INFLUVAC TETRA influenza virus haemagglutinin 0.5mL vaccine prefilled syringe with 16 mm needle, 2024

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Influenza virus haemagglutinin, Quantity: 15 microgram

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Suspension

Composition:

Excipient Ingredients: magnesium chloride hexahydrate; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; water for injections; potassium chloride; calcium chloride dihydrate; sodium chloride

Administration route:

Intramuscular, Subcutaneous

Units in package:

Singles pack (1 x syringe), Tens pack (10 x syringes)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the prevention of influenza caused by influenza virus, types A and B.,For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines.,INFLUVAC TETRA is indicated in adults and children from 6 months of age and older.

Product summary:

Visual Identification: Colourless clear liquid, filled in single-dose syringes (glass, type I); Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-11-02

Patient Information leaflet

INFLUVAC
® TETRA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about receiving this medicine, speak to your doctor, nurse or
pharmacist.
1.
WHY AM I RECEIVING INFLUVAC TETRA?
INFLUVAC TETRA is an influenza vaccine containing inactivated
fragments from four types of influenza virus. This type of vaccine
is also known as a quadrivalent influenza vaccine. INFLUVAC TETRA is
used to prevent certain types of influenza (commonly called
the flu) and can be used in adults and children 6 months of age and
older.
For more information, see Section 1. Why am I receiving INFLUVAC
TETRA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE INFLUVAC TETRA?
Do not receive INFLUVAC TETRA if you have had an allergic reaction to
INFLUVAC TETRA, to any other influenza vaccine or to
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
INFLUVAC TETRA is given by injection. Tell the doctor, nurse or
pharmacist if you have ever fainted when receiving an injection.
INFLUVAC TETRA is usually stored at the pharmacy or at the doctor's
clinic or surgery. If you need to store the vaccine, keep it in
the fridge between 2°C to 8°C. Do not freeze.
For more information, see Section 2. What should I know before I
receive INFLUVAC TETRA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INFLUVAC TETRA and affect how it
works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS INFLUVAC TETRA GIVEN?
•
The doctor, nurse or pharmacist will give INFLUVAC TETRA as an
injection.
•
Generally, a single dose of 0.5 mL is given each year. For children
less than 9 years of age who have not previously been
vaccinated, a second dose of 0.5 mL should be given after an interval
of at least 4 weeks.
More in

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
INFLUVAC
® TETRA
_(Influenza virus haemagglutinin) Suspension for Injection _
1
NAME OF THE MEDICINE
Quadrivalent Influenza Vaccine, surface antigen, inactivated
(influenza virus haemagglutinin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INFLUVAC TETRA
is a purified, inactivated influenza vaccine (surface antigen),
containing the following
four influenza strains recommended for the 2022 influenza season:
•
A/Victoria/2570/2019 (H1N1)pdm09-like strain
(A/Victoria/2570/2019, IVR-215)
•
A/Darwin/9/2021 (H3N2)-like strain
(A/Darwin/6/2021, IVR-227)
•
B/Austria/1359417/2021-like strain (B/Victoria lineage)
(B/Austria/1359417/2021, BVR-26)
•
B/Phuket/3073/2013-like strain (B/Yamagata lineage)
(B/Phuket/3073/2013, wild type)
Each 0.5 mL dose contains 15 micrograms haemagglutinin per each of the
above mentioned viral strains, for
a combined total amount of 60 micrograms. Each strain has been
propagated in fertilised hens’ eggs from
healthy chickens.
The type and amount of viral antigens in INFLUVAC TETRA conform to the
requirements of the Australian
Influenza Vaccine Committee (AIVC) for the 2021 southern hemisphere
influenza season.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
INFLUVAC TETRA is a clear colourless liquid for injection in
pre-filled syringes (glass, type I).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention of influenza caused by influenza virus, types A and
B.
For full details regarding recommendations for influenza vaccination,
please refer to the relevant National
Immunisation Guidelines.
INFLUVAC TETRA is indicated in adults and children from 6 months of
age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 6 MONTHS OF AGE AND OLDER
: 0.5 mL dose
For children less than 9 years of age who have not previously been
vaccinated, a second dose of 0.5 mL should
be given after an interval of at least 4 weeks.
INFLUVAC
®
TETRA – PRODUCT INFORMATION
2
The Australian Immunisation Han