FLUARIX SUSPENSION FOR INJECTION [SIN17468P]
Active ingredients: FLUARIX SUSPENSION FOR INJECTION
Product Info
FLUARIX SUSPENSION FOR INJECTION
[SIN17468P]
Product information
Active Ingredient and Strength | INFLUENZA VIRUS (NH) A/THAILAND/8/2022 (H3N2)-LIKE STRAIN - 15 MCG HAEMAGGLUTININ/0.5 ML |
Dosage Form | INJECTION, SUSPENSION |
Manufacturer and Country | GLAXOSMITHKLINE BIOLOGICALS, BRANCH OF SMITHKLINE BEECHAM PHARMA GMBH & CO. KG - GERMANY |
Registration Number | SIN17468P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BB02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
Indications
Fluarix 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 one influenza B virus lineage contained in the vaccine (see Pharmacodynamic effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The use of Fluarix should be based on official recommendations.
Dosing
Dosage and Administration
Fluarix should be administered as a single 0.5 mL injection.
Children 6 months to less than 9 years of age 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 less than 6 months have not been established.
Fluarix administration should be carried out by intramuscular injection, preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Contraindications
Contraindications
Hypersensitivity to any component of the vaccine (active substances, excipients) (see Qualitative and Quantitative Composition, List of Excipients – 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, other egg proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate.
