Consumer Information for: PRIORIX-TETRA

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-TETRA is a vaccine used in children from the age of 9 months up to 6 years of age for protection against measles, mumps, rubella and chicken pox (varicella) diseases.

PRIORIX-TETRA may be used in individuals up to 12 years of age based upon previous experience with the separate component vaccines, PRIORIX (combined measles, mumps and rubella vaccine, live, attenuated) and VARILRIX [varicella virus vaccine, live, attenuated (OKA-strain)].

  • Measles: Measles is an infectious illness caused by a virus. It is passed on by breathing in droplets in the air from infected people. The main signs of the illness include a rash, runny nose and a fever. Some people can get other symptoms that include ear infections, chest infections such as bronchitis and pneumonia, and fits. Measles can be fatal. These effects are more common in underfed or ill children.
  • Mumps: Mumps is an infectious illness also caused by a virus. It is passed on by breathing in droplets in the air from infected people. The main sign of the illness is swelling of the glands near the ears, on one or both sides of the face in the cheek area. Some people also have inflammation of the pancreas, inflammation of the ovaries or testicles that sometimes cause fertility problems in later life, meningitis, and deafness that continues after recovering from the illness itself.
  • Rubella: Rubella is an infectious illness also caused by a virus. The main signs of rubella are a rash and swollen glands. If pregnant women get rubella infection in the first 12 weeks of pregnancy it can cause damage to the unborn child in about nine out of 10 cases. This damage can include mental handicap, blindness, deafness and heart problems.
  • Varicella: Chickenpox (varicella) is an infectious illness caused by a virus called varicella zoster. It is passed on by close contact with infected people and by breathing in droplets in the air from infected people. It is most common in children under the age of 10 in whom it is usually mild. The main sign of the illness is a rash with raised red spots on the face and head which may spread to other parts of the body. Chickenpox can be more serious in adults, in pregnant women and patients who have a poor immune system.
What it does

PRIORIX-TETRA contains a live, weakened form of the measles, mumps, rubella and varicella viruses. When a person is given the vaccine, the immune system (the body’s natural defence system) will make antibodies against these viruses. These antibodies protect against measles, mumps, rubella and varicella infections.

The weakened viruses that are in PRIORIX-TETRA are rarely passed on from the person who has had the vaccine to other people. This can happen with the varicella virus only when the healthy person has developed blisters.

As with all vaccines, PRIORIX-TETRA may not completely protect all people who are vaccinated.

When it should not be used

Do not use PRIORIX-TETRA if your child:

  • Has previously experienced an allergic reaction to PRIORIX-TETRA, neomycin (an antibiotic) or any component contained in this vaccine (see What the medicinal ingredient is and What the important nonmedicinal ingredients are sections). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, if you had a skin rash (dermatitis) after treatment with neomycin, you can still be vaccinated with PRIORIXTETRA.
  • Has previously experienced an allergic reaction to any vaccine against measles, mumps, rubella and varicella diseases.
  • Has any severe illness or takes any medicine that weakens the immune system.
PRIORIX-TETRA must not be given during pregnancy. Pregnancy should be avoided for one month after vaccination. During this time your daughter should use an effective method of birth control to avoid pregnancy. If your daughter is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor or pharmacist before the vaccine is given.
What the medicinal ingredient is

Each 0.5 mL dose of PRIORIX-TETRA contains not less than 103.0 CCID50 of the Schwarz measles, not less than 104.4 CCID50 of the RIT 4385 mumps, not less than 103.0 CCID50 of the Wistar RA 27/3 rubella and not less than 103.3 PFU OKA varicella virus strains.

What the non-medicinal ingredients are

PRIORIX-TETRA contains the following nonmedicinal ingredients: amino acids, lactose, mannitol, sorbitol, and water for injection. Residue: neomycin sulphate.

What dosage form it comes in

PRIORIX-TETRA is supplied as a whitish powder in a single dose glass vial with either a glass ampoule or a pre-filled syringe* of clear colourless sterile liquid (diluent) for reconstituting the vaccine.
*Format not available in Canada.

When the vaccine is reconstituted it may vary from clear peach to fuchsia pink (bright pink).

