture of Pasteurella multocida adjuvanted with aluminium hydroxide. The vaccine vial should be thoroughly shaken before its contents are withdrawn. Only sterile syringes and needles should be used. The vaccine should be injected subcutaneously through an area of clean dry skin, with all precautions taken against contamination. The recommended site for inoculation is the chest wall behind the shoulder or the dewlap. DOSAGE Cattle, Buffaloes, Calves and Sheep 2 ml. VACCINATION REGIMEN Primary vaccination : 6months of age and above. Revaccination : Annually. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. A slight swelling may appear at the site of inoculation, which disappears quickly. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Do not allow the vaccine to freeze. Raksha-HS vaccine is available in polypropylene vials of 50 doses (100 ml).

14 Raksha-BQ ( Black Quarter Vaccine ) Raksha-BQ is recommended for prophylactic vaccination against Black Quarter in cattle and buffaloes. Raksha-BQ vaccine contains formalin treated culture of Clostridium chauvoei adjuvanted with aluminium hydroxide gel. The vaccine vial should be thoroughly shaken before its contents are withdrawn. Only sterile syringes and needles should be used. The vaccine should be injected subcutaneously through an area of clean dry skin, with all precautions taken against contamination. The recommended site for inoculation is the chest wall behind the shoulder or the dewlap. DOSAGE Cattle, Buffaloes and Calves - 2 ml. VACCINATION REGIMEN Primary vaccination : 6months of age and above. Revaccination : Annually. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. A slight swelling may appear at the site of inoculation, which disappears quickly. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Do not allow the vaccine to freeze. Raksha-BQ vaccine is available in polypropylene vials of 50 doses (100 ml).

15 Raksha-HS+BQ ( Haemorrhagic Septicaemia & Black Quarter Combined Vaccine ) Raksha-HS+BQ is recommended for prophylactic vaccination against Haemorrhagic Septicaemia and Black Quarter in cattle and buffaloes. Raksha-HS+BQ vaccine contains formalin inactivated cultures of Pasteurella multocida and Clostridium chauvoei adjuvanted with aluminium hydroxide gel. The vaccine vial should be thoroughly shaken before its contents are withdrawn. Only sterile syringes and needles should be used. The vaccine should be injected subcutaneously through an area of clean dry skin, with all precautions taken against contamination. The recommended site for inoculation is the chest wall behind the shoulder or the dewlap. DOSAGE Cattle, Buffaloes and Calves - 3 ml. VACCINATION REGIMEN Primary vaccination : 6months of age and above. Revaccination : Annually. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. A slight swelling may appear at the site of inoculation, which disappears quickly. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Do not allow the vaccine to freeze. Raksha-HS+BQ vaccine is available in polypropylene vials of 30 doses (90 ml).

16 Rakshavac-T (THEILERIOSIS VACCINE) RAKSHAVAC - T Vaccine is recommended for prophylactic vaccination against Theileriosis caused by Theileria annulata in crossbred and exotic cattle. DESCRIPTION Rakshavac-T is meant for prevention of Theileriosis caused by Theileria annulata in crossbred and exotic cattle. Rakshavac-T contains live schizonts grown in lymphoblast cell culture, attenuated by prolonged in-vitro passage. Attenuated schizonts do not produce the clinical disease. Immunised cattle can withstand the attack of infected ticks for a period of three years. In areas where the vaccinated animals are constantly exposed to tick bites, the immunity is constantly boosted and hence the immunity is conferred for life time. Where the animals are maintained in tick free condition, revaccination every 3 years is recommended. Remove the vial from liquid nitrogen container and thaw the vaccine concentrate in lukewarm (37 o C) water. Transfer the thawed vaccine concentrate using a sterile needle and syringe to the corresponding vaccine diluent vial and mix gently. The reconstituted vaccine should be injected subcutaneously through an area f clean dry skin with precautions taken against contamination. The recommended site for inoculation is midneck region. DOSAGE Cattle and Calves ml. Vaccine Vaccine Reconstitued Concentrate Diluent Vaccine Volume 5 Dose 13.0 ml 15.0 ml VACCINATION REGIMEN Cattle and calves of 2 months age and above only should be vaccinated. Vaccination of animals in advanced stage of pregnancy should be avoided. Immunity generally develops 6 weeks after vaccination. No other Vaccine should be administered for a period of 8 weeks after Theileriosis Vaccine. CAUTION Generally no adverse reactions are noticed. A few of the vaccinated animals may develop mild pyrexia and slight enlargement of the nearest pre-scapular lymphnode anytime from day 8 to day 20 post vaccination. In rare cases hypersensitivity may occur, immediate treatment with antihistaminics is advocated. TRANSPORT AND SRAGE Vaccine concentrate should be transported and stored in liquid nitrogen. The vaccine diluent should be stored in a cool and dark place. Reconstituted vaccine should be used immediately (with one hour) and should not be frozen for reuse. PACKING Vaccine concentrate Diluent : Vials of 5 doses. : Vials of 13 ml

17 Raksha-Anthrax (ANTHRAX SPORE VACCINE LIVE) Raksha - Anthrax vaccine is recommended for prophylactic vaccination against Anthrax in cattle and sheep. Raksha - Anthrax vaccine contains live spores of attenuated strain of Bacillus anthracis. Each dose contains Bacillus anthracis 5 x 10 6 spores. Syringes and needles must be sterilized before use. The vaccine should be injected by the route of subcutaneous or intramuscular through an area of clean, dry skin with precautions taken against contamination. DOSAGE Cattle and Sheep : 1 ml VACCINATION REGIMEN Primary vaccination : Vaccinate the animals Two weeks before grazing. Booster dose : Annually. SHELF LIFE When stored between 2 C to 8 C, the vaccine retains its potency for a period of Three years. CONTRA INDICATIONS Animals suffering from fever and those affected with intercurrent diseases should not be vaccinated. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Raksha - Anthrax vaccine is available in 50 ml (50 dose) polypropylene vials.

18 Bruvax (Brucella abortus (strain 19) vaccine, live IP (Vet)) Brucellosis is an infectious and contagious disease of zoonotic importance caused by gram negative coccobacilli (Brucella abortus, melitensis, ovis, suis and canis). The disease affects cattle, buffalo, pigs, sheep, goats, dogs, elk and occasionally horses. The disease is characterized by abortion, retained placenta and to a lesser extent orchitis and infection of accessory sex glands in males. Bruvax is a freeze dried vaccine and is used for the prevention of brucellosis (contagious abortion) in cattle. The vaccine contains live brucella abortus strain 19 bacteria. DESCRIPTION Light yellow flakes containing live Brucella abortus strain 19 bacteria in freeze dried powder. Each dose contains not less than 40 x 10 9 organisms. RECONSTITUTION Chill the diluent prior to reconstitution. Transfer a small amount of chilled diluent to vial containing freeze dried preparation mix well to ensure uniform suspension. Transfer the suspension to diluent vial and mix well. DOSAGE Serologically negative female calves of age 4 to 8 months only should be vaccinated with 2 ml of reconstituted vaccine. By subcutaneous route. SRAGE & TRANSPORTATION The vaccine must be stored and transported between 2 and 8 C. SHELF LIFE 12 months from the date of manufacture, when stored at recommended storage con- ditions. CONTRAINDICATIONS Male calves should not be vaccinated. Do not vaccinate pregnant animals. PRECAUTIONS Keep the reconstituted vaccine on ice. Use reconstituted vaccine immediately. Part use of the vial and restoring in deep freezer or refrigerator is not recommended. Strictly not for human use. Syringes, needles and gloves should be disinfected/sterilized after use. Keep the vaccine out of the reach of children. ADVERSE REACTIONS Generally no adverse reactions are noticed. A slight swelling and mild rise in body temperature, which may appear and disappear quickly. The vaccine may infect human beings, particularly after accidental inoculation. Any necessary treatment should begin without delay. It is advisable to use hand gloves and plain protecting glasses for eyes while carrying out vaccination. Bruvax is available in 5 dose pack (freeze dried) along with 10 ml of sterile diluent.

19 Bruvax Rev 1 (BRUCELLA MELITENSIS (REV 1) VACCINE (LIVE) B.P. (VET) Bruvax Rev1 is a freeze dried vaccine and is recommended for immunization against Brucellosis (contagious abortion) in sheep and goats. DESCRIPTION Bruvax Rev1, a freeze dried vaccine contains live Brucella melitensis Rev.1 strain bacteria. Light yellow flake containing live Brucella melitensis Rev.1 strain bacteria in lyophilized form. Each dose of vaccine contains x 10 9 live organism as per B.P (Vet). The vaccine is recommended for sheep and 4-6 months of age, should be vaccinated with 1 ml of reconstituted vaccine by subcutaneous route. TRANSPORT AND SRAGE The lyophilized vaccine must be transported and stored at 2 0 C to 8 0 C. RECONSTITUTION AND METHOD OF The lyophilized vaccine should be reconstituted with chilled diluent provided with this vaccine. Mix the vaccine properly in the diluent vial before inoculation. After thorough mixing, the vaccine must be inoculated subcutaneously using sterile syringe and separate sterile needle for each animal. The used vial should not be stored for future use. DOSAGE 1ml subcutaneously at mid neck region. ADVERSE REACTION No adverse reaction should occur following inoculation if used as directed. A single injection should offer life long immunity, but the vaccine does not afford absolute immunity in all animals. CONTRAINDICATIONS / WARNINGS Do not vaccinate the pregnant animals. Strictly not for human use. For veterinary use only. Keep the reconstituted vaccine in ice. Use reconstituted vaccine immediately. Part use of the vial and restoring in deep freezer or refrigerator is not recommended. PRECAUTIONS Brucella melitensis Rev.1 vaccine has zoonotic importance. Hence it should be handled with proper care to avoid accidental inoculation/inhalation/consumption. The used vials along with syringe, needles and gloves must be decontaminated with disinfectant before disposal. Keep the vaccine out of the reach of children. The vaccine may infect human beings, particularly after accidental inoculation. Any necessary treatment should begin without delay. It is advisable to use hand gloves and plain protecting glasses for eyes while carrying out vaccination. SHELF LIFE 12 months from the date of preparation when stored at recommended storage conditions (between 2 o C to 8 o C). PACKAGING Available as 5 dose, 10 dose, 20 dose, & 100 dose pack along with 5ml, 10ml, 20ml & 100ml sterile diluent. DISTRUCTION OF USED CONTAINERS The empty containers of the vaccine, used syringes and needles should be discarded properly and carefully CAUTION For veterinary use only.

20 Raksha-ET (Enterotoxaemia Vaccine) Raksha-ET is recommended for prophylactic vaccination against Enterotoxaemia in sheep and goats. Raksha-ET vaccine contains inactivated culture of anaerobically grown Clostridium Welchii Type D organisms. The prototoxin is converted into toxin by trypsinization. The toxin is then rendered non-toxic by formalisation. This is then adjuvanted with aluminium hydroxide gel. The vaccine vial should be thoroughly shaken before its contents are withdrawn. Only sterile syringes and needles should be used. The vaccine should be injected subcutaneously through an area of clean dry skin, with all precautions taken against contamination. DOSAGE Sheep and Goats - 2 ml. VACCINATION REGIMEN Primary vaccination : 4 months of age and above. Revaccination : Annually. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. A slight swelling may appear at the site of inoculation, which disappears quickly. SRAGE AND TRANSPORT The vaccine should be stored and transported between 2 C and 8 C. Do not allow the vaccine to freeze. Raksha-ET vaccine is available in polypropylene vials of 50 doses (100 ml).

21 Raksha PPR PESTE DES PETITS RUMINANTS (LIVING) VACCINE Raksha PPR (Live Attenuated) vaccine containing 10 3 TCID 50 virus per dose in freezedried form. DESCRIPTION RAKSHA - PPR vaccine contains live attenuated Peste des petits ruminants virus grown on Vero cell culture and freeze dried. The virus is comprised of ''Sungri 96'' strain which is the most effective and superior strain. RAKSHA - PPR is recommended for the prophylactic vaccination against Peste des petits ruminants in sheep & goats. The vaccine is presented as freeze dried preparation in vials. Vaccine diluent vials of 25ml, 50ml & 100ml are supplied for reconstituting freeze dried material. Chill the diluent prior to reconstitution. Draw two/five ml sterile diluent from sterile diluent vial using sterile syringe and reconstitute with the freeze dried vial. Shake well till the contents in the FD vials are completely dissolved. Draw the whole volume of reconstituted mixture using sterile syringe and inject back into the sterile diluent vial, shake gently to get virus suspension. Each ml of the reconstituted mixture contains one immunogenic dose against PPR. The whole contents of the reconstituted vaccine should be used immediately. Subcutaneous injection at mid neck region is advocated through an area of clean dry skin with all precautions taken. Sterile needles and syringes should be used for every withdrawal. DOSAGE Sheep and Goat : 1 ml reconstituted vaccine. VACCINATION REGIMEN Suitable age for vaccination is 4 months. CAUTION - Weak, debilitated and infested animals should not be vaccinated. - Sheep & Goat should be dewormed prior to vaccination. - Vaccination Should be completed at least one month prior to monsoons. - Vaccination Should not be taken up in the areas of disease outbreak. - Vaccination should be checked for cold chain before reconstitution & vaccination. - Vaccination should be taken up only under the supervision of a registered veteri nary practitioner. - Keep reconstituted vaccine on ice. - Use reconstituted vaccine immediately. - Part use of vial and storing in deep freeze or refrigerator is not recommended. - Fresh sterilized disposable needles are to be used for every sheep & goat to avoid cross contamination. - A maximum of 10 withdrawals should be made from reconstituted vaccine. - Vaccination of animals in advanced stage of pregnancy is not recommended. - In rare cases hypersensitivity may occur, immediate treatment with antihistaminic is advocated. Post vaccination reaction: Generally no adverse reactions are noticed. A few of vaccinated animals might show pyrexia and transient drop in milk yield. Vaccination could precipitate pre-incubating diseases in rare cases. Transportation and storage: The vaccine should be transported at 2 o C - 8 o C upon arrival should be stored at -20 o C. The diluent should be stored in a cool and dark place. Raksha - PPR vaccine is available in 25, 50 & 100 dose glass vials. Diluent: 25ml, 50ml, & 100ml in polypropylene vials.

