Patient Medication Information: uses, side effects, how to take - Hiberix
What the vaccine is used for:
HIBERIX is a vaccine used to protect your child against disease caused by Haemophilus influenzae type b (Hib).
Vaccination is the best way to protect against these diseases.
Haemophilus influenzae type b can cause swelling (inflammation). This can lead to serious problems such as: mental slowness (retardation), cerebral palsy, deafness, epilepsy or partial blindness. It can also cause swelling of the throat. This can cause death by suffocation. Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints and tissues of the eyes and mouth.
HIBERIX is for infants and children from 8 weeks of age.
What it does:
HIBERIX works by helping the body make its own protection (antibodies) which protect your child against these diseases.
As with all vaccines, HIBERIX may not fully protect all children who are vaccinated.
HIBERIX will only protect against infections caused by the Haemophilus influenzae type b for which the vaccine has been developed.
Children with a weakened immune system (such as due to HIV infection) may not get the full benefit from HIBERIX.
When it should not be used:
HIBERIX should not be used:
in children with known allergy to any component of the vaccine (see “What the nonmedicinal ingredients are” section) or children having shown signs of an allergic reaction after a previous dose of this vaccine or any injection containing Haemophilus influenzae type b. Signs of an allergic reaction may include shortness of breath and swelling of the face or tongue.
- if your child has an infection or a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.
What the medicinal ingredient is:
HIBERIX contains conjugated Haemophilus influenzae type b.
None of the components in the vaccine are infectious. You cannot get the diseases from the HIBERIX vaccine.
What the nonmedicinal ingredients are:
Lactose, sodium chloride and water for injection.
What dosage forms it comes in:
HIBERIX is supplied as a powder in a vial and a diluent (liquid) in a pre-filled syringe. The powder is white and the diluent is clear and colourless.
The 2 components are mixed together before they are given to your child.
WARNINGS AND PRECAUTIONS
BEFORE you use HIBERIX talk to your doctor or pharmacist if:
- your child has a bleeding problem or bruises easily. HIBERIX should be given with caution since bleeding may occur following vaccination.
- your child has an infection, or a temperature over 38°C, or both.
- your child has any known allergies.
- your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
- your child is taking any medicines or has an infection that affect the immune system (the body’s natural defence system) since your child may not get the full benefit from HIBERIX.
- your child has any serious health problem.
your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).
Fainting can occur following, or even before, any needle injection; therefore, tell the doctor or nurse if your child fainted with a previous injection.
| INTERACTIONS WITH THIS VACCINE |
HIBERIX can be given at the same time as other childhood vaccines. A different place for the injection will be used for each vaccine.
| PROPER USE OF THIS VACCINE |
| 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. |
Usual dose:
Your child will receive a total of 4 injections. Each injection will be given intramuscularly (into a muscle) at 2, 4 and 6 months of age. A booster should be given at 15 to 18 months.
Missed Dose:
If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Make sure your child finishes the complete vaccination course. If not, your child may not be fully protected against infection.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all vaccines, HIBERIX can cause side effects, although not everybody gets them.
Side effects that occurred during clinical trials with HIBERIX were as follows:
Allergic reactions
As with all injectable vaccines, your child may experience an allergic reaction. Allergic reactions are very rare (these may occur with up to 1 in 10,000 doses of the vaccine).
The signs of an allergic reaction may include: skin rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
These signs usually start very soon after the injection has been given. Take your child to see a doctor straight away if they happen after leaving the clinic.
Children who receive HIBERIX may occasionally have:
Very common (these may occur with more than 1 in 10 doses of the vaccine): irritability, feeling sleepy, fever, swelling, pain and redness at the injection site, loss of appetite, crying, restlessness, diarrhea.
Common (these may occur with up to 1 in 10 doses of the vaccine): vomiting.
Rare (these may occur with up to 1 in 1000 doses of the vaccine): fits (including fits due to fever).
Additionally, side effects not observed in clinical trials but reported after commercialisation of HIBERIX include:
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): fainting due to injection, collapse (sudden onset of muscle floppiness), periods of unconsciousness or lack of awareness, and paleness or bluish skin discoloration, temporarily stopping breathing, hives, rash, large swelling of the injected limb, hard lump at the injection site.
Tell your doctor as soon as possible if:
-Any of the common and very common conditions above persists or worsens.
-Your child develops any rare and/or very rare symptoms within days following the vaccination.
-If you noticed any side effects not mentioned in this leaflet.
Do not be alarmed by this list of possible side effects. It is possible that your child will have no side effects from vaccination.
This is not a complete list of side effects. For any unexpected effects while taking HIBERIX, contact your doctor or pharmacist.
HOW TO STORE IT
Store HIBERIX at 2° to 8°C. Do not freeze. Discard if the vaccine has been frozen. Store in the original package in order to protect from light.
After reconstitution immediate use is recommended.
Do not use after expiration date shown on the label. The date for last use corresponds to the last day of the month mentioned.
Store all vaccines out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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 you 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 By email: caefi@phac-aspc.gc.ca At the following website: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php By regular mail: The Public Health Agency of Canada Vaccine Safety Section 130 Colonnade Road Ottawa, Ontario K1A 0K9 Address Locator 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 HIBERIX product monograph, prepared for health professionals can be found at:
http://www.gsk.ca or by contacting the sponsor, GlaxoSmithKline Inc.
7333Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: August 14, 2019
©2019 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.