Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)
1ml1Units mL
GlaxoSmithKline Biologicals
Not Applicable Soma hati kamili
1 Infanrix TM-IPV Combined diphtheria-tetanus-acellular pertussis and inactivated polio QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International Units (IU) (25 Lf) Tetanus toxoid 1 not less than 40 International Units (IU) (10 Lf) Bordetella pertussis antigens Pertussis toxoid 1 25 micrograms Filamentous haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Poliovirus (inactivated) type 1 (Mahoney strain) 2 40 D-antigen unit type 2 (MEF-1 strain) 2 8 D-antigen unit type 3 (Saukett strain) 2 32 D-antigen unit 1adsorbed on aluminium hydroxide, hydrated (Al(OH) 3) 0.5 milligrams Al 3+ 2propagated in VERO cells Infanrix TM-IPV is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration. 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 poli Soma hati kamili