22 Raksharab (Rabies Veterinary Vaccine BP (Vet)) Raksharab is recommended for immunization of dogs and other domestic animals against rabies for prophylactic use. Raksharab Vaccine contains inactivated rabies virus with a potency > 1.0 I.U. per dose. The virus is propagated in BHK-21 Cell line, inactivated with an aziridine compound and concentrated. Aluminium hydroxide is added as an adjuvant. 1 ml. Subcutaneously / intramuscularly. PROPHYLACTIC USE Age - 3 months and above. IMMUNITY Immunity is conferred for 36 months. However, annual vaccination is recommended in endemic areas. PRECAUTIONS Shake well before use. Vaccinate only healthy animals. Malnutrition, helminth infestation, administration of immunosuppressive agents (like Corticosteroids, Radiation-therapy etc.) will interfere with immune response to the vaccine. POST VACCINATION REACTIONS Generally no adverse reactions are noticed. Occasionally a transient, palpable nodule may occur at the site of injection. SRAGE AND TRANSPORT Store and transport the vaccine between 2 C and 8 C till use. At no stage should the vaccine be allowed to freeze. SHELF LIFE 36 months from the date of manufacture, when stored at recommended storage conditions. Single dose vial Multidose vial containing 5 doses Multidose vial containing 10 doses : 1 ml : 5 ml : 10 ml

23 Megavac-6 Megavac - 6 contains : Distemper*, Hepatitis (CAV2)*, Parvovirus*, Hepatitis (CAV1), Leptospira canicola, Leptospira icterohaemorrhagiae. * : Live Attenuated viruses : Inactivated antigens The above canine vaccine contain the following live attenuated viruses and / or inactivated antigens. FEEZE DRIED VACCINES - LIVE Canine Distemper Live attenuated vaccine strain of canine distemper virus is grown on a continuous cell line and presented in a freeze dried form. Each dose contains > 10 3 TCID 50 live attenuated canine distemper virus. Continuous passage of the virus through tissue culture resulted in a highly attenuated virus vaccine of high purity, completely homogeneous and without side effects on susceptible pups. The safety of the vaccine is confirmed by intracerebral injection into susceptible pups and mice. Canine Contagious Hepatitis Live canine adenovirus type-2 (CAV-2) virus, causative organism of infectious laryngotracheitis is grown on a continuous cell line and presented in a freeze dried form. Each dose contains > 10 3 TCID 50 live attenuated CAV-2. The complete safety of CAV-2 strain and the total cross immunity properties with CAV-1, responsible agent for canine contagious hepatitis, has led to this choice for hepatitis vaccine. The safety of vaccine is confirmed by intravenous injection into sensitive pups. Canine Parvovirus Live attenuated canine parvovirus is grown on a continuous cell line and presented in a freeze dried form. Each dose contains > 10 3 TCID 50 live attenuated canine parvovirus. Parvovirus strain of canine origin is attenuated by continuous passages on cell cultures. The safety of this vaccine is determined by testing on susceptible pups and bitches at different stages of pregnancy. The potency of canine parvovirus is tested by injecting into seronegative pups and antibodies are checked by haemagglutination inhibition (HI) test and by virulent challenge of the dogs after a single injection of vaccine. Vaccinated dogs showed no clinical or haematological symptoms. No virus excretion was observed in the faeces. Megavac-P can be used to immunize puppies with low titres of maternal antibodies. AQUEOUS VACCINES - INACTIVATED Canine contagious Hepatitis Canine contagious hepatitis virus (canine adenovirus type-1) is grown on a continuous cell line and inactivated in such a manner that the virus loses its infectivity and retains its immunogenicity. Leptospirosis Leptospira canicola and Leptospira icterohaemorrhagiae are grown in a suitable medium and inactivated in such a manner that the culture loses its infectivity and retains its immunogenicity. The inactivated antigen incorporated in the vaccine contains > 2 x 10 8 bacteria each. The strains of leptospira used to produce this vaccine are free from any pathogenic activity on any species. The somatic antigens are purified and concentrated by ultrafiltration. The antigens are inactivated by formaldehyde, and are purified at the end of inactivation and hence the final vaccine does not contain any residual toxic material. The final potency and safety of vaccine is tested on hamsters and dogs, which have to be resistant to challenge, proving fatal to the controls. INDICATIONS For the active immunization against Canine Distemper, Canine Contagious Hepatitis, Canine Parvovirus disease, Leptospirosis. AND DOSAGE 1 ml intramuscularly or subcutaneously for the vaccine. Freeze dried vaccines may be reconstituted with either aqueous vaccines or sterile diluent just before use. Shake the reconstituted vaccines before use. Vaccine should be administered observing aseptic precautions. Continued

24 VACCINATION REGIMEN First vaccination : 8-9 weeks of age Second vaccination : 12 weeks of age Revaccination : Yearly (annual) IMMUNITY Adequate immunity is established approximately 10 to 15 days after vaccination in case of seronegative dogs. In case of pups containing maternal antibodies second vaccination is advocated for complete protection. Immunity lasts for 1 to 2 years and annual revaccinations are recommended for fool proof protection. ADVERSE REACTIONS / CONTRAINDICATIONS Dogs already sick and / or heavily infested with parasites should not be vaccinated. Utmost care should be taken while vaccinating pregnant bitches. Dogs under corticosteroid therapy should not be vaccinated. In rare cases hypersensivity may occur, immediate treatment with antihistaminics is advocated. Use sterile material for injection purpose EFFECTS WITH OTHER VACCINES Megavac-6 is safe and can be used with other commonly used vaccines. OVERDOSE Twice the dose is also very safe in target species WITHDRAWAL PERIOD Not applicable WARNINGS The veterinarian who administer the vaccine should wash the hands before and after vaccination with soap followed by clean running water. SHELF LIFE 24 months from the date of manufacture (when stored at recommended storage temperature). SRAGE AND TRANSPORT Store and transport the vaccine between 2 C and 8 C till use. At no stage should the vaccine be allowed to freeze. PACKING INFORMATION Megavac-6 is available in single dose packs. The vaccine is packed in glass vials. The glass vials are sealed with rubber bungs, aluminium flip off seals and labeled with corresponding labels. 25 doses are packed in a plastic tray / container. These trays are packed in polystyrene boxes with two cool packs with an outer corrugated boxes while transportation. DISTRUCTION OF USED CONTAINERS The empty containers of the vaccine, used syringes and needles should be discarded properly and carefully. CAUTION For veterinary use only. Back

25 Megavac-P (Inact.) (Canine Parvovirus vaccine inactivated (Vet)) Megavac - P (Inact.) vaccine contains tissue culture adapted strain of canine parvovirus grown on A-72 cell cultures and inactivated with ß-propiolactone. Aluminium hydroxide gel is used as an adjuvant. INDICATIONS For the active immunization against Canine parvovirus disease. AND DOSAGE 1 ml subcutaneously or intramuscularly per animal. Vaccine should be administered observing aseptic precautions. VACCINATION REGIMEN First vaccination :6 weeks of age. Second vaccination :3 weeks apart till the age of 18 weeks. Revaccination :Yearly (annual) IMMUNITY Adequate immunity is established approximately days after vaccination in case of seronegative dogs. In case of pups containing maternal antibodies second vaccination is advocated for complete protection. Immunity lasts for 1 to 2 years and annual revaccinations are recommended for foolproof protection. ADVERSE REACTIONS / CONTRAINDICATIONS Dogs already sick and / or heavily infested with parasites should not be vaccinated. Utmost care should be taken while vaccinating pregnant bitches. Dogs under corticosteroid therapy should not be vaccinated. In rare cases hypersensivity may occur, immediate treatment with antihistaminics is advocated. Use sterile material for injection purpose EFFECTS WITH OTHER VACCINES Megavac-P (inact.) is safe and can be used with other commonly used vaccines. OVERDOSE Twice the dose is also very safe in target species WITHDRAWAL PERIOD Not applicable WARNINGS The veterinarian who administers the vaccine should wash the hands before and after vaccination with soap followed by clean running water. SHELF LIFE 24 months from the date of manufacture (when stored at recommended storage temperature). SRAGE AND TRANSPORT Store and transport the vaccine between 2 C and 8 C till use. At no stage should the vaccine be allowed to freeze. PACKING INFORMATION Megavac-P (inact.) is available in single dose packs. The vaccine is packed in glass vials. The glass vials are sealed with rubber bungs, and flip off seals with the corresponding labels. 10 doses are packed in a carton. These cartons are packed in polystyrene boxes with two cool packs with an outer corrugated box while transportation. DISTRUCTION OF USED CONTAINERS The empty containers of the vaccine, used syringes and needles should be discarded properly and carefully. CAUTION For veterinary use only.

26 Megavac-CC (Canine Corona virus vaccine inactivated (Vet)) Megavac-CC vaccine contains tissue culture adapted strain of Canine Corona virus grown on A-72 cell cultures and inactivated with ß-propiolactone. Aluminium hydroxide gel is used as an adjuvant. INDICATIONS For the active immunization against Canine corona virus disease. AND DOSAGE 1 ml subcutaneously or intramuscularly per animal. Vaccine should be administered observing aseptic precautions. VACCINATION REGIMEN First vaccination :8-9 weeks of age Second vaccination :12 weeks Revaccination :Yearly booster is recommended. IMMUNITY Adequate immunity is established approximately days after vaccination in case of seronegative dogs. In case of pups possessing maternal antibodies second vaccination is advocated for complete protection. Immunity lasts for 1 to 2 years and annual revaccinations are recommended. ADVERSE REACTIONS / CONTRA INDICATIONS Dogs already sick and/or heavily infected with parasites should not be vaccinated. Utmost care should be taken while vaccinating pregnant bitches. Dogs under corticosteroid therapy should not be vaccinated. In rare cases hypersensitivity may occur, immediate treatment with antihistaminics is advocated. EFFECTS WITH OTHER VACCINES Megavac CC is safe and can be used with other commonly used vaccines. OVERDOSE Twice the dose is also very safe in target species. WITHDRAWAL PERIOD Not applicable WARNING The veterinarian who administers the vaccine should wash the hands before and after vaccination with soap followed by clean running water. SHELF LIFE 24 months from the date of manufacture (when stored at recommended storage temperature) SRAGE AND TRANSPORT Store and transport the vaccine between 2 c to 8 c till use. At no stage should the vaccine be allowed to freeze. PACKING INFORMATION Megavac - CC is available in single dose packs. The vaccine is packed in glass vials. The glass vials are sealed with rubber bungs, aluminium seals and flip off seals with the corresponding labels. 10 doses are packed in a carton. These cartons are packed in polystyrene boxes with two cool packs with an outer corrugated box while transportation. DISTRUCTION OF USED CONTAINERS The empty containers of the vaccine, used syringes and needles should be discarded properly and carefully. CAUTION For veterinary use only.

27 Ivectin (Veterinary Injection 1 % W/V) Ivermectin is a clear oil based injectable solution presented in colorless vials. Ivermectin belongs to the group macrolides, an antibiotic produced by actinomycetes micro-organisms. It is also known as macrocyclic lactones. It is highly potent parasiticide which show great activity against a wide range of endoparasites and ecto-parasites. The dose requirements is so minute that it requires only micrograms of drug as compared to milligrams of other drugs. This can be administered orally or parenterally. It s activity persists for along time. Ivermectin has got a wide safety margin of >30 times the recommended dose in cattle. Each ml contains Ivermectin 10 mg. Ivermectin is a mixture comprising of not less than 80% 22, 23-dihydroavermectin B la and not more than 20% 22, 23- dihydroavermectin B lb. ACTIVITY Ivermectin is effective against all stages of most of the major parasites including canine heartworm larvae. It is also a potent ectoparasiticide. Its mode of action restricts its use against tapeworms and flukes. Ivermectin acts on the parasites by effecting Gama Amino Butyric Acid (GABA) mediated signals between nerves and muscles. Flukes and tapeworms (Platyhelminths) are known not to use GABA as a neurotransmitter. Mammalian GABA engic neurons occur in the central nervous system and ivermectin dose not penetrate mammalian blood-brain barrier and hence it has low toxicity. The detailed activity against specific parasites in various hosts is mentioned in the table below. METABOLISM Ivermectin is readily absorbed, especially when given parenterally. High concentrations of drug are sustained in the tissues for long periods, after parenteral administration. Drug residues occur mainly in the liver and fat with very little in the muscle. The bulk drug is excreted in the faeces (98%) with only 2% in the urine. A withdrawl period of 21 days (28 days for cattle) before slaughter is required because of the persisting levels of drug in tissues, and milk from dairy cattle undergoing treatment with Ivermectin is not recommended for Human consumption. DOSAGE Cattle : 1.0 ml / 50 Kg B.Wt. Subcutaneously. Sheep : 0.5 ml / 25 Kg B.Wt. Subcutaneously. Pigs : 1.0 ml / 33 Kg B.Wt. Subcutaneously. Dogs : 0.02 ml / Kg B.Wt. Subcutaneously (in case of heart worms 6 mcg/kg once in 30 days). XICITY Ivermectin has a safety index of > 30 times the recommended dose in cattle. It should not be administered parenterally to horses, and is toxic in certain breeds of dogs like collies. The relatively high brain concentration of drug in these animals is due to genetic susceptibility to greater penetration of the blood brain barrier and results in the toxicity. Continued

28 ACTION OF IVERMECTIN (1% w/v INJECTABLE SOLUTION) IN VARIOUS ANIMALS ANIMAL DOSAGE PARASITES CONTROLLED Cattle Subcutaneous 1.0 ml/50 kg body weight Sheep Subcutaneous 0.5 ml/25 kg body weight Pigs Subcutaneous 1.0 ml/33 kg body weight Dogs Subcutaneous 0.02 ml / kg body weight Hypoderma bovis, Hypoderma lineatum, Dermatobia hominis, Haematopinus eurysternus, Lonognathus vituli, Sarcoptes scabiei var bovis, Boophilus microplus, Boophilus decoloratus, Screw worms, Chrysomia bezziana, Trichostrongylus axei, Haemonchus sps., Ostertagia sps., Ostertagia inhibited Larvae 4, Trichostrongylus sps., Nematodirus sps., Cooperia sps., Bunostomum sps., Strongyloides sps., Oesophagastomum sps, Chabertia sps., Trichuris sps., Dictyocaulus sps. Oestrus ovis, Sarcoptes scabiei, Psoregates var ovis, Trichostrongylus axei, Haemonchus sps., Ostertagia sps., Ostertagia inhibited Larvae 4, Trichostrongylus sps., Nematodirus sps., Cooperia sps., Bunostomum sps., Strongyloides sps., Oesophagastomum sps., Chabertia sps., Chabertia sps., Trichuris sps., Dictyocaulus sps. Haematopinus suis, Sarcoptes scabiei var suis, Hyostrongylus rubidus, Ascaris suum, Stongyloides ransomi, Oesophagastomum sps., Metastrongylus sps. Sarcoptes scabiei, Otodectes cynotis, Toxascaris leonina, Toxocara caninum / cati, Uncinaria stenocephala, Ancylostoma caninum, Trichuris vulpis, Dirifilaria (larval stages) Withdrawal Period Meat : 28 days, Milk : 28 days Presentation The Ivectin Injection is available in 1 ml, 7 ml and 50 ml packs. Back

29 Vetalben (Albendazole Suspension U.S.P 2.5% w/v) DESCRIPTION A liquid suspension containing Albendazole. Each ml contains Albendazole I.P. 25 mg. INDICATIONS A broad spectrum anthelmintic for treatment of gastrointestinal infestations due to roundworms, lungworms, tapeworms, liverflukes and amphistomes. Albendazole also has an ovicidal effect. DOSAGE FOR ROUNDWORMS / TAPEWORMS All animals except Dog & Cat 5 mg per kg body weight. i.e. 2 ml per 10 kg. body weight Dog and Cat mg per kg. body weight i.e. 0.4 ml to 1 ml per kg. body wt To be given in divided doses for 3 days Cattle / Buffalo Sheep & Goat FOR FLUKES 10 mg per kg body weight. i.e. 4 ml per 10 kg. body weight 7.5 mg per kg. body weight i.e. 3 ml per 10 kg. body weight In all animals, repeating the treatment 3 weeks after first dose and there after every two months, offers better control of worm infestation. By oral drenching. WITHDRAWAL PERIOD Meat : 14 days, Sheep : 10 days and Milk : 3 days WARNINGS Animals intended for human consumption should not be slaughtered during the treatment. Milk from the animals which are under treatment with Vetalben should not be used for human consumption. Before calculating the dosage, assess body weight as accurately as possible. PRECAUTIONS Dispose the used containers safely. Keep the drug out of reach of children. Shake well before use. Wash hands after use. Protect from light and freezing. Store in cool and dark place below 25 C. For veterinary use only. PACK Vetalben is available in 1 & 5 liter HDPE packs.

