Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Posology and method of administration** **Posology** - From the age of 2 months, 3 successive doses of 0.5 mL of IMOVAX POLIO should be administered at intervals of one or two months, followed by a first booster 12 months after the last dose. - _For subsequent boosters, an injection is given every 5 years in children and adolescents and every 10 years in adults._ - In countries where a live Oral Poliomyelitis vaccine (trivalent, bivalent or monovalent OPV) is used in the routine immunisation programme, IMOVAX POLIO may be used in association (co-administration) or in sequential use with OPV, in accordance with WHO recommendations and in agreement with the national recommendations in effect. **Method of administration** Administration is performed preferably via the intramuscular (IM) route, or via the subcutaneous (SC) route. Intramuscular injection will be preferably performed in the antero-lateral side of the thigh in young children and in the deltoid muscle in children, adolescents and adults. For instructions on use, handling and disposal, see section Special precautions for disposal and other handling – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS, INTRAMUSCULAR
Medical Information
**Therapeutic indications** This vaccine is indicated for the prevention of poliomyelitis in infants, children and adults, for primary and booster vaccination. IMOVAX POLIO must be used according to effective official recommendations.
**Contraindications** Hypersensitivity to the active substances or 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_, or to any vaccine containing the same substances, to neomycin, streptomycin or polymyxin B. Common transient contraindications to any vaccination: in case of fever or acute illness, it is best to postpone vaccination.
J07BF03
poliomyelitis, trivalent, inactivated, whole virus
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI PASTEUR
Active Ingredients
Inactivated Poliomyelitis Virus Type 2 (MEF-1)
8 D.U./0.5 mL
Inactivated Poliomyelitis Virus Type 1 (Mahoney)
40 D.U./0.5 mL
Documents
Package Inserts
Imovax Polio Injection PI.pdf
Approved: April 10, 2023