FLUARIX TETRA SUSPENSION FOR INJECTION

3.1 Therapeutic indications

Fluarix Tetra is indicated for active immunisation of adults and children from 6 months of age 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 (see Pharmacodynamics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The use of Fluarix Tetra should be based on official recommendations.

3.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 5.1 – 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), formaldehyde, gentamicin sulphate and sodium deoxycholate.

Immunisation should be postponed in patients with febrile illness or acute infection.

3.2 Posology and method of administration

Posology

Fluarix Tetra should be administered as a single 0.5 mL injection.

Children 6 months to less than 9 years, who have not previously been vaccinated against influenza should receive a second dose of 0.5 mL after an interval of at least 4 weeks.

Children aged <6 months:

The safety and efficacy of Fluarix Tetra in children aged <6 months have not been established.

Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).

Method of administration

Immunisation should be carried out by intramuscular injection.

Precautions to be taken before handling or administering the medicinal product.

For instructions for preparation of the medicinal product before administration, see section 5.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.