30 Vetalben 10% (Albendazole Suspension U.S.P 10 % w/v) Description A liquid suspension containing Albendazole. Composition Each ml contains Albendazole 100 mg. Indications A broad spectrum anthelmintic for treatment of gastrointestinal infestations due to roundworms, lungworms, tapeworms, liverflukes and amphistomes. Albendazole also has an ovicidal effect. Dosage FOR ROUNDWORMS / TAPEWORMS All animals except Dog & Cat 5 mg per kg body weight. i.e. 1 ml per 20 kg. body weight Dog and Cat mg per kg. body weight i.e. 1 ml to 2.5 ml per 10 kg. body wt To be given in divided doses for 3 days Cattle / Buffalo Sheep & Goat FOR FLUKES 10 mg per kg body weight. i.e. 1 ml per 10 kg. body weight 7.5 mg per kg. body weight i.e.1.50 ml per 20 kg. body weight In all animals, repeating the treatment 3 weeks after first dose and there after every two months, offers better control of worm infestation. Administration By oral drenching. Withdrawal Period Meat : 14 days, Sheep : 10 days and Milk : 3 days Warnings Animals intended for human consumption should not be slaughtered during the treatment. Milk from the animals which are under treatment with Vetalben should not be used for human consumption. Before calculating the dosage, assess body weight as accurately as possible. Precautions Dispose the used containers safely. Keep the drug out of reach of children. Shake well before use. Wash hands after use. Protect from light and freezing. Store in cool and dark place below 25 C. For veterinary use only. Pack Vetalben 10% is available in 1 & 5 liter HDPE packs.

31 Vetalben-T (Albendazole 150 mg tablets) Vetalben - T (Albendazole 150 mg) is a broad spectrum anthelmintic for the treatment of gastrointestinal infestations due to round worms, lungworms, tapeworms, liverflukes and amphistomes. DESCRIPTION White to off white coloured tablet. USES A broad spectrum multi-purpose anthelmintic for control of following types of internal parasites in cattle, sheep, and goats. Round worms, Lungworms, Tapeworms, Liverflukes and Amphistomes. DOSAGE AND Vetalben-T tablets are to be administered orally. All Animals except Dogs and Cats 5 mg /kg body weight ( One tablet of Vetalben-T [Albendazole 150 mg] per 30 kg body weight) against roundworms, lungworms and tapeworms. Dogs and Cats 50 mg /kg body weight (One tablet of Vetalben-T [Albendazole 150 mg] per 3 kg body weight) against roundworms, lungworms and tapeworms. CONTRA INDICATIONS When followed recommended dosage Vetalben-T is very safe in all species. However over dosage (five times the recommended dosage) may lead to adverse reactions in the healthy animals. Treat the pregnant animals only as per the dosage strictly. Keep the tablets out of the reach of children. WITHDRAWL PERIOD The milk from the animals (which underwent Vetalben-T treatment) is fit for human consumption only after 72 hour post treatment. The animals are fit for slaughter only after 14 days of post treatment. SRAGE Store in a dark place. Each strip (blister pack) contains 10 tablets. 10 strips are packed in a carton (Each carton contains 100 tablets).

32 Vetalben-300 (Albendazole 300 mg tablets) Vetalben 300 mg is a broad spectrum anthelmintic for the treatment of gastrointestinal infestations due to round worms, lungworms, tapeworms, liverflukes and amphistomes. DESCRIPTION Deep green coloured Boli. USES A broad spectrum multi-purpose anthelmintic for control of following types of internal parasites in cattle, sheep, and goats. Round worms, Lungworms, Tapeworms, Liverflukes and Amphistomes. DOSAGE AND Vetalben 300 mg tablets are to be administered orally. Animals Gastrointestinal Chronic Acute Fascioliasis round worms Fascioliasis due to due to Dircocoelium lung worms F.hepatica dendriticum tape worms Cattle 1 bolus for 40 kg b.w 1 bolus for 30 kg b.w 2 boli for 40 kg b.w Sheep & Goats ½ bolus for 40kg b.w 1 bolus for 40 kg b.w 2 boli for 40 kg b.w CONTRA INDICATIONS When followed recommended dosage Vetalben-300 is very safe in all species. However over dosage (five times the recommended dosage) may lead to adverse reactions in the healthy animals. Treat the pregnant animals only as per the dosage strictly. Keep the tablets out of the reach of children. WITHDRAWL PERIOD The milk from the animals (which underwent Vetalben-300 treatment) is fit for human consumption only after 72 hour post treatment. The animals are fit for slaughter only after 14 days of post treatment. SRAGE Store in a dark place. Each strip (blister pack) contains 5 boli. 10 strips are packed in a carton (Each carton contains 50 boli).

33 Vetalben-600 (Albendazole 600 mg bolus) Vetalben 600 mg is a broad spectrum anthelmintic for the treatment of gastrointestinal infestations due to round worms, lungworms, tapeworms, liverflukes and amphistomes. DESCRIPTION Deep Green coloured bolus. USES A broad spectrum multi-purpose anthelmintic for control of following types of internal parasites in cattle, sheep, and goats. Round worms, Lungworms, Tapeworms, Liverflukes and Amphistomes. DOSAGE AND Vetalben 600 mg tablets are to be administered orally. Animals Gastrointestinal Chronic Acute Fascioliasis Round worms Fascioliasis due to Dircocoelium Lung worms F.hepatica dendriticum Tape worms due to Cattle 1/2 bolus for 40 kg b.w 1/2 bolus for 30 kg b.w 1 bolus for 40 kg b.w Sheep & Goats ½ bolus for 40kg b.w 1/2 bolus for 40 kg b.w 1 bolus for 40 kg b.w CONTRA INDICATIONS When followed recommended dosage Vetalben-600 is very safe in all species. However over dosage (five times the recommended dosage) may lead to adverse reactions in the healthy animals. Treat the pregnant animals only as per the dosage strictly. Care should be taken not to exceed recommended dosage during the first month of pregnancy. Keep the tablets out of the reach of children. WITHDRAWL PERIOD The milk from the animals (which underwent Vetalben-600 treatment) is fit for human consumption only after 72 hour post treatment. The animals are fit for slaughter only after 14 days of post treatment. SRAGE Store in a dark place. Each strip (blister pack) contains 5 boli. 10 strips are packed in a carton (Each carton contains 50 boli).

34 Vetalben-Forte (Albendazole 2500 mg bolus) Vetalben-Forte is a broad spectrum anthelmintic for the treatment of gastrointestinal infestations due to round worms, lungworms, tapeworms, liverflukes and amphistomes. DESCRIPTION Deep Green coloured bolus. USES A broad spectrum multi-purpose anthelmintic for control of following types of internal parasites in cattle, sheep, and goats. Round worms, Lungworms, Tapeworms, Liverflukes and Amphistomes. DOSAGE AND Vetalben - Forte mg boli are to be administered orally. Flukes Roundworms & Tapeworms 1 bolus / 250 Kg.B.wt 1 bolus / 350 Kg.B.wt. CONTRA INDICATIONS When followed recommended dosage Vetalben-Forte is very safe in all species. However over dosage (five times the recommended dosage) may lead to adverse reactions in the healthy animals. Cows during the first 45 days of pregnancy should not under go the treatment with Vetalben-Forte. Keep the tablets out of the reach of children. WITHDRAWL PERIOD The milk from the animals (which underwent Vetalben-Forte treatment) is fit for human consumption only after 72 hour post treatment. The animals are fit for slaughter only after 21 days of post treatment. SRAGE Store in a dark place. Each strip (blister pack) contains 4 boli. 10 strips are packed in a carton (Each carton contains 40 boli).

35 Vetfen (Anthelmintic tablet & bolus) A unique broad spectrum anthelmintic tablets for eradication of multi helminth infestation, viz : Nematodes, Lungworms, and Tapeworms. Composition Each tablet of Vetfen - T contains Fenbendazole 150 mg. Each bolus of Vetfen-B contains Fenbendazole 1.5 g Each bolus of Vetfen-500 contains Fenbendazole 0.5 g Indications Infestation of gastrointestinal nematodes, lungworms and tapeworms viz. Haemonchus spp., Ostertagia spp., Trichostrongylus spp., Metastrongylus spp., Cooperia spp., Nematodirus spp., Neoascaris vitulorum, Oesophagostomum spp., Chabertia spp., Bunostomum spp., Capillaria spp., Trichuris spp., Strongyloids spp., Hylostrongylus rubidus, Ascaris suum, Dictyocaulus spp., Moniezia spp., etc in cattle, baffaloes, horses, camels, sheep, goats, pigs, dogs and cats. Vetfen also has ovicidal effect. DOSAGE For Roundworms / Tapeworms : To be administered 5 mg Fenbendazole / kg body weight in all animals (except in dogs/cats) for roundworms infestation i.e. one bolus of 1.5 g for 300 kg body weight. Or one tablet for 30 kg body weight in dogs and cats, the basic dosage is 50 mg Fenbendazole / kg body weight to be given daily in divided doses for 3 days. Pack Vetfen-T is available in strip of 10s, Vetfen-B in strip of 2s and Vetfen-500 in strip of 4s.

36 Vetfen-B (Anthelmintic bolus) Description A unique broad spectrum anthelmintic tablets for eradication of multi helminth infestation, viz : Nematodes, Lungworms, and Tapeworms. Composition Each bolus of Vetfen-B contains Fenbendazole 1.5 g Indications Infestation of gastrointestinal nematodes, lungworms and tapeworms viz. Haemonchus spp., Ostertagia spp., Trichostrongylus spp., Metastrongylus spp., Cooperia spp., Nematodirus spp., Neoascaris vitulorum, Oesophagostomum spp., Chabertia spp., Bunostomum spp., Capillaria spp., Trichuris spp., Strongyloids spp., Hylostrongylus rubidus, Ascaris suum, Dictyocaulus spp., Moniezia spp., etc in cattle, baffaloes, horses, camels, sheep, goats, pigs, dogs and cats. Vetfen also has ovicidal effect. DOSAGE For Roundworms / Tapeworms To be administered 5 mg Fenbendazole /kg body weight in all animals (except in dogs/cats) for roundworms infestation i.e. one bolus of 1.5 g for 300 kg body weight. or 150 mg for 30 kg body weight in dogs and cats, the basic dosage is 50 mg Fenbendazole / kg body weight to be given daily in divided doses for 3 days. Pack Vetfen-B is available in strip of 2 s.

37 Prazital (Tablet of Pyrental Pamoate + Praziquantel) Prazital is a formidable combination of Praziquantel and Pyrantel Pamoate and it offers assured elimination of roundworms, hookworms, ascarides and tapeworms. Each Tablet contains Praziquantel : 20 mg Pyrantel Pamoate : 230 mg INDICATIONS It is a broad spectrum endoparaciticide used for the treatment and elimination of roundworms, hookworms, ascarides and tapeworms in feline. PRAZIQAUNTEL Novel anthelmentic with excellent activity against all species of tapeworms and schistosomes. It belongs to the group lsoquinolones. Well distributed to all organs passes brain barrier. Effective against both adult and juveniles also against cestode larvae or adults at varied location - Muscle, brain, peritoneal cavity, bile duct, intestines etc-highly safe. PYRENTAL PAMOATE Poorly soluble in water-higher efficacy on parasites at lower end of large intestine. Cholinergic agonist-mimics effective of excessive amounts of acetyl choline-causes irreversible paralysis of worms. Highly effective against common hookworms (Ancylostoma caninum) and Ascarides. High safety index in dogs : 138 times therapeutic dose. Can be given mixed with food. DOSE One tablet per 4 kg B.wt. SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Part used tablets must be discarded. For Veterinary use only. SHELF LIFE 36 months from the date of manufacture, when stored at recommended storage conditions. SRAGE Store in a cool and dark place. The storage temperature should not exceed 25 C. Strip of 10 s

38 Prazital Plus (Tablet of Fenbendazole + Pyrental Pamoate + Praziquantel) Prazital is a formidable combination of Fenbendazole, Pyrantel Pamoate and Praziquantel and it offers assured elimination of roundworms, hookworms, ascarides and tapeworms. Each Tablet contains : Fenbendazole USP : 150 mg, Pyrantel Pamoate : 144 mg and Praziquantel : 50 mg INDICATIONS It is a broad spectrum endoparaciticide used for the treatment and elimination of roundworms, hookworms, ascarides and tapeworms in dogs and puppies. FENBENDAZOLE Longer availability in body than other benzimidazoles, which ensures complete elimination of round worms. Non-teratogenic, completely safe even in pregnant animals. Ovicidal and larvicidal. PYRENTAL PAMOATE Poorly soluble in water-higher efficacy on parasites at lower end of large intestine. Cholinergic agonist-mimics effective of excessive amounts of acetyl choline-causes irreversible paralysis of worms. Highly effective against common hookworms (Ancylostoma caninum) and Ascarides. High safety index in dogs : 138 times therapeutic dose. PRAZIQAUNTEL Novel anthelmentic with excellent activity against all species of tapeworms and schistosomes. It belongs to the group lsoquinolones. Well distributed to all organs passes brain barrier. Effective against both adult and juveniles also against cestode larvae or adults at varied location Muscle, brain, peritoneal cavity, bile duct, intestines etc-highly safe. Can be given directly or mixed with food. DOSE One tablet per 10 kg B.wt. SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Part used tablets must be discarded. For Veterinary use only SHELF LIFE 36 months from the date of manufacture, when stored at recommended storage conditions. SRAGE Store in a cool and dark place. The storage temperature should not exceed 25 C. Strip of 2 s

39 Levaxinide (Levamisole Hydrochloride and Oxyclozanide Suspension) Levaxinide is a broad spectrum anthelmintic (fluke and worm drench) for the treatment and control of nematode infections and chronic fasciolasis in cattle, sheep and goats. INDICATIONS A broad spectrum anthelmintic (fluke and worm drench) for the treatment and control of nematode infections and chronic fasciolasis in cattle, sheep and goats. It is also effective against amphistomes, paramphistomes and tapeworm segments. Each 5 ml contains Levamisole I.P (Vet) 75 mg and Oxyclozanide I.P. (Vet) 150 mg. By oral drenching. DOSAGE Cattle, Sheep and Goats (for roundworms) : 0.33 ml/kg body weight. General dosage Cattle Sheep and Goats : 33 ml / 100 kg body weight up to a maximum of 100 ml. : 5 ml up to 15 kg body weight and 10 ml up to 30 kg body weight. WITHDRAWAL PERIOD Meat : 14 days Milk : 24 hours SHELF LIFE 24 months from the date of manufacture. SRAGE Store in a cool and dark place (below 25 0 C) SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Shake well before use. PACKING Levaxinide is available in 1 lit. packs.

