Consumer medicine information

Flucelvax Quad Suspension for injection

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Flucelvax Quad

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flucelvax Quad Suspension for injection.

1. Why am I being given Flucelvax® Quad?


Flucelvax® Quad contains the active ingredient influenza virus haemagglutinin. Flucelvax® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 6 months and older.
For more information, see Section 1. Why am I being given Flucelvax® Quad? in the full CMI.

2. What should I know before being given Flucelvax® 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 Flucelvax® Quad? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Flucelvax® 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 Flucelvax® Quad given?

  • Flucelvax® Quad is given as an injection, usually into your upper arm muscle by a doctor, nurse or pharmacist.
  • In young children, the injection may be given in the thigh muscle of the leg.
  • Flucelvax® Quad is given once every year, as follows:
    - Adults and children 9 years and older: one injection of 0.5 mL.
    - Children 6 months 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).

More instructions can be found in Section 4. How is Flucelvax® Quad given? in the full CMI.

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

Things you should doCall your doctor straight away if you or your child do not feel well after having Flucelvax® Quad.
Keep an updated record of you and your child's vaccinations.
Keep any follow-up appointments with your doctor or clinic.

For more information, see Section 5. What should I know about being given Flucelvax® Quad? in the full CMI.

6. Are there any side effects?


Common side effects may include local reaction around injection site, headache, tiredness, muscle ache and nausea. Mostly these are mild and short lived. 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.

BRAND INFORMATION

Brand name

Flucelvax Quad

Active ingredient

Influenza virus vaccine, surface antigen, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures), suspension for injection containing Influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

This is a purified, inactivated, subunit influenza vaccine. Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase)*, for the 2024 influenza season representative of the following types:
A/Wisconsin/67/2022 (H1N1)pdm09-like virus (A/Georgia/12/2022 CVR-167) 15 micrograms HA**;
A/Massachusetts/18/2022 (H3N2)-like virus (A/Sydney/1304/2022) 15 micrograms HA**;
B/Austria/1359417/2021-like virus (B/Singapore/WUH4618/2021) 15 micrograms HA**;
B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**;
per 0.5 mL dose.
* Propagated in Madin Darby Canine Kidney (MDCK) cells.
** Haemagglutinin.
Flucelvax Quad is prepared in MDCK cells, adapted to grow freely in suspension in culture medium. The virus is inactivated with β-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Therefore Flucelvax Quad may contain traces of propiolactone, cetyltrimethylammonium bromide, and polysorbate 80 (see Section 4.3 Contraindications). Eggs are not used in the manufacturing process, therefore, Flucelvax Quad does not contain egg proteins. For the full list of excipients, see Section 6.1 List of Excipients.
The vaccine complies with the World Health Organization (WHO) recommendation and Australian Influenza Vaccine Committee (AIVC) for the 2024 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the AIVC as being antigenically equivalent to the reference virus.

3 Pharmaceutical Form

Flucelvax Quad is a clear to slightly opalescent suspension for injection.

4 Clinical Particulars

4.9 Overdose

There is no experience of overdose with Flucelvax Quad.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or the New Zealand Poisons Centre on 0800 POISON or 0800 767 4766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Flucelvax Quad has not been evaluated for genotoxic potential.
Carcinogenicity. Flucelvax Quad 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

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FLUCEQST.gif