Consumer medicine information


Influenza virus geriatric vaccine, surface antigen, trivalent (inactivated)


Brand name


Active ingredient

Influenza virus geriatric vaccine, surface antigen, trivalent (inactivated)




Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fluad.

What is in this leaflet

This leaflet answers some common questions about Fluad®.

It does not contain all the available information.

It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you having Fluad® against the benefits they expect it will have for you.

If you have any concerns about Fluad®, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What Fluad® is used for

Fluad® is a vaccine used to help prevent certain types of influenza or “flu”. It is recommended for people aged 65 years and over.

It is especially beneficial in people aged 65 and over with cardiovascular disease, respiratory disease or diabetes and those who are considered to have an increased risk of complications from influenza.

Influenza is a sudden respiratory infection caused by a virus. It is usually spread from one person to another by small droplets from coughs and sneezes. The virus enters the nose or throat and may spread to the lungs. It is very contagious. There are several kinds of influenza viruses however they all produce similar illness. Influenza is characterised by a sudden onset of headache, generalised aches and pain, fever that may be followed by a sore throat, a cough and a runny nose. The severity and types of symptoms can vary. Most people recover in about a week; however, infection with influenza in some people can lead to serious illness, especially the elderly and those who are “run down” or are in poor health.

Vaccination against influenza helps prevent infection with influenza and to control the spread of the disease.

How it works

Fluad® works by causing your body to produce its own protection against the three types of influenza virus it is made from. It does this by making substances called antibodies in the blood that fight the influenza virus. If a vaccinated person comes into contact with the influenza virus, the body is usually ready to destroy it.

Your body usually takes 2 – 3 weeks after vaccination to develop protection against influenza.

As influenza viruses can change from year to year, Fluad® may be changed to contain fragments of the new types of virus. Therefore vaccination is required yearly.

Please note that an influenza vaccine will only protect you against the types of influenza virus used to make it. It will not protect you from other types of influenza virus or from infections with other agents causing flu-like symptoms (such as the common cold).

Most people will produce enough antibodies against influenza. However, as with all vaccines, 100% protection cannot be guaranteed.

The virus in the vaccine has been killed. Therefore the vaccine cannot give you “the flu”.

Before you are given Fluad®

When you must not be given it

Do not have Fluad® if you have an allergy to:

  • Fluad® or any of the ingredients listed at the end of this leaflet
  • any other influenza vaccines
  • eggs and/or chicken proteins

Symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin rash, itching or hives

Do not have Fluad® if you have a high temperature or sudden illness. A minor illness such as a cold should not be a problem but talk to your doctor about this if being vaccinated.

Do not have Fluad® if you are pregnant or breastfeeding. Fluad® is not recommended for use during pregnancy.

Do not have Fluad® if you are under 65. Fluad® is not recommended for use in persons under 65 years.

Do not have Fluad® after the expiry date printed on the pack.

Do not have Fluad® if the packaging is torn or shows signs of tampering.

If you are not sure whether you should have Fluad®, talk to your doctor, nurse or pharmacist.

Before you are given Fluad®

Tell your doctor if you have reacted to previous vaccination with any of the following:

  • life-threatening allergic reaction (anaphylaxis)
  • difficulty breathing
  • swelling of the throat
  • fainting or collapse
  • shock-like state or being unresponsive for a long period of time
  • fits or convulsions
  • high temperature (greater than 40°C)
  • severe skin reaction at the injection site, including severe bruising

Tell your doctor if you have an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

  • Guillain-Barre Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles)
  • lowered immunity due to diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
  • lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy)
  • bleeding problems

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as latex, foods, preservatives or dyes

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Fluad® may interfere with each other. These include:

  • medicines used to control epilepsy or convulsions such as phenytoin, carbamazepine and phenobarbitone
  • theophylline, a medicine used to control asthma
  • warfarin, a medicine used to prevent blood clots
  • immunoglobulins, blood products used to prevent some infections
  • medicines which lower the immune system, such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy).

