Consumer medicine information

1. Why am I being given Afluria^® Quad?

Afluria^® Quad contains the active ingredient influenza virus haemagglutinin. Afluria^® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use only in people aged 5 years and older.
For more information, see Section 1. Why am I being given Afluria^® Quad? in the full CMI.

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

Tell your doctor, nurse or pharmacist if you or your child 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 or 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 being given Afluria^® Quad? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Afluria^® 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 Afluria^® Quad given?

• Afluria^® Quad is given as an injection, usually into the upper arm muscle by a doctor, nurse or pharmacist.

• Afluria^® Quad is given once every year as follows:
  - Adults and children 5 years and older: one injection of 0.5 mL.
  - Children 5 years to less than 9 years of age: One or two 0.5 mL doses. Children less than 9 years of age who have not been previously vaccinated against influenza, should receive a second dose (at least 4 weeks after the first dose).

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

6. Are there any side effects?

Common side effects may include local reaction around the injection site, flu-like symptoms and muscle pain. 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 or your child 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 or your child have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Afluria Quad vaccine is indicated for use only in persons aged 5 years and over. It must not be used in persons under 5 years (see Section 4.3 Contraindications).

1 Name of Medicine

Afluria Quad.
Inactivated quadrivalent influenza vaccine (split virion) suspension for injection; containing influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

For season 2025.
This is a purified, inactivated, split virion (split virus) vaccine. Each 0.5 mL dose contains antigens for the 2025 influenza season representative of the following types:
A/Victoria/4897/2022 (H1N1)pdm09-like virus (A/Victoria/4897/2022 IVR-238):15 micrograms HA*.
A/Croatia/10136RV/2023 (H3N2)-like virus (A/Croatia/10136RV/2023 X-425A): 15 micrograms HA*.
B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26): 15 micrograms HA*.
B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 BVR-1B): 15 micrograms HA*.
per 0.5 mL dose.
* HA = haemagglutinin.
Afluria Quad is manufactured in eggs and trace amounts of sodium taurodeoxycholate (TDOC) (≤ 5 microgram), ovalbumin (< 1 microgram/0.5 mL dose), sucrose, neomycin sulfate, polymyxin B sulfate, propiolactone and hydrocortisone may be present. For the full list of excipients, see Section 6.1 List of Excipients.
The type and amount of viral antigens in Afluria Quad vaccine conform to the requirements of the Australian Influenza Vaccine Committee for the winter of 2025. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.
The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, purified by zonal centrifugation, inactivated by propiolactone and disrupted by TDOC. Afluria Quad vaccine conforms in safety and sterility to the requirements of the British Pharmacopoeia.

3 Pharmaceutical Form

Suspension for injection. Afluria Quad vaccine is a clear to slightly opaque liquid with some sediment that resuspends upon shaking.

4 Clinical Particulars

4.9 Overdose

There is no specific information on overdose of influenza vaccines.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or the New Zealand Poisons Centre on 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

No nonclinical studies have been conducted with Afluria Quad vaccine. A rat reproductive and developmental toxicity study has been conducted with Seqirus' trivalent influenza vaccine, Fluvax. This study did not demonstrate any maternal or developmental toxicity.
Genotoxicity. Afluria Quad vaccine has not been evaluated for genotoxic potential.
Carcinogenicity. Afluria Quad vaccine has not been evaluated for carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

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