Fluad: Uses, Side Effects and Dosage

What is FLUAD® Pediatric and FLUAD® used for?

FLUAD® Pediatric/FLUAD® is an inactivated influenza virus vaccine against influenza subtypes A and B contained in the vaccine, indicated in children 6 months to less than 2 years of age and adults 65 years of age and older.

How does FLUAD® Pediatric and FLUAD® work?

FLUAD® Pediatric/FLUAD® provides active immunization of persons 6 months to less than 2 years of age and persons 65 years of age and older against influenza disease, used to prevent people from developing influenza (the flu), or reduce flu symptoms.

Like other influenza vaccines FLUAD® Pediatric/FLUAD® causes the body to produce antibodies against the virus. This means that when your body is exposed to the flu virus, your body is able to defend itself. The antibodies stop the attacking virus. You cannot catch influenza from the vaccine, since it only contains portions of the virus, and not the whole live virus. Your body takes 2 to 3 weeks to produce antibodies after vaccination. Therefore, if you are exposed to influenza immediately before or after your vaccination, you could still develop the illness. The vaccine will not protect you against the common cold, even though some of the symptoms are similar to influenza. Influenza viruses change all the time, so different vaccines are made every year. To stay protected against influenza, you need to be re-vaccinated every year before the winter season.

It is particularly important for some groups of people to be vaccinated. These include people with certain medical conditions, elderly people, people who are likely to be exposed to the infection and people on certain medications. If you are in doubt as to whether you should be vaccinated, talk to your local health professionals.

FLUAD® Pediatric/FLUAD® follows the World Health Organisation (WHO) and National Advisory Committee on Immunization (NACI) recommendation for vaccination for the northern hemisphere for the 2026-2027 season.

What are the ingredients in FLUAD® Pediatric and FLUAD®?

Medicinal ingredients:

Influenza virus vaccine (surface antigen, inactivated) subtypes A and B (2026/2027 season).

Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains:

A/Missouri/11/2025 (H1N1)pdm09-like virus,

A/Darwin/1454/2025 (H3N2)-like virus,

B/Tokyo/EIS13-175/2025-like virus.

This vaccine complies with the WHO recommendations (northern hemisphere) for the 2026/2027 season.

Non-medicinal ingredients:

Calcium chloride dihydrate, citric acid, disodium phosphate dihydrate, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sodium citrate, sorbitan trioleate, squalene and water for injections.

May also contain trace amounts of:

Cetyltrimethylammonium bromide (CTAB), egg proteins, formaldehyde, hydrocortisone, kanamycin, or neomycin.

For a full listing of nonmedicinal ingredients see Part I of the Product Monograph.

FLUAD® Pediatric and FLUAD® comes in the following dosage forms:

Each 0.5 mL dose contains 15 micrograms of influenza virus haemagglutinin (HA) and each 0.25 mL dose contains 7.5 micrograms of influenza virus HA from each of the following 3 strains:

A/Missouri/11/2025 (H1N1)pdm09-like virus,

A/Darwin/1454/2025 (H3N2)-like virus,

B/Tokyo/EIS13-175/2025-like virus.

• Sterile suspension for intramuscular injection provided as one or ten single dose prefilled glass syringes (Type I), without needles.
• FLUAD® Pediatric/FLUAD® does not contain thimerosal or any other preservative.
• The syringe plunger does not contain latex and FLUAD® is considered safe for use in persons with latex allergies

Do not use FLUAD® Pediatric and FLUAD® if:

• there is a history of hypersensitivity to egg proteins or other components of the vaccine, any of the excipients or in people who have had a life-threatening reaction to previous influenza vaccination. (For a complete listing, see Dosage Forms, Strengths, Composition and Packaging).

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

• are/is allergic to eggs or egg-products
• are/is allergic to any of the following: kanamycin and neomycin sulphate, hydrocortisone, formaldehyde, cetyltrimethylammonium bromide, or polysorbate 80
• have/has a fever, or you think you may be getting a fever
• had a serious reaction to any flu vaccine in the past
• have/has any known allergies
• have/has experienced any health problems

• are pregnant: ask your doctor for advice

• are/is currently on any medication (i.e. immunosuppressant, theophylline, anticoagulants such as warfarin)

Other warnings you should know about:

FLUAD® should not be administered to anyone with known allergies to eggs or egg products, or any other constituent of the vaccine or to anyone who has had a life-threatening reaction to previous influenza vaccination.

If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD® should be based on careful consideration of the potential benefits and risks.

