Tetraxim Vaccine Suspension for Injection in Prefilled Syringe

Adsorbed Diphtheria, Tetanus, Pertussis (acellular component) and Inactivated Poliomyelitis Vaccine I.P. Each dose (0.5 mL) contains: - Diphtheria toxoid (1) > = 30 IU (2) (3) - Tetanus toxoid (1) > = 40 IU (3) (4) - Bordetella pertussis antigens: Pertussis toxoid (1) 25 micrograms, Filamentous haemagglutinin (1) 25 micrograms - Poliomyelitis virus (inactivated) (4): - type 1 (Mahoney strain) (5) 40 DU (6) (7), - type 2 (MEF-1 strain) (5) 8 DU (6) (7), - type 3 (Saukett strain) (5) 32 DU (6) (7) (1) adsorbed on aluminium hydroxide, hydrated 0.3 mg Al^3+ (2) As mean value (3) Or equivalent activity determined by evaluation of immunogenicity (4) As lower confidence limit (p=0.95) (5) Produced on VERO cells (6) DU: D antigen unit (7) or equivalent antigenic quantity determined by a suitable immunochemical method. TETRAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B. Excipient(s) with known effect: Phenylalanine 12.5 micrograms