Patient Medication Information: uses, side effects, how to take - Actacel Hybrid
What the vaccine is used for:
ACTacel® Hybrid is a vaccine that is used to help prevent against invasive H. influenzae type b (Hib) infections, diphtheria, tetanus (lock jaw) and pertussis (whooping cough). 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 ACTacel® Hybrid will produce enough antibodies to help protect them against these 4 diseases. However, as with all vaccines, 100% protection cannot be guaranteed.
What the vaccine does:
ACTacel® Hybrid causes the body to produce its own natural protection against invasive Hib infections, diphtheria, tetanus and pertussis (whooping cough). 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 the vaccine should not be used:
Do not give ACTacel® Hybrid 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 ACTacel® Hybrid 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 ACTacel® Hybrid contains: Hib conjugate vaccine, diphtheria toxoid, tetanus toxoid, acellular pertussis vaccine (pertussis toxoid, filamentous haemagglutinin, pertactin and fimbriae types 2 and 3).
What the important non-medicinal ingredients are:
Aluminum phosphate (adjuvant), 2-phenoxyethanol, Tris (hydroxymethyl aminomethane), sucrose. Residual formaldehyde and glutaraldehyde are present in trace amounts.
For a full listing of non-medicinal ingredients see Part 1 of the product monograph.
What dosage forms the vaccine comes in:
ACTacel® Hybrid is supplied in two vials: one vial of freeze-dried Act-HIB® vaccine and one vial of liquid dose of 0.5 mL TRIPACEL® Hybrid 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 ACTacel® Hybrid:
- A high fever or serious illness. Wait until the child is better to give the vaccination.
- An allergy to any component of the vaccine.
- A serious nervous system adverse event following a previous pertussis vaccination.
- Diseases of the immune system or 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 taking 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 ACTacel® Hybrid with other vaccines or medicinal products in the same syringe.
ACTacel® Hybrid may be given at the same time but at separate sites with Hepatitis B vaccine, 7-valent pneumococcal conjugate vaccine, MMR and Varicella vaccines.
IMPORTANT: PLEASE READ sanofi pasteur 1.3.1 Product Monograph 376 – ACTacel® Hybrid Post NOL Change
Confidential/Proprietary Information
Product Monograph Template – Schedule D Page 28 of 28 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:
Not applicable to this vaccine.
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 ACTacel® Hybrid 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 ACTacel® Hybrid.
Serious side effects are extremely rare.
This is not a complete list of side effects. For any unexpected effects while taking ACTacel® Hybrid, contact your doctor, nurse or pharmacist.
HOW TO STORE THE VACCINE
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
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).
Last revised: May 2009
R2-0509 Canada
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected adverse events following vaccination.
If your child has had a serious or unexpected event following receipt of a vaccine, you may notify the Public Health Agency of Canada:
By toll-free telephone: 613-954-5590 (1-866-844-0018) By toll-free fax: 613-954-9874 (1-866-844-5931) By email: caefi@phac-aspc.gc.ca
By regular mail:
Vaccine Safety Section
Centre for Immunization & Respiratory Infectious Diseases
Public Health Agency of Canada
100 Eglantine Driveway
A/L0602C, Bldg #6
Tunney’s Pasture
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.