Patient Medication Information: uses, side effects, how to take - Havrix 1440
What HAVRIX is used for:
HAVRIX is a vaccine used to prevent hepatitis A disease. Vaccination is the best way to protect against this disease.
HAVRIX is approved for use in persons 12 months of age and older. The first dose of the vaccine should be given at least 2 weeks prior to anticipated exposure to hepatitis A disease.
How HAVRIX works:
The vaccine works by causing the body to produce its own protection (antibodies) against hepatitis A disease.
The ingredients in HAVRIX are:
Medicinal ingredients: The medicinal ingredient in HAVRIX is inactivated hepatitis A virus. None of the components of the vaccine are infectious.
Non-medicinal ingredients: Aluminium (as aluminium hydroxide), amino acids for injection, disodium phosphate, monopotassium phosphate, polysorbate 20, potassium chloride, sodium chloride and water for injection. Residue from the manufacturing process: neomycin sulphate.
HAVRIX comes in the following dosage forms:
HAVRIX is available as a suspension for injection.
Do not use HAVRIX if:
- you or your child have a known allergy to any component of the vaccine (see What are the ingredients in HAVRIX? above).
- you or your child have shown signs of a serious allergic reaction after a previous dose of this vaccine or any vaccine intended to protect against hepatitis A infection. Signs of an allergic reaction may include skin rash, shortness of breath and swelling of the face or tongue.
Immunization should be postponed if you or your child has a severe fever or infection.
To help avoid side effects and ensure proper use, talk to your healthcare professional before HAVRIX is given to you. Talk about any health conditions or problems you or your child may have, including if:
you or your child has a severe infection with a high temperature (over 38°C).
- you or your child have any known allergies.
- you or your child is on dialysis for kidney disease.
- you or your child have a poor immune system due to illness or drug treatment.
you are pregnant or breastfeeding.
- you or your child have a bleeding problem or bruise easily.
Please tell your healthcare professional if you are taking or have recently taken any other medicines. You can be given other vaccines at the same time as HAVRIX, however these vaccines will be given at different injection sites.
Fainting can occur following, or even before, any needle injection; therefore, tell the healthcare professional if you or your child fainted with a previous injection.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
HAVRIX and immune globulin (human) should be administered at separate injection sites.
When administration of other vaccines with HAVRIX is considered necessary, the vaccines must be given with different syringes and at different injection sites.
How to take HAVRIX:
HAVRIX is injected into the muscle in your upper arm or in the front of the thigh in young children.
Usual dose:
Primary Immunization
The first dose of the vaccine should protect you or your child with normal immunity from infection with hepatitis A virus within 2-4 weeks after the injection.
Booster Dose
To ensure that you or your child is protected long-term you or your child should have a second (booster) dose of the vaccine 6 to 12 months after the first injection.
Overdose:
| If you think you, or a person you are caring for, have received too much HAVRIX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you or your child misses a scheduled injection, talk to your healthcare professional to arrange another visit.
Possible side effects from using HAVRIX:
Like all vaccines, HAVRIX can have side effects. These are not all the possible side effects you may have when taking HAVRIX. If you experience any side effects not listed here, tell your healthcare professional.
Side effects that may occur are the following:
Very common (more than 10% of doses):
- Irritability.
- Headache.
- Pain and redness at the injection site, fatigue.
Common (between 1% and 10% of doses):
- Loss of appetite.
- Drowsiness.
- Diarrhea, nausea, vomiting.
- Swelling or hard lump at the injection site.
- Generally feeling unwell, fever.
Uncommon (between 0.1% and 1% of doses):
- Upper respiratory tract infection, runny or blocked nose.
- Dizziness.
- Rash.
- Aching muscles, muscular stiffness not caused by exercise.
- Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills.
Post-market side effects include: abnormal sensation (such as of burning, prickling, tickling or tingling, pins and needles), itching, chills, fits or seizures, narrowing or blockage of blood vessels, hives (red, often itchy spots which starts on the limbs and sometimes on the face and the rest of the body), joint pain.
Other post-market sides include: allergic reactions. These may be local or widespread 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 reactions may occur before leaving the doctor’s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently.
If any of the side effects get serious or if you notice any side effects not mentioned above, please tell your healthcare professional.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Suspected Side Effects for Vaccines For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional. Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada (PHAC), Health Canada (HC) and GSK cannot provide medical advice. |
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| For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (Reporting Adverse Events Following Immunization (AEFI) in Canada) and send it to your local Health Unit. |
Storage:
HAVRIX must be stored in a refrigerator between 2 and 8°C. Do not freeze. Discard if the vaccine has been frozen.
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 in the original package in order to protect from light.
Store all vaccines out of the sight and reach of children.
If you want more information about HAVRIX:
- 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 Drug Product Database website: (Drug Product Database: Access the database); the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.
Date of Authorization: 2025-07-08
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