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Fluzone® High-Dose
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this vaccine, speak
to your doctor, nurse or pharmacist.
Fluzone High-Dose is a vaccine. This vaccine is recommended to help protect against
influenza (flu) and associated pneumonia in persons aged 60 years and older.
For more information, see Section 1. Why am I using Fluzone High-Dose? in the full CMI.
Do not use if you have ever had an allergic reaction to Fluzone High-Dose or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section 2. What should I know before I am given Fluzone High-Dose? in the full CMI.
Some medicines may interfere with Fluzone High-Dose and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Fluzone High-Dose is administered to you by a health care professional.
More instructions can be found in Section 4. How is Fluzone High-Dose given? in the full CMI.
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Things you should do
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Tell your doctor, nurse or pharmacist if you notice
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 vaccine
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Fluzone High-Dose is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
However, if you need to store Fluzone High-Dose:
Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze.
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For more information, see Section 5. What should I know about being given Fluzone High-Dose? in the full CMI.
Serious side effects can include severe allergic reactions (anaphylaxis) including
swelling of the face, lips, tongue, throat or any other part of the body and which
may cause difficulty in swallowing or breathing (angioedema). See your doctor immediately if you notice this.
Common local side effects include pain, redness, swelling, hardness and bruising at
the injection site. Common systemic side effects include muscle aches, feeling unwell,
headache, shivering, nausea and tiredness.
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.
Fluzone® High-Dose
Active ingredient(s):
Inactivated Trivalent Influenza Vaccine (Split Virion) Influenza Virus Haemagglutinin
Consumer Medicine Information (CMI)
This leaflet provides important information about using Fluzone High-Dose. 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 Fluzone High-Dose.
Where to find information in this leaflet:
Fluzone High-Dose contains the active ingredient influenza virus haemagglutinin. Fluzone High-Dose is a vaccine. Vaccines are used to help protect you against infectious
diseases.
Fluzone High-Dose is recommended to help protect you against influenza (flu) and
associated pneumonia in persons aged 60 years and older. Influenza (flu) is a disease caused by different strains of the influenza virus.
The influenza virus can spread rapidly, especially in homes or institutions, where
it can be very easy for someone to catch flu and spread the disease.
Fluzone High-Dose works by helping the body to make antibodies. These antibodies help
the body to recognise the flu virus and help prevent the infection. It takes a few
weeks for the body to produce these antibodies.
Fluzone High-Dose will only help to prevent flu if it is caused by one of thethree
strains of virus contained in the vaccine or other strains closely related to them.
Fluzone High-Dose will not prevent flu if you are incubating the disease before vaccination
or if it is caused by another virus.
Previous injections of flu vaccine are unlikely to give you protection against the
current strains of flu virus most common this year, so you will need to receive a
vaccine against flu every year especially if you are at risk.
Your doctor will be able to recommend the best time for you to be vaccinated. Flu
is present every year, even when epidemics or outbreaks are not reported.
Do not use Fluzone High-Dose if:
you are allergic to the active ingredients, or any of the ingredients listed at the
end of this leaflet
you have ever had a severe allergic reaction after getting any flu vaccine.
Always check the ingredients to make sure you can receive this vaccine.
Check with your doctor if you:
have or have had Guillain-Barré syndrome (severe muscle weakness) after getting a
flu vaccine
have or have had an immune response problem because the immune response to the vaccine
may be diminished
have bleeding problems or bruise easily
have an illness with a high or moderate temperature or an acute illness, the vaccination
should be postponed until after you have recovered.
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?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with Fluzone High-Dose and affect how it works.
Tell your doctor, nurse or pharmacist if you are taking medicines that may reduce
your immune response such as corticosteroids (for example prednisone), medicines used
to treat cancer (chemotherapy), radiotherapy or other medicines affecting the immune
system.
Having other vaccines
Your doctor will advise you if Fluzone High-Dose may 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 Fluzone High-Dose.
Fluzone High-Dose is administered by your doctor, nurse or pharmacist as a single
0.5 mL injection injected into the muscles of the upper arm.
Call your doctor straight away if you notice:
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.
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 vaccine
Fluzone High-Dose is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
However, if you need to store Fluzone High-Dose:
Keep Fluzone High-Dose in the original packaging until it is time for it to be given.
Keep it in the refrigerator, store at 2C to 8C. Do not freeze Fluzone High-Dose.
Do not use Fluzone High-Dose after the expiry date which is stated on the carton after
EXP.
Do not use Fluzone High-Dose if the packaging is torn or shows signs of tampering.
Keep it where young children cannot reach it.
Getting rid of any unwanted vaccine
If you no longer need to use this vaccine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this vaccine after the expiry date.
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
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Less serious side effects
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What to do
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At the injection site:
pain
redness (erythema)
swelling, hardness (induration)
bruising
Itching (pruritis)
Systemic side effects:
muscle aches (myalgia)
feeling unwell (malaise)
headache
fever, chills (shivering)
feeling sick (nausea)
diarrhoea
cough
vertigo
tiredness (fatigue)
vomiting
dizziness
flushing
hives (urticaria)
joint pain (arthralgia)
night sweats
rash
inflammation of the nose (rhinorrhoea)
pain in extremity
inflammation of the throat (oropharyngeal pain)
abnormal lack of energy (asthenia)
temporary reduction in the number of blood particles called platelets (thrombocytopenia)
swollen glands in neck, armpit or groin (lymphadenopathy)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Severe allergic reactions (anaphylaxis) including swelling of the face, lips, tongue,
throat or any other part of the body and which may cause difficulty in swallowing
or breathing (angioedema)
rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose
and genitals (Stevens-Johnson Syndrome)
numbness or pins and needles sensation (paresthesia)
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
the body (encephalomyelitis and transverse myelitis, brachial neuritis, Guillain-Barré
Syndrome), fits (convulsions including febrile convulsions), facial palsy (Bell’s
palsy), vision disorders due to the optic nerves dysfunction (optic neuritis/neuropathy),
fainting (syncope) shortly after vaccination
blood vessel inflammation (vasculitis) which may result in skin rashes and in very
rare cases in temporary kidney problems, blood vessel opening (vasodilatation)
chest pain
wheezing, throat tightness, difficulty breathing (dyspnoea)
excess of blood in the white of the eye (ocular hyperaemia).
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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.
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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 vaccine.
Always make sure you speak to your doctor, nurse or pharmacist before you decide to
stop taking any of your medicines.
What Fluzone High-Dose 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)
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Other ingredients
(inactive ingredients)
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sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, octoxinol-9,
water for injection, and traces of formaldehyde.
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Potential allergens
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Fluzone High-Dose 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.
Fluzone High-Dose does not contain any antibiotics or preservative.
Fluzone High-Dose syringes are not made with natural rubber latex.
What Fluzone High-Dose looks like
Fluzone High-Dose is supplied as single-dose, 0.5mL pre-filled syringe without needles
(AUST R 473685)
Who distributes Fluzone High-Dose
Distributed in Australia by:
sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Freecall:1800 818 806
Email: medinfo.australia@sanofi.com
This leaflet was prepared in November 2025.
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