FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled syringe with needle

Summary of Product characteristics

                                1
AUSTRALIAN PRODUCT INFORMATION
FLUARIX TETRA (INFLUENZA VIRUS HAEMAGGLUTININ) SUSPENSION FOR
INJECTION
1
NAME OF THE MEDICINE
Quadrivalent influenza vaccine (split virion, inactivated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUARIX
TETRA
is
an
inactivated
and
purified
split
influenza
vaccine.
The
antigen
composition and strains for the 2021 influenza season corresponds to
the following types:
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019,
IVR-215)
A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019,
NIB-121)
B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type)
B/Phuket/3073/2013 – like strain (B/Phuket/3073/2013, wild type)
FLUARIX TETRA is prepared using whole virus cultivated in embryonated
hens' eggs. The
virus is concentrated and purified by clarification, adsorption and
centrifugation. The purified
whole virus is then treated with the detergent sodium deoxycholate and
again centrifuged, and
the resulting antigen suspension is inactivated with formaldehyde.
Each 0.5 mL vaccine dose contains 15 micrograms haemagglutinin of each
of four influenza
strains in phosphate buffered saline.
The manufacture of this product includes exposure to bovine derived
materials. No evidence
exists that any case of vCJD (considered to be the human form of
bovine spongiform
encephalopathy) has resulted from the administration of any vaccine
product.
FLUARIX TETRA meets the WHO requirements for biological substances and
influenza
vaccines and the European Pharmacopoeia requirements for influenza
vaccines.
The type and amount of viral antigens in FLUARIX TETRA conform to the
annual requirements
of the Australian Influenza Vaccine Committee (AIVC) and the New
Zealand Ministry of Health.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
2
3
PHARMACEUTICAL FORM
Suspension for injection.
FLUARIX TETRA is a colourless to slightly opalescent suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLUARIX TETRA is a quadrivalent vaccine indicated for act
                                
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