INFLUVAC TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

4.1. Therapeutic indications

Prophylaxis of influenza, especially those who run an increased risk of associated complications.

Influvac® Tetra is indicated in adults and children from 6 months of age.

The use of Influvac® Tetra 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), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin.

Immunization shall be postponed in patients with febrile illness or acute infection.

4.2. Posology and method of administration

Posology

Adults: 0.5 ml.

Pediatric patients

Children from 6 months to 17 years of age: 0.5 ml.

Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: 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 Influvac® Tetra in infants have not been established.

Method of Administration

Immunization should be carried out by intramuscular or deep subcutaneous injection. The preferred sites for intramuscular injection are 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 administrating the medicinal product:

For instructions for 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.