Consumer Information for: PRIORIX

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

PRIORIX is a vaccine used for protection against measles, mumps and rubella.

What it does

PRIORIX protects your child against measles, mumps and rubella. It works by helping the body to make its own antibodies which protect your child against these diseases. As with all vaccines, PRIORIX may not completely protect all people who are vaccinated.

When it should not be used

PRIORIX

  • vaccination should be delayed if you or your child has an infection with a high temperature.
  • vaccination should not be received if you think you or your child has previously had an allergic reaction to PRIORIX, neomycin (an antibiotic contained in the vaccine in trace amounts) or any other component contained in this vaccine. Signs of an allergic reaction may include skin rash, shortness of breath and swelling of the face and tongue. If you or your child has had a skin rash (dermatitis) after treatment with neomycin, your child can still be vaccinated with PRIORIX.
  • vaccination should not be received if you think your child has previously had an allergic reaction to any vaccine against measles, mumps and rubella
  • vaccination should not be received if you or your child’s defences against infections (immunity mechanisms) are severely impaired.
  • should not be administered to pregnant women. Furthermore, pregnancy should be avoided for one month after vaccination. Breastfeeding women can be vaccinated only where there is a clear need for vaccination. Inadvertent vaccination with PRIORIX of women who are unaware they are pregnant should not be a reason for termination of pregnancy.
What the medicinal ingredient is

Each 0.5 mL dose of the reconstituted vaccine contains as active ingredients not less than 103.0 CCID50 of the Schwarz measles, not less than 103.7 CCID50 of the RIT 4385 mumps, and not less than 103.0 CCID50 of the Wistar RA 27/3 rubella virus strains.

What the non-medicinal ingredients are

PRIORIX contains as inactive ingredients: amino acids, lactose, mannitol, sorbitol and water for injection. Residues: neomycin sulphate.

What dosage form it comes in

PRIORIX is provided as a freeze-dried vaccine for reconstitution with sterile diluent (water for injection).

Warnings and precautions

BEFORE you use PRIORIX talk to your doctor or pharmacist if you or your child:

  • has a high temperature (over 38°C), previous allergic reactions to this vaccine, neomycin or any ingredient in the vaccine.
  • ever had a severe allergic reaction to eggs or anything that contained eggs.
  • has an impaired defence against infections. You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness.
  • or somebody else in the family has a history of convulsions or allergic diseases.
  • is taking any other medicine or has recently received any other vaccine.
  • has any serious health problems.
  • has a condition called thrombocytopenia (decreased platelets which may lead to unusual bleeding or bruising).
  • is pregnant, or breastfeeding
As with other vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic events (severe allergic reaction that can be life threatening) following the administration of the vaccine.

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

In subjects who have received immune globulins or a blood transfusion, vaccination should be delayed for at least three months.

If a tuberculin test (skin test to check for tuberculosis) is to be performed, it should be done either before, at the same time as, or 4 to 6 weeks after vaccination with PRIORIX, otherwise the result of the tuberculin test may not be correct.

Your doctor may decide to give PRIORIX at the same time as other vaccines. A different injection site will be used for each vaccine.

Proper use of this medication

The vaccine must be administered by a health professional. A single 0.5 mL dose of the reconstituted vaccine is recommended.

Usual Dose

PRIORIX will be injected under the skin or into a muscle either in the upper arm or in the outer thigh.

PRIORIX should not be administered intravascularly (into a blood vessel).

Different injectable vaccines should always be administered at different injection sites.

PRIORIX may be given as a booster dose in subjects who have previously been vaccinated with another measles, mumps and rubella combined vaccine.

Overdose

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.

Missed Dose

Make sure you or your child finishes the complete vaccination course. If not, you or your child may not be fully protected against infection.

Side effects and what to do about them

Like all vaccines, PRIORIX may occasionally cause unwanted effects.

As with all injectable vaccines, there is a rare risk of allergic reactions. The signs of allergy may include local or widespread skin rash that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing which may lead to collapse. These reactions will usually occur before leaving the doctor’s office. However, you should seek immediate treatment in any event.

Side effects that occurred during clinical trials with PRIORIX were as follows: Very common: ≥ 10%

  • Redness at the injection site
  • Fever ≥38°C (rectal) or ≥37.5°C (axillary/oral)
Common: ≥ 1% and < 10%
  • Upper respiratory tract infection
  • Rash
  • Pain and swelling at the injection site
  • Fever ≥39.5°C (rectal) or ≥39°C (axillary/oral)
Uncommon: ≥ 0.1% and < 1%
  • Infection of the middle ear
  • Swollen glands in the neck, armpit or groin
  • Loss of appetite
  • Nervousness, abnormal crying, not being able to sleep (insomnia)
  • Discharge with itching of the eyes and crusty eyelids (conjunctivitis)
  • Bronchitis, cough
  • Swollen glands in the cheek
  • Diarrhoea, vomiting
Rare: ≥ 0.01% and < 0.1%
  • Allergic reactions
  • Seizures with fever
After the marketing of PRIORIX, the following additional side effects have been rarely reported:
  • Infection around the brain or spinal cord (meningitis)
  • Measles-like symptoms
  • Mumps-like symptoms (including transient, painful swelling of the testicles and swollen glands in the neck)
  • Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets, unusual bleeding or bruising under the skin
  • Infection or inflammation of the brain, spinal cord and peripheral nerves resulting in temporary difficulty when walking (unsteadiness) and/or temporary loss of control of bodily movements), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome)
  • Narrowing or blockage of blood vessels. This may include unusual bleeding or bruising under the skin (Henoch Schonlein purpura) or fever which lasts for more than five days, associated with a rash on the trunk sometimes followed by a peeling of the skin on the hands and fingers, red eyes, lips, throat and tongue (Kawasaki disease)
  • Severe condition of the skin that may affect the mouth and other parts of the body
  • Joint and muscle pains
If the child develops any other symptom within days following the vaccination, tell the doctor as soon as possible.

This is not a complete list of side effects. For any unexpected effects while taking PRIORIX, contact your doctor or pharmacist.

How to store

Store your vaccine in a refrigerator at 2 to 8°C.

Do not freeze.

Store in original packaging in order to protect from light.

Store all vaccines out of the reach and sight of children.

The expiry date is shown on the label and packaging. The vaccine should not be used after this date.

Reporting side effects

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:
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
Address Locator 6502A
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.

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: August 14, 2019

© 2019 GSK group of companies or its licensor Trademarks are owned by or licensed to the GSK group of companies.

Report a problem or mistake on this page
Please select all that apply:
Date modified: