Patient Medication Information: uses, side effects, how to take - Fluzone Quadrivalent (Sanofi Vaccines Canada, 7.5 mcg / 7.5 mcg / 7.5 mcg / 7.5 mcg, 15 mcg / 15 mcg / 15 mcg / 15 mcg)
What the vaccine is used for:
FLUZONE® Quadrivalent is a vaccine used to prevent influenza. Influenza (or flu) is an infection caused by the influenza virus.
This vaccine may be given to adults and children 6 months of age and older.
Flu symptoms can include fever, headache, muscle pain, runny nose, sore throat, extreme tiredness and cough. Some people get much sicker.
The influenza virus spreads when a person who has the flu coughs or sneezes into the air. Small droplets of the flu virus stay in the air for a short time then fall onto surfaces nearby. You can get the flu by:
breathing in these droplets through your nose or
mouth.
- the droplets landing directly on your eyes.
touching the hands of a person who has the flu and
then touching your eyes, nose or mouth.
touching surfaces that have been contaminated
with flu virus and then touching your eyes, nose or mouth.
What it does:
FLUZONE® Quadrivalent causes your body to produce its own protection against influenza virus. After you get a flu shot, your immune system produces antibodies against the strains of virus that are in the vaccine. The antibodies are effective for the duration of the flu season. When you are exposed to the virus, the antibodies will help to keep you from
getting sick. If you do get the flu, you may not be as sick.
When it should not be used:
FLUZONE® Quadrivalent should not be used in the following situations:
Do not give FLUZONE® Quadrivalent to anyone who has ever had a severe allergic reaction to:
- egg or egg products
- any component of FLUZONE® Quadrivalent
What the medicinal ingredient is:
This vaccine complies with the WHO (World Health Organization) recommendation (Northern hemisphere) for the 2020-2021 season.
Each 0.5 mL dose of FLUZONE® Quadrivalent contains killed split viruses from four strains of influenza virus for the 2020-2021 season. The viruses in FLUZONE® Quadrivalent are:
A/Guangdong-Maonan/SWL1536/2019
(H1N1)pdm09 - like strain
- A/Hong Kong/2671/2019 (H3N2) - like strain
- B/Phuket/3073/2013 - like strain
- B/Washington/02/2019 - like strain
What the important nonmedicinal ingredients are:
Sodium phosphate-buffered, isotonic sodium chloride solution, formaldehyde, and Triton® X-100. The multidose vial contains thimerosal.
What dosage forms it comes in:
Individual doses in a vial or a prefilled syringe.
The packaging of FLUZONE® Quadrivalent does not contain any latex.
WARNINGS AND PRECAUTIONS
FLUZONE® Quadrivalent will only protect against the strains of flu virus contained in the vaccine or those that are closely related.
FLUZONE® Quadrivalent will not protect against any other strains of flu virus.
IMPORTANT: PLEASE READ
If you have any of the following conditions, talk to your doctor, nurse or pharmacist BEFORE you use FLUZONE® Quadrivalent:
Diseases of the immune system or who are
having treatment that affects the immune system. The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
A bleeding disorder or taking blood-thinning
medications. Tell the person giving you the injection about your condition. There is a risk of excessive bleeding at the injection site if it is not done carefully.
Pregnant or breast-feeding women. It is
important that you understand the risks and benefits of vaccination. FLUZONE® should be given to a pregnant or nursing woman only if it is clearly needed. Tell the person giving you the injection if you are pregnant or breast-feeding.
- Allergy to egg protein or any component of the vaccine.
Fever or serious illness. Wait until the person is
better before giving the flu shot. A person who has a mild illness (such as a mild cold) may have the flu shot. Ask your doctor, nurse or pharmacist for advice.
A history of Guillain-Barré syndrome (GBS)
within 6 weeks of a previous influenza vaccination.
The use of FLUZONE® in infants under 6 months of age is not recommended.
As with all vaccines, FLUZONE® does not protect 100% of people immunized.
Pregnancy Registry
Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-888-621-1146.
INTERACTIONS WITH THIS VACCINE
FLUZONE® Quadrivalent must not be mixed with other vaccines or medicinal products in the same syringe.
PROPER USE OF THIS VACCINE
Usual dose:
For children 6 through 35 months - recommended dose is 0.25 mL or 0.5 mL. The National Advisory Committee on Immunization (NACI) recommends that children 6 to through 35 months of age should be given a full dose (0.5 mL).
For persons 3 years or older - recommended dose is 0.5 mL.
Children under 9 years of age who have not received a previous vaccination - 2 doses are required 4 weeks apart. The second dose is not needed if the child received one or more doses of influenza vaccine in a previous season.
For adults and children older than 1 year, inject the vaccine into the deltoid (shoulder) muscle.
For infants and children less than 1 year inject the vaccine into the mid-thigh muscle.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If a child’s second dose is missed, it can be given at any time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
A vaccine, like any medicine, may cause serious problems, such as severe allergic reactions. The risk of FLUZONE® Quadrivalent causing serious harm is extremely small. The small risks associated with FLUZONE® Quadrivalent are much less than the risks associated with getting the disease against which it protects.
The flu vaccine cannot cause influenza because it does not contain any live virus. The most common side effect is soreness where you got the injection. Children and adults might also notice muscle pain and infants may suffer from irritability.
Severe allergic reactions to the flu shots are very rare. A very rare but possible side effect of influenza vaccination is Guillain-Barré syndrome (GBS). This is an autoimmune disease that attacks the nervous system. GBS causes weakness and abnormal
sensations. Most patients recover fully. This is not a complete list of side effects. Talk to your doctor or nurse before receiving FLUZONE®.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after having FLUZONE® Quadrivalent.
For any unexpected effects after having FLUZONE® Quadrivalent, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Store in a refrigerator at 2° to 8°C (35° to 46°F). Do not freeze. Discard product if it has been exposed to freezing. Protect from light.
Do not use vaccine after expiration date.
Keep FLUZONE® Quadrivalent out of children’s reach.
A maximum of 10 total doses (0.25 mL dose or 0.5 mL dose) can be withdrawn from the multidose vial.
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected case reports on adverse events following immunization.
For Health Care Professionals:
If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events Following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory.
For the General Public:
Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events Following Immunization (AEFI) Form.
If you have any questions or have difficulties contacting your local health unit, please contact the Vaccine Safety Section at the Public Health Agency of Canada:
By toll-free telephone: 1-866-844-0018 By toll-free fax: 1-866-844-5931 Web: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
By regular mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
Address Locator: 6502A
Ottawa, ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: www.sanofi.ca or by contacting the vaccine producer, Sanofi Pasteur Limited, 1755 Steeles Avenue West, Toronto, Ontario, M2R 3T4.
Phone: 1-888-621-1146 or 416-667-2779. Business Hours: 7:30 a.m. to 7:30 p.m., Eastern Time, Monday to Friday.
R8-0420 Canada