2. What should I know before I receive INFLUVAC?
Do not receive INFLUVAC if you have had an allergic reaction to INFLUVAC, 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 is given by injection. Tell the doctor, nurse or pharmacist if you have ever
fainted when receiving an injection.
INFLUVAC 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 and affect how it works.
4. How is INFLUVAC given?
The doctor, nurse or pharmacist will give INFLUVAC as an injection.
Adults and children over 36 months of age: 0.5 mL. Children from 6 to 35 months of
age: 0.25 mL.
For children less than 9 years of age who have not previously been vaccinated, a second
dose of should be given after an interval of at least 4 weeks.
5. What should I know after receiving INFLUVAC?
|
Driving or using machines
|
INFLUVAC 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 before you drive a car or operate machinery.
|
6. Are there any side effects?
Most unwanted effects with INFLUVAC 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.
Serious side effects such as a serious allergic reaction may occur rarely.
Active ingredient(s):
Trivalent Influenza Vaccine, surface antigen, inactivated (influenza virus haemagglutinin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using INFLUVAC. 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.
Where to find information in this leaflet:
1. Why am I receiving INFLUVAC?
INFLUVAC is a trivalent influenza vaccine containing inactivated fragments from three
types of influenza virus.
INFLUVAC 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 is changed
to contain fragments of the new types of virus. Therefore, influenza vaccination is
recommended every year.
Please note that INFLUVAC will only protect you against the three 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 can be used in adults and children over the age of 6 months.
2. What should I know before I receive INFLUVAC?
Warnings
Do not receive INFLUVAC if:
You are allergic to any influenza vaccine or any of the ingredients listed at the
end of this leaflet. 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 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
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 is usually stored at the pharmacy, at the doctor's surgery or at the flu
vaccination clinic.
If you need to store INFLUVAC, 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 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 given?
How it is given
The doctor, nurse or pharmacist will give INFLUVAC as an injection.
For some people with bleeding problems, the injection may need to be given under the
skin (subcutaneously).
INFLUVAC should never be given into a vein (intravenously).
How much is given
The doctor, nurse or pharmacist will give based on the following age groups:
For adults and children over 36 months of age: a single 0.5 mL dose of INFLUVAC.
For children from 6 to 35 months of age: a single 0.25 mL dose of INFLUVAC.
For children less than 9 years of age who have not previously been vaccinated, a second
dose should be given after an interval of at least 4 weeks.
When it is given
INFLUVAC 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?
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
affects you.
INFLUVAC 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 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.
All medicines can have side effects. Most unwanted effects with INFLUVAC 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
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
|
Less serious side effects
|
What to do
|
|
Injection-site related:
Redness, swelling, bruising, soreness, itching or a hard lump around the injection
site.
Other body reactions:
Fever, headache, tiredness, shivering, generally feeling unwell
Muscle and joint aches/pains.
|
Speak to your doctor, nurse or pharmacist if you have any of these less serious side
effects and they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Allergic reaction:
Swelling of limbs, face, eyes, inside of nose, mouth or throat
Shortness of breath, breathing or swallowing difficulties
Hives, itching (especially of the hands or feet), reddening of skin (especially around
the ears), or severe skin reactions
Unusual tiredness or weakness that is sudden and severe.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
As with all vaccines given by injection there is a very small risk of such reactions.
Allergy to INFLUVAC is rare. Any such severe reactions will usually occur within the
first few hours of vaccination.
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 contains
|
Active ingredients
(main ingredient)
|
Each 0.5 mL dose of INFLUVAC contains 15 micrograms of each of the three types of
influenza virus fragments:
A/Missouri/11/2025 (H1N1)pdm09-like virus
A/Singapore/GP20238/2024 (H3N2)-like virus
B/Austria/1359417/2021 (B/Victoria lineage)-like virus
|
|
Other ingredients
(inactive ingredients)
|
Potassium chloride
Monobasic potassium phosphate
Dibasic sodium phosphate dihydrate
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Water for injections
|
|
Potential allergens
|
The vaccine also contains limited quantities of egg protein (ovalbumin or chicken
proteins), formaldehyde, cetrimonium bromide, sodium citrate, sucrose, gentamicin
sulfate, traces of tylosine tartrate, hydrocortisone and polysorbate 80.
|
Do not take this medicine if you are allergic to any of these ingredients.
INFLUVAC is not made with any human blood or blood products, or any other substances
of human origin.
What INFLUVAC looks like
INFLUVAC is a clear, colourless liquid.
It is available as packs of 10 in two presentations:
pre-filled (0.5 mL) glass syringe with 16 mm needle (AUST R 432790).
pre-filled (0.5 mL) glass syringe without needle (AUST R 432811).
Who distributes INFLUVAC
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
INFLUVAC® is a Viatris company trade mark.
This leaflet was prepared in November 2025.
INFLUVAC_cmi\Nov25/00