Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SUSPENSION
**4.2. Posology and method of administration** **Posology** Based on clinical experience with the trivalent vaccine, annual revaccination with influenza vaccine is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus might change from year to year. Adults: one dose of 0.5 mL. _Paediatric population_ - Children from 6 months to 17 years of age: one dose of 0.5 mL. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks. - Infants less than 6 months of age: the safety and efficacy of VaxigripTetra administration (active immunisation) have not been established. No data are available. Through passive protection, one 0.5 mL dose administered to a pregnant woman may protect infants from birth to almost 6 months of age; however, not all infants may be protected (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** The vaccine should be given by intramuscular or subcutaneous injection. The preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. _Precautions to be taken before handling or administering the medicinal product_ For instructions on preparation of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS, INTRAMUSCULAR
Medical Information
**4.1. Therapeutic indications** VaxigripTetra is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for: - active immunisation of adults, including pregnant women, and children from 6 months of age. The use of VaxigripTetra should be based on official recommendations.
**4.3. Contraindications** Hypersensitivity to the active substances, 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 component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9. Vaccination should be postponed in case of moderate or severe febrile disease or acute disease.
J07BB02
influenza, inactivated, split virus or surface antigen
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI WINTHROP INDUSTRIE - LE TRAIT (Primary and secondary packager)
SANOFI PASTEUR – VAL DE REUIL (VDR)
Active Ingredients
INFLUENZA VIRUS (SH) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
15 mcg/0.5 ml
INFLUENZA VIRUS (SH) A/Darwin/9/2021 (H3N2) - like strain ( A/Darwin/9/2021, IVR-228)
15 mcg/0.5 ml
INFLUENZA VIRUS (SH) B/Austria/1359417/2021 - likestrain(B/Michigan/01/2021, wildtype)
15 mcg/0.5 ml
INFLUENZA VIRUS (SH) A/Sydney/5/2021 (H1N1)pdm09 - like strain (A/Sydney/5/2021, SAN-013)
15 mcg/0.5 ml
Documents
Package Inserts
VaxigripTetra PI (SH2023).pdf
Approved: February 13, 2023