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.
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.
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.
4. How is Vaxigrip Tetra given?
Vaxigrip Tetra is given by your doctor, nurse or pharmacist.
5. What should I know about after being given Vaxigrip Tetra?
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Things you should do
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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.
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Looking after your medicine
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Vaxigrip Tetra is usually stored in the surgery or clinic, or at the pharmacy. However,
if you need to store Vaxigrip Tetra:
keep in the fridge between 2-8°C. Do not freeze.
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6. Are there any side effects?
Serious side effects can include severe allergic reactions, pain situated on the nerve
route, fits, neurological disorders that may result in stiff neck, confusion, numbness,
pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part
or all of the body and blood vessel inflammation which may result in skin rashes and
in very rare cases temporary kidney problems. See your doctor immediately if you notice this.
Common side effects include pain, tenderness, redness, swelling, bruising and hardness
at the injection site, headache, muscle aches, feeling unwell, fever, and shivering.
In children, other common side effects include irritability, abnormal crying, drowsiness,
appetite loss and vomiting. For more information, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): Influenza virus haemagglutinin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Vaxigrip Tetra. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Vaxigrip Tetra.
This vaccine can be given to adults and children so you may be reading this leaflet
for you or for your child.
Where to find information in this leaflet:
1. Why am I using Vaxigrip Tetra?
Vaxigrip Tetra contains the active ingredient influenza virus haemagglutinin.
Vaxigrip Tetra is a vaccine for persons 6 months of age and older. This vaccine helps
to protect you or your child against influenza (flu). 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.
When a person is given the vaccine, the immune system (the body’s natural defence
system) will produce its own protection against the influenza virus. None of the ingredients
in the vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different types of strains
that can change every year. This is why you need to be vaccinated every year. The
greatest risk of catching flu is during the cold months between June and September.
If you were not vaccinated in the autumn, it is still sensible to be vaccinated up
until the spring since you run the risk of catching flu until then. Your doctor will
be able to recommend the best time to be vaccinated.
As with all vaccines, Vaxigrip Tetra may not fully protect all persons who are vaccinated.
2. What should I know before I am given Vaxigrip Tetra?
Warnings
Do not use Vaxigrip Tetra:
if you are allergic to the active ingredients or any of the ingredients listed at
the end of this leaflet.
Symptoms 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. If you are not sure if you are allergic, talk
to your doctor, nurse or pharmacist before you receive Vaxigrip Tetra.
Always check the ingredients to make sure you can receive this vaccine.
Tell your doctor, nurse or pharmacist:
If you have an acute illness with or without high temperature.
If you have or have had an immune response problem because the immune response to
the vaccine may be diminished.
If you have a bleeding problem or bruise easily.
If you have ever fainted from an injection. Fainting, sometimes with falling, can
occur during, following, or even before, any injection with a needle.
If you have or have had Guillain-Barré syndrome (severe muscle weakness) after getting
a flu vaccine.
If you have a known allergy to egg protein.
After vaccination, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Your doctor
will discuss the possible risks and benefits of having Vaxigrip Tetra during pregnancy
or breastfeeding.
Vaxigrip Tetra can be used in all stages of pregnancy.
Vaxigrip Tetra may be used during breast-feeding.
Due to the known adverse consequences of influenza infection in pregnant women, health
authorities recommend vaccination for pregnant women.
Your doctor should make sure the benefits of vaccination outweigh the risks when recommending
Vaxigrip Tetra.
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 any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy, supermarket or health food shop.
Your doctor will advise you if Vaxigrip Tetra is to be given with another vaccine.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect Vaxigrip Tetra.
4. How is Vaxigrip Tetra given?
How much is given
Vaxigrip Tetra is given by your doctor, nurse or pharmacist as a 0.5 mL injection
in the muscle in the upper arm (preferably). For infants, the injection is normally
given into the muscle of the thigh.
Children less than 9 years old, who have not been vaccinated against influenza before
require a second injection a month later. Doses of influenza vaccine for infants and
young children are decided by your doctor based on the official national recommendations.
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.
Driving or using machines
Do not drive or use machines if you are feeling unwell after vaccination. Wait until
any effects of the vaccine have worn off before you drive or use machines.
Looking after your medicine
Vaxigrip Tetra is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store Vaxigrip Tetra:
keep it where young children cannot reach it.
keep Vaxigrip Tetra in the original pack until it is time for it to be given.
keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Vaxigrip Tetra.
Do not use Vaxigrip Tetra after the expiry date which is stated on the carton after
EXP.
Do not use Vaxigrip Tetra if the packaging is torn or shows signs of tampering.
Getting rid of any unwanted medicine
Medicines including vaccines should not be disposed of via wastewater or household
waste. Ask your doctor, nurse or pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
What Vaxigrip Tetra contains
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Active ingredient
(main ingredient)
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Influenza virus haemagglutinin of the following strains
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238)
A/Thailand/8/2022 (H3N2)-like strain (A/California/122/2022, SAN-022)
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
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Other ingredients
(inactive ingredients)
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Sodium chloride, potassium chloride, dibasic sodium phosphate dihydrate, monobasic
potassium phosphate, water for injections, and traces of ovalbumin (egg protein),
neomycin, octoxinol-9 and formaldehyde.
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Potential allergens
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Vaxigrip Tetra may contain less than 0.05 microgram ovalbumin (egg protein) per dose.
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Do not take this vaccine if you are allergic to any of these ingredients.
Vaxigrip Tetra syringes are not made with natural rubber latex.
What Vaxigrip Tetra looks like
Vaxigrip Tetra suspension for injection is clear and slightly opalescent in colour.
Vaxigrip Tetra is available in packs of 1 or 10 single dose (0.5 mL) pre-filled syringes
with one separate needle or no needle provided per syringe.
AUST R 299922 – prefilled syringe needle free *
*Not all pack sizes may be marketed.
Who distributes Vaxigrip Tetra
Distributed by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
This leaflet was prepared in November 2023.
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