PART 1 B SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

Transcription

1 BIOVETA, a. s. Komenského 212, Ivanovice na Hané, Czech Republic, PART 1 B SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

2 SUMMARY OF PRODUCT CHARACTERISTICS

3 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BioBos Respi 3 suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaccination dose (2 ml) contains: Active substances: Bovine respiratory syncytial virus (BRSV) inactivated, strain BIO-24 RP 1* Bovine parainfluenza 3 virus inactivated (PI3V), strain BIO-23 RP 1* Mannheimia (Pasteurella) haemolytica inactivated, strain DSM 5283, serotype A1 RP 1* * RP = Relative potency (ELISA) in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals. Adjuvants: Aluminium hydroxide hydrated for adsorption Quillaja saponin (Quil A) 8.0 mg 0.4 mg Excipients: Thiomersal Formaldehyde 35% solution 0.2 mg max. 1 mg For the full list of excipients, see section PHARMACEUTICAL FORM Suspension for injection. Rosy liquid with sediment. 4. CLINICAL PARTICULARS 4.1 Target species Cattle. 4.2 Indications for use, specifying the target species For active immunisation of cattle against: - bovine parainfluenza 3 virus, to reduce infection, - bovine respiratory syntytial virus, to reduce infection and clinical signs, - germs of Mannheimia (Pasteurella) haemolytica serotype A1, to reduce clinical signs and lung lesions. Onset of immunity: 3 weeks Duration of immunity: 6 months Safety and efficacy studies were performed in sero-negative calves. 4.3 Contraindications

4 Do not use in cases of hypersensitivity to the active substances, to the adjuvants or to any of the excipients. 4.4 Special warnings for each target species Vaccinate healthy animals only. 4.5 Special precautions for use Special precautions for use in animals: Basic immunisation needs to be initiated on time, so that the protection is fully developed from the beginning of the risky period of the animal. Basic immunisation of calves needs to be completed before common stabling or during quarantine. It is recommended to vaccinate all animals in the breed, if vaccination is not contraindicated in some animals, so that the infectious burden was minimised. Failure to vaccinate each animal helps to maintain and transfer pathogens and development of the disease in the breed. The level of antibody responses may be reduced by maternal antibodies obtained from the mothers in calves up to 3 months of age. Respiratory infections in calves are often associated with poor hygiene practices. Therefore general enhancement of hygiene practices is important to ensure good immunisation effect in vaccinated animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) Following vaccination a localised swelling may be observed very commonly at the injection site which relates to the adjuvant content. This swelling could reach up to 6 cm and usually subsides within 2 3 weeks after vaccination. There may be a common transient slight increase in body temperature lasting up to 3 days after vaccination. Anaphylactic-type reactions may occur very rarely after vaccination. In such cases, appropriate symptomatic treatment should be administered. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 4.7 Use during pregnancy, lactation or lay Do not use during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route

5 Vaccine dose 2 ml The vaccine is administered subcutaneously. Heat up the vaccine before use to a temperature of 15 to 25 C and shake the content of the vial. Basic immunisation: Calves from non-immune dams: 2 injections 3 weeks apart from 2 weeks of age Calves from immune dams: 2 injections 3 weeks apart from 3 months of age Revaccination: In problematic breeds, another revaccination is recommended within a period of 6 months after basic immunisation, possibly before risky period in particular breed (e.g. transfer of animals, change of the stabling system, etc.) Overdose (symptoms, emergency procedures, antidotes), if necessary No other adverse effects than those mentioned under section 4.6 (Adverse reactions) have been observed after administration of an overdose of the vaccine. Local reactions after subcutaneous administration of high dose were higher (up to 9 cm in diameter) than after standard dose Withdrawal periods Zero days. 5. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Immunologicals for cattle; inactivated viral and bacterial vaccines. ATCvet code: QI02AL04 The vaccine is intended for active immunisation of cattle against bovine respiratory syntitial virus, parainfluenza 3 virus and germs of Mannheimia (Pasteurella) haemolytica. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aluminium hydroxide hydrated for adsorption Thiomersal Formaldehyde 35% solution Quillaja saponin (Quil A) Water for injection Natrium chloride 6.2 Major incompatibilities Do not mix with any other veterinary medicinal product. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after first opening the immediate packaging: 10 hours Special precautions for storage Store in a refrigerator (2 C 8 C). Protect from frost

