Details for: PEDIACEL
Company: SANOFI PASTEUR LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243167 | PEDIACEL | PERTACTIN; PERTUSSIS TOXOID; DIPHTHERIA TOXOID; TETANUS TOXOID; 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; HAEMOPHILUS INFLUENZAE TYPE B-PRP; TETANUS PROTEIN; FILAMENTOUS HAEMAGGLUTININ; FIMBRIAE | 3 MCG / 0.5 ML; 20 MCG / 0.5 ML; 15 LF / 0.5 ML; 5 LF / 0.5 ML; 40 UNIT / 0.5 ML; 8 UNIT / 0.5 ML; 32 UNIT / 0.5 ML; 10 MCG / 0.5 ML; 30 MCG / 0.5 ML; 20 MCG / 0.5 ML; 5 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
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
PEDIACEL® is a vaccine that is used to help prevent diphtheria, tetanus (lock jaw), pertussis (whooping cough), polio and invasive H. influenzae type b (Hib) infections. This vaccine may be given to children aged 2 months or older. It may also be given as a booster to children up to age 7.
The majority of children who are vaccinated with PEDIACEL® will produce enough antibodies to help protect them against these 5 diseases. However, as with all vaccines, 100% protection cannot be guaranteed.
What it does
PEDIACEL® causes the body to produce its own natural protection against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis and invasive Hib infections. After your child receives the vaccine, the body begins to make substances called antibodies. Antibodies help the body to fight disease. If a vaccinated person comes into contact with one of the germs that cause these diseases, the body is usually ready to destroy it.
When it should not be used
- Do not give PEDIACEL® to a child who has an allergy to any ingredient in the vaccine or has had an allergic reaction after receiving a vaccine that contained similar ingredients.
- Do not give PEDIACEL® to a person who has had a serious nervous system disorder within 7 days after a previous pertussis vaccine. In case of progressive nervous system disorder or uncontrolled epilepsy, vaccination may be considered only after a treatment has been established and the condition is stabilized.
What the medicinal ingredient is
Each 0.5 mL dose of PEDIACEL® contains: diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine (pertussis toxoid, filamentous haemagglutinin, fimbriae types 2 and 3, pertactin), inactivated polio vaccine, Hib conjugate vaccine.
What the non-medicinal ingredients are
Aluminum phosphate, 2-phenoxyethanol, polysorbate 80, bovine serum albumin, trace amounts of formaldehyde, glutaraldehyde, neomycin, streptomycin and polymyxin B.
What dosage form it comes in
PEDIACEL® is a liquid vaccine that is injected into a muscle. A single dose is 0.5 mL.
Warnings and precautions
If your child has any of the following conditions, talk to your doctor or pharmacist BEFORE the child receives PEDIACEL®:
- A high fever or serious illness. Wait until the child is better to give the vaccination.
- An allergy to any component of the vaccine or the container.
- A serious nervous system adverse event following a previous pertussis vaccination.
- Diseases of the immune system or who are taking a medical treatment that affects the immune system. The vaccine may provide your child with a lower level of protection than it does for people with healthy immune systems. If possible, try to postpone the vaccination until after your child has completed the treatment.
- A bleeding disorder or take blood-thinning medications. Tell the person giving the injection about your child’s condition. The injection must be done carefully to prevent excessive bleeding.
- A higher risk of seizure than the general population. A fever-reducing medication may be given to your child.
Interactions with this medication
DO NOT mix PEDIACEL® with other vaccines or medicinal products in the same syringe.
Proper use of this medication
Usual Dose
A single dose of 0.5 mL is recommended for routine immunization of infants at 2, 4, 6 and 18 months of age and in children up to their 7th birthday.
The vaccination should be given in the muscle, preferably in the thigh for children up to 1 year-old. In children >1 year of age, the shoulder is the preferred site since use of the thigh results in limping due to muscle pain.
Overdose
Missed Dose
If immunization is delayed for any reason – the recommended schedule is:
- 3 single doses of 0.5 mL with 2 months between doses
- a 4th dose given 6 to 12 months after the 3rd dose.
Side effects and what to do about them
A vaccine, like any medicine, may cause side effects. Up to one third of children who receive PEDIACEL® may have mild side effects such as redness, swelling or tenderness around the injection site. Other common reactions include fever, increased crying, fussiness, being less active and decreased eating. These side effects are usually mild and last no more than 3 to 4 days. Severe reactions, such as high fever, swelling and redness of the entire arm or leg, or a serious allergic reaction are very rare.
Tell your doctor, nurse or pharmacist as soon as possible if your child is not feeling well after receiving PEDIACEL®.
Serious side effects are extremely rare.
This is not a complete list of side effects. For any unexpected effects while taking PEDIACEL®, contact your doctor, nurse or pharmacist.
How to store
Store the vaccine in a refrigerator at 2° to 8°C (35° to 46°F). Do not freeze. Throw the product away if it has been exposed to freezing.
Do not use after the expiration date.
Keep out of reach of children.
Reporting 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)
Email: caefi@phac-aspc.gc.ca
Web: www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
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: 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: November 2011.