These medicines may be affected by Fluad®. Your doctor will consider whether adjustment of your medication is necessary.

Having other vaccines

Tell your doctor if you have had any vaccines in the last 4 weeks. Fluad® may be given with another vaccine.

Your doctor and pharmacist may have more information on medicines and vaccines to be careful with or to avoid during vaccination with Fluad®.

How Fluad® is given

Fluad® is given as an injection, usually into your shoulder muscle by a doctor or nurse.

How much is given

A single 0.5 mL dose.

When it is given

Fluad vaccine is usually given before the start of the influenza season or when recommended by your doctor or nurse.

Vaccination for influenza should be repeated every year as new types of influenza virus can appear each year.

After having Fluad®

Things you must do

Keep an updated record of your vaccinations.

Keep any follow-up appointments with your doctor or clinic.

Have any blood tests when your doctor says to. Your doctor may wish to test your body’s response to Fluad® to make sure that you have developed protection against influenza.

Things to be careful of

Be careful driving or operating machinery until you know how Fluad® affects you. Fluad® should not normally interfere with your ability to drive or operate machinery. However, it may cause dizziness, light-headedness or tiredness in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having Fluad®.

Fluad® may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

  • local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars
  • flushing or redness of the skin
  • headaches
  • tiredness, weakness or fatigue
  • generally feeling unwell
  • fever
  • chills, increased sweating
  • soreness, aching muscles, muscle tenderness or weakness (not caused by exercise)
  • nausea

These are the more common side effects of Fluad®. Mostly these are mild and usually disappear within 1-2 days without treatment.

Tell your doctor immediately if you notice any of the following:

  • abscess at the injection site
  • unusual bleeding, bruising or purple spots on the skin
  • skin rash, itchy spots or red lumps on the skin
  • painful, swollen joints
  • earache or temporary hearing loss
  • severe dizziness, unsteadiness when walking or spinning sensation or vertigo
  • sore throat, difficulty swallowing
  • fast heart beat
  • tingling of the hands or feet, or sudden numbness or weakness in the legs or arms

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • 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, (anaphylaxis)
  • pinkish, itchy swellings on the skin, also called hives or nettle rash (urticaria)
  • narrowing of blood vessels which may result in skin rashes (vasculitis) and in some cases involve the kidneys
  • shortness of breath, wheezing or trouble breathing
  • fits or convulsions
  • feeling weak or paralysed, or generally feeling sore or tender
  • passing little or no urine, which may be associated with nausea, loss of appetite and weakness
  • rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting (shock)
  • 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

These are very serious side effects. You may need urgent medical attention or hospitalisation.

All of these side effects are rare.

Other side effects not listed above may occur in some patients. Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storing Fluad®

Fluad® is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Fluad®:

  • Keep it where children cannot reach it.
  • Keep Fluad® in the original pack until it is time for it to be given.
  • Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Fluad®.
    Freezing destroys the vaccine

Product description

What it looks like

Fluad® is a milky-white liquid in a pre-filled syringe.


  • Active ingredients:
    Each 0.5 mL contains 15 micrograms of influenza virus fragments (influenza virus haemagglutinins) from each of the following types of influenza virus:
    - A/Michigan/45/2015 (H1N1) pdm09 - like strain
    - A/Switzerland/8060/2017 (H3N2)– like strain
    - B/Phuket/3073/2013 - like strain
    These strains have been recommended by the Australian Influenza Vaccine Committee for the 2019 Southern Hemisphere winter.
  • Other ingredients
    Adjuvant: MF59C.1: containing squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate, water for injection.
    Other: sodium chloride, potassium chloride, monobasic potassium phosphate , dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injection.

Fluad® may also contain traces of kanamycin sulfate, neomycin sulfate, formaldehyde, chicken proteins, cetyltrimethylammonium bromide (CTAB), sucrose, barium sulphate, and hydrocortisone as residues of the manufacturing process.

