Fluviral (Id Biomedical Corporation of Quebec, PM 00053162): Uses, Side Effects and Dosage

What the vaccine is used for:

FLUVIRAL is a trivalent vaccine for use in adults and children greater than 6 months of age to provide active immunization against 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 commons symptoms are: high temperature (fever), sore throat, coughing, general aches and pains, headaches, weakness and tiredness.

What it does:

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 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, FLUVIRAL may not fully protect all people who are vaccinated.

When it should not be used:

If you had a severe allergic reaction (e.g., anaphylaxis) to egg proteins, a previous dose of any influenza vaccine produced in eggs or any ingredient in the vaccine.

What the medicinal ingredient is:

This vaccine complies with the World Health Organization (WHO) recommendation (Northern Hemisphere) for the 2019-2020 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/Brisbane/02/2018 (H1N1)pdm09-like virus;
• A/Kansas/14/2017 (H3N2)-like virus;
• B/Colorado/06/2017-like virus.

What the important nonmedicinal ingredients are:

Phosphate buffered saline, polysorbate 80, α-tocopheryl hydrogen succinate, thimerosal. Trace amounts of: egg proteins,

ethanol, formaldehyde, sodium deoxycholate, and sucrose.

What dosage forms it comes in:

• multidose vial (type 1 glass) of 5 mL for 10 doses

The packaging does not contain latex.

WARNINGS AND PRECAUTIONS

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.

BEFORE you receive FLUVIRAL talk to your doctor or nurse 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.
• You have a bleeding problem or bruise easily.
• You have a weakened immune system due to HIV infection or due to medicines that suppress the immune system.
• You have fainted before or after a previous injection.
• If you are taking any other medicines or you have recently received any other vaccine.
• If Guillain-Barré (GBS) has occurred within 6 weeks of receiving a previous influenza vaccination.

• If you are pregnant or breast-feeding seek advice from your doctor.

INTERACTIONS WITH THIS MEDICATION

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.

PROPER USE OF THIS MEDICATION

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:

In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

As with all medicines, FLUVIRAL may cause side effects in some persons. If any side effect worries you, or you have any unusual symptoms, please contact your doctor, nurse or pharmacist.

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

• Pain 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
• Redness and swelling at the injection site, fever, chills, malaise, chest tightness
• Join 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

This is not a complete list of side effects. For any unexpected effects while taking FLUVIRAL, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Stored in a refrigerator at +2° C to +8° C.

Do not freeze.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at: http://www.gsk.ca or by contacting the sponsor: GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario L5N 6L4

1-800-387-7374

Last revised: 26 April 2019

^©2019 GSK group of companies or its licensor.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM