Mencevax ACWY. 1 Name of the medicinal product Mencevax ACWY.
|
|
- Ralph Johnston
- 6 years ago
- Views:
Transcription
1 Mencevax ACWY 1 Name of the medicinal product Mencevax ACWY. 2 Qualitative and Quantitative Composition Mencevax ACWY is a lyophilized, preparation of purified polysaccharides from Neisseria meningitidis (meningococcus) of serogroup A, C, W 135 and Y. Mencevax ACWY meets the World Health Organisation requirements for biological substances and for meningococcal meningitis vaccines. Each 0.5 ml dose of the reconstituted vaccine contains 50 µg of each of the polysaccharide serogroups A, C, W 135 and Y. 3 Pharmacuetical form Lyophilised powder for reconstitution with solution for injection. 4 Clinical particulars 4.1 Therapeutic indications Mencevax ACWY is indicated for the active immunization of adults and children over 14 years of age against meningococcal meningitis caused by meningococci of serogroups A, C, W 135 and Y. The vaccine is particularly recommended for subjects at risk, for example those living in or visiting areas where the disease is epidemic or highly endemic. It is also recommended for subjects living in closed communities and close contacts of patients with disease caused by meningococci of serogroups A, C, W 135 and Y. It may also be used in individuals with terminal complement component deficiency, proferdin deficiency and functional or actual splenectomy 4.2 Posology and method of administration Posology The recommended dose of the vaccine must be administered. One immunizing dose of the reconstituted vaccine is contained in 0.5 ml. Method of administration Mencevax ACWY is for subcutaneous use only. Mencevax ACWY should under no circumstances be administered intravenously. 4.3 Contra-indications Mencevax ACWY should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration of Mencevax ACWY
2 4.4 Special warnings and special precautions for use As with other vaccines, the administration of Mencevax ACWY should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for immunization. Mencevax ACWY gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W 135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response. The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroup W 135 and Y. However, the seroconversion rate for the serogroup A is acceptable in children from the age of 6 months onwards. As with all injectable vaccines, appropriate medical treatment should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine should remain under medical supervision for 30 minutes after immunization. As with all vaccination, a solution of 1:1000 adrenalin should be available for injection should an anaphylactic reaction occurs. Mencevax vaccine should not under any circumstances be injected by the intravenous route. 4.5 Interaction with other medicaments and other forms of interaction Mencevax ACWY can be administered at the same time as other vaccines. Different injectable vaccines should always be administered at a different injection site. 4.6 Pregnancy and lactation Adequate human data on use during pregnancy and lactation and adequate animal reproduction studies are not available. On theoretical grounds, avoiding the administration of Mencevax ACWY is prudent unless there is a substantial risk of infection. 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects Mencevax ACWY may cause erythema, slight induration and tenderness or pain at the site of injection. Extremely rarely, headache, fatigue, fever, allergic reactions, including anaphylactoid reactions and somnolence have been reported. Miscellaneous neurological reactions have been reported very rarely although a causal relationship to Mencevax vaccine has not been established. 4.9 Overdose
3 5 Pharmacological properties 5.1 Pharmacodynamic properties Mencevax ACWY induces bactericidal antibodies against meningococci of the serogroups A, C, W 135 and Y. Administration of a single 0.5 ml dose of Mencevax ACWY elicits a significant bactericidal antibody response against meningococci of serogroups A, C, W 135 and Y in about 95% of subjects. Polysaccharide A is known to be immunogenic in infants from the age of six months. The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroups W 135 and Y. 5.2 Pharmacokinetik properties Evaluation of pharmacokinetic is not required for vaccines 5.3 Preclinical safety data 6 Pharmaceutical particulars 6.1 List of excipients Vaccine: lactose Diluent: Sterile saline solution (and phenol for multidose presentations). 6.2 Incompatibilities Mencevax ACWY should not be mixed with other vaccines. 