Patient Medication Information: uses, side effects, how to take - Pentacel (Sanofi Vaccines Canada, Liquid, Powder For Solution)
What the vaccine is used for:
PENTACEL® is a vaccine that is used to help prevent against 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 PENTACEL® 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:
PENTACEL® 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 PENTACEL® 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 PENTACEL® 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 PENTACEL® contains: Hib conjugate vaccine, diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine (pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3) and inactivated polio vaccine.
What the important nonmedicinal ingredients are:
Aluminum phosphate (adjuvant), 2-phenoxyethanol, polysorbate 80, Tris (hydroxymethyl) aminomethane residual formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, polymyxin B, and sucrose. For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage forms it comes in:
PENTACEL® is supplied in two vials: one vial of freeze-dried Act-HIB® vaccine and one vial of liquid dose of 0.5 mL QUADRACEL® vaccine which are then combined for injection into a muscle.
WARNINGS AND PRECAUTIONS
If your child has any of the following conditions, talk to your doctor, nurse or pharmacist BEFORE the child receives PENTACEL®:
- 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 (AW) may be given to your child.
INTERACTIONS WITH THIS VACCINE
DO NOT mix PENTACEL® with other vaccines or medicinal products in the same syringe.
PENTACEL® may be given at the same time but at separate sites with Hepatitis B vaccine, 7-valent IMPORTANT: PLEASE READ
pneumococcal conjugate vaccine, MMR and Varicella vaccines.
PROPER USE OF THIS VACCINE
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:
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 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 PENTACEL® 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 have 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 PENTACEL®.
Serious side effects are extremely rare.
This is not a complete list of side effects. For any unexpected effects while taking PENTACEL®, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
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 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)
Email: caefi@phac-aspc.gc.ca
Web: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
Mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
Ottawa, Ontario
K1A 0K9
A/L 6502A
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.
R8-1111 Canada