2. What should I know before I am/my child is given FLUMIST?
Do not use if you/your child have ever had an allergic reaction to any medicine containing
influenza virus, eggs or egg proteins (e.g. ovalbumin), gentamicin (an antibiotic),
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you/your child 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/my child is given FLUMIST? in the full CMI.
3. What if I am/my child is taking other medicines?
Some medicines may interfere with FLUMIST and affect how it works. Tell your healthcare
professional if you/your child are taking any other medicines, including any medicines,
vitamins or supplements that you buy without a prescription.
A list of these medicines is in Section
3. What if I am/my child is taking other medicines? in the full CMI.
4. How is FLUMIST given?
FLUMIST is given by a trained healthcare professional
FLUMIST is a nasal spray not an injection. It must not be injected.
5. What should I know after having FLUMIST?
|
Things you should do
|
Keep an updated record of you/your child’s vaccinations
Keep any follow-up appointments with your doctor or clinic
|
|
Looking after your vaccine
|
FLUMIST is usually stored in the doctor’s surgery, clinic or pharmacy. However, if
you need to store FLUMIST:
Keep FLUMIST in the original pack until it is time for it to be given.
Keep it in the refrigerator between 2oC and 8oC. Protect from light. Do not freeze – freezing destroys vaccine.
|
6. Are there any side effects?
The following side effects may occur after you/your child have FLUMIST.
Common side effects include runny or stuffy nose, loss of appetite, generally feeling
unwell, headache, fever, muscle tenderness or weakness/aches not caused by exercise,
nose bleeds.
Serious side effects include sudden signs of allergy such as rash, itching or hives
on the skin, swelling of face, lips, tongue or other parts of the body, shortness
of breath and wheezing or difficulty breathing, feeling weak or paralysed, or generally
feeling sore or tender, headache and high temperature associated with hallucinations,
confusion, paralysis of part or all of the body, disturbances of behaviour, speech
and eye movements, stiff neck and sensitivity to light.
Active ingredient(s):
influenza virus vaccine
Consumer Medicine Information (CMI)
This leaflet provides important information about using FLUMIST. You should also speak to your healthcare professional if you would like further information
or if you have any concerns or questions about using FLUMIST.
Where to find information in this leaflet:
1. Why am I/my child being given FLUMIST?
FLUMIST contains three different types (strains) of influenza virus – two Type A (H1N1
and H3N2) and one Type B (Victoria lineage) strain. It is a vaccine used to help prevent certain types of influenza (flu).
FLUMIST may be given to a child (including adolescents) aged 24 months (2 years) to
under 18 years old.
Influenza (flu) is an infectious disease caused by different types of influenza viruses.
It can spread very rapidly, particularly in homes and at kindergartens/preschools
and schools. The most common symptoms include fever, headache, general aches and pains,
sore throat, runny nose, coughing, weakness and tiredness.
Vaccination for the flu helps to prevent infection as well as controlling the spread
of flu within the community including to the very young, the elderly and other people
at risk.
New types of viruses can appear each year. Every year the World Health Organization
(WHO) and the Australian Influenza Vaccine Committee (AIVC) decide which virus types
should be in flu vaccines for the next flu season in Australia (typically from May
to October). This means that the viruses in the vaccines usually change every year,
so previous season flu vaccines are unlikely to give protection from the flu in the
next season. It is recommended that flu vaccines be given every year, particularly
for people who are at risk or are in contact with others at risk.
Like all vaccines, FLUMIST may not fully protect all people who are vaccinated. It
will only help to prevent flu if it is caused by one of the strains in the vaccine
or another strain which is closely related to one in the vaccine.
FLUMIST will not help prevent the flu if it is caused by another strain of virus or
if you already have the virus prior to vaccination. It also will not help prevent
other diseases that have flu-like symptoms (e.g. the common cold).
FLUMIST will not give you/your child the flu.
How flu vaccines work
Flu vaccines (injections and nasal sprays) work by helping the body to produce its
own protection against the flu. They do this by making substances called antibodies
to fight flu viruses. If a vaccinated person comes into contact with a flu virus the
body usually destroys it.
