Details for: IMOVAX POLIO
Company: SANOFI PASTEUR LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01959042 | IMOVAX POLIO | INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 1 MAHONEY; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 2 MEF1; INACTIVATED POLIOMYELITIS VACCINE (V.C.O.) TYPE 3 SAUKETT | 40 UNIT / 0.5 ML; 8 UNIT / 0.5 ML; 32 UNIT / 0.5 ML | SUSPENSION | SUBCUTANEOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
IMOVANE® Polio is a vaccine used to prevent poliomyelitis (also known as polio).
Polio is a disease caused by three types of poliovirus. People can get polio from drinking water or eating food with the polio virus in it. It is also spread from person to person. While most infections do not result in illness, severe infections can kill nerve cells. This leaves muscles permanently weak or damaged. About 1 in every 100 persons infected with the virus becomes paralyzed. Polio can paralyze muscles used for breathing, talking, eating and walking. It can also cause death.
This vaccine may be given to adults and children 2 months of age and older.
What it does
IMOVANE® Polio causes your body to produce its own natural protection against polio viruses. After you get an IMOVANE® Polio injection, your body begins to make substances called antibodies. Antibodies help your body to fight disease. When you are exposed to polio viruses, the antibodies will help to keep you from getting sick.
When it should not be used
IMOVANE® Polio should not be used in the following situations:
Do not give IMOVANE® Polio to anyone who has had an allergic reaction to any component of the vaccine or its container.
Do not give IMOVANE® Polio to a person who has a fever or serious illness. Wait until the person is better before giving the vaccine. A person who has had a mild illness (such as a mild cold) may have the vaccine. Ask your doctor, nurse or pharmacist for advice.
What the medicinal ingredient is
Each 0.5 mL dose of IMOVANE® Polio contains killed purified viruses from three strains of poliomyelitis viruses
What the non-medicinal ingredients are
calf serum protein, formaldehyde, neomycin, polymyxin B, streptomycin and 2-phenoxyethanol
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage form it comes in
A syringe containing a liquid vaccine dose of 0.5 mL for subcutaneous injection.
Warnings and precautions
BEFORE you use IMOVANE® Polio talk to your doctor, nurse or pharmacist if you or your child have any of the following conditions:
- Persons with diseases of the immune system or taking a medical 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.
- Persons who have bleeding disorders or are on blood-thinning medications. Tell the person giving you the injection about your condition. There is a risk of excessive bleeding where you get the injection if it is not done carefully.
- Pregnant or breast-feeding women. It is important that you understand the risks and benefits of vaccination. IMOVANE® Polio 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.
Interactions with this medication
IMOVANE® Polio must not be mixed with other vaccines or medicinal products in the same syringe.
Proper use of this medication
For persons 2 months of age and older, the recommended dose is 0.5 mL. The vaccine should be given under the skin (subcutaneously), preferably in the deltoid (shoulder) region.
Most people get polio vaccine when they are children. Children usually get 5 doses of IPV: at 2 months of age, a dose 2 months later, at 18 months of age and booster doses at 4 - 6 years and 14 - 16 years.
Most adults do not need polio vaccine because they were already vaccinated as children. But some adults are at higher risk and should consider polio vaccination: people travelling to areas of the world where polio is common, laboratory workers who might handle polio virus, people who may be in contact with children who received oral polio vaccine, and people in communities or groups with disease caused by the polio virus.
People who have not received at least 4 doses of any polio vaccines during their lifetime should do so using IMOVANE® Polio. People in any of the higher risk groups may need a polio vaccine booster if more than 10 years have elapsed since the last dose of their complete polio vaccination series.
Overdose
Not applicable to this vaccine.
Missed Dose
If a 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 IMOVANE® Polio causing serious harm is extremely small. The small risks associated with IMOVANE® Polio are much less than the risks associated with getting the disease against which it protects.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after receiving IMOVANE® Polio.
Serious side effects are extremely rare.
Side effects of this polio vaccine (IPV) are generally mild and last for only a few days after getting the needle. Some people get mild pain, swelling and redness at the spot where the needle was given.
This is not a complete list of side effects. For any unexpected effects after receiving IMOVANE® Polio, contact your doctor, nurse or pharmacist.
How to store
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.
Do not use vaccine after expiration date.
Keep out of the reach of children.
Reporting side effects
To monitor drug safety, Health Canada collects information on
serious and unexpected effects of drugs. If you suspect you
have had a serious or unexpected reaction to this drug you
may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax: 866-678-6789
By email: cadrmp@hc-sd.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
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:
http://www.sanofipasteur.ca
You may also contact the vaccine producer, Sanofi
Pasteur Limited, for more information.
Telephone: 1-888-621-1146 (no charge) or
416-667-2779 (Toronto area).
Business hours: 8 a.m. to 5 p.m. Eastern Time,
Monday to Friday.
This leaflet was prepared by Sanofi Pasteur Limited.
Last revised: December 2010.
R6-1210 Canada