Pentaxim Description

Powder and suspension for suspension for injection.
PENTAXIM consists of a syringe pre-filled with a cloudy, whitish, sterile suspension and a vial of white powder.
After reconstitution one dose (0.5 mL) contains: Diphtheria toxoid¹ ≥20 IU^2,3 (30Lf); Tetanus toxoid¹ ≥40 IU^3,4 (10Lf); 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 antigen units⁶; Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated with tetanus protein 18-30 micrograms.
¹Adsorbed on hydrated aluminium hydroxide 0.3 mg Al³⁺.
²As lower confidence limit (p=0.95), and not less than 30 IU in mean value.
³Or equivalent potency determined by immunogenicity assessment.
⁴As a lower confidence limit (p=0.95).
⁵Produced on VERO cells.
⁶Or equivalent antigen quantity determined using an appropriate 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: Concerning the adsorbent, see as previously mentioned.
Suspension for injection: 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.
Powder: Sucrose, Tromethamol, Concentrated hydrochloric acid for pH adjustment.