Pentaxim Description

After reconstitution 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) 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⁾; Polysaccharide of Haemophilus influenzae type b 10 micrograms, conjugated to the tetanus protein 18-30 micrograms.
⁽¹⁾ Adsorbed on aluminium hydroxide, hydrated 0.3 mg Al³⁺.
⁽²⁾ As mean value.
⁽³⁾ Or equivalent activity determined by an immunogenicity evaluation.
⁽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.
Pentaxim may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see "Contraindications").
Excipient(s) with known effect: Phenylalanine 12.5 micrograms (see "Precautions").
Excipients/Inactive Ingredients: Suspension for injection: Hanks' 199 medium (without phenol red), Acetic acid glacial and/or sodium hydroxide (for pH adjustment), Formaldehyde, Phenoxyethanol, Anhydrous ethanol, Water for injections.
Hanks' 199 medium is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (such as glucose) diluted in water for injections.
Powder: Saccharose, Tromethamol, Concentrated hydrochloric acid for pH adjustment.
Concerning the adsorbent, see previously mentioned.