VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

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.

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.