40 Rafonide (Rafoxanide Suspension I.P (Vet) 3%) Rafonide (Rafoxanide 3% suspension) is an Anthelmintic and is used for the treatment and control of Liverflukes and other worms. DESCRIPTION Rafonide is an anthelmintic liquid suspension used for the treatment and control of mature and immature Fasciola flukes, Haemonchus, Bonostomus round worms, Nasal bots and Fly maggots. Each 5 ml contains Rafoxanide I.P. (Vet) : 150 mg INDICATIONS Rafonide is used for the treatment and control of Liver flukes and other worms. By oral drenching DOSAGE Calf, Cattle, Buffaloes, Sheep, Goats : 1 ml for 4 kg B.Wt SHELF LIFE 24 months from the date of manufacture. SRAGE Store in a cool and dark place (below 25 0 C) SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Shake well before use. WITHDRAWAL PERIOD Meat : 28 days Milk : 10 days (for cows) & 7 days (for Goats) Rafonide is available in 1 liter pack

41 Trichloben (Triclabendazole 5% w/v Suspension) Trichloben is used for the treatment and control of mature and immature liver flukes Fasciola hepatica and Fasciola gigantica in sheep and goats. Each 5 ml contains Triclabendazole 250 mg. INDICATIONS Trichloben is used for the treatment and control of mature and immature liver flukes Fasciola hepatica and Fasciola gigantica in sheep and goats. DOSAGE Sheep and Goats : 1 ml per 5 kg B.Wt. By oral drenching SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Shake well before use. WITHDRAWAL PERIOD Meat : 28 days and Milk : 10 days (in case of cows) & 7 days (in case of Goats) SRAGE Store in a cool and dark place (below 25 0 C) PACKING Trichloben is available in 1.0 lit. packs

42 Prozal (Diminazene Aceturate Granules) DESCRIPTION Prozal is a Chemotherapeutic Agent used for the treatment and control of Typanosomiasis, Babesiosis and Theileriosis in animals. Each 2.36 gram contains 1.05 gram of Diminazene aceturate. INDICATIONS Prozal is a very effective and well tolerated drug used for the treatment and control of Typanosomiasis, Babesiosis and Theileriosis in animals. Trypanosomiasis : Caused by Trypanosoma congolense, T.vivax, T.brucei Babesiosis ( Piroplasmes ) : Caused by Babesia bovis, B. bigemina, B. ovis, B. motasi, B.canis and Theileria annulata. Prozal is also suitable for the treatment of mixed infections with trypanosomes and piroplasmes also pyrexia of unknown origin. CONTRA INDICATIONS Do not use for camels and dogs. DOSAGE & The dose for all animals when infected with Babesiosis, T.congolense, T.vivax is 0.8 g of Prozal granules per 100 kg b.w. For infections with T.brucei, twice this quantity is indicated. 5 ml of injection solution per 100 kg b.w. Preparation of injection solution : Dissolve 2.36 g of Prozal in 12.5 ml water (amounts 15 ml) The Prozal granules dissolve rapidly in the volume of indicated for injection. The prepared Injection solution is stable for 5 days and when stored at a cool place for 14 days. The injection solution must be protected from sunlight and must be stored in sealed glass vials. Prozal can be administered either by deep intramuscular route or by subcutaneous route. SRAGE Store in a cool and dry place. Prozal is available in 2.36 g glass bottles and 2.36 g sachets. 100 sachets are packed in a corrugated box.

43 Trepanol (Quinapyramine Sulphate & Quinapyramine Chloride Injection) DESCRIPTION Trepanol is used for the treatment and control of Typanosomiasis in cattle, camels, horses and dogs. Each 2.5 g of Trepanol contains : Quinapyramine Sulphate : 1.5 g Quinapyramine Chloride : 1.0 g INDICATIONS Trepanol is a very effective and well tolerated drug used for the treatment and control of Trypanosomiasis in cattle, camels, horses and dogs. Trypanosomiasis Caused by Trypanosoma congolense, T. vivax, T. brucei, T. evansi, T.equiperdurm, T.equinum, T.simiae. Trepanol is also suitable for the treatment of mixed infections of trypanosomes. Generally Trepanol provides 2-3 months prophylaxis. PRECAUTIONS Trepanol is safe and free from side effects. However stressed animals should be rested before treatment. If mild salivation, restlessness or tremors are observed the animal should be kept quiet until symptoms subside. DOSAGE & Preparation of injection solution Dissolve 2.5 g of Trepanol in 15 ml sterile water. For the treatment of T. congolense 1 ml of injection solution per 45 kg b.w. For T. evansi, T. equiperdum, T. equinum 1.3 ml of injection solution per 45 kg b.w. For T. vivax, T. brucei (mixed infection with T. congolense), T. simiae 2 ml of injection solution per 45 kg b.w. Trepanol can be administered by subcutaneous route. Behind the shoulder and midline of the dewlap or caudal fold are the common sites for injection in cattle. In horses in front of the shoulder is the usual site for injection. SRAGE Store in a cool and dry place. Trepanol is available in 2.5 g glass bottles along with diluent.

44 Tikkil (Powder) (Cypermethrin WDP 10 % w/w) DESCRIPTION Tikkil is a highly effective ecto parasiticide containing synthetic pyrethroid Cypermethrin high Cis 10% w/w. Each gm contains Cypermethrin high Cis 10% w/w INDICATIONS Tikkil is a broad spectrum ectoparasiticide used for the control of flies of cattle and horses, blowfly larve, biting lice, ticks and headflies of sheep and mites of poultry, scabies and mange mites of cattle, sheep and dog ticks and lice. MODE OF ACTION Tikkil exerts its action on sodium channels of parasite nerve axons causing initial excitement and then paralysis. INDICATIONS Flies on cattle and horses, blowfly larve, biting lice, ticks and head flies on sheep and remites on poultry, scab and mange mites on cattle, sheep and dogs. CONTRA INDICATIONS Treatment of lambs less than one week of age or treatment of animals during hot weather should be avoided. Not to be applied on the tail region of the lambs because this could interfere with ewe-lamb recognition. WARNING Wash udders of sprayed animals before milking and apply only to unbroken lesions. Accidental splashes on skin must be washed immediately with soap and plenty of water. PREACUTIONS Avoid contact with concentrate and emulsion. Accidental splashes on skin and clothes must be washed with soap and plenty of water. Avoid contact with skin, eyes or swallowing. Avoid breathing spray mist. Wear protective clothing. Do not eat, drink and smoke during treatment. Wash hands thoroughly after use before eating, drinking and smoking. In case of indisposition, seek medical aid. If swallowed refer to a doctor or nearest hospital. Apply symptomatic therapy. Do not treat ill, weak, exhausted or thirsty animals. Keep the product out of reach of children, pets and foodstuff. Tikkil should not be sprayed on feed and feed bags. Keep away from heat open flame. Destroy empty sachets / pouches. ANTIDOTE In case of ingestion, carry out gastric lavage with care to prevent aspiration. Treat symptomatically. WITHDRAWAL PERIOD No withdrawal period for milk. 3 days pre-slaughter interval for meat. DOSAGE & Tikkil is to be mixed with water and sprayed on the animal. DOSAGE AND Dilution rate / Lit. Water Use for Cattle, Camel 1 gm Whole body spray dip, initial charge & replenishment Cattle 5 gm Back line spray 0.5 lit / animal. Sheep and Goats 1 gm Dip, initial charge & replenishment. Dogs 1 gm Whole body spray or wash Poultry 1 gm 60 lit of spray mixture per 1000 birds Animal Hosing 20 gm 5 liters of emulsion per 100 sq.m. surface SRAGE Store in a cool and dry place. Tikkil is available in 5 gm and 15 gm sachets / pouches.

45 Tikkil (Solution) ( Cypermethrin High Cis Emulsifiable Concentrate (Vet.)) Tikkil is a highly effective ecto parasiticide containing synthetic pyrethroid Cypermethrin high Cis 10% w/v. Each ml contains Cypermethrin high Cis 10% w/v (100 g per liter). INDICATIONS Tikkil is a broad spectrum ectoparasiticide used for the control of ticks, lice, scab and mange mites, and flies on Cattle, Sheep, Goat, Horse, Camel, Poultry, Dogs and Farm Premises. MODE OF ACTION Tikkil exerts its action on sodium channels of parasite nerve axons causing initial exitement and then pralysis. INDICATIONS Flies on cattle and horses, blowfly larve, biting lice, ticks and headflies on sheep and remites on poultry, scab and mange mites on cattle, sheep and dogs. CONTRA INDICATIONS Treatment of lambs less than one week of age or treatment of animals during hot weather should be avoided. Not to be applied on the tail region of the lambs because this could interfere with ewe-lamb recognition. WARNING Wash udders of sprayed animals before milking and apply only to unbroken lesions. Accidental splashes on skin must be washed immediately with soap and plenty of water. PREACUTIONS Avoid contact with concentrate and emulsion. Accidental splashes on skin and clothes must be washed with soap and plenty of water. Avoid contact with skin, eyes or swallowing. Avoid breathing spray mist. Wear protective clothing. Do not eat, drink and smoke during treatment. Wash hands thoroughly after use before eating, drinking and smoking. In case of indisposition, seek medical aid. If swallowed refer to a doctor or nearest hospital. Apply symptomatic therapy. Do not treat ill, weak, exhausted or thirsty animals. Keep the product out of reach of children, pets and foodstuff. Tikkil should not be sprayed on feed and feed bags. Keep away from heat open flame. Destroy empty containers. ANTIDOTE In case of ingestion, carry out gastric lavage with care to prevent aspiration. Treat symptomatically. WITHDRAWAL PERIOD No withdrawal period for milk. 3 days preslaughter interval for meat. DOSAGE & Tikkil can be used either as a spray or dip treatment. Dosage And Administration Species Dilution rate with Water Application Cattle 1 ml / lit water (for ticks) Whole body spray dip, initial charge & Camel replenishment Cattle 5 ml / lit water (for flies) Back line spray 0.5 lit / animal. Sheep 1 ml / lit water (for scab & lice) Dip, initial charge & replenishment. Dogs 1 ml / lit water (for ticks, lice, mites, flies) Whole body spray or wash Poultry 1 ml / lit water (for ticks, lice, mites, flies) 60 lit of spray mixture per 1000 birds Animal 20 ml / lit water 5 liters of emulsion per 100 sqm surface Housing SRAGE Store in a cool and dry place. Tikkil is available in 15 ml and 50 ml Aluminium bottles.

46 Oxytetracycline (Oxytetracycline Dyhidrate) I.P 50 mg DESCRIPTION Oxytetracycline Injection is a golden yellow aqueous solution. Each ml contains Oxytetracycline Dyhydrate I.P. 50 mg. INDICATIONS For the treatment of systemic, respiratory, gastro intestinal and urinary infections caused by oxytetracycline sensitive organisms. Haemoprotozoal diseases like Thieleriosis, Trypanosomiasis, Babesiosis and Anaplasmosis. Oxytetracycline injection may be given by intravenous, intramuscular or subcutaneous routes. DOSAGE Cattle, Buffaloes & Horses Calves, Sheep, Goats, Pigs and Dogs : mg/kg b.wt. depending on severity of infection. : 0.5 ml to 1.0 ml (per 5 Kg body wt. for 3-5 days). FOR POULTRY For chicks upto 4 weeks of age, use diluted solution by adding 3 parts of sterile water to one part of Oxytetracycline injection. Chicks upto 2 weeks of age : ½ ml diluted injection Chicks 2-4 weeks of age : 1 ml diluted injection Chicks 4-8 weeks of age : ½ ml undiluted injection Chicks over weeks of age : 1 ml of undiluted injection CAUTION Generally well tolerated. However, weak and debilitated animals do not tolerate it well. Milk form lactating cows, buffaloes undergoing treatment as well as up to 48 hours after completion of treatment, should not be used for human consumption. WITHDRAWAL PERIOD Meat : 14 days Milk : 3 days PACKING 30 ml, 50 ml and 100 ml vials.

47 Tetroxin-DS (Oxytetracycline Injection 100mg/m) DESCRIPTION Tetroxin - DS is a clear and stable solution of Oxytetracycline dihydrate. Each ml contains : Oxytetracycline dihydrate I.P. 100 mg INDICATIONS For the treatment of systemic, respiratory, gastro intestinal and urinary infections caused by Oxytetracycline sensitive organisms. DOSAGE AND Cattle, Horses, Foals, Calves, Pigs & Sheep : 5 10 mg / kg / day 1-2 ml /20 kg intramuscular (IM), Slow intravenous (IV) Dogs & Cats : 10 mg / kg / day 0.5 ml / 5 kg - IM Treatment should be repeated 2 4 days at 24 hours intervals. If there is no response to treatment, the diagnosis and therapy should be reviewed after 48 hours. Treatment of anaplasmosis in cattle requires ten treatments with a dosage of 10 ml per 100 kg body weight. PRECAUTIONS Intravenous injections must be given slowly. In cold weather Tetroxin-DS should be warmed to about 20 C before injection. Do not administer to horses under stress, as fatal diarrhea may occasionally arises. Store in a cool place. Protect from light. WITHDRAWAL PERIOD Meat : 15 days Milk : 3 days Tetroxin - DS is available in 30 ml & 100 ml packs.

48 Tetroxin-LA (Oxytetracycline Injection 20 % Long Acting ) DESCRIPTION Tetroxin-LA 20% is a clear and stable solution of Oxytetracycline dihydrate. Each ml contains : Oxytetracycline dihydrate I.P. 200 mg equivalent to anhydrous Oxytetracycline in 2- Pyrrolidone vehicle system. INDICATIONS For the treatment of systemic, respiratory, gastro intestinal and urinary infections caused by Oxytetracycline sensitive organisms. Tetroxin - LA injection may be given by intramuscular injection in divided doses to be administered at 2 to 3 sites. By subcutaneous route in poultry and rabbits. DOSAGE Cattle, Buffaloes, Sheep, Goats, Pigs & Camels : Single dose at the rate of 1 ml per 10 Kg. Body wt. Poultry and Rabbits : 1 ml per 4 Kg body wt. PRECAUTIONS Generally well tolerated. However, weak and debilitated animals do not tolerate well. Milk from lactating cows, buffaloes undergoing treatment as well as upto 48 hours after completion of treatment, should not be used for human consumption. WITHDRAWAL PERIOD Meat : 22 days Milk : 3 days Tetroxin - L.A. is available in 100 ml packs.

49 Gyroflox (Enrofloxacin10% Injection) Each ml of injection contains Enrofloxacin 100 mg. INDICATIONS Gyroflox being a broad spectrum antibacterial is indicated in either single or mixed bacterial infections. In Livestock Gyroflox is effective against E.coli, Salmonella Spp., Pasteurella Spp., Klebsiella Spp., Moraxella bovis, Campylobacter Spp., Haemophilus Spp., Pseudomonas aeruginosa, Brucella canis. Stephylococcus Spp., Streptococcus Spp., Corynebacterium pyogenes, Clostridium perfringens, Erysipelothrix, Mycoplasma Spp., and others like Leptospira Spp. Hence Gyroflox is suitable for the treatment of infections such as : Coli-diarrhoea, Coli Septicaemia, Bronchopneumonia, Enzootic pneumonia, Salmonellosis, Acute Mastitis, Enteritis, Colibacillosis, Clostridiosis, MMA Complex, Urinary tract infection, Wound infection and Secondary bacterial infection associated with viral diseases. In Poultry Gyroflox is effective in infections with Gram - negative and Gram positive bacteria and Mycoplasma. BENEFITS Effective against all major bacterial infections of gastrointestinal, respiratory and urogenital systems. A true broad spectrum antibacterial that controls gram-negative and gram-positive bacteria and mycoplasma infections. Acts rapidly against proliferating and dormant phase of pathogens. Maximum effective concentration in blood serum is achieved within 1-2 hours. Able to penetrate placenta and blood brain barrier. Safe and free from side effects. Contains safe preservative-methyl & Propyl Paraben. Gyroflox injection should be administered by subcutaneous / Intravenous route only. Tablet by oral route : 1 tablet/10 kg Body wt. DOSAGE Ruminants Dog, Cat Poultry : 1 ml/40 kg Body wt. : 1 ml/20 kg Body wt. : 1 ml/10 kg. Body wt. PACK Gyroflox injection is available in 2 ml, 15 ml & 50 ml vials. SHELF LIFE 24 months from the date of manufacture when stored at the recommended storage conditions. WITHDRAWAL PERIOD Meat : 14 days, Milk : Not applicable CAUTION AND CONTRAINDICATIONS Gyroflox should not be administered to dogs below 12 months of age and is not to be used to treat horses. Gyroflox is not recommended in combination with chloramphenicol, Macrolides, Tetracyclines, Megnesium and Aluminium containing substances might hamper the absorption of Gyroflox from the gastro-intestinal tract. WARNING Keep the drug out of reach of children. Shake will before use. Protect from light and freezing. Store in cool and dark place below 25 C. For veterinary use only.

