INFLUVAC, suspension for injection 0.5ml

3.1 Therapeutic indications

Prophylaxis of influenza; especially those who run an increased risk of associated complications. Influvac® 2021 is indicated in adults and children from 6 months of age. The use of Influvac® 2021 should be based on official recommendations.

Vaccination is particularly recommended for the following categories of patients, depending on national immunization policies:

• Persons aged ≥ 65 years, regardless their health condition.
• Adults and children with chronic disorders of the pulmonary or cardiovascular systems, including asthma.
• Adults and children with chronic metabolic diseases such as diabetes mellitus.
• Adults and children with chronic renal dysfunction.
• Adults and children with immunodeficiencies due to disease or immunosuppressant medication (e.g., cytostatics or corticosteroids) or radiotherapy.
• Children and teenagers (6 months – 18 years) who receive long-term acetylsalicylic acid containing medication, and might therefore be at risk for developing Reye’s syndrome following an influenza infection.

3.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 5.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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

3.2 Posology and method of administration

Posology

Adult: 0.5 ml.

Paediatric Population:

Children from 36 months onwards: 0.5 ml.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml may be given, for detailed instructions on administering a 0.25 ml or 0.5 ml dose, see section 5.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. The dose given should be in accordance with existing national recommendations. For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Children less than 6 months: the safety and efficacy of Influvac® 2021 in children less than 6 months have not been established. No data are available.

Method of Administration

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

Precautions to be taken before handling or administrating 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.