Details for: ACT-HIB
Company: SANOFI PASTEUR LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01959034 | ACT-HIB | HAEMOPHILUS INFLUENZAE TYPE B-PRP; TETANUS PROTEIN | 10 MCG / 0.5 ML; 30 MCG / 0.5 ML | POWDER FOR SOLUTION | INTRAMUSCULAR |
| 01959034 | ACT-HIB | HAEMOPHILUS INFLUENZAE TYPE B-PRP; TETANUS PROTEIN | 10 MCG / 0.5 ML; 30 MCG / 0.5 ML | KIT | 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
Act-HIB® is a vaccine that protects against infection with Haemophilus influenzae type b (Hib). Hib causes bacterial meningitis and other serious infections. All children 2 months to 5 years of age should receive Hib vaccine, usually combined with QUADRACEL®. Children over 5 years old usually do not need Hib vaccine, but some older children or adults with special health conditions should get it. These conditions include removal of the spleen, sickle cell disease, HIV/AIDS, certain cancers, or other conditions. Persons who have or are going to have cochlear implants also should get Hib vaccine. Ask your doctor or nurse for details.
What it does
Act-HIB® causes your (or your child’s) body to produce its own protection against Hib bacteria. After receiving a Hib vaccine, your (or your child’s) immune system produces antibodies. Antibodies help the body to fight disease. When you are exposed to the Hib bacteria, the antibodies will help to keep you (or your child) from getting sick. As with all vaccines, As with all vaccines, Act-HIB® does not protect 100% of people immunized.
When it should not be used
You (or your child) have had an allergic reaction to a previous dose of Act-HIB® or to any component of Act-HIB® or its container.
You (or your child) have a fever or serious illness. Wait until you are better before taking 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
polyribose ribitol phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b, covalently bound to tetanus protein.
What the non-medicinal ingredients are
Sodium chloride solution, Sucrose, Tris (hydroxymethyl) aminomethane.
What dosage form it comes in
Each single dose of Act-HIB® is a freeze-dried vaccine to be dissolved in 0.5 mL of the diluent for Act-HIB.
Freeze-dried Act-HIB® may also be dissolved in a single dose of QUADRACEL® or TRIPACEL® if both vaccines are needed.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you (or your child) take Act-HIB®. Talk about any health conditions or problems you or child may have, including if you or your child:
- Have a weakened immune system. The vaccine may provide you (or your child) with a lower level of protection than it does for people with healthy immune systems.
- Have a coagulation disorder or are on anticoagulant therapy. Tell the person giving the injection about your/your child’s condition. There is a risk of excessive bleeding at the site of injection if it is not done carefully.
- Are pregnant or breast-feeding. It is important that you understand the risks and benefits of vaccination. Act-HIB® should be given to a pregnant or nursing woman only if it is clearly needed. Tell the person giving the injection if you (or your child) are pregnant or breast-feeding.
- Have an allergy to any component of the vaccine or the container.
Tell your healthcare professional about all the medicines you (or your child) take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
Act-HIB® may be mixed with its own diluent, with TRIPACEL®, or with QUADRACEL®. Act-HIB® must not be mixed with other vaccines or medicinal products in the same syringe.
Proper use of this medication
Usual Dose
Each dose is a single injection of 0.5 mL given intramuscularly.
Infants receive one injection at 2, 4, and 6 months of age, followed by a booster at 18 months of age.
If your infant does not start his/her series at 2 months of age, ask your doctor or nurse when the doses of Hib vaccine are needed.
Older children or adults usually receive one injection.
Overdose
Missed Dose
If a dose is missed, it can be given at any time.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Act-HIB®. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warning and Precautions.
A vaccine, like any medicine, may cause serious problems, such as severe allergic reactions. The risk of Act-HIB® causing serious harm is extremely small. The small risks associated with Act-HIB® are much less than the risks associated with getting the diseases against which it protects.
Some children may have mild pain, swelling and redness for a few days at the spot where the needle was given. A very few children may get a mild fever, rash or hives.
Serious side effects are extremely rare.
If you have a troublesome side symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store the vaccine 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 after the expiration date.
Keep out of reach of children.
Reporting side effects
Reporting Suspected Side Effects
For the General Public:
Should you (or your child) experience an adverse event following immunization, please report it
to your doctor, nurse, or pharmacist.
Should you require information related to the management of the side effect, please contact your
healthcare provider. The Public Health Agency of Canada, Health Canada and Sanofi Pasteur
Limited cannot provide medical advice.
For Health Care Professionals:
If a patient experiences an adverse event following immunization, please complete the appropriate
Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory
(http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the Sanofi Pasteur Limited website (www.sanofipasteur.ca), or by calling the Sanofi Pasteur Limited Vaccine Information Service at 1-888-621-1146 (no charge) or 416-667-2779 (Toronto area). Business hours are 7:30 a.m. to 7:30 p.m. EST Monday to Friday.
This leaflet was prepared by Sanofi Pasteur Limited.
Last revised: January 2019