Details for: HAVRIX - SUS IM 1440 ELISA UNITS/ML
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02187078 | HAVRIX - SUS IM 1440 ELISA UNITS/ML | HEPATITIS A VACCINE, INACTIVATED | 1440 UNIT / ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
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
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.
What it does
The vaccine works by causing the body to produce its own protection (antibodies) against hepatitis A disease.
When it should not be used
HAVRIX® should not be used:
- if you or your child have a known allergy to any component of the vaccine (see What the important medicinal ingredient is and What the important nonmedicinal ingredients are sections).
- if 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.
What the medicinal ingredient is
The medicinal ingredient in HAVRIX® is inactivated hepatitis A virus. None of the components of the vaccine are infectious.
What the non-medicinal ingredients are
HAVRIX® contains the following nonmedicinal ingredients: Aluminum hydroxide, amino acids for injection, disodium phosphate, monopotassium phosphate, neomycin sulphate, polysorbate 20, potassium chloride, sodium chloride and water for injection.
What dosage form it comes in
HAVRIX® is presented as a suspension for injection.
Warnings and precautions
BEFORE you use HAVRIX® talk to your doctor or pharmacist 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 doctor 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 doctor or nurse if you or your child fainted with a previous injection.
Interactions with this medication
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.
Proper use of this medication
Usual dose
HAVRIX® is injected into the muscle in your upper arm or in the front of the thigh in young children.
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.
Missed Dose
If you or your child misses a scheduled injection, talk to your doctor to arrange another visit.
Side effects and what to do about them
Like all vaccines, HAVRIX® can have side effects.
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.
If any of the side effects get serious or if you notice any side effects not mentioned above, please tell your doctor.
This is not a complete list of side effects. For any unexpected effects while taking HAVRIX®, contact your doctor or pharmacist.
How to store
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 all vaccines out of the reach and sight of children.
Store in the original package in order to protect from light.
Reporting 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:
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 product monograph, prepared for health professionals can be found at:
http://www.gsk.ca
or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: July 3, 2018
© 2018 GlaxoSmithKline Inc. All Rights Reserved
HAVRIX and ENGERIX-B are registered trademarks of GlaxoSmithKline Biologicals SA, used under license by GlaxoSmithKline Inc.