Patient Medication Information: uses, side effects, how to take - Afluria Tetra
What is AFLURIA® TETRA used for?
AFLURIA® TETRA is indicated for active immunization of persons aged 5 years and older against influenza disease caused by the influenza virus types A and B contained in the vaccine.
AFLURIA® TETRA vaccine helps prevent influenza, often called “the flu.” Influenza is caused by infection with specific influenza viruses. New types of influenza viruses can appear each year. AFLURIA® TETRA vaccine contains fragments of four different types of influenza virus. Each year the World Health Organization decides which four types of viruses are most suitable to include in the vaccine.
For this season (2024 – 2025) the viruses A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Thailand/8/2022 (H3N2)-like virus, B/Austria/1359417/2021-like virus and B/Phuket/3073/2013-like virus.
You cannot catch influenza from the vaccine, as the virus in the vaccine has been killed and split into small non-infectious particles.
The National Advisory Committee on Immunization (NACI) encourages annual influenza vaccination for all Canadians who are able to have the vaccine.
Vaccination against influenza is recommended every year, for anyone wanting to lower their chance of catching influenza.
How does AFLURIA® TETRA work?
AFLURIA® TETRA vaccine works by helping your body to protect itself against infection by the types of influenza viruses that are in the vaccine. The vaccine stimulates the body to make substances called antibodies. Antibodies fight the influenza virus. If you have been vaccinated, when you come into contact with the influenza viruses in the vaccine, your body is usually able quickly to destroy the virus, which may prevent you from getting influenza.
Your body takes a few weeks after vaccination to fully develop effective protection against the influenza virus.
Protection against influenza generally requires one dose of AFLURIA® TETRA vaccine. Some people including children who have not received influenza vaccination before may require two doses.
Most people make satisfactory antibodies against the influenza virus. However, as with all vaccines, 100% protection cannot be guaranteed.
The chance of having a severe unwanted reaction after having AFLURIA® TETRA vaccine is very small. Whereas, the risks of not being vaccinated against influenza may be very serious.
What are the ingredients in AFLURIA® TETRA?
Medicinal ingredients:
Each 0.5 mL dose of the vaccine contains 15 mcg of hemagglutinin (HA) from each influenza strain
- A/Victoria/4897/2022 (H1N1)pdm09-like virus
- A/Thailand/8/2022 (H3N2)-like virus
- B/Austria/1359417/2021-like virus
- B/Phuket/3073/2013-like virus
Non-medicinal ingredients:
- Calcium chloride
- Dibasic sodium phosphate (anhydrous)
- Monobasic potassium phosphate
- Monobasic sodium phosphate
- Potassium chloride
- Sodium chloride
- Thimerosal*
- Water for injection
*Thimerosal is included in multi-dose vials only.
Each dose may also contain trace amounts of sodium taurodeoxycholate, ovalbumin (egg protein), beta-propiolactone, neomycin sulfate, polymyxin B sulfate, hydrocortisone and sucrose.
AFLURIA® TETRA vaccine does not contain lactose, gluten, tartrazine or any azo dyes. The syringe and vial components do not contain latex. AFLURIA® TETRA is considered safe for use in persons with latex allergies.
AFLURIA® TETRA comes in the following dosage forms:
AFLURIA® TETRA is supplied as a suspension for intramuscular injection in either a 0.5 mL, single dose, pre-filled syringe or a 5 mL multidose vial.
Do not use AFLURIA® TETRA if:
Your child is under 5 years of age. AFLURIA® TETRA vaccine is only approved for use in children aged 5 years and over.
You or your child have or previously have had an allergy to:
- AFLURIA® TETRA or any of the ingredients listed in this leaflet
- eggs
- the antibiotics neomycin sulfate or polymyxin B sulfate.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AFLURIA® TETRA. Talk about any health conditions or problems you may have, including if you or your child:
have or have had a reaction to vaccination with any of the following:
- severe allergic reaction
- difficulty breathing
- swelling of the throat
- fainting or collapse
- fits or convulsions
- high temperature (greater than 38.5°C)
- severe skin reaction at the injection site, including severe bruising.
have an infection or temperature higher than 38.5°C.
Your doctor may decide to delay vaccination until the illness has passed. A minor illness such as a cold is not usually a reason to delay vaccination.
- have low immunity due to ill health, for example, some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
- have low immunity due to treatment with medicines such as corticosteroids, cyclosporine or other medicines, used to treat cancer (including radiation therapy)
- have allergies or allergic reactions, including; runny, blocked or itchy nose; itchy rash or hives; swelling of the face, lips, mouth or tongue
- have or have had Guillain-Barré Syndrome (GBS), an illness which affects the nervous system and causes paralysis
- have allergies to other medicines or other substances
are pregnant or breast feeding. Your healthcare professional will be able to discuss the potential risks and benefits of having AFLURIA® TETRA while you are pregnant or breastfeeding.
- have experienced fainting, or feeling faint, with a previous injection. Fainting can occur following, or even before, any vaccination. Appropriate measures should be taken to prevent injury from falling.
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 AFLURIA® TETRA:
Interactions have not been established between influenza vaccines in general and other vaccines or medications.
How AFLURIA® TETRA is given:
- AFLURIA® TETRA is given as an injection into the muscle of your upper arm.
Usual dose:
AFLURIA® TETRA is given once every year as follows:
- Adults and children 5 years and over: one injection of 0.5 mL
For children 5 to less than 9 years old who are receiving influenza vaccine for the first time, it is recommended that a follow-up (booster) dose of AFLURIA® TETRA is given 4 weeks after the first dose.
Overdose:
| If you think you have been given too many doses of AFLURIA® TETRA or have been given it by mistake, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
Children 5 years to less than 9 years of age who have not been previously vaccinated against Influenza should receive a second dose after 4 weeks. In case the second dose is missed, talk to your healthcare professional and arrange another visit as soon as possible.
What are possible side effects from using AFLURIA® TETRA?
These are not all the possible side effects you may have when taking AFLURIA® TETRA. If you experience any side effects not listed here, tell your healthcare professional.
The following are the more common side effects of AFLURIA® TETRA. Mostly these are mild and short lived. Tell your doctor if you or your child notice any of these and they worry you:
- Reaction around the injection site such as tenderness, bruising, redness, warmth, pain, swelling, the formation of hard lumps or decreased ability to move the injected limb
- Flu-like symptoms, such as headache, tiredness, fever, sore throat, runny nose, blocked nose, sneezing, cough, chills
- Vomiting, nausea, diarrhea
- Aching muscles
- Dizziness
The following table lists more serious side effects that may need urgent medical attention or hospitalization. These side effects are rare.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| Tingling or numbness | ✓ | ||
Allergic reaction Typical symptoms include rash, itching or hives on the skin, swelling of the face, lips tongue or other parts of the body | ✓ | ||
| Shortness of breath, wheezing or trouble breathing | ✓ | ||
| Fit, convulsions or seizure including convulsion associated with fever | ✓ | ||
| Bleeding or bruising more easily than normal | ✓ | ||
| Little or no urine | ✓ | ||
| Severe stabbing or throbbing nerve pain | ✓ | ||
| Neck stiffness, headache and high temperature associated with hallucinations, confusion, paralysis of part or all of the body, disturbances or behavior, speech | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| and eye movements and sensitivity to light. | ||
| Guillain-Barré syndrome (GBS). GBS may make you feel weak; you may have difficulty moving around or you may experience numbness and tingling in your limbs. | ||
| ✓ | ||
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.
Reporting Suspected Side Effects for Vaccines For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional. Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Seqirus cannot provide medical advice. For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit. |
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Storage:
Store in a refrigerator between 2°C and 8°C. Protect from light. Do not freeze. If frozen, do not use.
Keep out of reach and sight of children.
If you want more information about AFLURIA® 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.seqirus.ca, or by calling 1855-358-8966.