SUMMARY CMI

INFLUVAC^® TETRA

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about receiving this medicine, speak to your doctor, nurse or pharmacist.

1. Why am I receiving INFLUVAC TETRA?

INFLUVAC TETRA is an influenza vaccine containing inactivated fragments from four types of influenza virus. This type of vaccine is also known as a quadrivalent influenza vaccine. INFLUVAC TETRA is used to prevent certain types of influenza (commonly called the flu) and can be used in adults and children 6 months of age and older.

For more information, see Section 1. Why am I receiving INFLUVAC TETRA? in the full CMI.

2. What should I know before I receive INFLUVAC TETRA?

Do not receive INFLUVAC TETRA if you have had an allergic reaction to INFLUVAC TETRA, to any other influenza vaccine or to any of the ingredients listed at the end of the CMI.

Talk to your doctor, nurse or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

INFLUVAC TETRA is given by injection. Tell the doctor, nurse or pharmacist if you have ever fainted when receiving an injection.

INFLUVAC TETRA is usually stored at the pharmacy or at the doctor's clinic or surgery. If you need to store the vaccine, keep it in the fridge between 2°C to 8°C. Do not freeze.

For more information, see Section 2. What should I know before I receive INFLUVAC TETRA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with INFLUVAC TETRA and affect how it works.

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How is INFLUVAC TETRA given?

• The doctor, nurse or pharmacist will give INFLUVAC TETRA as an injection.
• Generally, a single dose of 0.5 mL is given each year. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.

More information can be found in Section 4. How is INFLUVAC TETRA given? in the full CMI.

5. What should I know after receiving INFLUVAC TETRA?

For more information, see Section 5. What should I know after receiving INFLUVAC TETRA? in the full CMI.

6. Are there any side effects?

Most unwanted effects with INFLUVAC TETRA are mild and usually clear up within a few days.

In adults and children, common side effects include pain and discomfort at the injection site, headache, tiredness, muscle and joint aches/pains, generally feeling unwell, shivering and sweating.

In children, other common side effects include stomach effects such as diarrhoea, vomiting and loss of appetite, irritability, drowsiness, and fever.

Serious side effects such as a serious allergic reaction may occur rarely.

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.

FULL CMI

INFLUVAC^® TETRA

Active ingredient(s): Quadrivalent Influenza Vaccine, surface antigen, inactivated (influenza virus haemagglutinin)

Consumer Medicine Information (CMI)

This leaflet provides important information about using INFLUVAC TETRA. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about receiving INFLUVAC TETRA.

Where to find information in this leaflet:

1. Why am I receiving INFLUVAC TETRA?
2. What should I know before I receive INFLUVAC TETRA?
3. What if I am taking other medicines?
4. How is INFLUVAC TETRA given?
5. What should I know after receiving INFLUVAC TETRA?
6. Are there any side effects?
7. Product details

1. Why am I receiving INFLUVAC TETRA?

INFLUVAC TETRA is a quadrivalent influenza vaccine containing inactivated fragments from four types of influenza virus.

INFLUVAC TETRA is used to prevent certain types of influenza (commonly called the flu). The vaccine works by causing the body to produce its own protection (antibodies) against four different types of influenza virus.

Each year new types of influenza virus can appear, so every year INFLUVAC TETRA is changed to contain fragments of the new types of virus. Therefore, influenza vaccination is recommended every year.

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

INFLUVAC TETRA can be used in adults and children over the age of 6 months.

2. What should I know before I receive INFLUVAC TETRA?

Warnings

Do not receive INFLUVAC TETRA if:

• You are allergic to any influenza vaccine or any of the ingredients listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• You currently have a severe infection or fever. A minor infection such as a cold should not be a problem, but talk to your doctor, nurse or pharmacist about this before being vaccinated.

Check with your doctor, nurse or pharmacist if:

• You have received INFLUVAC TETRA before and became unwell.
• You have ever had an illness affecting the nervous system, especially Guillain-Barre Syndrome (GBS). If you have had GBS, you may be more likely to develop GBS following influenza vaccination than someone who has never had GBS.
• You have any medical conditions, such as an immune deficiency condition, thrombocytopenia, coagulation disorder or bleeding disorder.
• You have ever fainted or fallen or felt faint just before or after receiving an injection.

Pregnancy and breastfeeding

Check with your doctor, nurse or pharmacist if you are pregnant or intend to become pregnant. They will discuss with you the benefits and risks of receiving INFLUVAC TETRA when pregnant.

Tell your doctor, nurse or pharmacist if you are breast feeding. They will discuss the risks and benefits of vaccination however the vaccine is not expected to cause problems for breast-fed babies.

Storage

INFLUVAC TETRA is usually stored at the pharmacy, at the doctor's surgery or at the flu vaccination clinic.

If you need to store INFLUVAC TETRA, always:

• Keep it in the refrigerator stored between 2°C to 8°C. Do not freeze as freezing destroys the vaccine.
• Keep it where young children cannot reach it.
• Keep it in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any leftover INFLUVAC TETRA that has expired or has not been used.

3. What if I am taking other medicines?

Tell your doctor, nurse or pharmacist if you have received another vaccine this year or if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

4. How is INFLUVAC TETRA given?

How it is given

The doctor, nurse or pharmacist will give INFLUVAC TETRA as an injection.

For some people with bleeding problems, the injection may need to be given under the skin (subcutaneously).

INFLUVAC TETRA should never be given into a vein (intravenously).

How much is given

For adults and children over 6 months of age, the doctor, nurse or pharmacist will give a single 0.5 mL dose of INFLUVAC TETRA.

For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.

When it is given

INFLUVAC TETRA is generally given as a single dose in autumn each year before the start of the flu season.

You should receive a repeated vaccination every year as new types of influenza virus can appear each year.