Warnings and precautions

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

  • Has a severe infection with a high temperature. In these cases, the vaccination will be postponed until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
  • Has a history of febrile convulsions (fits) or a family history of convulsions. In this case your child should be closely monitored after vaccination as fever may occur 5 to 12 days after vaccination.
  • Has had previous allergic reactions, impaired defense against infection or is pregnant.
  • Has a history or a family history of allergies.
  • Has ever had a severe allergic reaction to eggs or anything that contained eggs.
  • Has had a side effect after vaccination against measles, mumps or rubella that involved easy bruising or bleeding for longer than usual.
  • Has had a blood or plasma transfusion, or human immunoglobulin within the last three months. If so, the antibody response to PRIORIX-TETRA may be low so it is usual to wait for three months before giving PRIORIX-TETRA.
  • Is due to have a skin test for possible tuberculosis. If this test is done within 6 weeks after receiving PRIORIX-TETRA, the result may not be reliable.
  • Has a weakened immune system. Your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness.
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.

Like other vaccines, PRIORIX-TETRA cannot completely protect your child against catching chickenpox. However, people who have been vaccinated and catch chickenpox usually have a very mild disease, compared with people who have not been vaccinated.

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

Tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.

Aspirin or Aspirin-type products (also known as salicylates) should not be taken for 6 weeks after vaccination, since we now know that Reye’s Syndrome, a rare disease of the brain and liver, could occur.

PRIORIX-TETRA can be given at the same time as other vaccines. A different injection site will be used for each vaccine.

Proper use of this medication

Usual Dose

Your child will receive two doses of PRIORIX-TETRA. Your doctor will advise you when to take the second dose.

PRIORIX-TETRA will be given as an injection under the skin or into the muscle. Your doctor may wipe the skin with alcohol or other disinfecting agents and will let the skin dry before the injection

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 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

The safety of measles-mumps-rubella and varicella vaccines has been well characterised in clinical trials and postmarketing surveillance. PRIORIX (combined measles, mumps and rubella vaccine, live, attenuated) and VARILRIX [varicella virus vaccine, live, attenuated (OKA-strain)], have been used in Canadian market since 2002 and 2003 respectively. Over 144 million doses of PRIORIX and 14 million doses of VARILRIX have been distributed worldwide since 1997 and 1994 respectively. No safety concerns outside the recognized and reported safety profile has been identified to date.

Like other vaccines, PRIORIX-TETRA may occasionally cause unwanted effects, although not everybody gets them.

As with all injectable vaccines, there is an extremely small risk of 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. Such reactions may 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-TETRA were as follows:

  • Very common (these may occur with more than 1 in 10 doses of the vaccine):
    • local pain
    • local redness
    • fever greater than 37.5°C*
  • Common (these may occur with up to 1 in 10 doses of the vaccine):
    • local swelling
    • fever greater than 39°C*
    • irritability
    • rash (spots and/or blisters)
  • Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
    • upper respiratory tract infection
    • crying
    • generally feeling unwell
    • swollen glands in the cheek
    • diarrhea
    • vomiting
    • loss of appetite
    • inability to sleep
    • fatigue
    • lack of energy
    • nervousness
    • runny nose
    • swollen glands in the neck, armpit and groin
  • Rare (these may occur with up to 1 in 1,000 doses of the vaccine):
    • bronchitis
    • infection of the middle ear
    • coughing
    • seizures with fever
After commercialization the following additional side effects have been reported rarely in people vaccinated with PRIORIX-TETRA:
  • infection around the brain or spinal cord (meningitis)
  • shingles (herpes zoster)
  • measles-like symptoms
  • mumps-like symptoms (including transient, painful swelling of the testicles and swollen glands in the neck)
  • 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), stroke, inflammation of some nerves, possibly with tingling or numbness, or loss of 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)
  • 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
  • severe condition of the skin that may affect the mouth and other parts of the body
  • chickenpox-like rash
  • joint and muscle pains
* Higher rates of fever were observed after administration of the first dose of PRIORIX-TETRA when compared to PRIORIX and VARILRIX vaccines administered separately at the same visit.

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

How to store

Store PRIORIX-TETRA in a refrigerator (2 to 8°C) and in the original package in order to protect from light.

Do not freeze.

Keep out of the reach and sight of children.

Do not use PRIORIX-TETRA after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 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.

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