PENTAXIM Powder and suspension for suspension for injection Ref.[28288] Active ingredients: Diphtheria toxoid Haemophilus influenzae B, combinations with toxoids Pertussis filamentous hemagglutinin Pertussis toxoid Poliomyelitis, serotype 1 Poliomyelitis, serotype 2 Poliomyelitis, serotype 3 Tetanus toxoid

After reconstitution one dose (0.5 ml) contains:

Diphtheria toxoid^(1)(2)*: ≥ 30 I.U

Tetanus toxoid^(1)(2)**: ≥ 40 I.U

Bordetella pertussis antigens:
Pertussis toxoid⁽¹⁾: 25 micrograms
Filamentous haemagglutinin⁽¹⁾: 25 micrograms

Poliomyelitis virus (inactivated)

• type 1 (Mahoney strain)⁽⁵⁾: 40 DU⁽³⁾⁽⁴⁾
• type 2 (MEF-1 strain)⁽⁵⁾: 8 DU⁽³⁾⁽⁴⁾
• type 3 (Saukett strain)⁽⁵⁾: 32 DU⁽³⁾⁽⁴⁾

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) Or equivalent activity determined by immunogenicity evaluation
(3) Or equivalent antigenic quantity determined by a suitable immunochemical method
(4) DU: D antigen unit.
(5) Produced on Vero cells

^* As mean value
^** As lower confidence limit (p=0.95)

PENTAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see Section 4.4).

Excipients with known effect: Phenylalanine: 12.5 micrograms (See section 4.4).

For the full list of excipients, see Section 6.1.