Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)), hepatitis B surface antigen
GlaxoSmithKline Biologicals S.A.
J07CA12
diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Vaccines
Hepatitis B; Tetanus; Immunization; Whooping Cough; Poliomyelitis; Diphtheria
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Revision: 13
Withdrawn
2000-10-23
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, com ponent) (Pa), hepatitis B (rDNA) (HBV), poliom yelitis (inactivated) (IPV) 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 40 IU _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Hepatitis B surface antigen 2,3 10 micrograms Poliovirus (inactivated) type 1 (Mahoney strain) 4 40 D-antigen unit type 2 (MEF-1 strain) 4 8 D-antigen unit type 3 (Saukett strain) 4 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al 3+ 2 produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO4) 0.2 milligrams Al 3+ 4 propagated in VERO cells For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection Infanrix Penta is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliom y elitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Primary vaccination: The primary vaccination schedule consists of three doses of 0.5 m l (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months). There should be an interval of at least 1 month between doses. 2 Medicinal product no longer authorised The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth. Locally established immunoprophylactic measures against hepatitis B should be m a intained. Where a dose of hepatitis B vaccine is given at Read the complete document
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, com ponent) (Pa), hepatitis B (rDNA) (HBV), poliom yelitis (inactivated) (IPV) 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 40 IU _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Hepatitis B surface antigen 2,3 10 micrograms Poliovirus (inactivated) type 1 (Mahoney strain) 4 40 D-antigen unit type 2 (MEF-1 strain) 4 8 D-antigen unit type 3 (Saukett strain) 4 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al 3+ 2 produced in yeast cells ( _Saccharomyces cerevisiae_ ) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO4) 0.2 milligrams Al 3+ 4 propagated in VERO cells For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection Infanrix Penta is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliom y elitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Primary vaccination: The primary vaccination schedule consists of three doses of 0.5 m l (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months). There should be an interval of at least 1 month between doses. 2 Medicinal product no longer authorised The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth. Locally established immunoprophylactic measures against hepatitis B should be m a intained. Where a dose of hepatitis B vaccine is given at Read the complete document