Pentaxim Description

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) 29 D antigen units⁶, Type 2 (MEF-1) 7 D antigen units⁶, Type 3 (Saukett) 26 D antigen units⁶; Haemophilus influenzae type b polysaccharide 10 micrograms, conjugated with tetanus protein 18-30 micrograms.
¹ Adsorbed on hydrated aluminium hydroxide 0.3 mg of 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 a lower confidence limit (p=0.95).
⁵ Produced on VERO cells.
⁶ These D-antigen quantities expressed by using parallel line method are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method (sigmoid method).
PENTAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see Contraindications).
Excipient 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, Trometamol, Concentrated hydrochloric acid for pH adjustment.