FLUARIX TETRA SUSPENSION FOR INJECTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Influenza Virus (SH) A/Thailand/8/2022 (H3N2) - like strain; Influenza Virus (SH) A/Victoria/4897/2022 (H1N1)pdm09-like strain; Influenza Virus (SH) B/Austria/1359417/2021 - like strain; Influenza Virus (SH) B/Phuket/3073/2013-like strain

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J07BB02

Pharmaceutical form:

INJECTION, SUSPENSION

Composition:

Influenza Virus (SH) A/Thailand/8/2022 (H3N2) - like strain 15mcg HA/0.5ml; Influenza Virus (SH) A/Victoria/4897/2022 (H1N1)pdm09-like strain 15mcg HA/0.5ml; Influenza Virus (SH) B/Austria/1359417/2021 - like strain 15mcg HA/0.5ml; Influenza Virus (SH) B/Phuket/3073/2013-like strain 15mcg HA/0.5ml

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2015-03-23

Summary of Product characteristics

1
FLUARIX TETRA
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), SUSPENSION
FOR
INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Fluarix Tetra suspension for injection in pre-filled syringe
Influenza vaccine (split virion, inactivated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluarix Tetra is an inactivated influenza vaccine (split virion),
containing antigens (propagated in
embryonated eggs) equivalent to the following strains:
A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022,
IVR-238);
A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237);
B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26);
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type).
Each 0.5 mL vaccine dose contains 15 µg haemagglutinin of each of the
recommended strains.
This vaccine complies with the World Health Organisation (WHO)
recommendation (Southern
Hemisphere) for the season
2024
.
For the full list of excipients, see
_section 5.1. _
Fluarix Tetra may contain traces of Formaldehyde, Sodium Deoxycholate,
Ovalbumin,
Gentamicin Sulphate and Hydrocortisone. The maximum amount of
Ovalbumin that may be
present is not more than 0.05 micrograms per dose.
3.
CLINICAL 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_
).
The use of Fluarix Tetra should be based on official recommendations.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fluarix Tetra should be administered as a single 0.5 mL injection.
2
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 i