50 Gyroflox (Tablets) (Enrofloxacin Tablets 50 mg) Each tablet contains Enrofloxacin 50 mg. INDICATIONS Gyroflox being a broad spectrum antibacterial is indicated in either single or mixed bacterial infections. In Livestock Gyroflox is effective against E.coli, Salmonella Spp., Pasteurella Spp., Klebsiella Spp., Moraxella bovis, Campylobacter Spp., Haemophilus Spp., Pseudomonas aeruginosa, Brucella canis. Stephylococcus Spp., Streptococcus Spp., Corynebacterium pyogenes, Clostridium perfringens, Erysipelothrix, Mycoplasma Spp., and others like Leptospira Spp. Hence Gyroflox is suitable for the treatment of infections such as : Coli-diarrhoea, Coli Septicaemia, Bronchopneumonia, Enzootic pneumonia, Salmonellosis, Acute Mastitis, Enteritis, Colibacillosis, Clostridiosis, MMA Complex, Urinary tract infection, Wound infection and Secondary bacterial infection associated with viral diseases. In Poultry Gyroflox is effective in infections with Gram - negative and Gram - positive bacteria and Mycoplasma. In Dogs & Cats For the treatment of diseases associated with bacteria susceptible to enrofloxacin. BENEFITS Effective against all major bacterial infections of gastrointestinal, respiratory and urogenital systems. A true broad spectrum antibacterial that controls gram-negative and gram-positive bacteria and mycoplasma infections. Acts rapidly against proliferating and dormant phase of pathogens. Maximum effective concentration in blood serum is achieved within 1-2 hours. Able to penetrate placenta and blood brain barrier. Safe and free from side effects. Tablet by oral route DOSAGE 1 tablet/10 kg Body wt. PACK Strip of 10 s

51 Gyroflox (Enrofloxacin 10% Oral Suspension) Each ml of Gyroflox Suspension contains Enrofloxacin 100 mg. INDICATIONS Gyroflox being a broad spectrum antibacterial is indicated in either single or mixed bacterial infections. In Livestock Gyroflox is effective against E.coli, Salmonella Spp., Pasteurella Spp., Klebsiella Spp., Moraxella bovis, Campylobacter Spp., Haemophilus Spp., Pseudomonas aeruginosa, Brucella canis. Stephylococcus Spp., Streptococcus Spp., Corynebacterium pyogenes, Clostridium perfringens, Erysipelothrix, Mycoplasma Spp., and others like Leptospira Spp. Hence Gyroflox is suitable for the treatment of infections such as : Coli-diarrhoea, Coli Septicaemia, Bronchopneumonia, Enzootic pneumonia, Salmonellosis, Acute Mastitis, Enteritis, Colibacillosis, Clostridiosis, MMA Complex, Urinary tract infection, Wound infection and Secondary bacterial infection associated with viral diseases. In Poultry Gyroflox is effective in infections with Gram - negative and Gram - positive bacteria and Mycoplasma. Gyroflox is used for the treatment of colibacillosis, salmonellosis and infections caused by mycoplasma. Before administration, check the sensitivity of the causing agent to enrofloxacin with an antibiogram. Provided that an increase of resistances can appear during treatment, the speciality should only be administered after ensuring the bacteriological diagnostic and when resistance to other antibiotics exists In Dogs & Cats For the treatment of diseases associated with bacteria susceptible to enrofloxacin. Benefits : Effective against all major bacterial infections of gastrointestinal, respiratory and urogenital systems. A true broad spectrum antibacterial that controls gram-negative and gram-positive bacteria and mycoplasma infections. Acts rapidly against proliferating and dormant phase of pathogens. Maximum effective concentration in blood serum is achieved within 1-2 hours. Able to penetrate placenta and blood brain barrier. Safe and free from side effects. Oral through the drinking water DOSAGE General Dosage for Poultry : 0.1 ml of Gyroflox oral per kg. body weight.. It is obtained by administering 0.5 litres (50 g of enrofloxacin) per 1000 litres of drinking water for three consecutive days. In the case of salmonellosis, the length of treatment is 5 days.: Renew medicated water after 24 hours. The general dosage for all Ruminants : 0.25 ml / 10 Kg B.Wt. for 3-5 days Dogs & Cats : 0.5 ml per 10 kg. B. Wt. WITHDRAWAL PERIOD Meat : 14 days, Milk : 3 days. CAUTION Do not exceed the recommended dosage. Do not administer in case of resistance to the quinolones, because of cross-resistance. In relation to fluoroquinolones, a complete cross-resistance exists. Do not treat animals with previous case of streptococcal infections. Like fluoroquinolones, enrofloxacin has a damaging action on articulations, especially in young animals. Consequently, caution must be taken in not increasing excessively the dose and length of treatment. Antagonic effects can appear administering it together with chloramphenicol, maccolides, or tetracyclines. PACK Gyroflox is available in 1.0 lit. packs.

52 Inimox (Amoxycillin + Cloxacillin Injection) DESCRIPTION Inimox is a Crystalline Injectable Powder presented in glass vials Each 2000 mg Vial contains : Amoxycillin Sodium B.P. equivalent to Anhydrous Amoxycillin 1g Cloxacilin Sodium I.P. equivalent to Cloxacilin 1g INDICATIONS Inimox is a tried combination therapy for though infection like Mastitis, Metritis Calf Scours, HS, BQ, E-Coli Infections Brucellosis Pneumonia, Respiratory tract infections Pyelonephritis, Salmonellosis By intramuscular or intravenous route DOSAGE 5-10 mg per kg body wt. by intramuscular or intravenous route after dissolving the contents of the vials with sterile water for injection for 3-5 days or as directed by the veterinarian. WITHDRAWAL PERIOD Meat : 2 weeks Milk : 3 days PACKING 2000 mg and 4000 mg. in glass vials.

53 G-Cin (Gentamicin 10% Water Soluble Powder) G-Cin WSP (Gentamicin 10% Water Soluble Powder) is used for treatment and control of Gastrointestinal infections in poultry, calves and swine. Other gastrointestinal infections caused by Gentamicin susceptible microorganisms. It is also used for the treatment of swine dysentery. Each gram Gentamicin Sulphate is equivalent to Gentamicin 100 mg. INDICATIONS In Cattle : G-Cin WSP is used for the treatment and control of Gastrointestinal infections, caused by gentamicin susceptible microorganisms. In Poultry : For prevention of early chick mortality due to E.coli, Salmonella spp. & Pseudomonas spp., Fowltyphoid, C.R.D, infectious coryza and paratyphoid infections. For reduction and elimination of micro-organisms like Mycoplasma & Salmonella from hatching eggs by dipping them in Gentamicin medicated water before incubation. Other gastrointestinal infections caused by gentamicin susceptible microorganisms. Orally by drinking water CONTRAINDICATIONS Hypersensitivity to gentamicin DOSAGE Calves : 5 g of powder per 100 kg. b.wt. twice on the first day only, and 4 g of powder once in a day thereafter for 3 5 days. Poultry : 0.5 gm of powder in 1.0 liter of drinking water for 5 to 7 days. Swine : 5 g of powder per 100 kg b.wt. or 5g of powder per 10 liters of drinking water at 12 hours intervals for 3 5 days. For the treatment of swine dysentery : g of powder in 100 liters of drinking water for 3 5 days. SIDE EFFECTS : Nil WARNING Do not use Gentamicin powder concurrently with Chloramphenical. WITHDRAWAL PERIOD Meat : 10 days SRAGE Store in a cool and dark place (below 25 0 C) G-Cin WSP is available in 500 g packs.

54 Sulfamin Injection B.P (Vet) DESCRIPTION A clear aqueous injectable solution containing Sulphadimidine Sodium. Each ml contains : Sulphadimidine Sodium I.P. 333 mg. INDICATIONS Sulfamin is recommended for the treatment of systemic, enteric infections in domestic animals due to sulphonamide sensitive organisms. It is indicated in the treatment of Haemorrhagic septicaemia, bronchopneumonia, calf diphtheria, bacterial enteritis and actinobacillosis. It is also indicate as a supportive therapy in metritis and mastitis of adult cattle and in coccidiosis of calves. Sulfamin injection may be given by intravenous or subcutaneous routes. DOSAGE 30 ml per 50 Kg. Body weight initial dose. 15 ml per 50 Kg. Body weight on subsequent days over a period of 4 to 6 days. PRECAUTIONS Generally well tolerated. However, weak and debilitated animals do not tolerate well. Sulfamin injection is available in 100 ml and 450 ml packs.

55 Vetylosin (Tylosin Water Soluble Powder) gm. Water soluble powder Each Vetylosin pack contains active Tylosin base : 100 gm. DOSAGE Poultry 0.50 gm. of Vetylosin per liter of drinking water (for 2 to 5 days) Calves 1.0 gm. of Vetylosin dissolved in water / milk per lactating calf (daily 2 times for 5 to 7 days). Orally by drinking water. INDICATIONS Poultry : For the treatment and control of CRD and infectious synusitis. Lactating Calves : For the treatment and control of pneumonia associated with pasteurellas and mycoplasmas. WITHDRAWAL PERIOD Poultry : 24 hours Meat (Calves) : 21 days SHELF LIFE 24 months from the date of manufacture. SRAGE Store in a cool and dark place (below 25 0 C) SPECIAL INSTRUCTIONS Keep the drug out of the reach of children. Shake well before use. PACKING Vetylosin is available in g packs.

56 Lithiomony Lithium Antimony Thiomalate Injection DESCRIPTION Lithium Antimony Thiomalate is an organic compound offered as aqueous solution.. Each ml contains : Lithium Antimony Thiomalate : 6% w/v Equivalent to 12 mg Antimony Trioxide : Chlorocresol (preservative) IP : 0.1% w/v INDICATIONS Lithium Antimony Thiomalate should be administered by deep intramuscular route preferably at the gluteal muscles. DOSAGE For Nasal Granuloma 15 ml to 20 ml on three occasions at weekly intervals. Papillomatosis 15 ml to 20 ml on 4-6 occasions on alternative days. As warts necrose, they should be enucleated and suitably dressed. Filariasis and Leishmaniasis in canines 1 ml to 2.5 ml on 4-6 occasions on alternative days. The dosage may be gradually increased. Lithiomony injection is available in 50 ml glass vials.

57 Inigesic (Analgesic, antipyretic & anti-inflammatory injection & bolus) Each ml of injection contains Paracetamol IP 150 mg., Diclofenac Sodium IP 25mg., Benzyl alcohol IP 1% w/v. Each uncoated bolus contains Diclofenac Sodium IP 250mg., Paracetamol IP 1500 mg. INDICATIONS For the treatment of pain and fever associated with injury and surgery, chronic inflammatory conditions, fever caused by inflammation, smooth muscle swelling in per acute and acute mastitis. Also in other inflammatory conditions viz.rheumatoid arthritis, ostearthritis, tenosynovitis, mystis, neuritis, fibrositis, coxitis, gonitis, swelling in traumatic and surgical wounds and also in ephemeral fever, neuralgia and lumbago. Inigesic injection should be administered by deep intramuscular route. DOSAGE Injection Bolus Large animals Small animals : 1 ml per 25 kg body wt. : 1-2 boli twice daily. : 1/2 1 bolus twice daily. Do not use in cat and Horse PACK Inigesic injection is available in 30 ml vials. Inigesic bolus is available in strip of 2 Boli.

58 Nimovet Nimesulide Injection 10% w/v Each ml contains: Nimesulide 100 mg DESCRIPTION Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that has antipyretic and analgesic properties. The anti-inflammatory, analgesic and antipyretic activities of Nimesulide, a drug belonging to the same class of Sulfonanilide, have been demonstrated in a number of experimental models and in numerous clinical trials. The compound is weakly acidic (pka = 6.5) and differs from other NSAIDs as it contains in its chemical structure the acid group of the Sulfonanilide molecule. Nimesulide has exhibited a pharmaceutical power similar to other agents, such as Indomethacin, Diclofenac, Piroxicam and Ibuprofen in standard animal models of inflammation. The analgesic potency of Nimesulide is similar to that of ibuprofen and indomethacin. Nonetheless Nimesulide has shown a higher antipyretic potency than indomethacin, ibuprofen, aspirin and Paracetamol. The mechanism by which Nimesulide exerts its action is complex. Nimesulide appears to act at different stages of the inflammatory reaction and selectively, it is a COX-2 inhibitor. Nimesulide has the unique feature of exhibiting multifaceted actions. Nimesulide inhibits Prostaglandin synthesis at the sites of inflammation. It acts as a competitive inhibitor of histamine and in-vitro reduces the super oxide anion formation by activated neutrophils. Nimesulide and its active metabolite also appear to have direct anti-oxidant properties against various free radicals. It also inhibits the platelet activating factor and integrin. Nimesulide may prevent the cartilage damage by inhibiting metalloprotienase and cytokines. DOSAGE RECOMMENDATION: DOGS AND CATS 3-5 mg per Kg B.wt. CATTLE, BUFFALOES, SHEEP AND GOATS 2-4 mg. per Kg B.wt. ROUTE OF Intra-muscular. DOSAGE INTERVAL At 24 hourly intervals. INDICATIONS FOR USE Pyrexia, Musculoskeletal affections (Limping, Lameness, joint affections, sprain, trauma, wounds, arthritis, Bursitis, Sinuvitis etc) ENT affections (Rhinitis, Pharyngytis, Otitis etc) Other Systemic or infectious diseases (Upper or lower respiratory tract infections, FMD, Contagious ecthyma, mastitis etc) Post operative or surgical inflammatory conditions. CONTRA-INDICATIONS Acute renal failures, Marked hepatic dysfunctions, blood dyscrasias, pregnancy, ulcerative gastro intestinal diseases, cardiac diseases and in neonates. NOT BE USED IN HORSES. SPECIAL PRECAUTIONS Warfarin poisoning, Haemolytic diseases, renal and hepatic dysfunctions, severe cardiac diseases and in pregnancy. POSSIBLE SIDE EFFECTS In dogs and cats, Nimesulide may be painful, especially in large doses, in a few cases, it may cause mild gastritis in dogs. Abortion may occur if administered to pregnant animals. In very high doses, Nimesulide may cause gastric irritation and toxicity symptoms in liver and Kidney. Rarely, it causes acute renal failure in new borne and young calves, in puppies and Kitten.

