Tetraxim Description

One dose (0.5 mL) contains: Diphtheria toxoid⁽¹⁾ ≥30 IU⁽²⁾⁽³⁾; Tetanus toxoid⁽¹⁾ ≥40 IU⁽²⁾⁽³⁾; Bordetella pertussis antigens; Poliomyelitis virus (inactivated).
Bordetella pertussis antigens: Pertussis toxoid⁽¹⁾ 25 micrograms; Filamentous haemagglutinin⁽¹⁾ 25 micrograms.
Poliomyelitis virus (inactivated): Type 1 (Mahoney strain)⁽⁴⁾ 40 DU⁽⁵⁾⁽⁶⁾; Type 2 (MEF-1 strain)⁽⁴⁾ 8 DU⁽⁵⁾⁽⁶⁾; Type 3 (Saukett strain)⁽⁴⁾ 32 DU⁽⁵⁾⁽⁶⁾.
⁽¹⁾ Adsorbed on hydrated aluminium hydroxide 0.3 mg Al³⁺.
⁽²⁾ IU: International Unit.
⁽³⁾ Or equivalent activity determined by evaluation of immunogenicity.
⁽⁴⁾ Produced on VERO cells.
⁽⁵⁾ DU: D-antigen unit.
⁽⁶⁾ Or equivalent antigenic quantity determined by a suitable immunochemical method.
Excipients/Inactive Ingredients: Aluminium hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other ingredients are: Hanks' medium 199 without phenol red (complex mixture of amino acids including phenylalanine, mineral salts, vitamins and other components such as glucose), glacial acetic acid and/or sodium hydroxide for pH adjustment, formaldehyde, phenoxyethanol, anhydrous ethanol and water for injections.