6 Protect from light. 6.5 Nature and composition of immediate packaging The vaccine is filled to glass vials: hydrolytic class I: 10 ml vials containing 10 ml (5 doses) hydrolytic class II: 50 ml vials containing 50 ml (25 doses), 100 ml vials containing 100 ml (50 doses) And to plastic vials: 15 ml vials containing 10 ml (5 doses), 60 ml vials containing 50 ml (25 doses), 120 ml vials containing 100 ml (50 doses) All types of vials are closed with rubber chlorobutyl stopper and secured with aluminium seal. The product is delivered in the following pack size: a/ plastic box with a cover, with 10 cavities 10 x 10 ml b/ cardboard box: 1 x 10 ml, 1 x 50 ml, 1 x 100 ml c/ carton for mass packaging 10 x 10 ml Each package contains an approved "Package leaflet. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Bioveta, a. s. Komenského 212/ Ivanovice na Hané Czech Republic 8. MARKETING AUTHORISATION NUMBER 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.

7 LABELLING AND PACKAGE LEAFLET

8 A. LABELLING

9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE 1x10 ml, 10x10ml, 1x50 ml, 1x100 ml/ cardboard box 10x10 ml / covered plastic box with 10 cavities: label /shawl etiquette 50ml, 100ml / etiquette} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BioBos Respi 3 suspension for injection for cattle 2. STATEMENT OF ACTIVE SUBSTANCES Each vaccination dose (2 ml) contains: Active substances: Bovine respiratory syncytial virus (BRSV) inactivated, strain BIO-24 RP 1* Bovine parainfluenza virus (PI3V) inactivated, strain BIO-23 RP 1* Mannheimia (Pasteurella) haemolytica inactivated, strain DSM 5283, serotype A1 RP 1* * RP = Relative potency (ELISA) in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals. 3. PHARMACEUTICAL FORM Suspension for injection. 4. PACKAGE SIZE 1x10 ml, 10x10 ml 1x50 ml, 1x100 ml <50 ml, 100 ml - etiquette> 5. TARGET SPECIES Cattle. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD Withdrawal period: Zero days.

10 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP: Once opened use by10 hours. 11. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Protect from frost. Protect from light SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet. 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bioveta, a. s., Komenského 212/12, Ivanovice na Hané, Czech Republic 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Batch:

11 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {10 ml /etiquette} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BioBos Respi 3 suspension for injection for cattle 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Each vaccination dose (2 ml) contains: Active substances: Bovine respiratory syncytial virus (BRSV) inactivated, strain BIO-24 RP 1 Bovine parainfluenza 3 virus (PI3V) inactivated, strain BIO-23 RP 1 Mannheimia (Pasteurella) haemolytica inactivated, strain DSM 5283, serotype A1 RP 1 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml 4. ROUTE(S) OF ADMINISTRATION Subcutaneous use. 5. WITHDRAWAL PERIOD Withdrawal period: Zero days. 6. BATCH NUMBER Batch {number} 7. EXPIRY DATE EXP {month/year} Once opened use by 10 hours. 8. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only.