59 Pesurea Bolus (INTRAUTERINE BOLUS WITH NITROFURAZONE, UREA & METRONIDAZOLE) DESCRIPTION Pesurea is highly hygroscopical water soluble bolus ideal for intrauterine use. Pesurea Bolus is an ideal combination of a broad specturum antibacterial (Furazolidone), a proteolytic agent that acts effectively in the presence of necrotic debris and uterine fluids (Urea) and a proven antibiotic effective in anaerobic conditions (Metronidazole) Each bolus contains: Nitrofurazone BP : 60 mg Urea : 5000 mg Metronidazole IP : 1000 mg Why Metronidazole? Metronidazole is an antibacterial & antiprotozoal especially effective against anaerobic infections. It is an effective antibiotic against certain protozoal infections, especially Giardia. MODE OF ACTION The normal body tissues of the body depend on oxygen for survival. However, abscessed tissues and tumors with poor central circulation do not receive blood supply and oxygen. Only anaerobic bacterial can survive these conditions. In anaerobic conditions, the Metronidazole molecule changes so as to inhibit the DNA repair enzymes that would normally repair the cells. This means death for anaerobic bacteria but no effect on aerobic tissues. Metronidazole is also able to modify cell mediated immunity so as to normalize excessive immune reactions, especially in the large intestine. INDICATIONS For prevention or control of uterine infections associated with retained placenta, metritis, cervicitis and vaginitis AND DOSAGE Using aseptic precautions, insert by hand two to four boluses into each of the affected and normal uterine horns. Based on severity, repeat treatment after 24 hours. Strip of four boli.

60 Calgonate Injection B.P (Vet) DESCRIPTION Calgonate is a mixture of calcium gluconate and boric acid. Calcium Gluconate I.P. : 20.80% w/v (Equivalent to Calcium 1.86% w/v) Boric Acid I.P. : 4.25 % Chlorocresol I.P. (as Preservative) : 0.1 % Water for injection I.P. : q.s. INDICATIONS Calgonate is recommended for the treatment of acute and chronic hypocalcaemia in cows, buffaloes, ewes, doe and sows. It is extensively used in clinical and subclinical cases of milk fever in cows, buffaloes and other species of domestic animals. It is also recommended for the prevention and treatment of drug induced liver damage. Calgonate may be administered by subcutaneous or intravenous injection. When administered intravenously it is of utmost importance to inject the solution slowly as it has been reported that calcium ions, in some individual animals may have a depressant effect on the myocardium. It is also desirable to warm the Calgonate solution to body temperature before administration. DOSAGE Cows, Buffaloes Ewes, Doe and Sows : 200 ml to 300 ml : 30 ml to 50 ml Calgonate Injection is available in 450 ml pack.

61 Miphocal (Calcium Borogluconate injection with Magnesium and Phosphorous) DESCRIPTION Calcium Borogluconate with Magnesium and Phosphorous is a solution of calcium borogluconate with phosphorous and magnesium in an organic combination and dextrose. Calcium Gluconate I.P.(Equivalent to Calcium 1.86% w/v) Boric Acid I.P. Magnesium Hypophosphite Anhydrous Dextrose I.P. Chlorocresol I.P. (as preservative) Water for Injection I.P. : 20.80% w/v : 4.25% w/v : 5.0 % w/v : 20.0 % w/v : 0.1 % w/v : q.s. INDICATIONS Miphocal is recommended for the treatment of milk fever due to hypocalcaemia or when it is associated with hypomagnesaemia and hypophosphataemia. ADMININSTRATION Miphocal may be administered by subcutaneous route. Being a hypertonic solution, may occasionally produce temporary local tissue swelling. It is suggested that before intravenous administration the solution should be warmed to body temperature. Calcium and Magnesium ions if injected rapidly may cause coronary depression and hence it is advisable to administer this preparation slowly and also with a few interruptions. DOSAGE Cows, buffaloes Ewes, doe and sows : 200 ml to 300 ml : 30 ml to 50 ml Miphocal is available in multidose Bottles of 450 ml.

62 Bovoplex-C.C. (Vitamin B complex with Liver Extract & Choline Chloride) DESCRIPTION A dark brown injectable solution containing B complex, Vitamins, Liver Extract and Choline Chloride. Each ml contains Thiamine hydrochloride I.P. 25 mg Riboflavin Phosphate Sodium I.P. 1.5 mg Vitamin B6 I.P. 5.0 mg Niacinamide I.P. 50 mg Cyanocobalamine I.P. 50 mcg. Choline Chloride I.P. 25 mg Phenol (as Preservative) I.P. 0.5% w/v Liver inj. crude having B12 activity of not less than 2 mcg. Of Cyanocobalamine. INDICATIONS Primarily as supportive therapy in conditions leading to liver Dysfunction viz. liver fluke infestation, fatty degeneration of liver, in the treatment of anorexia and B complex Vitamin deficiency conditions. Bovoplex - CC injection should be administered by deep intramuscular route only. DOSAGE Cattle, buffaloes and horses : 10 ml daily Calves, sheep, goats and pigs : 5 ml daily Dogs and cats : 2 to 5 ml daily The treatment should be given for a minimum of 3 days. SRAGE Store in a cool and dark place. PACK Bovoplex - CC injection is available in 30 ml vials.

63 Mastect (for detection of mastitis) Mastect is a booklet of Bromothymol blue impregnated strips of paper. Mastect is unique and simple aid developed by the National Dairy Development Board, Anand for detection of clinical / subclinical mastitis by milk examination in dairy animals under field conditions. DIRECTIONS OF USE Clean the udder with water and wipe dry with clean towel before milking. Handle MASTECT with dry hands. Use a separate strip for each quarter of the udder. Discard first few strippings of milk. Tear off a strip from the booklet and put one drop of milk on it. Observe the immediate colour change, if any. Compare the colour change with the colour index in the inner side of the booklet s cover. Interpretation of changed colour should be as follows Yellow Normal Yellowish Green Suspected Mastitis * Green Subclinical Mastitis Blue Clinical Mastitis * = Repeat the next day. PRECAUTIONS Mastect should be stored in a dry and dark place. Mastect may give a false test in ketosis and other similar conditions where milk composition changes.

64 Xylaxin (Xylazine Hydrochloride Injection) Xylaxin injection (2% Solution) contains Xylazine Hydrochloride mg per ml. INDICATIONS Xylaxin injection is recommended for inducing sedation and analgesia in various animals, for restraining of animals for routine observations, minor surgical interventions, immobilization of animals during transportation and transhipment or any similar functions. It can also be used as a preanaesthetic to general anaesthesia. By intramuscular route. For horses intravenous. Species Dose in mg.per Kg. Body weight Dose per average adult Cattle 0.1 to to 3.0 ml Horses 1.0 to to 50.0 ml Dogs 1.0 to to 1.5 ml Cats 1.0 to to 0.5 ml Sheep 0.1 to to 0.5 ml Goats 0.05 to to 0.75 ml Camels 0.1 to to 20.0 ml Wild Deers 1.5 to to 4.5 ml Elephants 0.1 to to 20.0 ml CONTRA-INDIACATIONS Xylaxin should not be used in conjunction with tranquilizers or neuroleptic drugs. Animals in the last term of pregnancy should not be given the drug as it may induce early parturition or abortion. Cats and dogs with oesophageal obstruction, intestinal torsion or hernia as well as animals with pulmonary disorders should not be injected with Xylaxin. PRECAUTIONS After administration of Xylaxin the animal should be left undisturbed as excitement may reduce the level of sedation. Accidental falls and injury to be avoided during the induction of sedation by keeping the animal under observation after the onset of sedation. Caution is required while administering the drug in weak and debilitated animals. SIDE EFFECTS Xylaxin is well tolerated in most animals without any side effects. A brief rise in blood pressure may occur which gradually becomes normal. Sweating and urination in horses, liquid and soft faeces in cattle, emesis in cats and dogs are some of the effects. The drug is rapidly excreted from the body. ANTIDOTE Yohimbine hydrochloride and 4-amino pyridine are the antidotes for Xylaxin. Xylaxin is available in 30 ml. Vials.

65 Trophovet (Pregnant Mare Serum Gonadotrophin BP (Vet)) Trophovet is capable of supplementing and can be used in place of Follicle Stimulating Hormone of the anterior pituitary gland. Trophovet stimulates development of the ovarian follicle in the female and has spermatogenic activity in the male by its effect on the seminiferous tubules. DESCRIPTION Trophovet is presented as a freeze-dried product containing 5000 I.U. Pregnant Mare Serum Gonadotrophin BP (Vet) together with diluent. DOSAGE AND SPECIES INDICATION DOSAGE AND Mare Anoestrus 3000 to 6000 IU i.m./s.c. followed by HCG 1500 to 3000 IU at the time of Service. Cattle Anoestrus, Superovulation 500 to 1000 I.U. i.m., 1500 to 3000 IU i.m. between 8 to 13 days of the cycle. Bitch Induction of oestrus Daily s.c. inj. of 500 IU or 20 IU/kg body wt. For 10 days. Inject 500 IU HCG on day 10. Ewe Induction of oestrus & synchronization 400 to 700 IU i.m. after removal of vaginal sponges containing Progesterone. Male Animals Bull Impaired spermatogenesis 1000 IU to 3000 IU i.m. twice weekly for 4 to 6 weeks. Ram / Buck Impaired spermatogenesis 500 to 750 IU i.m. twice weekly for 4 to 6 weeks. Dog Impaired spermatogenesis 400 to 1000 IU i.m. twice weekly for 4 to 6 weeks. Following reconstitution with the 5 ml diluent, each ml will contain 200 I.U. Normal aseptic precautions should be observed while injecting. In rare cases, anaphylactic reactions may be seen as with all protein preparations. Adrenaline injection is the standard treatment. Corticosteroids can also be used. CONTRA-INDICATIONS Since multiple ovulation occurs following administration of TROPHOVET, it is not advisable to permit service or insemination during the first heat produced, except when used specifically for it. SRAGE AND TRANSPORT Store and transport between 2 and 8 C. Freeze-dried preparation : 1000 I.U. Vial. Diluent : 5.0 ml. Vial.

66 For the use of a Registered Medical Practitioner or a Hospital or a Laboratory Only. RABIES VACCINE B.P 'Rab/Vac' 1 dose for Human Use Purified Vero Cell Rabies Vaccine Abhayrab Purified Inactivated Rabies Vaccine prepared on Vero cells. For the prophylactic or post exposure immunization. Prepared using L.Pasteur 2061/Vero Rabies strain. Clinical studies with Abhayrab shows neutralizing antibody responses both after primary and secondary immunizations. PER SINGLE DOSE Freeze-dried Vaccine : 1 immunizing dose contains the protective activity of equal to or greater than 2.5 International Units (IU) even after exposure at 37 o C for one month. Rabies Virus (L.Pasteur 2061/VERO) propogated on Vero cell line inactivated with beta-propiolactone. 0.01% added as preservative. Maltos Human Serum Albumin : q.s. per immunizing dose. : q.s. per immunizing dose. The antibiotics Neomycin, Kanamycin and Polymixin B sulphate used in the cell and virus cultures are eliminated to the greatest extent during purification procedures and cannot be detected in the final vaccine. INDICATIONS - For active immunization against Rabies both for prophylaxis and post-bite therapy in all age groups of humans - For immunizing against Rabies after exposure (after contact with a rabid or suspected rabid animal). See Table-1 for W.H.O. recommendations - For prophylactic immunization of all high risk group of persons such as Veterinarians, Municipal workers, Medical and Paramedical personnel, Forest and Zoo personnel, Hunters, Laboratory personnel working with suspected Rabies materials and Pet owners. DOSAGE Prophylaxis: Three immunizing doses on 0, 7 and 21 or 28 days followed by annual booster. Post-Exposure: One immunizing dose on post exposure days 0, 3, 7, 14, 28 and 90 each. Reconstitute the freeze-dried vaccine with the diluent supplied along with the vaccine. Administer the reconstituted vaccine (entire quantity of the vial) by deep intramuscular route in the deltoid region or by subcutaneous route. The reconstituted vaccine is to be used immediately and shall not be stored for administration later. INCOMPATIBILITIES None CONTRAINDICATIONS Post-exposure immunization As Rabies is a dreaded disease; no contraindications are to be considered in case of post-bite therapy. Pre-exposure immunization In case of pregnancy or acute febrile illness, the vaccination should be postponed. SPECIAL CONDITIONS Use In Pregnancy Pregnancy Category C. Animal reproductive studies have not been conducted with Abhayrab. It is also not known whether Abhayrab can cause fetal abnormalities when administered to a pregnant women or can affect reproduction capacity. Abhayrab should be given to a pregnant women only If clearly needed. Use In Lactation: - As Rabies is always fatal in humans, there are no contraindications. It can be used in lactation in case of suspected rabid contamination. Use In Children's: - As Rabies is always fatal, there is no age limitation. It can be used in all ages of children's in case of suspected rabid contamination. CAUTIONS 1. Concurrent use of immunosuppressive agents like corticosteroids shall be avoided as it may hamper in the development of protective antibodies. 2. In case of severe bites and at the site of injuries, nearer to head local infiltration of the wounds with antirabies immunoglobulins is recommended. 3. Delay in the commencement of post-bite therapy, incomplete and irregular therapy can cause failure of protection. Continued

67 SRAGE To be stored at temperatures between +2 O C to +8 O C. Do not freeze. Box of 1 dose vial along with Diluent Ampoule (0.5 ml), Sterile disposable syringe with needle and vaccination card. Rabies Antiserum I.P AbhayRIG Table 1 Guide for post exposure treatment (W.H.0. Recommendations) Category Type of contact with the Course of action to be followed suspected or confirmed rabid animal I Touching or feeding of animal, None, if reliable case history licks on intact skin available II Nibbling of uncovered skin, Administer vaccine immediately. minor scratches or abrasion Stop the treatment if the without bleeding, licks on animal remains healthy for broken skin a period of 10 days or has been killed humanely and found to be negative for Rabies by appropriate laboratory techniques. III Single or Multiple transdermal Administer rabies bites or scratches with saliva immunoglobulins and (i.e.licks) vaccine immediately. Stop treatment if the animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques. Back

68 For The Use Of Registered Medical Practioner Or Hospital Or Laboratory Only Abhay RIG Rabies Antiserum I.P Each vial contains Equine antirabies immunoglobulin fragments not less than 300 I.U/ml. Cresol I.P = 0.25% v/v as a preservative Glycine I.P g/ml Sodium Chloride I.P g/ml Water For Injection I.P q.s PHARMACEUTICAL FORM Solution for injection by intramusclar route 5 ml vial, 1500 IU THERAPEUTIC INDICATION AbhayRIG provides passive immunization against rabies. AbhayRIG is indicated for the prevention of rabies in patients at risk of being exposed to rabies after contact with a rabid animal or an animal presumed to be rabid. AbhayRIG itself does not constitute an antirabies treatment and should always be used in conjuction with rabies vaccine. CONTRAINDICATIONS Should be used with extreme caution in subject with a history of allergic symptoms or hypersensitivity to horse serum. In case of doubt, it is essential to ask your doctor or pharmacist for advise. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Despite the high degree of purification of the serum. It is recommended to perform a skin test before administering heterologous serum. The skin test consists of intradermal injection of 0.1 ml of 1:10 dilution of AbhayRIG on the outside of the forearm so as to obtain an orange ring type appearance (3 mm diameter in duration). An equivalent intradermal injection of physiological saline solution is used as control The observations made 15 minutes after intradermal injection is considered to be positive if erythema (>6mm), local oedema or a systemic reaction is observed and the control is negative. A positive test result is not a formal contraindication for the use of seropathy, but it should be considered as a warning. A negative test is not an absolute guarantee for the absence of an immediate allergic type reaction. DRUG INTERACTIONS Rabies prevention requires simultaneous administration of antirabies immunoglobulin and vaccine. Anti rabies vaccine should be inoculated in different parts of the body contra-laterally if possible. In this case interference is minimized. AbhayRIG should not be administered in the same syringe as the vaccine. PREGNANCY AND LACTATION The safety of AbhayRIG when used during pregnancy has not been established in clinical trials in human beings. Considering the lethal risk associated with rabies, Pregnancy is not a contraindication to the administration of AbhayRIG subsequent to exposure to rabid animal. Table: Guide for Post Exposure Treatment Category Type of contact with the Recommended Treatment suspected or confirmed domestic or wild animals or Animals unavailable for observations I Touching or feeding of animal, None, if reliable case licks on intact skin history available II Nibbling of uncovered skin, Administer vaccine immediately. Stop the minor scratches or abrasion treatment if the animal remains healthy without bleeding, licks for a period of 10 days** or has been on broken skin killed humanely and found to be negative for Rabies by appropriate laboratory techniques. III Single or Multiple transdermal Administer rabies immunoglobulins and bites or scratches with saliva vaccine immediately. ** Stop treatment (i.e.licks) if the animal remains healthy throughout the observation period of 10 days*** or if animal is euthanised and found to be negative for rabies by appropriate laboratory techniques. ** If an apparently healthy dog or cat in or from a low risk area is placed under observation it may be justified to delay specific treatment. *** This observation applies only to dogs and cats. Continued

