Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SUSPENSION
**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_.
INTRAMUSCULAR
Medical Information
**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.
J07BB02
influenza, inactivated, split virus or surface antigen
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG
GlaxoSmithKline Biologicals SA
GlaxoSmithKline Biologicals (Filling)
Active Ingredients
Influenza Virus (SH) A/Sydney/5/2021 (H1N1)pdm09-like strain
15mcg HA/0.5ml
Influenza Virus (SH) A/Darwin/9/2021 (H3N2) - like strain
15mcg HA/0.5ml
Documents
Package Inserts
Fluarix Tetra Susp for Inj in PFS PI.pdf
Approved: April 21, 2023