6.3 Shelf life The expiry date of the vaccine is indicated on the label and on packaging. When stored under prescribed conditions of temperatures between +2 o C and +8 o C, the shelf life is two years. After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If it is not use within eight hours, it should be discarded because of the risk of contamination. It is recommended to protect the reconstituted vaccine from direct sunlight. 6.4 Special precautions for storage The lyophilized vaccine should be stored in a refrigerator between +2 o C and +8 o C or in a freezer. The diluent can be stored at ambient temperature. When supplies of Mencevax ACWY are distributed from a central cold-store, it is good practice to arrange transport under refrigerated conditions, particularly in hot climates. If the lyophilized vaccine has been accidentally exposed to high temperatures not exceeding the
4 time and temperature limits indicated below, the expiry date no longer applies: it should preferably either be used immediately or stored at 20 o C. If it is thought that the thermal stability limits have been exceeded, the lyophilized vaccine should be discarded or, if economically justified, be re-tested for potency before use. - Additional information on the stability The following experimental data give an indication of the stability of the vaccine and are not recommendations for storage (see under special precautions for storage). Mencevax ACWY is stable for at least 6 months when storage at +22 o C. At a temperature of +45 o C, it retains its potency for at least 3 months and for 1 week at +60 o C. The reconstituted vaccine is stable for 1 month when kept at +4 o C and for at least 1 week at +25 o C and about 4 days when kept at +37 o C. 6.5 Nature and contents of container Mencevax ACWY is presented as a white pellet in a glass vial. The sterile diluent for the monodose presentation is clear and colourless and presented in a glass vial or ampoule. The sterile diluent for the multidose presentation (which contains phenol) can show a slight cloudiness and/or pink coloration and is presented in a glass vial. 6.6 Instruction for use, handling The vaccine should be inspected visually for any foreign particulate matter and/or other coloration prior to administration. In the event of either being observed, discard the vaccine. Mencevax ACWY must be reconstituted by adding the entire contents of the supplied container of diluent to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent. Mencevax is a trademark. Reg. No. HARUS DENGAN RESEP DOKTER Imported by P.T. SmithKline Beecham Pharmaceuticals Bogor, Indonesia Manufacturer Glaxo SmithKline, Biologicals s.a Rue de I Institut 89,B-1330 Rixensatt Belgium
5
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2014
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in May 2014 TITLE Neisseria meningitidis serogroups A, C, W-135 and Y vaccine SCOPE Trade Names
More informationMENCEVAX ACWY PRODUCT INFORMATION
MENCEVAX ACWY PRODUCT INFORMATION Group A, C, W135 and Y polysaccharide meningococcal vaccine DESCRIPTION MENCEVAX ACWY is a lyophilized preparation of purified polysaccharides from Neisseria meningitidis
More informationSummary of Product Characteristics
Summary of Product Characteristics 1) NAME OF THE MEDICINAL PRODUCT Meningococcal A conjugate vaccine 5 micrograms, Lyophilized Brand name- MenAfriVac 2) QUALITATIVE AND QUANTITATIVE COMPOSITION After
More informationMENCEVAX ACWY PRODUCT INFORMATION
MENCEVAX ACWY PRODUCT INFORMATION Group A, C, W-135 and Y polysaccharide meningococcal vaccine NAME OF THE MEDICINE Mencevax ACWY meningococcal polysaccharide vaccine DESCRIPTION Mencevax ACWY is a lyophilized
More informationInfanrix TM Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa) vaccine
Infanrix TM Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa) vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Infanrix TM contains diphtheria toxoid, tetanus toxoid and three purified
More information1. QUALITATIVE AND QUANTITATIVE COMPOSITION
INFANRIX 1. QUALITATIVE AND QUANTITATIVE COMPOSITION contains diphtheria toxoid, tetanus toxoid, and three purified pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and 69 kilodalton
More informationPriorix TM Measles, mumps and rubella vaccine (live, attenuated)
Priorix TM Measles, mumps and rubella vaccine (live, attenuated) QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived
More informationFor the use only of Registered Medical Practitioners or a Hospital or a Laboratory HIBERIX
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory HIBERIX Haemophilus type b conjugated vaccine IP 1. NAME OF THE MEDICINAL PRODUCT Haemophilus type b conjugated vaccine
More informationMeningococcal polysaccharide vaccine Group A, Group C, Group Y and Group W-135
