VAXIGRIP TETRA Inactivated Quadrivalent Influenza Vaccine (Split Virion) influenza virus haemagglutinin 60 mcg 0.5 mL suspension for injection in pre-filled syringe needle free 2024 Season

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Influenza virus haemagglutinin, Quantity: 15 microgram

Dostopno od:

Sanofi-Aventis Australia Pty Ltd

Farmacevtska oblika:

Injection, suspension

Sestava:

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

Pot uporabe:

Intramuscular, Subcutaneous

Enote v paketu:

10 Syringe + 10 needle, 1 Syringe + 1 needle

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Vaxigrip Tetra is indicated 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 for:,- active immunisation of adults, including pregnant women, and children from 6 months of age and older,- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections 4.2 Dose and method of administration, 4.4 Special warnings and precautions for use, 4.6 Fertility, pregnancy and lactation and 5.1 Pharmacodynamic properties ? clinical trials).

Povzetek izdelek:

Visual Identification: Colourless opalescent liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

2019-05-20

Navodilo za uporabo

VAXIGRIP TETRA
V
A
X
I
G
R
I
P
T
E
T
R
A
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VAXIGRIP TETRA?
Vaxigrip Tetra is a vaccine. This vaccine helps to protect you or your
child against influenza (flu). Vaxigrip Tetra is used to prevent
flu in persons of 6 months of age and older. If you are pregnant, one
dose of vaccine given to you during pregnancy may protect
your baby from birth to less than 6 months of age.
For more information, see Section 1. Why am I using Vaxigrip Tetra? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN VAXIGRIP TETRA?
Do not use if you have ever had an allergic reaction to Vaxigrip Tetra
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Vaxigrip Tetra? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Vaxigrip Tetra and affect how it
works. Tell your doctor, nurse or pharmacist if you are taking,
have recently taken or might take any other vaccines or medicines,
including medicines obtained without a prescription.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS VAXIGRIP TETRA GIVEN?
Vaxigrip Tetra is given by your doctor, nurse or pharmacist.
More instructions can be found in Section 4. How is Vaxigrip Tetra
given? in the full CMI.
5.
WHAT SHOULD I KNOW ABOUT AFTER BEING GIVEN VAXIGRIP TETRA?
THINGS YOU
SHOULD DO
Call your doctor straight away if:
you notice signs of allergic reaction may include difficulty
breathing, shortness of breath, swelling of the face,
lips, throat or tongue, cold, clammy skin, palpitations, dizziness,
weakness, fainting, rash or itching.
LOOKING AFTER
YOUR MEDICINE
Vaxigrip Tetra is usuall

Lastnosti izdelka

Property of the Sanofi group -
vaxi-tetra-ccdsv7-piv5-03dec21
Page 1
AUSTRALIAN PRODUCT INFORMATION – VAXIGRIP TETRA
INACTIVATED QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION),
INFLUENZA VIRUS HAEMAGGLUTININ
1
NAME OF THE MEDICINE
Inactivated quadrivalent influenza vaccine, split virion (Influenza
virus haemagglutinin)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vaxigrip Tetra is formulated to contain the following four influenza
strains*:
ACTIVE SUBSTANCE
QUANTITY
(PER 0.5 ML DOSE)
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019,
IVR-
215)
15 micrograms
HA**
A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, IVR-228)
15 micrograms
HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
15 micrograms
HA**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
15 micrograms
HA**
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
The type and amount of viral antigens contained in Vaxigrip Tetra
conform to the annual
requirements of the Australian Influenza Vaccine Committee (AIVC) and
the World Health
Organisation (WHO) recommendations for the 2022 season.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
Property of the Sanofi group -
vaxi-tetra-ccdsv7-piv5-03dec21
Page 2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vaxigrip Tetra is indicated 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. for:
- active immunisation of adults, including pregnant women, and
children from 6 months of age and
older
- passive protection of infant(s) from birth to less than 6 months of
age following vaccination of
pregnant women (see Sections 4.2 Dose and method of administration,
4.4 Special warnings and
precautions for use, 4.6 Fertility, pregnancy and lactation and 5.1
Pharmacodynamic prope