Fluad® does not contain lactose, gluten, tartrazine or any other azo dyes.


Fluad® sponsored by:

Seqirus Pty Ltd
ABN 26 160 735 035
63 Poplar Road
Parkville VIC 3052

Aust R 90339

Aust R 306718

Date of Revision:
21 November 2019

Fluad® is a registered trademark of Seqirus UK Limited or its affiliates.

Published by MIMS January 2020


Brand name


Active ingredient

Influenza virus geriatric vaccine, surface antigen, trivalent (inactivated)




1 Name of Medicine

Inactivated influenza vaccine (surface antigen), suspension for injection, adjuvanted; containing Influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

Fluad is a purified, inactivated, surface antigen influenza vaccine, adjuvanted with MF59C.1 in a milky-white suspension for injection.
Each 0.5 mL dose contains influenza virus surface antigens of each of three purified surface antigens representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2019 season:
A/Michigan/45/2015 (H1N1) pdm09 - like virus (A/Singapore/GP1908/2015 (IVR-180)): 15 microgram HA* per dose;
A/Switzerland/8060/2017 (H3N2) - like virus (A/Brisbane/1/2018 (X-311)): 15 microgram HA* per dose;
B/Phuket/3073/2013 - like virus (B/Phuket/3073/2013 (BVR-1B)): 15 microgram HA* per dose.
* HA = haemagglutinin.
Fluad vaccine is prepared from virus grown in embryonated hens' eggs and inactivated with formaldehyde before purification and combination with MF59C.1, an adjuvant known to increase the immunogenicity of vaccines. MF59C.1 contains the oil squalene which is obtained from shark liver and is also found in humans as a metabolite of cholesterol and as a normal component of cell membranes.
The type and amount of viral antigens in Fluad conform to the requirements of the Australian Influenza Vaccine Committee for the 2019 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.


For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Fluad is a milky-white suspension for intramuscular injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

4.2 Dose and Method of Administration

A single 0.5 mL dose should be administered by intramuscular injection into the deltoid muscle.
Fluad should not be administered sub-cutaneously or intravascularly. Gently shake before use. After shaking, the normal appearance of Fluad is a milky-white suspension.
Visually inspect the contents of each Fluad pre-filled syringe for particulate matter or discoloration prior to administration. If either condition is observed, do not use the contents.
Fluad is for single use in a single patient only, discard any residue.
Annual vaccination is recommended.

4.3 Contraindications

Hypersensitivity to eggs, chicken proteins, kanamycin sulfate, neomycin sulfate, formaldehyde, or cetyltrimethylammonium bromide (CTAB), any constituent of the vaccine or in anyone who has had an anaphylactoid reaction to previous influenza vaccination.
Immunisation should be postponed in patients with acute febrile illness.

4.4 Special Warnings and Precautions for Use

Fluad should not be administered intravascularly or sub-cutaneously.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case a rare anaphylactic event occurs following the administration of the vaccine.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
If Guillain-Barre syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluad should be based on careful consideration of the potential benefits and risks.
A protective response may not be elicited in all vaccine recipients.
The syringe is for single use only and should not be used in more than one person.
The syringe and all associated syringe components for Fluad AUST R 306718 prefilled syringe needle-free do not contain natural rubber latex. Fluad AUST R 90339 pre-filled syringe with attached needle cannot be considered to be latex-free as the sheath covering the needle contains natural rubber latex. See Section 6.5 Nature and Contents of Container for further information.

Use in the elderly.

Fluad is approved for active immunization against influenza in the elderly (see Section 4.1 Therapeutic Indications). Also see Section 5 Pharmacological Properties.

Paediatric use.

No data available.

