PENTAXIM VACCINE

**4.1 Therapeutic Indications** PENTAXIM (DTaP-IPV-Hib) is indicated for the joint prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive _Haemophilus influenzae_ type b infections (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.,), - for primary vaccination in infants from the age of 2 months, - for booster vaccination, one year after primary vaccination during the second year of life. This vaccine does not protect against infections caused by the other types of _Haemophilus influenzae_ nor against meningitis caused by other micro-organisms.

**4.3 Contraindications** - Hypersensitivity: - to one of the active substances of PENTAXIM, - to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_, - glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during manufacturing, and which may be present in trace amounts), - pertussis vaccine (acellular or “whole cell”). - Severe reaction after a previous injection of the vaccine or a vaccine containing the same substances. - Vaccination should be postponed in case of fever or acute illness. - Progressive encephalopathies. - Encephalopathy within 7 days of a previous dose of any vaccine containing pertussis antigens (“whole cell” or acellular pertussis vaccine).

SANOFI-AVENTIS SINGAPORE PTE. LTD.

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