MENOMUNE ACYW-135 Meningococcal polysaccharide vaccine Group A, Group C, Group Y and Group W-135 Description The vaccine is a freeze-dried preparation of the group specific antigens from Neisseria meningitidis,
More informationBoostrix polio. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS
Boostrix polio 1. NAME OF THE MEDICINAL PRODUCT boostrix polio Combined diphtheria, tetanus, acellular pertussis and enhanced inactivated polio vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION boostrix
More informationWHO PACKAGE INSERT. GlaxoSmithKline Biologicals FluLaval. Dossier First - Chapter 1 to 10 for WHO
77 WHO PACKAGE INSERT 11 Chapter 4_Annex 4.4-1_ WHO leaflet_en - Page 1 78 1. NAME OF THE MEDICINAL PRODUCT, suspension for injection Influenza vaccine (split virion, inactivated) 2. QUALITATIVE AND QUANTITATIVE
More informationNEW ZEALAND DATA SHEET
1. PRODUCT NAME NEW ZEALAND DATA SHEET HIBERIX Haemophilus influenzae type b (Hib) powder and diluent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose
More informationPOLIORIX. Poliomyelitis Vaccine (Inactivated) IP. Inactivated Polio Virus Type 3 (Saukett strain)
POLIORIX Poliomyelitis Vaccine (Inactivated) IP QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.5 ml) of the vaccine cultivated on a continuous VERO cell line contains: Inactivated Polio Virus Type
More informationSUMMARY OF PRODUCT CHARACTRISTICS
1. NAME OF THE MEDICINAL PRODUCT Purified, Inactivated, Lyophilized Rabies Vaccine, Prepared on Vero Cells INDIRAB 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative Formula per dose of 0.5 ml (Single
More informationTYPHERIX PRODUCT INFORMATION (Salmonella typhi Vi polysaccharide)
TYPHERIX PRODUCT INFORMATION (Salmonella typhi Vi polysaccharide) DESCRIPTION TYPHERIX is a colourless, sterile liquid containing the cell surface Vi polysaccharide extracted from Salmonella typhi Ty2
More informationFluarix NH. 1. NAME OF MEDICINAL PRODUCT Fluarix NH Influenza vaccine (split virion, inactivated)
Fluarix NH 1. NAME OF MEDICINAL PRODUCT Fluarix NH Influenza vaccine (split virion, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluarix NH is an inactivated influenza vaccine (split virion),
More informationSUMMARY OF PRODUCT CHARACTRISTICS
1. NAME OF THE MEDICINAL PRODUCT Typhoid (Vi Capsular Polysaccharide)-Tetanus Toxoid Conjugate Vaccine. Typbar-TCV 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative Formula per dose of 0.5 ml (Single
More informationSUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) I.P. Injectable, Suspension for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains:
More informationIf official recommendations call for additional doses of measles, mumps, rubella and/or varicella, Priorix-Tetra can be used for these doses.
Page 1 of 7 INFORMATION FOR HEALTH PROFESSIONALS Home Consumers Health Professionals Regulatory Other Hot Topics Search PRIORIX-TETRA Live attenuated measles, mumps, rubella and varicella vaccine Presentation
More informationPriorix TM Measles, mumps and rubella vaccine
Priorix TM Measles, mumps and rubella vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn
More informationThis vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary and booster vaccinations.
NAME OF THE MEDICINAL PRODUCT IMOVAX POLIO, suspension for injection in a prefilled syringe or multidose Poliomyelitis vaccine (inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml)
More informationFor the use only of Registered Medical Practitioners or a Hospital or a Laboratory
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory INFANRIX Diphtheria Tetanus and Pertussis (Acellular Component) Vaccine (Adsorbed) Ph. Eur. 1. NAME OF THE MEDICINAL PRODUCT
More informationSummary of product characteristics As per Annexure C. SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1
Summary of product characteristics As per Annexure C SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1 1. NAME OF THE MEDICINAL PRODUCT. ANNEXURE C to MODULE I Measles, Mumps & Rubella Vaccine
More informationHIBERIX PRODUCT INFORMATION
HIBERIX PRODUCT INFORMATION NAME OF THE MEDICINE HIBERIX Haemophilus influenzae type b (Hib) vaccine DESCRIPTION Powder and diluent for solution for injection. After reconstitution, 1 dose (0.5 ml) contains:
More informationADT Booster Data Sheet
1. PRODUCT NAME ADT Booster. Diphtheria and Tetanus Vaccine (adsorbed) for revaccination. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ADT Booster is a suspension for intramuscular injection, containing
More informationPriorix TM Measles, mumps and rubella vaccine
Priorix TM Measles, mumps and rubella vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) CORE SPC FOR HUMAN TETANUS IMMUNOGLOBULIN FOR INTRAMUSCULAR USE (CPMP/BPWG/3730/02)