If the dose is missed

Talk to your doctor, nurse or pharmacist and arrange another visit as soon as possible.

5. What should I know after receiving INFLUVAC TETRA?

As with any vaccine, a protective immune response may not be elicited in all vaccines.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how INFLUVAC TETRA affects you.

INFLUVAC TETRA should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or light-headedness. Make sure you know how you react to INFLUVAC TETRA before you drive a car, operate machinery, or do anything that could be dangerous if you are dizzy or light-headed.

6. Are there any side effects?

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well during or after receiving a dose of INFLUVAC TETRA.

All medicines can have side effects. Most unwanted effects with INFLUVAC TETRA are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

However, some side effects may need medical attention. As with all vaccines given by injection there is a very small risk of serious reactions. Allergy to INFLUVAC TETRA is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

Ask your doctor, nurse or pharmacist if you have any questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems if you are in Australia or https://nzphvc.otago.ac.nz/reporting if you are in New Zealand. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available with a doctor's prescription or from a flu vaccination clinic.

What INFLUVAC TETRA contains

Do not take this medicine if you are allergic to any of these ingredients.

INFLUVAC TETRA is not made with any human blood or blood products, or any other substances of human origin.

What INFLUVAC TETRA looks like

INFLUVAC TETRA is a clear, colourless liquid.

It is available in packs of 1 or 10 as a pre-filled (0.5 mL) glass syringe with 16 mm needle (AUST R 292237).

Who distributes INFLUVAC TETRA

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

Distributed in New Zealand by:

Viatris Ltd
PO Box 11-183
Ellerslie AUCKLAND
www.viatris.co.nz
Telephone: 0800 168 169

INFLUVAC® TETRA is a Viatris company trade mark.

This leaflet was prepared in November 2023.

InfluvacTetra_cmi\Nov23/00

Published by MIMS December 2023

1 Name of Medicine

Quadrivalent Influenza Vaccine, surface antigen, inactivated (influenza virus haemagglutinin).

2 Qualitative and Quantitative Composition

Influvac Tetra is a purified, inactivated influenza vaccine (surface antigen), containing the following four influenza strains recommended for the 2024 influenza season:
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238).
A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237).
B/Austria/1359417/2021-like strain (B/Victoria lineage) (B/Austria/1359417/2021, BVR-26).
B/Phuket/3073/2013-like strain (B/Yamagata lineage) (B/Phuket/3073/2013, wild type).
Each 0.5 mL dose contains 15 microgram haemagglutinin per each of the above mentioned viral strains, for a combined total amount of 60 microgram. Each strain has been propagated in fertilised hens' eggs from healthy chickens.
The type and amount of viral antigens in Influvac Tetra conform to the requirements of the Australian Influenza Vaccine Committee (AIVC) and the New Zealand Ministry of Health for the 2024 southern hemisphere influenza season.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Influvac Tetra is a clear colourless liquid for injection in pre-filled syringes (glass, type I).

4 Clinical Particulars

4.1 Therapeutic Indications

For the prevention of influenza caused by influenza virus, types A and B.
For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines.
Influvac Tetra is indicated in adults and children from 6 months of age and older.

4.2 Dose and Method of Administration

Adults and children 6 months of age and older.

Children less than 6 months of age.

Administration.

Instructions for use/handling.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues of eggs (ovalbumin, chicken proteins), formaldehyde, cetrimonium bromide, polysorbate 80, or gentamicin.
Anaphylaxis following a previous dose of any influenza vaccine.
Immunisation should be postponed in patients with febrile illness or acute infection.
Refer to the relevant National Immunisation Guidelines for full details on contraindications and precautions.

4.4 Special Warnings and Precautions for Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Influvac Tetra should under no circumstances be administered intravascularly.
As with other vaccines administered intramuscularly, Influvac Tetra should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
Influvac Tetra is not effective against all possible strains of influenza virus. Influvac Tetra is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Interference with serological testing: see subheading Effects on laboratory tests below.
This medicine contains sodium, less than 1 mmol (23 mg) per dose, i.e. essentially 'sodium free'.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium free'.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. If Influvac Tetra is given at the same time as other vaccines, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Influvac Tetra has no or negligible influence on the ability to drive and use of machines.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

a) Summary of the safety profile.

b) Tabulated list of adverse reactions.

Adverse reactions reported from post-marketing surveillance.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Vascular disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

Given the nature of the product and mode of administration the probability of overdosage is negligible.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) or 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Adults 18 years of age and older.

Children 3 to 17 years of age.

Children 6-35 months of age.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose contains 0.10 mg potassium chloride, 0.10 mg monobasic potassium phosphate, 0.67 mg dibasic sodium phosphate dihydrate, 4.0 mg sodium chloride, 0.067 mg calcium chloride dihydrate, 0.05 mg magnesium chloride hexahydrate and q.s. to 0.5 mL water for injections.
Influvac Tetra antigens have been produced from eggs and are inactivated by formaldehyde treatment. Each 0.5 mL may also contain not more than 100 nanogram ovalbumin, 0.01 mg formaldehyde, 0.02 mg cetrimonium bromide, 1 mg sodium citrate, 0.2 mg sucrose, 1 nanogram gentamicin sulfate, traces of tylosine tartrate, hydrocortisone and polysorbate 80, which are used during the manufacturing process.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).
The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Keep out of the sight and reach of children.
Store between 2 and 8 degrees Celsius. Refrigerate. Do not freeze. Store in the original package in order to protect from light.

6.5 Nature and Contents of Container

Single-dose 0.5 mL pre-filled glass syringe, available in packs of 1 or 10:

Australian Register of Therapeutic Goods (ARTG).

6.6 Special Precautions for Disposal

Any unused medicine or waste material should be disposed of immediately.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes