Flulaval Tetra: Uses, Side Effects and Dosage

What is FLULAVAL TETRA used for?

• FLULAVAL TETRA is a quadrivalent vaccine for use in adults and children greater than 6 months of age to prevent influenza caused by influenza virus types A and B contained in the vaccine.

• Influenza is a disease of the upper airways and lungs caused by infection with a flu virus. The most commons symptoms are: high temperature (fever), sore throat, coughing, general aches and pains, headaches, weakness and tiredness.

How does FLULAVAL TETRA work?

FLULAVAL TETRA causes the body’s immune system to make antibodies to protect the person from being infected by certain types of influenza virus. This vaccine is only effective against infection by A and B virus types it is designed to prevent and closely related types of virus. None of the ingredients in the vaccine can cause influenza. As with all vaccines, FLULAVAL TETRA may not fully protect all people who are vaccinated.

What are the ingredients in FLULAVAL TETRA?

Medicinal ingredients:

This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) for the 2024 – 2025 season.

Each 0.5 mL dose of the vaccine contains 15 micrograms of haemagglutinin, a type of protein that has been purified from killed and split influenza viruses. The four virus strains in this vaccine are:

• 15 µg HA - A/Victoria/4897/2022 (H1N1)pdm09-like virus
• 15 µg HA - A/Thailand/8/2022 (H3N2)-like virus
• 15 µg HA - B/Phuket/3073/2013-like virus
• 15 µg HA - B/Austria/1359417/2021-like virus.

Serious Warnings and Precautions

• 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.

Non-medicinal ingredients:

Phosphate buffered saline, polysorbate 80, α-tocopheryl hydrogen succinate. Trace amounts of: egg proteins, ethanol, formaldehyde, sodium deoxycholate, and sucrose.

The multidose vial presentation contains thimerosal as a preservative.

The single-dose pre-filled syringe presentation does not contain thimerosal or any other preservative.

FLULAVAL TETRA comes in the following dosage forms:

• multidose vial of 5 mL (10 doses of 0.5 mL each)
• single-dose pre-filled syringe of 0.5 mL

Do not use FLULAVAL TETRA if:

• you had a severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLULAVAL TETRA. Talk about any health conditions or problems you may have, including if you:

• have a severe infection with a high temperature. In these cases, the vaccination will be postponed until you recover. A minor infection should not be a problem.
• have a bleeding problem or bruise easily.
• have a weakened immune system due to HIV infection or due to medicines that suppress the immune system.
• have fainted before or after a previous injection.
• are taking any other medicines or you have recently received any other vaccine.
• have had Guillain-Barré syndrome (GBS) within 6 weeks of receiving a previous influenza vaccination.

• are pregnant or breast-feeding.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLULAVAL TETRA:

• FLULAVAL TETRA must not be mixed with any other vaccine in the same syringe. If FLULAVAL TETRA is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

How to take FLULAVAL TETRA:

Usual dose:

One injection of 0.5 mL into the shoulder muscle or the mid-thigh muscle.

Children 6 months to less than 9 years of age who have not been vaccinated against influenza in the past will receive a second injection at least one month after the first injection.

Overdose:

What are possible side effects from using FLULAVAL TETRA?

These are not all the possible side effects you may have when taking FLULAVAL TETRA. If you experience any side effects not listed here, tell your healthcare professional.

Very common (may occur with more than 1 in 10 doses):

• Pain at the injection site
• Fatigue
• Headache
• Aching muscles
• Joint pain.

Common (may occur with up to 1 in 10 doses)

• Redness and swelling at the injection site
• Shivering
• Fever
• Feeling sick, diarrhea, vomiting, stomach pain

In children, very common side effects are irritability and drowsiness. A common side effect was loss of appetite.

Contact your healthcare professional urgently if you experience:

• Allergic reaction (including anaphylactic and anaphylactoid reactions). These can be recognized by:

  • itchy rash of the hands and feet
  • swelling of the eyes and face
  • difficulty in breathing or swallowing
  • sudden drop in blood pressure and loss of consciousness.
• Temporary inflammation of the nerves causing pain, weakness and paralysis called Guillain-Barré syndrome.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Keep out of reach and sight of children.

Store in a refrigerator between 2 and 8°C.

Do not freeze.

If you want more information about FLULAVAL TETRA

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.

Last Revised Apr 30, 2024

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