Tetraxim Description

One 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-I strain)⁽⁵⁾ 8 DU^{(6) (7)}, type 3 (Saukett strain)⁽⁵⁾ 32 DU^{(6) (7)}.
⁽¹⁾ Adsorbed on aluminium hydroxide, hydrated 0.3 mg Al³⁺.
⁽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.
Excipients with known effect: Phenylalanine 12.5 micrograms.
Excipients/Inactive Ingredients: Hanks' medium 199 (without phenol red), Glacial acetic acid and/or sodium hydroxide (for pH adjustment), Formaldehyde, Phenoxyethanol, Anhydrous ethanol, Water for injections.
Hanks' medium 199 is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (such as glucose) diluted in water for injections.