European Medicines Agency Human Medicines Evaluation Unit London, 27 July 2005 CPMP/BPWG/3730/02 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) CORE SPC FOR HUMAN TETANUS IMMUNOGLOBULIN FOR INTRAMUSCULAR
More informationSUMMARY OF PRODUCT CHARACTERISTICS
Registration No. 1B 12/46 Importer / Manufacturer: GPO-MBP SUMMARY OF PRODUCT CHARACTERISTICS 1. ME OF THE MEDICAL PRODUCT ORAL POLIOMYELITIS VACCINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vaccine
More informationBOOSTRIX. Combined diphtheria, tetanus, acellular pertussis vaccine
BOOSTRIX Combined diphtheria, tetanus, acellular pertussis vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 Tetanus toxoid 1 Bordetella pertussis antigens
More informationHavrix 1440 Adult / 720 Junior Inactivated hepatitis A vaccine
Proposed Package Insert (updated 1Jun12) Havrix 1440 Adult / 720 Junior Inactivated hepatitis A vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. One dose (1.0 ml) of Havrix 1440
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Varilrix, 10 3.3 PFU/0.5ml, powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml)
More informationHavrix 1440 Adult / 720 Junior Inactivated hepatitis A vaccine
Havrix 1440 Adult / 720 Junior Inactivated hepatitis A vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. One dose (1.0 ml) of Havrix 1440 Adult contains : Hepatitis A virus (inactivated)
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET Name of the Medicinal Product MENITORIX Haemophilus type b and Neisseria meningitidis group C conjugate vaccine Presentation MENITORIX is presented as a powder and diluent for reconstitution
More informationFluarix. 1. NAME OF MEDICINAL PRODUCT Fluarix Fluarix Junior Influenza vaccine (split virion, inactivated)
Fluarix 1. NAME OF MEDICINAL PRODUCT Fluarix Fluarix Junior Influenza vaccine (split virion, inactivated) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluarix is an inactivated influenza vaccine (split
More informationTWINRIX GlaxoSmithKline
TWINRIX GlaxoSmithKline 1. Name of medicinal product Twinrix 2. Qualitative and quantitative composition Twinrix is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated
More informationPriorix TM Measles, mumps and rubella vaccine
Priorix TM Measles, mumps and rubella vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn
More information2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Priorix 1. NAME OF THE MEDICINAL PRODUCT Priorix Measles, mumps and rubella vaccine (live, attenuated). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Priorix is a lyophilised mixed preparation of the attenuated
More informationRotarix TM. Rotavirus vaccine
Rotarix TM Rotavirus vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1 ml) contains: Live attenuated human rotavirus RIX4414 strain not less than 10 6.0 CCID 50 PHARMACEUTICAL
More informationBOOSTRIX QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACEUTICAL FORM CLINICAL PARTICULARS. Indications. Dosage and Administration
BOOSTRIX Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 Tetanus
More informationCERVARIX GlaxoSmithKline
CERVARIX GlaxoSmithKline International Data Sheet. Version 2 (31/01/2007) Cervarix 1. Name of the medicinal product CervarixTM Human Papillomavirus vaccine Types 16 and 18 (Recombinant, AS04 adjuvanted).
More informationFluarix. Fluarix Junior. Influenza vaccine (split virion, inactivated)
Fluarix Fluarix Junior Influenza vaccine (split virion, inactivated) QUALITATIVE AND QUANTITATIVE COMPOSITION Fluarix is an inactivated influenza vaccine (split virion), containing antigens (propagated
More informationCHANGCHUN CHANGSHENG LIFE SCIENCES LTD. Address: No.1615Yueda Road, Changchun, China Postcode: Summary of Product Characteristics
Summary of Product Characteristics 1. Name of the medicinal product Generic name: Varicella Vaccine (live) I.P, Freeze-dried 2. Qualitative and quantitative composition The composition of the product is
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Tritanrix HepB, suspension for injection Diphtheria, tetanus, inactivated whole cell pertussis and hepatitis B recombinant,
More informationRECONSTITUTION, DOSING AND ADMINISTRATION
Prescribing Information can be found within this document CORRECT RECONSTITUTION FOR SC AND IV ADMINISTRATION VELCADE (bortezomib) 3.5 mg powder for solution for injection is available for intravenous
More informationPentabio Vaccine (DTP-HB-Hib)
SUMMARY OF PRODUCT CHARACTERISTICS Product Name Pharmaceutical Form Strength Presentation : Pentabio : Suspension for injection : 1, 5 and 10 doses : Box of 10 vials @ 0.5 ml Box of 10 vials @ 2.5 ml Box
More informationCLINICAL PHARMACOLOGY INFANRIX DTPa vaccine, induces antibodies against all vaccine components.
