Basic Information
PENTAXIM VACCINE
INJECTION, POWDER, FOR SUSPENSION
Regulatory Information
SIN14795P
June 5, 2015
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
May 30, 2025
XJ07CA06
Company Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Active Ingredients
(Prefilled Syringe) Poliovirus (inactivated) - Type 1 (Mahoney)
Strength: 40 DU/0.5 mL
Strength: min. 40 IU/0.5 mL
Strength: min. 30 IU/0.5 mL
(Prefilled Syringe) Poliovirus (inactivated) - Type 2 (MEF-1)
Strength: 8 DU/0.5 mL
Strength: 10 μg/0.5 mL
Strength: 25 μg/0.5 mL
Strength: 32 DU/0.5 mL
Strength: 25 μg/0.5 mL
Strength: 18 - 30 μg/0.5 mL
Detailed Information
Contraindications
**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).
Indication Information
**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.