Patient Medication Information: uses, side effects, how to take - Vaxigrip
What the vaccine is used for:
VAXIGRIP® 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:
VAXIGRIP® 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 six to 12 months. 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:
VAXIGRIP® should not be used in the following situations:
Do not give VAXIGRIP® to anyone who has ever had a severe allergic reaction to:
- egg or egg products
- chicken protein
- any component of VAXIGRIP® or its container.
What the medicinal ingredient is:
Each 0.5 mL dose of VAXIGRIP® contains killed split viruses from three strains of influenza virus for the 2014-2015 season. The viruses in VAXIGRIP® are:
- A/California/7/2009 (H1N1)pdm09-like strain
- A/Texas/50/2012 (H3N2)-like strain
- B/Massachusetts/2/2012-like strain.
What the important nonmedicinal ingredients are:
Thimerosal (only in the multidose vial), sodium phosphate-buffered, isotonic sodium chloride solution, formaldehyde, Triton® X-100, sucrose and neomycin What dosage forms it comes in:
Individual doses in a prefilled syringe or a vial that contains enough vaccine for many doses.
WARNINGS AND PRECAUTIONS
VAXIGRIP® will only protect against the strains of flu virus contained in the vaccine or those that are closely related.
VAXIGRIP® will not protect against any other strains of flu virus.
If you have any of the following conditions, talk to your doctor, nurse or pharmacist BEFORE you use VAXIGRIP®:
- 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. Tell the person giving you the injection if you are pregnant or breast-feeding.
- Allergy to egg protein or to any component of the vaccine or the container.
- 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.
IMPORTANT: PLEASE READ
The use of VAXIGRIP® in infants under 6 months of age is not recommended.
As with all vaccines, VAXIGRIP® does not protect 100% of people immunized.
INTERACTIONS WITH THIS MEDICATION VAXIGRIP® must not be mixed with other vaccines or medicinal products in the same syringe.
PROPER USE OF THIS MEDICATION
Usual dose:
For children 6 to 35 months - recommended dose is 0.25 mL or 0.5 mL. The National Advisory Committee on Immunization (NACI) now recommends that children 6 to 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 VAXIGRIP® causing serious harm is extremely small. The small risks associated with VAXIGRIP® 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. It may last a couple of days. You might also notice fever, fatigue and muscle aches within 6 to 12 hours after your shot. These side effects may last a day or two.
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 VAXIGRIP®.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after having VAXIGRIP®.
For any unexpected effects after having VAXIGRIP®, 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. Protect from light. Discard product if it has been exposed to freezing.
Do not use vaccine after expiration date.
Discard multidose vials of VAXIGRIP® 7 days after first use.
Keep VAXIGRIP® out of children’s reach.
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects 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 your child 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 Vaccine Safety Section at Public Health Agency of Canada:
By toll-free telephone: (1-866-844-0018) By toll-free fax: (1-866-844-5931) By email: caefi@phac-aspc.gc.ca
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
A/L 6502A
Ottawa, Ontario
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: http://www.sanofipasteur.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. This leaflet was prepared by Sanofi Pasteur Limited. Last revised: April 2014.
R20-0414 Canada