INFANRIX PRODUCT INFORMATION NAME OF THE MEDICINE Diphtheria-tetanus-acellular pertussis (DTPa) vaccine DESCRIPTION INFANRIX DTPa vaccine is a sterile suspension which contains diphtheria toxoid, tetanus
More informationDATA SHEET PRIORIX-TETRA. Name of Medicinal Product
DATA SHEET Name of Medicinal Product PRIORIX-TETRA Live attenuated measles, mumps, rubella and varicella vaccine Presentation PRIORIX-TETRA is a sterile lyophilised mixed preparation of the attenuated
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 2. QUALITATIVE
More informationHavrix TM 1440 Adult / 720 Junior
Havrix TM 1440 Adult / 720 Junior 1. NAME OF THE MEDICINAL PRODUCT Havrix 1440 Adult Havrix 720 Junior Inactivated hepatitis A vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Havrix 1440 Adult One
More informationTRANSPARENCY COMMITTEE OPINION. 4 March 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 4 March 2009 MENCEVAX powder and solvent for solution for injection Meningococcal polysaccharide vaccine for serogroups
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1/50 1. NAME OF THE MEDICINAL PRODUCT ENGERIX B 10 micrograms/0.5 ml Suspension for injection Hepatitis B recombinant vaccine, adsorbed 2. QUALITATIVE AND QUANTITATIVE
More informationAUSTRALIAN PRODUCT INFORMATION - TRUMENBA (Meningococcal group B vaccine) suspension for injection pre-filled syringe
AUSTRALIAN PRODUCT INFORMATION - TRUMENBA (Meningococcal group B vaccine) suspension for injection pre-filled syringe 1. NAME OF THE MEDICINE Meningococcal group B vaccine. 2. QUALITATIVE AND QUANTITATIVE
More information2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citanest with Octapressin Dental 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Prilocaine Hydrochloride 30 mg (54 mg/1.8
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Human proteins g/l g/l of which human immunoglobulin at least to. 180 IU/ml 180 IU/vial
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT UMAN BIG 180 IU/ml Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. UMAN BIG 180 IU/1
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) CORE SPC FOR HUMAN NORMAL IMMUNOGLOBULIN FOR SUBCUTANEOUS AND INTRAMUSCULAR USE (CPMP/BPWG/282/00)
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 25 July 2002 EMEA/ COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) CORE SPC FOR HUMAN NORMAL IMMUNOGLOBULIN
More informationAUSTRALIAN PRODUCT INFORMATION NIMENRIX TM (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine)
AUSTRALIA PRODUCT IFORMATIO IMERIX TM (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) 1 AME OF THE MEDICIE Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine.
More informationNimenrix TM QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimenrix TM Meningococcal polysaccharide serogroups A,, W-135 and Y conjugate vaccine QUALITATIVE AND QUANTITATIVE OMPOSITION After reconstitution, 1 dose (0.5 ml) contains 5 micrograms of polysaccharide
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Human Medicines Evaluation Unit London, 27 April 2006 CPMP/BPWG/4027/02 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE CORE SPC FOR HUMAN PLASMA DERIVED
More informationMeningococcal Meningitis Vaccine (NmVac-2 A+ C ) Meningococcal Polysaccharide Vaccine Groups A+ C Combined
How is meningitis transmitted? Meningococcal Meningitis Vaccine (NmVac-2 A+ C ) Meningococcal Polysaccharide Vaccine Groups A+ C Combined Neisseria meningitidis causes meningitis disease in infants, children
More information1. TRADE NAME OF THE MEDICINAL PRODUCT
1. TRADE NAME OF THE MEDICINAL PRODUCT IGANTET 250 I.U. solution for injection in pre-filled syringe IGANTET 500 I.U. solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationMenveo Group A,C,W135 and Y conjugate vaccine - Summary of Produ...
