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.
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, except egg proteins (e.g. ovalbumin). People with egg allergy, including severe
egg allergy, can be safely vaccinated unless they have previously experienced a serious
side effect from influenza vaccines.
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.
3. What if I am taking other medicines?
Some medicines may interfere with INFLUVAC TETRA and affect how it works.
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.
5. What should I know after receiving INFLUVAC TETRA?
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Driving or using machines
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INFLUVAC TETRA should not normally interfere with your ability to drive a car or operate
machinery.
In some people vaccination can cause dizziness or light-headedness. Make sure you
know how you react to INFLUVAC TETRA before you drive a car or operate machinery.
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6. Are there any side effects?
Most unwanted effects with INFLUVAC TETRA are mild and usually clear up within a few
days.
In adults and children, common side effects include pain and discomfort at the injection
site, headache, tiredness, muscle and joint aches/pains, generally feeling unwell,
shivering and sweating.
In children, other common side effects include stomach effects such as diarrhoea,
vomiting and loss of appetite, irritability, drowsiness, and fever.
Serious side effects such as a serious allergic reaction may occur rarely.
Active ingredient(s):
Quadrivalent Influenza Vaccine, surface antigen, inactivated (influenza virus haemagglutinin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INFLUVAC TETRA. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about receiving INFLUVAC TETRA.
Where to find information in this leaflet:
1. Why am I receiving INFLUVAC TETRA?
INFLUVAC TETRA is a quadrivalent influenza vaccine containing inactivated fragments
from four types of influenza virus.
INFLUVAC TETRA is used to prevent certain types of influenza (commonly called the
flu). The vaccine works by causing the body to produce its own protection (antibodies)
against four different types of influenza virus.
Each year new types of influenza virus can appear, so every year INFLUVAC TETRA is
changed to contain fragments of the new types of virus. Therefore, influenza vaccination
is recommended every year.
Please note that INFLUVAC 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).
INFLUVAC TETRA can be used in adults and children over the age of 6 months.
2. What should I know before I receive INFLUVAC TETRA?
Warnings
Do not receive INFLUVAC TETRA if:
You are allergic to any influenza vaccine or any of the ingredients listed at the
end of this leaflet, except egg proteins (e.g. ovalbumin). People with egg allergy,
including severe egg allergy, can be safely vaccinated unless they have previously
experienced a serious side effect from influenza vaccines. Signs of an allergic reaction
may include itchy skin rash, shortness of breath and swelling of the face or tongue.
You currently have a severe infection or fever. A minor infection such as a cold should
not be a problem, but talk to your doctor, nurse or pharmacist about this before being
vaccinated.
Check with your doctor, nurse or pharmacist if:
You have received INFLUVAC TETRA before and became unwell.
You have ever had an illness affecting the nervous system, especially Guillain-Barre
Syndrome (GBS). If you have had GBS, you may be more likely to develop GBS following
influenza vaccination than someone who has never had GBS.
You have any medical conditions, such as an immune deficiency condition, thrombocytopenia,
coagulation disorder or bleeding disorder.
You have ever fainted or fallen or felt faint just before or after receiving an injection.
Pregnancy and breastfeeding
Check with your doctor, nurse or pharmacist if you are pregnant or intend to become
pregnant. They will discuss with you the benefits and risks of receiving INFLUVAC
TETRA when pregnant.
Tell your doctor, nurse or pharmacist if you are breast feeding. They will discuss
the risks and benefits of vaccination however the vaccine is not expected to cause
problems for breast-fed babies.
Storage
INFLUVAC TETRA is usually stored at the pharmacy, at the doctor's surgery or at the
flu vaccination clinic.
If you need to store INFLUVAC TETRA, always:
Keep it in the refrigerator stored between 2°C to 8°C. Do not freeze as freezing destroys
the vaccine.
Keep it where young children cannot reach it.
Keep it in the original pack until it is time for it to be given.
Ask your pharmacist what to do with any leftover INFLUVAC TETRA that has expired or
has not been used.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you have received another vaccine this year
or if you are taking any other medicines, including any that you buy without a prescription
from your pharmacy, supermarket or health food shop.
4. How is INFLUVAC TETRA given?
How it is given
The doctor, nurse or pharmacist will give INFLUVAC TETRA as an injection.
For some people with bleeding problems, the injection may need to be given under the
skin (subcutaneously).
INFLUVAC TETRA should never be given into a vein (intravenously).
How much is given
For adults and children over 6 months of age, the doctor, nurse or pharmacist will
give a single 0.5 mL dose of INFLUVAC TETRA.
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.
When it is given
INFLUVAC TETRA is generally given as a single dose in autumn each year before the
start of the flu season.
You should receive a repeated vaccination every year as new types of influenza virus
can appear each year.
If the dose is missed
Talk to your doctor, nurse or pharmacist and arrange another visit as soon as possible.
5. What should I know after receiving INFLUVAC TETRA?
As with any vaccine, a protective immune response may not be elicited in all vaccines.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how INFLUVAC
TETRA affects you.
INFLUVAC TETRA should not normally interfere with your ability to drive a car or operate
machinery. But in some people vaccination can cause dizziness or light-headedness.
Make sure you know how you react to INFLUVAC TETRA before you drive a car, operate
machinery, or do anything that could be dangerous if you are dizzy or light-headed.
6. Are there any side effects?
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
during or after receiving a dose of INFLUVAC TETRA.
All medicines can have side effects. Most unwanted effects with INFLUVAC TETRA are
mild and usually clear up within a few days. These effects, as with other vaccines,
generally occur around the injection site.
However, some side effects may need medical attention. As with all vaccines given
by injection there is a very small risk of serious reactions. Allergy to INFLUVAC
TETRA is rare. Any such severe reactions will usually occur within the first few hours
of vaccination.
Ask your doctor, nurse or pharmacist if you have any questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor 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
This medicine is available with a doctor's prescription or from a flu vaccination
clinic.
What INFLUVAC TETRA contains
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Active ingredients
(main ingredient)
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Each 0.5 mL dose of INFLUVAC TETRA contains 15 micrograms of each of the four types
of influenza virus fragments:
A/Victoria/4897/2022 (H1N1)pdm09-like strain
A/Croatia/10136RV/2023 (H3N2)-like strain
B/Austria/1359417/2021-like (B/Victoria lineage) virus
B/Phuket/3073/2013-like (B/Yamagata lineage) virus
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Other ingredients
(inactive ingredients)
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Potassium chloride
Monobasic potassium phosphate
Dibasic sodium phosphate dihydrate
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Water for injections
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Potential allergens
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The vaccine also contains limited quantities of egg protein (ovalbumin), formaldehyde,
cetrimonium bromide, sodium citrate, sucrose, gentamicin sulfate, trace amounts of
chicken proteins, traces of tylosine tartrate, hydrocortisone and polysorbate 80.
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Do not take this medicine if you are allergic to any of these ingredients, except
egg proteins (e.g. ovalbumin). People with egg allergy, including a history of anaphylaxis,
can be safely vaccinated unless they have reported a serious adverse reaction to influenza
vaccines.
INFLUVAC TETRA is not made with any human blood or blood products, or any other substances
of human origin.
What INFLUVAC TETRA looks like
INFLUVAC TETRA is a clear, colourless liquid.
It is available in packs of 1 or 10 as a pre-filled (0.5 mL) glass syringe with 16
mm needle (AUST R 292237).
Who distributes INFLUVAC TETRA
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
INFLUVAC® TETRA is a Viatris company trade mark.
This leaflet was prepared in November 2024.
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