Pentaxim Description

The powder is white and the solvent cloudy whitish.
The active substances are: After reconstitution one dose (0.5 ml) contains: Diphtheria toxoid¹ >20 IU^2,3 (30 Lf), Tetanus toxoid¹ >40 IU^3,4 (10 Lf), Bordetella pertussis antigens: Pertussis toxoid¹ 25 micrograms, Filamentous haemagglutinin¹ 25 micrograms, Poliomyelitis virus (inactivated)⁵ Type 1 (Mahoney) 40 D antigen units⁶, Type 2 (MEF-1) 8 D antigen units⁶, Type 3 (Saukett) 32 D antigens units⁶, Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated with tetanus protein 18-30 micrograms.
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 Produced on VERO cells.
⁶ Or equivalent quantity of antigen determined by an appropriate immunochemical method.
Excipients/Inactive Ingredients: The other ingredients are: Suspension for injection: Hanks' Medium 199 without phenol red, Glacial acetic acid and/or sodium hydroxide (for pH adjustment), Formaldehyde, Phenoxyethanol, Ethanol, anhydrous, 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.
Powder: Sucrose, Trometamol, Concentrated hydrochloric acid for pH adjustment.