Menveo Group A,C,W135 and Y conjugate vaccine Summary of Product Characteristics Updated 09-Oct-2015 GlaxoSmithKline UK 1. Name of the medicinal product Menveo powder and solution for solution for injection
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT GAMMANORM, 165 mg/ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (SC/IMIg) Human
More informationNIMENRIX PRODUCT INFORMATION. Meningococcal polysaccharide serogroups A, C, W-135 and Y conjugate vaccine
IMERIX PRODUCT IFORMATIO AME OF THE MEDICIE Meningococcal polysaccharide serogroups A, C, W-135 and Y conjugate vaccine DESCRIPTIO IMERIX is supplied as a white powder in a glass vial, together with a
More informationBotulinum Toxin Type A for Injection Ph.Eur. Brand Name: BOTO GENIE
Summary of Product Characteristics of Botulinum Toxin Type A for Injection Ph.Eur. Brand Name: BOTO GENIE Manufactured By: BIO-MED (P) LTD. C-96, Site No. 1, Bulandshahr Road Industrial Area, Ghaziabad
More informationFarmadol. Paracetamol 10 mg/ml INFUSION SOLUTION
Farmadol Paracetamol 10 mg/ml INFUSION SOLUTION Composition Each ml contains: Paracetamol 10 mg Pharmacology Pharmacodynamic properties The precise mechanism of the analgesic and antipyretic properties
More informationSummary of product characteristics As per Annexure C. SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1
Summary of product characteristics As per Annexure C SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1 1. NAME OF THE MEDICINAL PRODUCT. ANNEXURE C to MODULE I Inactivated Trivalent Influenza
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DigiFab, 40 mg/vial digoxin immune Fab, Powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each glass vial
More informationFasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
1. NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 ml of Fasturtec concentrate
More informationNEW ZEALAND DATA SHEET
EW ZEALAD DATA SHEET 1. PRODUCT AME injection with diluent. Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine. 2. QUALITATIVE AD QUATITATIVE COMPOSITIO After reconstitution, 1 dose
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Havrix Junior Monodose Vaccine suspension for injection in a pre-filled syringe Hepatitis A (inactivated) vaccine (adsorbed) Havrix Junior
More informationFor the use only of a Registered Medical Practitioner or a Hospital or a Laboratory SYNFLORIX
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory SYNFLORIX Pneumococcal Polysaccharide and Non-Typeable Haemophilus influenzae (NTHi) Protein D Conjugate Vaccine, adsorbed
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET 1. PRODUCT NAME VARILRIX (human albumin-free) live attenuated varicella vaccine Each dose of the reconstituted vaccine contains not less than 10 3.3 plaque-forming units (PFU) of
More informationSummary of product characteristics (SmPC)
Summary of product characteristics (SmPC) What is it and what does it contain? An agency of the European Union Table of contents 1.What is the summary of product characteristics (SmPC)? 2.Where SmPC information
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DigiFab (referred to as DIGIFAB) 40 mg/vial digoxin immune Fab, Powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationRotarix TM. Rotavirus vaccine. 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain
Rotarix TM Rotavirus vaccine QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain not less than 10 6.0 CCID50 PHARMACEUTICAL FORM Oral suspension.
More informationVACCINE MANAGEMENT. Recommendations for Handling and Storage of Selected Biologicals. January 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES
VACCINE MANAGEMENT Recommendations for Handling and Storage of Selected Biologicals January 2001 DEPARTMENT OF HEALTH AND HUMAN SERVICES DTaP: Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine
More informationTwinrix Inactivated hepatitis A and rdna hepatitis B vaccine (adsorbed)
Twinrix Inactivated hepatitis A and rdna hepatitis B vaccine (adsorbed) QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. One dose (1.0 ml) contains: Hepatitis A virus (inactivated) 1,2
More informationFor the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM. Oxiconazole Nitrate Cream
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM Oxiconazole Nitrate Cream QUALITATIVE AND QUANTITATIVE COMPOSITION ZODERM E CREAM contains: Oxiconazole
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL PRODUCT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Registration No.: 1C 10/54 (NBC) Importer / Manufacturer: MSD (Thailand) Ltd. / Merck Sharp & Dohme Corp., West Point, Pennsylvania 19486, USA SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICAL
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET 1. PRODUCT NAME PRIORIX powder for injection with diluent Live trivalent attenuated measles, mumps and rubella vaccine. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PRIORIX is a lyophilised
