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, nurse or pharmacist.
1. Why am I using FluQuadri?
FluQuadri is a vaccine. This vaccine helps to protect you against influenza (flu).
FluQuadri is used to prevent flu in persons of 6 months of age and older.
2. What should I know before being given FluQuadri?
Do not use if you have ever had an allergic reaction to FluQuadri 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 FluQuadri 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 FluQuadri given?
FluQuadri is given by your doctor, nurse or pharmacist.
5. What should I know about being given FluQuadri?
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Things you should do
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Tell your doctor, nurse or pharmacist after you or your child receive the vaccine
have signs of allergic reactions that 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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FluQuadri is usually stored in the surgery or clinic, or at the pharmacy. However,
if you need to store FluQuadri:
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, inflammation of nerves
leading to weakness, fainting, dizziness, tingling or numbness of hands or feet, temporary
inflammation of nerves, fits, temporary reduction in the number of platelets, swollen
glands in neck, armpit or groin. 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, cough, runny nose and vomiting.
Active ingredient(s):
Influenza virus haemagglutinin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FluQuadri. 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 using FluQuadri.
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 FluQuadri?
FluQuadri contains the active ingredient influenza virus haemagglutinin.
FluQuadri is a vaccine for persons 6 months of age and older. This vaccine helps to
protect you against influenza (flu).
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 the flu.
Flu is a disease that can spread rapidly and is caused by different types of strains
that can change every year. Therefore, this is why you might 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 influenza until
then. Your doctor will be able to recommend the best time to be vaccinated.
As with all vaccines, FluQuadri may not fully protect all persons who are vaccinated.
2. What should I know before being given FluQuadri?
Warnings
Do not use FluQuadri:
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 FluQuadri.
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 FluQuadri during
pregnancy or breastfeeding. 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
FluQuadri.
3. What if I am taking other medicines?
Some medicines may interfere with FluQuadri 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 FluQuadri is to be given with another vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FluQuadri.
4. How is FluQuadri given?
How much is given
FluQuadri 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 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 being given FluQuadri?
Things you should do
Call your doctor straight away if:
You notice signs of allergic reaction which 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
FluQuadri is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store FluQuadri:
keep it where young children cannot reach it.
keep FluQuadri 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 FluQuadri.
Do not use FluQuadri after the expiry date which is stated on the carton after EXP.
Do not use FluQuadri if the packaging is torn or shows signs of tampering.
Getting rid of 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 in Australia or in New Zealand at https://nzphvc.otago.ac.nz/reporting. By reporting
side effects, you can help provide more information on the safety of this medicine.
7. Product details
What FluQuadri 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, dibasic sodium phosphate, monobasic sodium phosphate, water for injection,
and traces of ovalbumin (egg protein), octoxinol-9 and formaldehyde.
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Potential allergens
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FluQuadri contains less than 1 microgram ovalbumin (egg protein) per dose.
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Do not receive this vaccine if you are allergic to any of these ingredients.
FluQuadri does not contain any antibiotics or preservative.
FluQuadri syringes are not made with natural rubber latex.
What FluQuadri looks like
FluQuadri suspension for injection is clear and slightly opalescent in colour.
FluQuadri is available in packs of 5 single dose (0.5 mL) pre-filled syringes with
or without separate needles. Not all packs may be marketed.
Who distributes FluQuadri
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in November 2023.
fluq-ccdsv2-cmiv11-13nov23