Fluarix Tetra Influenza Vaccine

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

INFLUENZA SPLIT VIRUS, INACTIVATED

Διαθέσιμο από:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Διεθνής Όνομα):

INFLUENZA SPLIT VIRUS, INACTIVATED

Μονάδες σε πακέτο:

1units Units; 1units Units

Κατασκευάζεται από:

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

Φύλλο οδηγιών χρήσης

Not Applicable

Αρχείο Π.Χ.Π.

INTERNATIONAL PRODUCT INFORMATION
CONFIDENTIAL
1
FLUARIX TETRA
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED), SUSPENSION
FOR
INJECTION
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/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021, IVR-227);
B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26);
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type).
This vaccine complies with the WHO recommended strains (Northern
Hemisphere) for the
season 2023/2024.
Each 0.5 mL vaccine dose contains 15 µg haemagglutinin of each of the
recommended
strains.
Fluarix Tetra meets the WHO requirements for biological substances and
influenza vaccines
and the European Pharmacopoeia requirements for influenza vaccines.
CLINICAL INFORMATION
INDICATIONS
Fluarix Tetra is a quadrivalent vaccine indicated for active
immunisation of adults and
children from 6 months of age for the prevention of influenza disease
caused by influenza
virus types A and B contained in the vaccine (see
_Pharmacodynamics_
).
The use of Fluarix Tetra should be based on official recommendations.
DOSAGE AND ADMINISTRATION
Fluarix Tetra 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 <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).
INTERNATIONAL PRODUCT INFORMATION
CONFIDENTIAL
2
CONTRAINDICATIONS
Fluarix Tetra should not be administered to subjects with known
hypersensitivity after previous
administration