More informationCONJUGATE MENINGOCOCCAL (ACWY) VACCINE
Cumbria & Lancashire Vaccine PGD Group ADVISORY INFORMATION FOR USE WITH PATIENT SPECIFIC DIRECTION OR INDIVIDUAL PRESCRIPTION SIGNED BY GP OR NON-MEDICAL PRESCRIBER. CONJUGATE MENINGOCOCCAL (ACWY) VACCINE
More informationHuman plasma protein 50 mg/ml of which at least 96% is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml
Hepatect CP 1. NAME OF THE MEDICINAL PRODUCT Hepatect CP 50 IU/ml; solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. Human plasma protein 50 mg/ml of which
More informationSUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT Poliomyelitis Vaccine, Live (Oral) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.1 ml = 2 drops contains: Polio Virus Type 1 (Sabin strain) Not less than 10
More informationInactivated hepatitis A and rdna hepatitis B vaccine (adsorbed) 720 ELISA Units Hepatitis B surface antigen 3,4
Twinrix TM 1. NAME OF THE MEDICINAL PRODUCT Twinrix TM Inactivated hepatitis A and rdna hepatitis B vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. One dose (1.0ml)
More informationSUMMARY OF PRODUCT CHARACTERISTICS. INFANRIX-IPV+Hib powder and suspension for suspension for injection
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT INFANRIX-IPV+Hib powder and suspension for suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular component) (Pa),
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Generic Name: Influenza vaccine (human, live attenuated) Pandemic, Freeze dried
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Generic Name: Influenza vaccine (human, live attenuated) Pandemic, Freeze dried Brand Name: NASOVAC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NeisVac-C 1 0.5 ml Suspension for injection in pre-filled syringe Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed 2 QUALITATIVE
More informationGlaxoSmithKline Biologicals Rotarix WHO PACKAGE INSERT. Rotarix TM 1 WHO Package insert
GlaxoSmithKline Biologicals Rotarix WHO PACKAGE INSERT Rotarix TM 1 WHO Package insert GlaxoSmithKline Biologicals Rotarix Method of administration Rotarix is for oral use only. ROTARIX SHOULD UNDER NO
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Albuman 40 g/l is a solution containing 40 g/l (4%) of total protein of which at least 95% is human albumin.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Albuman 40 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Albuman 40 g/l is a solution containing 40 g/l (4%)
More informationSUMMARY OF THE PRODUCT CHARACTERISTICS. The content of electrolyte ions per sachet when made up to 125 ml of solution.
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Molaxole powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains following active substances Macrogol
More informationDATA SHEET. Product Summary. 1. Trade Name of Medicinal Product. Protamine Sulphate Injection BP. 2. Qualitative and Quantitative Composition
DATA SHEET Product Summary 1. Trade Name of Medicinal Product Protamine Sulphate Injection BP 2. Qualitative and Quantitative Composition Protamine Sulphate 10mg/ml 3. Pharmaceutical Form Solution for
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE CORE SPC FOR HUMAN ANTI-D IMMUNOGLOBULIN FOR INTRAMUSCULAR USE Revision 1
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 20 September 2007 CPMP/BPWG/574/99 Rev. 1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of the product: 1.1 Product name: EQUIRAB Rabies Antiserum - Equine 1.2 Strength: 1000 I.U. / 5 ml 1.3 Pharmaceutical Dosage form: Injection 2. Qualitative and
More informationSynflorix. Pneumococcal polysaccharide and Non-Typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine, adsorbed
Synflorix Pneumococcal polysaccharide and Non-Typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine, adsorbed QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains 1 microgram
More informationAminosteril N-Hepa 8%, solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Title Page Information Aminosteril N-Hepa 8% November 2001 1 (7) 1. NAME OF THE MEDICINAL PRODUCT Aminosteril N-Hepa 8%, solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution
More informationFor the use only of Registered Medical Practitioners or a Hospital or a Laboratory COBADEX SYRUP
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory COBADEX SYRUP Vitamin B12-B Complex Liquid QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml (one teaspoonful) contains:
More informationMODEL INSERT MEASLES, MUMPS AND RUBELLA (MMR) COMBINED VACCINE
MODEL INSERT MEASLES, MUMPS AND RUBELLA (MMR) COMBINED VACCINE DESCRIPTION The vaccine is a freeze-dried powder containing three viruses - measles, mumps and rubella. a) The measles vaccine component is
More information