Fluviral (Id Biomedical Corporation of Quebec, PM 00085961): Uses, Side Effects and Dosage

What FLUVIRAL is used for:

FLUVIRAL is a trivalent vaccine for use in adults and children from 6 months of age for the prevention of influenza disease 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 common symptoms are: high temperature (fever), sore throat, coughing, general aches and pains, headaches, weakness and tiredness.

How FLUVIRAL works:

FLUVIRAL 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 type A and B viruses. None of the ingredients in the vaccine can cause influenza. As with all vaccines, FLUVIRAL may not fully protect all people who are vaccinated.

The ingredients in FLUVIRAL are:

Medicinal ingredient(s): This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) for the 2026 - 2027 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 three virus strains in this vaccine are:

• A/Missouri/11/2025 (H1N1)pdm09-like virus
• A/Darwin/1454/2025 (H3N2)-like virus
• B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus

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

The multi-dose vial presentation contains thimerosal as a preservative.

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

FLUVIRAL comes in the following dosage form(s):

• 6 mL multi-dose vial (type 1 glass) containing 5 mL of vaccine (10 doses of 0.5 mL)
• single-dose pre-filled syringe of 0.5 mL

The packaging does not contain latex.

Do not use FLUVIRAL 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 receive FLUVIRAL. 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 an occurrence of Guillain-Barré (GBS) within 6 weeks of receiving a previous influenza vaccination.

• are pregnant or breastfeeding seek advice from your doctor.

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 FLUVIRAL:

• FLUVIRAL must not be mixed with any other vaccine in the same syringe. If FLUVIRAL 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 FLUVIRAL:

• FLUVIRAL will be given to you by a healthcare professional in a healthcare setting.

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:

Possible side effects from using FLUVIRAL:

These are not all the possible side effects you may have when taking FLUVIRAL. 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 and redness at the injection site
• Fatigue
• Headache
• Aching muscles
• Loss of appetite
• Drowsiness
• Irritability

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

• Red eyes
• Feeling sick, vomiting, diarrhea, stomach pain
• Swelling at the injection site, fever, chills, malaise, chest tightness
• Joint pain
• Sore throat, cough

Contact your doctor, nurse or pharmacist 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:

Store in a refrigerator between 2^oC and 8°C.

Do not freeze.

Keep out of reach and sight of children.

If you want more information about FLUVIRAL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.gsk.com; or by calling 1-800-387-7374.

GlaxoSmithKline Inc.

Date of Authorization: 2026-05-01

©2026 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.