Consumer medicine information

1. Why am I being given Fluad^® Quad?

Fluad^® Quad contains the active ingredient influenza virus haemagglutinin. Fluad^® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 65 years and older only.
For more information, see Section 1. Why am I being given Fluad^® Quad? in the full CMI.

2. What should I know before being given Fluad^® Quad?

Tell your doctor, nurse or pharmacist if you have ever had an allergic reaction to any influenza vaccine 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 being given Fluad^® Quad? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fluad^® Quad 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.

4. How is Fluad^® Quad given?

Fluad^® Quad is given as an injection usually, into your upper arm muscle by a doctor, nurse or pharmacist.
Fluad^® Quad is given once every year, one injection of 0.5 mL.
More instructions can be found in Section 4. How is Fluad^® Quad given? in the full CMI.

5. What should I know about being given Fluad^® Quad?

6. Are there any side effects?

Common side effects may include local reaction around the injection site, fatigue and headache. Mostly these are mild and usually disappear within 3 days without treatment. Serious side effects are rare.
Sudden signs of allergy may be a serious side effect. If you experience this, tell your doctor immediately. Typical symptoms include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body.
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.

1 Name of Medicine

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

2 Qualitative and Quantitative Composition

Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase) of each of four strains representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2025 season.
A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022 IVR-238): 15 microgram HA*.
A/Croatia/10136RV/2023 (H3N2)-like virus (A/Croatia/10136RV/2023 NYMCX-425A): 15 microgram HA*.
B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26): 15 microgram HA*.
B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 BVR-1B): 15 microgram HA* per 0.5 mL dose.
*HA = haemagglutinin.
Fluad Quad 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 adjuvant is a squalene based oil-in-water emulsion. Squalene is of fish origin. It is also a normal component in the human body and is easily metabolized and excreted. For a full list of excipients, see Section 6.1 List of Excipients.
The type and amount of viral antigens in Fluad Quad conform to the requirements of the Australian Influenza Vaccine Committee for the 2025 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.
Fluad Quad is manufactured in eggs and trace amounts of kanamycin sulfate, neomycin sulfate, ovalbumin (≤ 1 microgram/0.5 mL dose), formaldehyde (≤ 1 microgram/0.5 mL dose), cetrimonium bromide (≤ 18 microgram/0.5 mL dose), sucrose and hydrocortisone may be present as residues of the manufacturing process.

3 Pharmaceutical Form

Fluad Quad is a milky-white suspension for injection.

4 Clinical Particulars

4.9 Overdose

There are no data on overdose with Fluad Quad.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity (60 microgram HA/dose), local tolerance and sensitization (45 microgram HA/dose). For the reproductive and development toxicity, see Section 4.6 Fertility, Pregnancy and Lactation.
Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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