The body usually takes several weeks after vaccination to develop protection against
flu viruses.
Your healthcare professional can recommend the best time for you/your child to be
vaccinated for the coming flu season.
2. What should I know before I am/my child is given FLUMIST?
Warnings
Do not use FLUMIST if you/your child:
are allergic to any vaccines containing influenza virus, eggs or egg proteins (e.g.
ovalbumin), gentamicin (an antibiotic), or any of the ingredients listed at the end
of this leaflet. Always check the ingredients to make sure you can use this vaccine.
have a blood disorder or a cancer that affects the immune system; or you/your child
have been told by your doctor that you have a weakened immune system as a result of
a disease, medicine or other treatment.
have been taking, or have recently been told to take aspirin (a substance in many
medicines used to relieve pain and lower fever).
are less than 24 months (2 years) old.
have Guillain-Barre Syndrome-a rare condition where the body’s immune system attacks
the nerves, causing weakness and tingling in your arms and legs that can get worse
over time.
Check with your healthcare professional if you/your child:
have allergies to any other medicines, foods, preservatives or dyes.
have or have had asthma/wheezing
may need to be in contact with anyone who has a weakened immune system (e.g. a parent/grandparent
undergoing cancer treatment, or someone in isolation following a bone marrow transplant).
During treatment, 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/your child’s healthcare professional if you/your child are pregnant
or intend to become pregnant.
Talk to your/your child’s healthcare professional if you/your child are breastfeeding
or intend to breastfeed.
Your healthcare professional can discuss with you/your child the risks and benefits
involved.
3. What if I am/my child is taking other medicines?
Tell your healthcare professional if you/your child are taking any other medicines
or vaccines, including any medicines, vitamins or supplements that you buy without
a prescription from your pharmacy, supermarket or health food shop.
You/your child should not be given aspirin (a substance in many medicines used to
relieve pain and lower fever) for at least 4 weeks after vaccination with FLUMIST,
unless your healthcare professional tells you otherwise.
Some medicines may interfere with FLUMIST
and affect how it works. These include:
medicines which affect the body’s immune response such as corticosteroids (e.g. prednisolone),
some cancer treatments (chemotherapy) or radiotherapy.
flu-specific antiviral medicines such as oseltamivir and zanamivir
These medicines may be affected by FLUMIST or may affect how well it works. Your healthcare
professional will advise whether or not you/your child should have the vaccine.
Check with your healthcare professional if you are not sure about what medicines,
vitamins or supplements you/your child are taking and if these affect FLUMIST.
Your healthcare professional have more information on medicines to be careful with
or avoid while taking this vaccine.
Having other vaccines
FLUMIST may be given at the same time as other vaccines (e.g. for measles, mumps,
rubella etc).
4. How is FLUMIST given?
FLUMIST is given by a trained healthcare professional (e.g. doctor or nurse). Unlike
other flu vaccines, it is a nasal spray not an injection.
FLUMIST must not be injected.
How much is given and how will it be given
Children (including adolescents) aged 24 months to less than 18 years of age are given
one single nasal applicator (200 µL) of FLUMIST.
This is administered by the healthcare professional as one spray (half the applicator;
100 µL) in one nostril. A clip is then removed and the other half of the applicator
(100 µL) is sprayed into the other nostril.
You/your child can breathe normally when it is given - there is no need to sniff in.
Some children who have not previously had FLUMIST may need a second vaccination a
month later. Please ask your healthcare professional if this includes you/your child
and when/how to arrange for another visit if required.
If you have any concerns, ask your healthcare professional.
When will it be given
FLUMIST is usually given annually before the start of each flu season.
If you forget to get FLUMIST
If you forget to get your/your child's annual vaccination or your child's second vaccination
(if advised by your doctor), talk to your doctor or nurse to arrange a visit as soon
as possible.
If you have trouble remembering to arrange for an annual vaccination, ask your healthcare
professional for some hints.
If too much FLUMIST is given
Overdose is unlikely as your healthcare professional gives you/your child the nasal
spray and these are supplied as single-use nasal applicators.
If you think that you/your child have been given too much FLUMIST, you/your child
may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know after having FLUMIST?
