País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
DIPHTHERIA TOXOID
GLAXOSMITHKLINE PTE LTD
J07CA02
min 30 iu/0.5 ml
INJECTION
INTRAMUSCULAR
Prescription Only
GLAXOSMITHKLINE BIOLOGICALS SA
2003-04-25
_ _ 1_ _ INFANRIX TM -IPV COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS AND INACTIVATED POLIO QUALITATIVE AND QUANTITATIVE COMPOSITION _INFANRIX_ _TM_ _-IPV_ contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton outer membrane protein) adsorbed on aluminium salts. It contains three types of inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain. The diphtheria and tetanus toxoids obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I Bordetella pertussis from which the PT, FHA and pertactin are extracted and purified. FHA and pertactin are treated with formaldehyde, PT is treated with glutaraldehyde and formaldehyde, and irreversibly inactivated. The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated with formaldehyde. The DTPa-IPV components are formulated in saline. _INFANRIX_ _TM_ _-IPV_ meets the World Health Organisation requirements for the manufacture of biological substances, of diphtheria, tetanus, pertussis and combined vaccines, and of inactivated poliomyelitis vaccines. A 0.5 ml dose of vaccine contains not less than 25 Lf ( min. 30 IU) of adsorbed diphtheria toxoid, not less than 10 Lf ( min. 40 IU) of adsorbed tetanus toxoid, 25 µg of PT, 25 µg of FHA, 8 µg of pertactin, 40 D antigen units of type 1 (Mahoney), 8 D antigen units of type 2 (MEF-1) and 32 D antigen units of type 3 (Saukett) of the polio virus. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS INDICATIONS _INFANRIX_ _TM_ _-IPV_ is indicated for active immunisation in infants from the ag Llegiu el document complet