Tetraxim Description

One dose (0.5 mL) contains: Diphtheria toxoid⁽¹⁾ ≥20 IU⁽²⁾⁽³⁾ (30 Lf); Tetanus toxoid⁽¹⁾ ≥40 IU⁽³⁾⁽⁴⁾ (10 Lf); Bordetella pertussis antigens; Poliomyelitis virus (inactivated).
Bordetella pertussis antigens: Pertussis toxoid⁽¹⁾ 25 micrograms; Filamentous haemagglutinin⁽¹⁾ 25 micrograms.
Poliomyelitis virus (inactivated)⁽⁵⁾: Type 1 (Mahoney) 29 D-antigen units⁽⁶⁾; Type 2 (MEF-1) 7 D-antigen units⁽⁶⁾; Type 3 (Saukett) 26 D-antigen units⁽⁶⁾.
⁽¹⁾Adsorbed on hydrated aluminium hydroxide 0.3 mg Al³⁺.
⁽²⁾As lower confidence limit (p=0.95) and not less than 30 IU in mean value.
⁽³⁾Or equivalent potency determined by immunogenicity assessment.
⁽⁴⁾As lower confidence limit (p=0.95).
⁽⁵⁾Cultivated in VERO cells.
⁽⁶⁾These antigen quantities are strictly the same as those previously expressed as D-antigen units 40-8-32, for type 1, 2, and 3 viruses respectively, when measured by another appropriate 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 effect 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.