Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid
GlaxoSmithKline Biologicals S.A.
J07CA05
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Vaccines
Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from six weeks onwards (see section 4.2).
Revision: 15
Withdrawn
1996-07-19
Medicinal product no longer authorised 31 B. PACKAGE LEAFLET Medicinal product no longer authorised 32 PACKAGE LEAFLET: INFORMATION FOR THE USER TRITANRIX HEPB SUSPENSION FOR INJECTION Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING THIS VACCINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This vaccine has been prescribed for your child. Do not pass it on to others. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Tritanrix HepB is and what it is used for 2. Before your child receives Tritanrix HepB 3. How Tritanrix HepB is given 4. Possible side effects 5. How to store Tritanrix HepB 6. Further information 1. WHAT TRITANRIX HEPB IS AND WHAT IT IS USED FOR Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. • DIPHTHERIA : Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death. • TETANUS (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine. • PERTUSSIS (Whooping cough): Pertussis is a hig Aqra d-dokument sħiħ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Tritanrix HepB, suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 IU Tetanus toxoid 1 not less than 60 IU _Bordetella pertussis _ (inactivated) 2 not less than 4 IU Hepatitis B surface antigen 2,3 10 micrograms 1 Adsorbed on aluminium hydroxide, hydrated 0.26 milligrams Al 3+ 2 Adsorbed on aluminium phosphate 0.37 milligrams Al 3+ 3 Produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ The recommended dose is 0.5 ml. Primary vaccination: The primary vaccination schedule consists of three doses within the first six months of life. Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age. Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued. In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age. Three vaccine doses must be administered at intervals of at least 4 weeks. When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection. In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified. This may require separate vaccination with HBV and DTPw Aqra d-dokument sħiħ