Things you/your child should do
Keep an updated record of you/your child’s vaccinations.
Keep any follow-up appointments with your/your child’s doctor or clinic.
Things to be careful of
Wherever possible, the person who has been vaccinated should avoid close contact with
anyone who has a weakened immune system (e.g. parent/grandparent undergoing cancer
treatment, or someone in isolation following a bone marrow transplant) for 1-2 weeks
following vaccination.
Looking after your vaccine
FLUMIST is usually stored in the doctor’s surgery, clinic or pharmacy. However if
you need to store FLUMIST:
Keep FLUMIST in the original pack until it is time for it to be given.
Keep it in the refrigerator between 2oC and 8oC. Protect from light. Do not freeze – freezing destroys the vaccine.
Before use, the vaccine may be taken out of the refrigerator once for a maximum period
of 12 hours at a temperature not above 25°C. If the vaccine has not been used after
this 12 hour period, it should be discarded.
Keep it where young children cannot reach it.
Getting rid of any unwanted vaccine
FLUMIST is usually stored and disposed of at the doctor's surgery, clinic or pharmacy.
However if you need to dispose of either full or empty FLUMIST nasal applicators you
should return these to the doctor's surgery, clinic or pharmacy for appropriate vaccine
disposal. No medicines, including vaccines, should ever be disposed of via wastewater
or household waste.
FLUMIST should not be given after the expiry date.
6. Are there any side effects?
All medicines, including vaccines, can have side effects. If you/your child do experience
any side effects, most of them are minor and temporary. However, some side effects
may need medical attention.
Tell your healthcare professional as soon as possible if you/your child feel unwell
after having the vaccine.
See the information below and, if you need to, ask your healthcare professional if
you/your child have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
runny or stuffy nose
loss of appetite
generally feeling unwell
headache
fever, chills, cough, sore throat
muscle tenderness or weakness/aches not caused by exercise
nose bleeds
|
Speak to your doctor if you/your child have any of these less serious side effects
and they worry you.
They are the more common side effects and usually mild and short-lived
|
Serious side effects
|
Serious side effects
|
What to do
|
|
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath and wheezing or
difficulty breathing
feeling weak or paralysed, or generally feeling sore or tender
headache and high temperature associated with hallucinations, confusion, paralysis
of part or all of the body, disturbances of behaviour, speech and eye movements, stiff
neck and sensitivity to light
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you/your child notice any of these serious side effects.
You may need urgent medical attention or hospitalisation. These side effects are rare.
|
Tell your healthcare professional if you notice anything else that may be making you/your
child 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/your child 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 vaccine.
Always make sure you speak to your healthcare professional before you decide to stop
taking any of your medicines.
7. Product details
This vaccine is only available with a doctor's prescription.
What FLUMIST contains
|
Active ingredients
(main ingredients)
|
Three strains of influenza virus
Type A (H1N1)
Type A (H3N2)
Type B (Victoria lineage)
|
|
Other ingredients
(inactive ingredients)
|
sucrose
dibasic potassium phosphate
monobasic potassium phosphate
hydrolysed gelatin (porcine Type A)**
arginine hydrochloride
monosodium glutamate monohydrate
water for injections
|
|
Potential allergens
|
*Egg products (FLUMIST may contain trace amounts of egg protein [ovalbumin <0.24µg/dose])
*Antibiotics (gentamicin sulfate <0.015 µg/dose)
|
*from the manufacturing process
**derived from pig
Do not take this vaccine if you are allergic to any of these ingredients.
FLUMIST contains no preservatives (e.g. thiomersal), lactose, gluten, tartrazine or
any azo dyes.
What FLUMIST looks like
FLUMIST comes in a single-use glass pre-filled nasal applicator (looks like a small
syringe). The nozzle, cap and plunger are made of plastic or rubber. The applicators
do not contain latex.
Each applicator contains 200 µL of colourless to pale yellow liquid (vaccine) which
may contain small white particles. It may come in boxes of 1 or 10 applicators (AUST
R 470065).
Who distributes FLUMIST
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared on 31 Oct 2025
® FLUMIST is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2025
VV-RIM-10046708 v2.0