69 IMPORTANT NOTES ACTION Washing the wound copiously with soap and water Application of 70% alcohol, tincture of iodine, povidine iodine or any other suitable disinfectant (after all traces of soap have been removed) Proper infiltration of the wound with rabies immunoglobulin (RIG) of Human or Equine orign. As much as anatomically feasible should be infiltrated into and around the wound and the remaining. If any to be injected (by intramuscular route only) in the deltoid region away from the site of vaccine administration Administration of potent cell culture vaccine as per recognized schedules RESULTS Helps reduce the viral load by physically removing virus particles (with running water) and subsequently by inactivating some of the remaining virions by chemical disruption. This simple action, if promptly carried out, can significantly reduce the risk of developing rabies. Alcohol or other disinfectants lead to further inactivation of the remaining virions by chemical disruption. RIG is a specific-rabies-virus-neutralising antibody that immediately neutralizes the rabies virus on contact. Once the viruses are coated with antibody. They can not absorb onto and enter the nerve endings. This results in a further reduction (and in some cases complete obliteration) of the inoculated virus. Even in deeper tissues where the soap or alcohol may not have reached. Potent cell culture vaccine when administered according to the approved schedules results in the systemic production of anti-rabies antibodies after a lag period of 7 to 14 days. These circulating antibodies reach the wound site through the systemic circulation and are able to neutralize any remaining virus particles. FIRST-AID TREATMENT All the areas of the site of the bite or scratch site which may be infected with rabies virus should be immediately and thoroughly washed with soap or detergent with running water and 70% alcohol or an iodine preparation is applied AbhayRIG should be injected as soon as possible in case of suspected exposure. DOSAGE AND ADMINISYTRATION OF AbhayRIG For the prevention of rabies, combined immunoglobulin and rabies vaccine treatment is recommended for all category III exposure as per WHO classification of exposure. The recommended dose of AbhayRIG is 40IU/Kg of the body weight, if anatomically feasible, as much as possible of the dose should be infiltrated around the wounds. Administer the remainder of the dose, if any by deep intramuscular injection at a site separate from that used for the vaccine. Ensure that the wound has been adequately infiltrated with immunoglobulin locally before suturing, if suturing is necessary. The first dose of the vaccine should be inoculated at the same time as that of AbhayRIG, but at a different site on the body. In no cases should the dosage of AbhayRIG be exceeded because immunoglobulin may partially suppress active production of antibodies. Children and adults receive the same dose of 40 IU/Kg of body weight. In case the volume of AbhayRIG is low or insufficient for infiltration in case of child or in case of large bite site then it can be diluted in normal saline. When indicated, begin anti tetanus treatment and administer anti microbial drugs to control infections other than rabies. Discard any unused portion. UNDESIRABLE EFFECTS Immediate or delayed hypersensitive type reactions may be developed on administration of AbhayRIG. The observed immediate reactions are anaphylactoid reactions with hypertension, dyspnoea and urticaria. Delayed reactions consist of inflammatory reaction, fever, pruritis, rash or urticaria, adenopathy and arthralagia. Inform your doctor or pharmacist if you experience any undesirable effect. SRAGE CONDITIONS Store at a temperature between 2 o C and 8 o C in a refrigerator. DO NOT FREEZE. Vials of 5 ml. Each vial contains not less than 1500 IU of equine antirabies Immunoglobulin. Back

70 MEASLES, MUMPS AND RUBELLA VACCINE E.P Live, Attenuated, Freeze-dried Abhay-Vac 3 DESCRIPTION The vaccine is prepared from live, attenuated viruses, measles (Edmonston-Zagreb strain) and rubella (RA27/3 strain) grown in human diploid cells (HDC) and mumps (L-Zagreb strain) grown in cell culture of freezed dried vaccine dissolved with sterile water for injections enclosed. The dissolved vaccine is clear yellow to clear pink shade. When reconstituted as directed, each single human dose (0.5ml) contains not less than CCID 50 of measles virus CCID 50 of mumps virus CCID 50 of rubella virus. Inactive ingredients (Stabilizers) are: sorbitol, gelatin, L-arginin, maltose, sodium chloride, lactalbum hydrolysate and L-alanin. The production and control of measles, mumps and rubella vaccine (live) satisfies national requirements and the respective monograph of European pharmacopoeia (3 rd Edition) INDICATIONS The combined vaccine induces active protection against several infectious diseases i.e measles, mumps and rubella. The vaccine should be used at the age when children lose their passive protection by maternal antibodies for an optimal immunoreaction to be achieved by immunization. On immunization with the combined measles, mumps and rubella (MMR) vaccine, according to the two dose vaccination protocol, most children and adolescents presently receive two doses of the measles, mumps, rubella vaccine. The first dose is recommended to be given at the age of months. The second dose of MMR vaccine should be routinely administered at the age of 6-7 years. DOSAGE AND A vaccine dose is 0.5 ml. The freeze-dried vaccine should be dissolved immediately before use. A sterile needle and syringe should be used to draw the indicated amount of water for injection and to inject it into the vial with freeze-dried vaccine. Five vaccine doses are dissolved in 2.5 ml water for injection. Shaking the content gently to avoid the formation of foam, the vaccine is quickly dissolved, forming a homogenous suspension. Before vaccination, the vaccine should be warmed to body temperature by holding it in hand. Care must be taken for the vaccine not to come in contact with the disinfectant. The vaccine should be subcutaneously injected in the upper arm, in the deltoid region. In case of multi dosage packages, a new sterile syringe and needle must be used with each individual dose. Microbiologically, the vaccine should be used immediately upon package opening. If the vaccine is not used immediately, the user is responsible for the time and storage of open vaccine. Dissolved vaccine can be stored for a maximum of 8 hr at +2 o C to +8 o C, unless the vaccine has been opened and dissolved under controlled and validated aseptic conditions. ADVERSE REACTIONS Local Transient pain and irritation (edema, induration, erythema) at the site of injection. General: Side effects usually restricted to the individuals sensitive to some of the vaccines components have been recorded in 5-15% of subjects vaccinated with MMR vaccine after the first dose. Elevated body temperature occurring (Approximately) a week after the vaccination, and rash are the most common reactions to vaccination with a live attenuated measles virus. Rare reactions to mumps component manifest as elevated body temperature, swollen parotid glands and rash. Side effects associated with the rubella component are related to the vaccinee s age: arthralgia and arthritis after immunization are reported in the older groups of vaccinated girls. CONTRAINDICATIONS AND SPECIAL WARNINGS Vaccination is contraindicated in the following states - Febrile state - Pregnancy - immunodeficiency and immunosupression (primary and secondary caused by malignant diseases or use of drugs such as antimetabolites, corticosteroids, Continued

71 alkilating compounds and irritation) - Within three months from blood or plasma transfusion or immunoglobulin therapy, or within six months from exsanguinal transfusion. - hypersensitivity to the vaccine ingredients Diarrhea and mild acute diseases of the upper respiratory tract as well as HIV seropositive are not contraindications for the use of vaccines. Before immunization, through history must be taken. The children in higher risk of infectious diseases should be vaccinated in separate. They include the children with asthma, cystic fibrosis, celiac diseases, chronic pulmonary diseases, congenital cardiac diseases, Down syndrome, stable neurological status, malnutrition, and premature irrespective of the grade of prematurity. At least one month should elapse between the uses of two live viral vaccine, if not simultaneously administered. Tuberculin test (Mantoux test) should be performed before or two months after vaccination against measles, MMR, because of the vaccine may induce transient inhibition of cellular immunity. The MMR vaccine can be administered simultaneously with other live viral vaccines (diphtheria, tetanus and pertusis vaccine) without interfering any component immunogenicity. On simultaneous administration, mixing of other vaccines with measles, mumps and rubella vaccine in the same syringe is not advised. Keep adrenalin injection ready in case of anaphylactic shock. SRAGE The vaccine should be protected from light and stored at a temperature of +2 o C to +8 o C SHELF LIFE The expiration date of the freeze dried vaccine is 24 months from the last date of initiation of potency test. 5 dose vials plus ampoule with diluent (2.5 ml) Back

72 MEASLES VACCINE E.P Live, attenuated, freeze-dried Abhay-M DESCRIPTION The vaccine is prepared from live, attenuated measles virus ((Edmonston-Zagreb strain ) grown in human diploid cells (HDC). Freeze-dried vaccine is dissolved with sterile water for injections enclosed. The dissolved vaccine is yellow to clear pink shade. When reconstituted as directed, each single human dose (0.5ml) contains not less than: CCID 50 of measles virus Inactive ingredients (stabilizers) are: sorbitol, gelatine, L-arginin, maltose, sodium chloride, lactalbumin hydrolysate and L-alanin. The production and control of measles vaccine (live) satisfies national requirements and the respective monograph of European Pharmacopoeia (3 rd ed.) INDICATIONS The vaccine induces active protection against measles. The vaccine should be used at the age when children lose their passive protection by maternal antibodies for an optimal immunoreaction to be achieved by immunization. A single dose of measles vaccine is sufficient to provide prolonged immunity to infection. In countries where the incidence and mortality from measles in the first year of life is high, the recommended age for Immunization is as soon as possible after 9 months of age. Countries where measles are lss of a problem may decide to immunize later. DOSAGE AND A vaccine dose is 0.5ml. The freeze-dried vaccine should be dissolved immediately before use. A sterile needle and syringe should be used to draw the indicated amount of water for injection and to inject it into the vial with freeze-dried vaccine. Ten vaccine doses are dissolved in 5.0ml water for injection. Shaking the content gently to avoid the formation of foam, the vaccine is quickly dissolved, forming homogenous suspension. Before vaccination, the vaccine should be warmed to body temperature by holding it in hand. Care must be taken for the vaccine not to come in contact with disinfectant. The vaccine should be administered subcutaneously in the upper arm, in the deltoid muscle region. In case of multi-dosage packages, a new sterile syringe and needle must be used with each individual dose. Microbiologically, the vaccine should be used immediately upon package opening. If the vaccine is not used immediately, the user is responsible for the time and storage of open vaccine. Dissolved vaccine can be stored for a maximum of 8 hr at C to +8 0 C, unless the vaccine has been opened and dissolved under controlled and validated aseptic conditions. ADVERSE REACTIONS Mild adverse events: Within 24 hours of vaccination, recipients may experience transient pain and irritation at the site of injection. Mild systemic reactions may also occur like moderate fever, which occurs in 5-15% of recipients and rash, which occurs in approximately 2% of vaccines. The rash typically occurs 7-10 days after the vaccination and lasts 2 days. Severe adverse events: Hypersensitivity reactions, including urticaria at the injection site, rarely occur. Anaphylactic reactions are extremely rare( 1 to 2 per million doses of measles vaccine) and could be caused by allergy to gelatine, a stabilizer used in vaccine production. The risk of post-vaccination encephalitis/encephalopathy is less than one per million doses of measles vaccine, which is 1000 times less than th erisk from natural measles infection. Measles vaccination reduces the occurrence of subacute sclerosing panencephalitis. On rare occasions use of a measles containing vaccine can cause febrile seizures. There are no scientifically based results, which can prove the association between measles vaccination and inflammatory bowel disease and autism. CONTRAINDICATIONS Vaccination is contraindicated in the following states: - febrile state, - pregnancy, - immunodeficiency and immunosupression (primary or secondary caused by malignant diseases or use of drugs such as antimetabolics, corticosteroids, alkilating compounds and irradiation) Within three months from blood or plasma transfusion or immunoglobin therapy, or within six months from exsanguinal transfusion. Hypersensitivity to vaccine ingredients Diarrhea and mild acute diseases of the upper respiratory tract as well as HIV Continued

73 seropositivity are not contraindications for the use of vaccine. Before immunization, thorough history must be taken. The children in higher risk of infectious diseases should be vaccinated in separate. They include the children with asthma, cystic fibrosis celiac diseases, chronic pulmonary diseases, congenital cardiac diseases. Down syndrome, stable neurological status, malnutrition, and premature irrespective of the grade of prematurity. At least one month should elapse between the uses of two live viral vaccines, if not simultaneously administered. The measles vaccine can be administered simultaneously with other live viral vaccines (poliomyelitis, hepatitis B and yellow fever vaccine) and bacterial vaccines (diphtheria, tetanus and pertussis vaccine) without interfering with any component immunogenicity. On simultaneous administration, mixing of other vaccines with measles, vaccine in the same syringe is not advised. Tuberculin test (Mantoux test) should be performed before or two months after vaccination against measles, because the vaccine may induce transient inhibition of cellular immunity. Keep adrenaline injection ready in case of anaphylactic shock. SRAGE The vaccine should be protected from light and stored at a temperature of +2 o C to +8 o C SHELF LIFE The expiration date of the freeze - dried vaccine is 24 months from the last date of potency test. 10 dose vials plus ampoule with diluent (5.0ml) Back

74 For The Use Of Registered Medical Practioner Or Hospital Or Laboratory Only Abhay-M TM Vaccine, (I.P.) DESCRIPTION The freeze-dried measles vaccine vial contains live attenuated measles virus (Edmonston-Zagreb strain) propagated on human diploid cells (MRC-5). The freeze dried measles vaccine is a white or nearly white pellet. POTENCY Each does of 0.5ml contains Active lngredients: Not less than 1000 CCID 50 of measles virus Other Ingredients: 2.5% of gelatin. 5% of sorbiol. When reconstituted with the provided diluent (Sterile water for Injection)it yields a clear suspension for injection. CLINICAL PHARMACOLOGY Measles is a common childhood disease, caused by the measles virus that may be associated with serious complications and or death. For example, pneumonia and encephalitis are caused by measles. Abhay-M TM generates specific protective immune response against measles. INDICATIONS AND USAGE - For active immunization of all susceptible children at 9 months of age or at the earliest thereafter. - Measles vaccine is also recommended for children and adolescents who have never had documented measles or who have received live attenuated vac cine before the age of 12 months. - Persons of any age known to be sero-negative. - Minor illness, such as the common cold are not a contraindication to immuniza tion. CONTRAINDICATIONS - Acute febrile illness. - Known Allergy to any component of Abhay-M TM - Severely compromised renal function. - Decompensated cardiac status. - CNS Disorders. - Pregnancy. - Individuals with blood dyscrasias, lymphomas, or other generalized malignancies. - individuals undergoing treatment with immuno suppressive agents of any kind or with primary immunodeficiency. WARNINGS - If Abhay-M TM is used in persons who are otherwise immunocompromised, the expected immune response may not be obtained. - Administration of the vaccine should be deferred at least 3 months after administration of human immunoglobulin, plasma or whole blood. If repeated or large amounts of these substances have been given, a longer interval should be allowed. - Administration of attenuated live virus measles vaccine may temporarily de press tuberculin skin sensitivity. Therefore, if tuberculin test is to be done, it should be scheduled before administering measles vaccine or on the day of vaccination with reading 48 to 72 hours later. Otherwise, it should be post poned for 4 to 6 weeks. This avoids the possibility of a false negative re sponse. Although tuberculosis may be exacerbated by natural measles in fection, there is no evidence that measles vaccine has such effect. PRECAUTIONS - Extreme caution should be exercised if the vaccine is administered to per sons with a history of anaphylactic reactions and/thrombocytopenia. - The possibility of allergic reactions in individuals sensitive to components of the vaccine should be evaluated. Epinephrine HCI solution (1:1000) should be available for immediate use in case an anaphylactic or acute hypersensitivity reac tion occurs. Continued

