Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide
GlaxoSmithKline Biologicals S.A.
J07CA10
diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
Vaccines
Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Diphtheria
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.The use of Quintanrix should be determined on the basis of official recommendations.
Revision: 2
Withdrawn
2005-02-17
Medicinal Product no longer authorised 32 B. PACKAGE LEAFLET Medicinal Product no longer authorised 33 PACKAGE LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING THIS MEDICINE. - Keep this leaflet until your child has finished the complete vaccination course. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for your child and should not be passed on to others. IN THIS LEAFLET : 1. What Quintanrix is and what it is used for 2. Before your child receives Quintanrix 3. How Quintanrix is given 4. Possible side effects 5. Storing Quintanrix 6. Further information QUINTANRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus_ _type b conjugate vaccine (adsorbed) - The active substances contained in 1 dose (0.5 ml) of Quintanrix are: Diphtheria toxoid 1 not less than 30 International Units Tetanus toxoid 1 not less than 60 International Units Inactivated _Bordetella pertussis_ 2 not less than 4 International Units Hepatitis B surface antigen (rDNA) 2, 3 10 micrograms _Haemophilus influenzae_ type b polysaccharide (polyribosylribitol phosphate) 2 2.5 micrograms conjugated to tetanus toxoid as a carrier 5-10 micrograms 1 adsorbed on aluminium hydroxide, hydrated Total: 0.26 milligrams Al 3+ 2 adsorbed on aluminium phosphate Total: 0.40 milligrams Al 3+ 3 produced in _Saccharomyces_ _cerevisae_ cells by recombinant DNA technology - The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and water for injections. MARKETING AUTHORISATION HOLDER AND MANUFACTURER: GlaxoSmithKline Biologicals s.a. Rue de l’Institut 89 B-1330 Rixensart Belgium 1. WHAT QUINTANRIX IS AND WHAT IT IS USED FOR Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing Lire le document complet
Medicinal Product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus_ _type b conjugate vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International Units Tetanus toxoid 1 not less than 60 International Units Inactivated _Bordetella pertussis_ 2 not less than 4 International Units Hepatitis B surface antigen (rDNA) 2, 3 10 micrograms _Haemophilus influenzae_ type b polysaccharide (polyribosylribitol phosphate) 2 2.5 micrograms conjugated to tetanus toxoid as a carrier 5-10 micrograms 1 adsorbed on aluminium hydroxide, hydrated Total: 0.26 milligrams Al 3+ 2 adsorbed on aluminium phosphate Total: 0.40 milligrams Al 3+ 3 produced in _Saccharomyces_ _cerevisae_ cells by recombinant DNA technology For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. The lyophilised _Haemophilus influenzae_ type b (HIB) component is a white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by _Haemophilus influenzae_ type b and for booster immunisation of young children during the second year of life. The use of Quintanrix should be determined on the basis of official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Primary vaccination: _ The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendatio Lire le document complet