Immunocompromised patients may have a diminished immune response to FLUAD® Pediatric/FLUAD®.

FLUAD® may be given at the same time as other vaccines. There are no data to assess the concomitant administration of FLUAD® Pediatric with other vaccines.

Do not mix with any other vaccine in the same syringe.

As with any vaccine, immunization with FLUAD® may not protect 100% of individuals against influenza disease.

Immunosuppressive therapies may reduce immune response to FLUAD® Pediatric/FLUAD®.

USE IN SPECIFIC POPULATIONS

• Safety and effectiveness of FLUAD® has not been established in pregnant women and nursing mothers.
• Safety and effectiveness in children over 2 years of age and adolescents has not been established.
• Antibody responses were lower in the geriatric population than in younger adult subjects.

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 FLUAD® Pediatric and FLUAD®:

Overview

No interaction between FLUAD® Pediatric/FLUAD® and other vaccines or medication is known.

Drug-Drug Interactions

FLUAD® may be given at the same time as other vaccines. There are no data to assess the concomitant administration of FLUAD® Pediatric with other vaccines. FLUAD® Pediatric/FLUAD® should not be mixed with any other vaccine in the same syringe. Immunization should be carried out on separate limbs. It should be noted that the systemic adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Although a possible interaction has been suggested in the literature between influenza vaccination and the use of warfarin and theophylline, clinical studies have not shown any adverse effects attributable to these drugs in people receiving influenza vaccine. There were no studies designed to evaluate the drug interactions with FLUAD® Pediatric/FLUAD®.

How FLUAD® Pediatric and FLUAD® is given:

Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection).

Usual dose:

Children 6 months to <2 years of age: A single dose of 0.25 mL.

Children 6 months to <2 years of age who have not been previously vaccinated against influenza, should receive a second dose after at least 4 weeks.

Adults aged 65 years and over: A single dose of 0.5 mL.

Immunization should be carried out by intramuscular injection only.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.

Overdose:

No data are available.

What are possible side effects from using FLUAD® Pediatric and FLUAD®?

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

Vaccination with FLUAD® Pediatric/FLUAD® (influenza vaccine, surface antigen, inactivated) cannot cause influenza because the vaccine does not contain live virus. Respiratory disease after vaccination represents coincidental illness unrelated to influenza vaccination.

Occasionally people have side effects with influenza vaccines. The most common of these are fever, feeling unwell, shivering, tiredness, headache, sweating, muscle joint pain, and warmth. Skin reactions include redness, swelling, pain, ecchymosis (blue/black staining of the skin) and a hardening of the skin at the injection site and itching. These reactions will normally disappear without treatment in a day or two.

In clinical studies for FLUAD® in elderly population, the most common (≥10%) adverse reactions reported were headache, muscle pain, and fatigue as well as local pain, thickening, swelling, and redness at injection site.

In clinical studies for FLUAD® Pediatric in children 6 months to <2 years, the most common (≥10%) adverse reactions reported were irritability, fever, vomiting , sleepiness, change in eating habits, diarrhea, and persistent crying as well as local redness, tenderness, and thickening at injection site.

Rarely (≤ 0.1%), neuralgia (nerve pain), paresthesia (numbness and tingling), convulsions (seizures), thrombocytopenia (a blood disorder), lymphadenopathy (swelling of the glands in the neck, armpit or groin), muscular weakness, and allergic reactions (this might include but is not limited to breathing or swallowing difficulties, or swelling in the face or skin) have been reported with influenza vaccination. In rare cases, allergic reactions may lead to shock.

Vasculitis (inflammation of blood vessels) temporarily affecting the kidneys, exudative erythema multiforme (severe skin rash), neurological disorders (affecting the nerves and brain), such as encephalomyelitis, and neuritis, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week) and extensive swelling of injected limb lasting more than one week have also been rarely reported.

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:

This product should be stored at 2°C to 8°C (in a refrigerator), not frozen. The syringe should be kept in the outer carton, thus protecting it from light.

FLUAD® Pediatric/FLUAD® can be administered following a 2 hour exposure at temperatures between 8° and 25°C. This is not, however, a recommendation for storage.

Do not use vaccine after the expiration date.

Keep out of reach and sight of children.

If you want more information about FLUAD® Pediatric and FLUAD®:

• 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 http://www.seqirus.ca, or by calling 1-855-358-8966.

Distributed by: Seqirus Canada Inc. 16766 TransCanada Hwy. Suite 504, Kirkland, Québec, H9H 4M7

Last Revised April 28, 2026