Effects on laboratory tests.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, hepatitis C and, especially HTLV1 have been observed. The Western Blot technique disproves the results. The transient false positive reactions could be due to the IgM response to the vaccine.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Fluad must not be mixed with other preparations for injection.
Fluad may be given at the same time as other vaccines although no clinical data on concomitant administration with other vaccines are available. Immunisation should be carried out on separate limbs. It should be noted that any adverse reactions might be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic P450 system. Results from studies have been variable in the degree of interaction and time after vaccination for the interaction to take effect. The interaction may be idiosyncratic. Patients taking warfarin, theophylline, phenytoin, phenobarbitone or carbamazepine should be advised of the possibility of interaction and told to look out for signs of elevated levels of medication.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Animal reproduction studies have not been conducted with Fluad. There are no adequate and well-controlled studies in pregnant women. Fluad is indicated for persons 65 years and over.
No data available.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following information is based on clinical trials conducted with an earlier formulation of Fluad that contained thiomersal (an organomercuric compound) 0.05 mg per dose as a preservative which may have contributed to the nature and incidence of post-immunisation reactions observed in these studies.
A higher incidence of mild post-immunisation reactions have been reported with Fluad compared to non-adjuvanted vaccines.
Most commonly reported reactions after treatment are:
Local reactions, including redness, swelling, induration, pain at the injection site and ecchymosis.
Systemic reactions including fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia.
These reactions usually disappear within 1-2 days without treatment.

Clinical trial data.

Table 1 shows the post-immunisation reactions (onset 0 to 6 days) reported in elderly subjects in Fluad Phase II/III studies. These reactions were self-limited, mild in nature and of short duration.
Studies providing data following second and third annual vaccinations of Fluad confirmed that revaccination gave a similar adverse effect profile.

Post-marketing study data.

In a large post-marketing study including approximately 10,000 Fluad-treated patients and approximately 5,000 patients vaccinated with a non-adjuvanted vaccine, no difference in the incidence of adverse effects requiring a physician visit with Fluad treated patients (0.3%) compared to patients treated with a non-adjuvanted vaccine (0.4%) was seen.
Hospitalisation during the influenza season occurred in 5.4% of subjects given Fluad and in 5.7% of subjects given a non-adjuvanted vaccine. Death during the influenza season was reported for 0.91% of patients given Fluad and for 0.83% of patients given a non-adjuvanted vaccine. These differences were not statistically significant.
Adverse events considered at least possibly related to Fluad vaccination and requiring a physician visit occurred uncommonly (0.1% to < 1%) to rarely (0.01% to < 0.1%) as follows:

Reported uncommonly.

Body as a whole.


Reported rarely.

Body as a whole.

Injection site reaction; asthenia; injection site pain; malaise; allergic reaction; chills; pain; rheumatoid arthritis.



Digestive system.

Cholangitis; diarrhoea; enteritis; pancreatitis.


Arthralgia; arthrosis; myalgia.

Nervous system.


Respiratory system.

Asthma; bronchitis.

Skin and appendages.

Rash; urticarial.

Adverse reactions from post-marketing spontaneous reports.

As these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
In addition to the adverse reactions observed during clinical trials, the following adverse reactions were reported from post marketing surveillance in subjects older than 65 years of age:

Blood and lymphatic system disorders.

Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy.

General disorders and administration site conditions.

Extensive swelling of injected limb lasting more than one week, Injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).

Immune system disorders.

Allergic or immediate hypersensitivity reactions, including anaphylactic shock.

Musculoskeletal and connective tissue disorders.

Muscular weakness.

Nervous system disorders.

Encephalomyelitis, Guillain-Barre Syndrome, convulsions, neuritis, neuralgia, paraesthesia.

Skin and subcutaneous tissue disorders.

Generalised skin reactions including erythema multiforme, urticaria, pruritus or non-specific rash.

Vascular disorders.

