Consumer medicine information

Vaxigrip Tetra 60 mcg/0.5 mL Suspension for injection

Influenza virus vaccine, split virion, quadrivalent (inactivated)

BRAND INFORMATION

Brand name

Vaxigrip Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vaxigrip Tetra 60 mcg/0.5 mL Suspension for injection.

1. Why am I using Vaxigrip Tetra?


Vaxigrip Tetra is a vaccine. This vaccine helps to protect you or your child against influenza (flu). Vaxigrip Tetra is used to prevent flu in persons of 6 months of age and older. If you are pregnant, one dose of vaccine given to you during pregnancy may protect your baby from birth to less than 6 months of age.
For more information, see Section 1. Why am I using Vaxigrip Tetra? in the full CMI.

2. What should I know before I am given Vaxigrip Tetra?


Do not use if you have ever had an allergic reaction to Vaxigrip Tetra or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you 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 I am given Vaxigrip Tetra? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Vaxigrip Tetra and affect how it works. Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How is Vaxigrip Tetra given?


Vaxigrip Tetra is given by your doctor, nurse or pharmacist.
More instructions can be found in Section 4. How is Vaxigrip Tetra given? in the full CMI.

5. What should I know about after being given Vaxigrip Tetra?

Things you should doCall your doctor straight away if:
you notice signs of allergic reaction 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.
Looking after your medicineVaxigrip Tetra is usually stored in the surgery or clinic, or at the pharmacy. However, if you need to store Vaxigrip Tetra:
  • keep in the fridge between 2-8°C. Do not freeze.

For more information, see Section 5. What should I know about after being given Vaxigrip Tetra? in the full CMI.

6. Are there any side effects?


Serious side effects can include severe allergic reactions, pain situated on the nerve route, fits, 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 of the body and blood vessel inflammation which may result in skin rashes and in very rare cases temporary kidney problems. See your doctor immediately if you notice this.
Common side effects include pain, tenderness, redness, swelling, bruising and hardness at the injection site, headache, muscle aches, feeling unwell, fever, and shivering. In children, other common side effects include irritability, abnormal crying, drowsiness, appetite loss and vomiting. 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.

BRAND INFORMATION

Brand name

Vaxigrip Tetra

Active ingredient

Influenza virus vaccine, split virion, quadrivalent (inactivated)

Schedule

S4

 

1 Name of Medicine

Inactivated quadrivalent influenza vaccine, split virion (influenza virus haemagglutinin).

2 Qualitative and Quantitative Composition

Vaxigrip Tetra is formulated to contain the following four influenza strains* (see Table 1):
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VAXTET01.gif The type and amount of viral antigens contained in Vaxigrip Tetra conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the World Health Organisation (WHO) recommendations for the 2025 season.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.

4 Clinical Particulars

4.9 Overdose

Cases of administration of more than the recommended dose (overdose) have been reported with Vaxigrip Tetra. When adverse reactions were reported, the information was consistent with the known safety profile of Vaxigrip Tetra described in Section 4.8 Adverse Effects (Undesirable Effects).
For information on the management of overdose, contact the Poisons Information Centre, on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Vaxigrip Tetra has not been tested for genotoxic potential.
Carcinogenicity. Vaxigrip Tetra has not been tested for carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure and CAS number. Not applicable/defined for vaccines.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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