FLUARIX TETRA inactivated split influenza vaccine suspension for injection 0.5 mL pre-filled PRTC syringe without needle, SH2024 influenza season

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin, Quantity: 15 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Influenza virus haemagglutinin

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: dl-alpha-tocopheryl acid succinate; potassium chloride; sodium chloride; water for injections; polysorbate 80; dibasic sodium phosphate dodecahydrate; magnesium chloride hexahydrate; octoxinol 10; monobasic potassium phosphate

Administration route:

Intramuscular

Units in package:

10, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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 the influenza virus types A and B contained in the vaccine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).,The use of FLUARIX TETRA should be based on official recommendations.

Product summary:

Visual Identification: 1.25 ml glass syringes with Luer lock adapter and plastic rigid tip cap (PRTC) with new composition of syringe tip cap; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-08-19

Patient Information leaflet

FLUARIX
TETRA
1
FLUARIX TETRA
_Inactivated Split Influenza Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about FLUARIX
TETRA vaccine. It does not contain
all the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you or
your child having FLUARIX TETRA
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING FLUARIX TETRA TALK
TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT FLUARIX TETRA IS
USED FOR
FLUARIX TETRA is used to help
prevent certain types of influenza.
The vaccine works by causing the
body to produce its own protection
(antibodies) against four different
types of influenza virus.
The types of influenza antigen
contained in FLUARIX TETRA may
change from one year to another.
Each year, the Australian Influenza
Vaccine Committee (AIVC)
recommends which ones to include.
This decision is based on the types of
influenza virus thought most likely to
occur during the next flu season.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT FLUARIX
TETRA WILL ONLY PROTECT YOU
AGAINST THE FOUR TYPES OF INFLUENZA
VIRUS USED TO MAKE THE VACCINE. IT
WILL NOT PROTECT YOU FROM INFLUENZA
CAUSED BY OTHER TYPES OF INFLUENZA
VIRUS OR FROM INFECTIONS WITH OTHER
AGENTS CAUSING FLU-LIKE SYMPTOMS
(SUCH AS THE COMMON COLD).
FLUARIX TETRA cannot give you
or your child influenza because the
viruses in the vaccine have been
killed.
Influenza is an infectious illness and
is spread by small droplets from the
nose, throat or mouth of an infected
person. The most common
symptoms of influenza include fever,
sore throat, runny nose, coughing,
general aches and pains, headache,
weakness and tiredness, Most people
recover completely within a week.
The risk of serious complications
(e.g. pneumonia and death) is greater
in very young, very o

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 2022 influenza season corresponds to
the following types:
A/Victoria/2570/2019 (H1N1)pdm09-like virus
A/Darwin/9/2021 (H3N2)-like virus
B/Austria/1359417/2021-like (B/Victoria lineage) virus
B/Phuket/3073/2013-like (B/Yamagata lineage) virus
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 active
immunisation of adults and
children from 6 months of age for the prevention of influenza disease
caused