Vasculitis which may be associated with transient renal involvement.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at

4.9 Overdose

Overdosage is unlikely to have any untoward effect.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or the New Zealand Poisons Centre on 0800 Poison or 0800764766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Fluad has been shown to evoke antibody responses to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies provide protection against clinical illness in a high proportion of vaccinees.
Seroprotection from Fluad is generally obtained within 2 to 3 weeks. The duration of post vaccination immunity varies, but it is usually 6-12 months.
The antibody response to Fluad is increased when compared to the response to vaccines without adjuvant, and is most pronounced for B and A/H3N2 influenza antigens. This increased response is even more pronounced in elderly persons with low pre-immunisation titres and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases). A similar immunogenicity profile has been noted after a second and third immunisation with Fluad.
Significant antibody rises after immunisation with Fluad has also been shown against heterovariant strains, antigenically different from those included in the vaccine.
Influenza viral strains undergo antigenic changes from year to year. Therefore the antigen component of Fluad is revised for every flu season and annual vaccination is recommended.

Clinical trials.

The following information is based on clinical trials conducted with an earlier formulation of Fluad that contained thiomersal (an organomercuric compound) 0.05 mg per dose as a preservative.
A pooled analysis of 12 Phase II/III studies and 1 post-marketing study included data from 2102 subjects given a first vaccination with Fluad and 1498 subjects vaccinated with a comparator vaccine. Fluad resulted in higher GMR's to each of the influenza antigens, a higher percentage of subjects with seroconversion and a higher percentage of subjects with HI titres ≥ 40 compared with the combined influenza vaccine comparators for the B, A/H3N2 and A/H1N1 antigens. Increased efficacy in the prevention of influenza in comparison with non-adjuvanted influenza vaccines has not been demonstrated. See Table 2.
Similarly patients with a history of cardiovascular, respiratory or diabetes disease given Fluad also achieved better immunogenic responses than those subjects given the comparator non-adjuvanted vaccine. See Table 3.
A comparison of immunogenicity data from elderly subjects immunised with the thiomersal-containing formulation and the thiomersal-free formulation indicates that there is no difference in the immunogenicity profile measured at days 0 and 21 post immunisation between the two treatment groups.
Although it is generally recognised that vaccine-induced haemagglutination inhibition antibody titres measured against influenza antigens from strains causing disease in the community are a surrogate marker of efficacy, a precise threshold for protection or an absolute correlation between magnitude of antibody titre and reduction in clinical symptoms has not been established.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data


No data available.


No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Fluad (0.5 mL) contains the following excipients:
MF59C.1 (a proprietary adjuvant): containing 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, sodium citrate dihydrate 0.66 mg, citric acid monohydrate 0.04 mg, water for injections.

Other excipients.

See Table 4.
Fluad may also contain kanamycin sulfate, neomycin sulfate, formaldehyde, chicken proteins (such as ovalbumin), cetyltrimethylammonium bromide (CTAB), sucrose, barium sulfate, and hydrocortisone as residues of the manufacturing process.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

Fluad has a shelf life of 12 months when stored at +2°C to +8°C.

6.4 Special Precautions for Storage

Store at +2°C to +8°C. Do not freeze. Protect from light.

6.5 Nature and Contents of Container

Not all presentations or pack sizes may be marketed.

AUST R 306718.

Fluad inactivated influenza vaccine (surface antigen) suspension for injection, adjuvanted, 0.5 mL syringe, needle-free (AUST R 306718) is a 0.5 mL suspension for injection in a needle-free pre-filled syringe (type I glass).
The syringe and all associated syringe components do not contain natural rubber latex.
Pack sizes: 1's, 10's.

AUST R 90399.

Fluad inactivated influenza vaccine (surface antigen) suspension for injection, adjuvanted, 0.5 mL syringe, fixed needle (AUST R 90339) is a 0.5 mL suspension for injection in a pre-filled syringe (type I glass) with attached needle.
The sheath covering the needle contains natural rubber latex (see Section 4.4 Special Warnings and Precautions for Use).
The syringe barrel, plunger and rubber stopper are not manufactured with natural rubber latex.
Pack sizes: 1's; 10's.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)


Summary Table of Changes