12 B. PACKAGE LEAFLET

13 PACKAGE LEAFLET: BioBos Respi 3 suspension for injection for cattle 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorization holder and manufacturer responsible for batch release: Bioveta, a. s., Komenského 212/12, Ivanovice na Hané, Czech Republic 2. NAME OF THE VETERINARY MEDICINAL PRODUCT BioBos Respi 3 suspension for injection for cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each vaccination dose (2 ml) contains: Active substances: Bovine respiratory syncytial virus (BRSV) inactivated, strain BIO-24 RP 1* Bovine parainfluenza 3 virus (PI3V) inactivated, strain BIO-23 RP 1* Mannheimia (Pasteurella) haemolytica inactivated, strain DSM 5283, serotype 1A RP 1* * RP = Relative potency (ELISA) in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals. Adjuvants: Aluminium hydroxide hydrated for adsorption Quillaja saponin (Quil A) Excipients: Thiomersal Formaldehyde 35% solution 8.0 mg 0.4 mg 0.2 mg max. 1 mg Pinkish liquid with sediment. 4. INDICATION For active immunisation of cattle against: - bovine parainfluenza 3 virus, to reduce infection, - bovine respiratory syntytial virus, to reduce infection and clinical signs, - germs of Mannheimia (Pasteurella) haemolytica serotype A1, to reduce clinical signs and lung lesions. Onset of immunity: 3 weeks Duration of immunity: 6 months

14 Safety and efficacy studies were performed in sero-negative calves. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances, to the adjuvants or to any of the excipients. 6. ADVERSE REACTIONS Following vaccination a localised swelling may be observed very commonly at the injection site which relates to the adjuvant content. This swelling could reach up to 6 cm and usually subsides within 2 3 weeks after vaccination. There may be a common transient slight increase in body temperature lasting up to 3 days after vaccination. Anaphylactic-type reactions may occur very rarely after vaccination. In such cases, appropriate symptomatic treatment should be administered. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Cattle. 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Vaccine dose 2 ml The vaccine is administered subcutaneously. Basic immunisation: Calves from non-immune dams: 2 injections 3 weeks apart from 2 weeks of age Calves from immune dams: 2 injections 3 weeks apart from 3 months of age Revaccination: In problematic breeds, another revaccination is recommended within a period of 6 months after basic immunisation, possibly before risky period in particular breed (e.g. transfer of animals, change of the stabling system, etc.). 9. ADVICE ON CORRECT ADMINISTRATION Heat up the vaccine before use to a temperature of 15 to 25 C and shake the content of the vial. Vaccinate only healthy animals. 10. WITHDRAWAL PERIOD

15 Zero days. 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. Store in a refrigerator (2 C 8 C). Protect from frost. Protect from light. Do not use this this veterinary medicinal product after the expiry date which is stated on the label. Shelf-life after first opening the immediate packaging: 10 hours. 12. SPECIAL WARNINGS Special precautions for use in animals: The basic immunization should be started in time so that the protection has been fully developed until the start of animals risk period. The basic immunization of calves must be finished before their joint stabling or during quarantine. It is recommended to vaccinate all animals in the herd, unless the vaccination is contraindicated in some animals, to minimize the infection stress. Omission of individual animals helps preserve and transfer pathogens and develop the disease in the herd. The level of antibody responses may be reduced by maternal antibodies obtained from the mothers in calves up to 3 months of age. Respiratory infections in calves are often connected with a poor hygiene practices. Therefore, the total improvement of hygiene practices is important for ensuring a good immunization effect in vaccinated animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Use during pregnancy, lactation: Do not use during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. Overdose (symptoms, emergency procedures, antidotes): No undesirable effects except those mentioned under section 6. (Adverse reactions) were observed. The local reactions after subcutaneous administration of excessive dose were larger (up to 9 cm in diameter) than after a standard dose. Incompatibilities: Do not mix with any other veterinary medicinal product. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

16 Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION The vaccine is filled in glass vials of hydrolytic class I or II and plastic vials compliant with Ph.Eur., closed with rubber chlorobutyl puncturable stopper, secured with aluminium seal. Pack size: 1 x 10 ml, 10 x 10 ml 1 x 50 ml, 1 x 100 ml Not all pack sizes may be marketed.