75 UNDESIRABLE EFFECTS Abhay-M TM is generally well tolerated. Adverse events include LOCAL: Erythema and/or swelling around the site of injection. SYSTEMIC: Fever starting 5-12 days after vaccination, Rash, Seizures, Thrombocytopenia and Encephalopathy have been reported to be associated with measles vaccination. DOSAGE AND DOSAGE: One dose (0.5ml) of Abhay-M TM at 9 months of age, or as soon as possible there after followed by MMR Vaccine at months is recommended. : The vaccine should be administered by subcutaneous injection near the insertion of the deltoid muscle. The vaccine must not be injected intravenously. The site of the injection should be prepared with a suitable antiseptic. CAUTION: A new sterile disposable syringe should be used for each dose of the vaccine. WITHDRAWING THE STERILE DILUENT FROM A SEALED GLASS AMPOULE: Tap the ampoule to ensure that the diluent is in the lower portion, wipe the neck of the lower portion and wipe the neck of the ampoule with a suitable antiseptic. Snap off the top of the ampoule. With a sterile syringe and needle withdraw the required volume of sterile diluent from the ampoule. RECONSTITUTION OF FREEZE DRIED VACCINE: - Remove the flip off. - Do not remove tha rubber stopper from the vial. - Apply a piece of cotton with a suitable antiseptic to the surface of the rubber stopper of the vial and inject the sterile diluent into the vial gently. - Roll the vial gently between both palms to allow dissolution of the pellet without formation of foam. Withdraw the required dose (0.5ml) of the reconstituted vaccine into the syringe. - Carefully insert the needle into the subcutaneous tissue. IMMUNIZATION REGIMEN Primary-Immunization Schedule 1st Dose 9-12 months 2nd Dose (As MMR) months Dose for children out of step 2 MMR doses separated by an with schedule and older interval of at least 4 weeks. than one year. IMMUNIZATION IN SPECIAL SITUATIONS Pregnancy: Abhay-M TM should not be administered to pregnant woman and pregnancy should be avoided for four weeks following vaccination. PHARMACEUTICAL PARTICULARS Incompatibilities The EPI recommends simultaneous administration of measles vaccine with other EPI vaccines. SHELF LIFE Two years from the date of manufacture. Abhay-M TM Single dose and Multidose freeze-dried measles vaccine is presented in amber colored vials. - Single dose vial of lyophilized vaccine. - Five dose vial of lyophillzed vaccine. - Ten dose vial of lyophilized vaccine. Special Precautions for Storage The Abhay-M TM vaccine vial must be stored in the dark at or below +8 0 C. The Diluent Continued

76 (sterile water for injection) should not be frozen but should be kept cool. It is important to protect both the lyophilized and reconstituted vaccine from light. Instructions for use and handling Sterile disposable syringe free of preservatives, antiseptics and detergents should be used for each injection and/or reconstitution of the vaccine. A 25 guage, 5/8'' needle is recommended. The vaccine should preferably be used immediately after reconstitution. The unused reconstituted vaccine must be stored at +2 o C to +8 o C and used within 8 hours otherwise it must be discarded. Back

77 For The Use Of Registered Medical Practioner Only Elovac - B Hepatitis B Vaccine B.P(r DNA) DESCRIPTION Elovac-B (Recombinant Hepatitis - B vaccine) is a noninfectious recombinant DNA vaccine. It is a sterile suspension of purified major surface antigen of Hepatitis B virus (HBV). The Hepatitis B surface antigen (HBsAg) is produced from cultures of genetically engineered Pichia pastoris, containing the gene that codes for the HBsAg. The HBsAg protein released by disruption of Pichia pastoris cells is purified by various physiochemical methods. The purified antigen is adsorbed on Aluminium hydroxide gel to get bulk vaccine. The vaccine does not contain any material of human or animal origin. Elovac-B is commercially available as a sterile suspension, ready to use for I.M.injection. The vial must be shaken well before administration. Paediatric & Adolescent dose: Each 0.5ml dose contains 10mcg of Hepatitis B surface antigen (purified) adsorbed on 0.25mg Aluminium as Aluminium hydroxide and 0.025mg of Thiomersal as preservative. Adult dose Each 1 ml adult dose contains 20 mcg of Hepatitis B surface antigen (purified) adsorbed on 0.5 mg Aluminium as Aluminium hydroxide and 0.05mg of Thiomersal as preservative. CLINICAL PHARMACOLOGY Elovac-B generates specific protective immune response against HBsAg. For protection against HBV infection the anti-hbsag titre (Anti-HBs antibodies) should be more than or equal to 10 mlu/ml. INDICATIONS AND USAGE Elovac-B Vaccine is indicated for immunization against infection caused by all known subtypes of Hepatitis B virus. Routine vaccination New born, infants, children and adolescents. Vaccination of defined high risk populations High risk populations 1. People who have a job that involves contact with human blood (Ex: Health care personnel, Military personnel etc.). 2. Travelers to area where Hepatitis B is common. 3. Injectable drug abusers. 4. Patients who may require multiple blood transfusions. 5. Persons originating from areas of high endemicity. 6. Persons who have sex with someone infected with HBV 7. Persons who have sex with more than one partner. 8. Men who have sex with men. 9. People who live in the same house with someone who has chronic HBV infection. 10.Infants born to HBV positive mothers. CONTRAINDICATIONS Elovac-B Should not be administered to any person who has experienced a hypersensitivity reaction to any component of any Hepatitis B recombinant DNA vaccine. Elovac-B Should not be administered to subjects with severe febrile infections. WARNINGS Elovac-B may not prevent infection, if the vaccinee, at the time of immunization was harboring an unrecognized Hepatitis B infection. Not all vaccinees respond in the same manner to a given vaccine. The immune response may be dependant upon many factors. Some are mentioned below. Age over 40 years, Gender: Male, Smokers, Obese individuals, patients with immunodeficiency diseases or those receiving immuno-suppressive therapy or those who received the vaccine on the gluteal region, may have an unsatisfactory antibody titre. Hence adequate anti-hbs antibody titres may not be obtained after a primary course of immunization. In such persons additional doses of the vaccine may be required. The vaccine does not prevent infection by Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E or other pathogens known to infect the liver. Pregnancy: Adequate human and animal data on use during pregnancy is not available. Hepatitis B vaccine should be used during pregnancy only when definitely indicated, Continued

78 and the possible benefits outweigh the possible risks to the foetus. However as with all inactivated viral vaccines we don't anticipate any harm to the foetus. Lactation: Adequate human and animal data on use during lactation is not available. Caution should be exercised when Hepatitis B vaccine is administered to lactating women. Patients who develop symptoms suggestive of Hypersensitivity after an injection should not receive further injections of the vaccine. Interactions with other vaccines Elovac-B vaccine can be administered concomitantly with DPT, TT, DT, and OPV, if required. Elovac-B vaccine can be given together with Measles-Mumps-Rubella vaccines, Haemophilus influenza B vaccine, Hepatitis A vaccine and BCG vaccine. Different injections should be given at different sites using separate needles and syringes. Interchangeability with other Hepatitis B vaccines Elovac-B can be used for primary vaccinations as well as for booster doses. Even if the person has been vaccinated by any other Hepatitis B vaccine, the subsequent vaccination series may be continued using Elovac-B PRECAUTIONS - Caution and care should be exercised in administering the Vaccine to individuals with severe compromised cardiopulmonary status as systemic reaction could pose a significant risk - As with any injectable vaccine, epinephrine should be available for use in case of anaphylaxis or anaphyiactic reaction. - The vaccine should be well shaken before use. - In presence of minor infection Elovac-B to be used only when clearly needed and the possible advantage outweighs the possible risks. UNDESIRABLE EFFECTS Most common undesirable effects: Injection site: Mind soreness, indurations and erythema. Uncommon undesirable effects classified by body system: SYSTEMIC: Fatigue, low-grade fever and malaise. SKIN AND APPENDAGES: Rash, pruritis and urticaria. MUSCULOSKELETAL SYSTEM: Arthralgia and myalgia. DIGESTIVE SYSTEM: Nausea, vomiting, diarrhoea and abdominal pain. HEPABILIARY SYSTEM: Abnormal liver function tests. NERVOUS SYSTEM: Dizziness and paresthesia. Extremely rare undesirable effects classified by body system: SYSTEMIC: Anaphylaxis, serum sickness, angioedema and erythema multiforme. MUSCULOSKELETAL SYSTEM: Arthritis. CVS: Syncope and hypotension. NERVOUS SYSTEM: Neuropathy, neuritis (including Guillain - Barre' syndrome, opticneuritis), encephalitis and meningitis. RESPIRARY SYSTEM: Bronchoconstriction like symptoms. LYMPHOID SYSTEM: Lymphadenopathy. DOSAGE AND DOSAGE: - NEONATES AND CHILDREN TILL THE AGE OF 19 YEARS: The recommended dose of Elovac-B is 10mcg of antigen protein in 0.5ml sus pension. - ADULT OVER THE AGE OF 19 YEARS: The recommended dose of Elovac-B is 20mcg of antigen protein in 1ml sus pension. - Elovac-B SHOULD NEVER BE GIVEN INTRAVENOUSLY. - Elovac-B Should be injected intramuscularly in the anterolateral thigh for neo nates and infants. - Elovac-B should be intramuscularly in the deltoid for adults. - Elovac-B should be not be administered in the gluteal region as the immune response may be lower. - Elovac-B may be administered subcutaneously in patients with severe bleed ing tendencies (e.g. haemophilics). Preparation for administration: - Elovac-B is presented as a ready to use suspension. Continued

79 - The vaccine should be shaken well to obtain a homogenous turbid white suspen sion. - The vaccine should be used as supplied and no dilution is necessary. - The vaccine should be inspected visually for particulate material or discolouration prior to administration. - Sterile needle and syringe should be used for withdrawal of vaccine. - Aseptic techniques should be followed. - Any vaccine remaining in a single dose vial should be discarded. Immunization Regimen: Primary immunization with Elovac-B consists of three intramuscular doses. The second dose given one month after the first and the third dose administered at least four months after the second dose of Elovac-B Immunization Schedule: 1st dose Given on fixed date 2nd dose 4-10 weeks after the 1st dose 3rd dose 4-20 weeks after the 2nd dose A booster dose is recommended 12 months after the 1st dose. A second booster dose may be required after 8 years in the high risk population if the antibody titre falls below 10 miu/ml. nization should start immediately after birth and preferably use 0, 1 and 2 months schedule. - Chronic haemodialysis Patients The recommended dosage of Elovac-B vaccine is 40 mcg (2ml) using a 0,1,2, 6 months vaccination schedule. Anti-HBs surveillance every 3-6 months is war ranted so as to maintain the accepted protective level of 10mlU/ml. Elovac-B is presented as a sterile ready to use slightly turbid white suspension for intra-muscular administration. Elovac-B is marked as: - 0.5ml and 1ml single dose vial ml and 10.0ml Multi-dose Vial. SRAGE: Protect form light. DO NOT GREEZE. Discard vial if contents are frozen. Elovac-B Must be stored and transported between +2 o C & + 8 o C. Elovac-B Must not be diluted to administer. Immunization in special situations - Known/presumed exposure to HBV First dose of Elovac-B vaccine can be administered simultaneously with Hepa titis B immunoglobulin, which however must be given at a separate injection site. - Neonates born to HBV carrier Mother First dose of Elovac-B vaccine can be administered simultaneously with Hepa titis B immunoglobulin, which must be given at separate injection site. The immu Back

80 For The Use Of Registered Medical Practioner Or Hospital Or Laboratory Only Abhay-X TM Tetanus Vaccine (Adsorbed) I.P. DESCRIPTION Abhay - X TM Tetanus Vaccine (Adsorbed) manufactured by Human Biologicals Institute, for intramuscular injection, is a sterile suspension of Aluminium phosphate adsorbed tetanus toxoid in isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish in colour. Each dose of 0.5ml contains: Active Ingredients: Tetanus toxoid > 5 Lf to < 25 Lf Other ingredients: Adsorbed on AIPo 4 > 1.5mg Thiomersal 0.01% as preservative. CLINICAL PHARMACOLOGY Natural immunity to Clostridium tetani does not occur. The antigen present in tetanus vaccine is from the formaldehyde treated exotoxin of Clostridium tetani. Following adequate immunization with tetanus vaccine, it is thought that protection persists for at least 10 years. INDICATIONS AND USAGE - All Infants 6 to 8 weeks of age or older, all children and all adults should be immu nized against tetanus with the primary series of tetanus vaccine and booster injec tion every 10 years. - Persons at increased risk of receiving lacerations and abrasions through their occu pation or recreational activities. - Pregnant woman who are not immunized or inadequately immunized. - Persons who are injured. CONTRAINDICATIONS - Patients with a history of systemic hypersensitivity to toxoids or any of the components of the vaccine. - Infants and children with high fever or acute illness. WARNINGS - Tetanus vaccine should not be given more frequently than once in every ten years for person with wound who has experienced severe Arthus type hyper sensitivity during the previous dose. - Pregnant Woman if infected with malaria, the transplacental transfer of antitoxin may be impaired. Pregnancy: There is extensive human experience in the administration of Tetanus Vaccine products and there is no evidence of teratogenicity. Lactation: There is no information on the excretion of Tetanus vaccine antigens or antibodies in breast milk during breast-feeding; however, it is unlikely that there is passage of the vaccine. PRECAUTIONS An antihistamine may be indicated for mild allergic reactions. For anaphylactic reactions, adrenaline or epinephrine (1 in 1000) may be used. UNDESIRABLE EFFECTS Local: Pain at the injection site followed by local redness or swelling and itching at the injection site is common which subsides without treatment. Systemic: Mild to moderate fever may be observed as systemic undesirable effect in few cases. DOSAGE AND Dosage: 0.5ml Intramuscular. From birth to the age of 7 years every child must receive at least 5 doses of a TT containing vaccine. Individuals 7 years of age and older who have not been immunized previously against tetanus, the primary immunization series of Tetanus Vaccine Adsorbed consists of three doses given at intervals of 4 to 8 weeks between the first and second dose and 6 to 12 months between the second and third dose as recommended by Immunization Practices Advisory Committee(ACIP 2 ) Preparation For Administration: Shake the vial to disperse the contents thoroughly immediately before withdrawing Continued