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Priorix-Tetra: Uses, Side Effects and Dosage

Updated:
Strength:
1000 CCID50 / 25118.9 CCID50 / 1000 CCID50 / 1995.2623 PFU
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Patient Medication Information: uses, side effects, how to take - Priorix-Tetra

What PRIORIX-TETRA 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)].

How PRIORIX-TETRA works:

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.

The ingredients in PRIORIX-TETRA are:

Medicinal ingredient(s): 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 of OKA varicella virus strains.

Non-medicinal ingredients: amino acids, lactose, mannitol, sorbitol, and water for injection. Residue: neomycin sulphate

PRIORIX-TETRA comes in the following dosage form(s):

PRIORIX-TETRA is supplied as a whitish powder in a single dose glass vial with a pre-filled syringe of clear colourless sterile liquid (diluent) for reconstituting the vaccine.

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

Do not use PRIORIX-TETRA if:

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 The ingredients in PRIORIX-TETRA are). 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 PRIORIX-TETRA.
  • has previously experienced an allergic reaction to any vaccine against measles, mumps, rubella and varicella diseases.
  • has any severe illness or have recently received or are still taking any medicine that weakens the immune system (including high dose corticosteroids).

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.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive PRIORIX-TETRA. Talk about any health conditions or problems you may have, including if you:

  • have 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.
  • have 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.
  • have had previous allergic reactions, impaired defense against infection or is pregnant.
  • have a history or a family history of allergies.
  • have ever had a severe allergic reaction to eggs or anything that contained eggs.
  • have had a side effect after vaccination against measles, mumps or rubella that involved easy bruising or bleeding for longer than usual.
  • have 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.
  • are 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.
  • have a weakened immune system or will be starting a medicine that weakens the 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.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with PRIORIX-TETRA:

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.

How to take PRIORIX-TETRA:

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:

If you think you, or a person you are caring for, have taken too much PRIORIX-TETRA, 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.

Missed dose:

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

Possible side effects from using PRIORIX-TETRA:

These are not all the possible side effects you may have when taking PRIORIX-TETRA. If you experience any side effects not listed here, tell your healthcare professional.

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

As with all injectable vaccines, there is a 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.

Inflammation of the brain (encephalitis) has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines including PRIORIX-TETRA. Fatal cases have been observed, especially in people with weakened immune systems. If you develop any of the following symptoms, contact your doctor urgently and inform them that you have received PRIORIX-TETRA:

  • loss or reduced levels of consciousness, convulsions or loss of control of bodily movements, accompanied by fever and headache.

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):

  • nose and throat 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):

  • inflammation of the airways in the lungs (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:

  • allergic reactions
  • 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
  • damage to the brain caused by an interruption to its blood supply (stroke)
  • inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome)
  • 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)
  • 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.

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 GlaxoSmithKline Inc. cannot provide medical advice.

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:

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

Do not freeze.

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.

Keep out of the reach and sight of children.

If you want more information about PRIORIX-TETRA:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes the 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: 2026-03-02

©2026 GSK group of companies or its licensor

Trademarks are owned by or licensed to the GSK group of companies

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02297884

Approved according to the text: March 2, 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Priorix-Tetra

DIN 02297884
Schedule(s) SCHEDULE D
Active ingredient(s) Measles virus live attenuated (schwarz strain) 1000 CCID50, Mumps virus live attenuated (rit 4385 strain) 25118.9 CCID50, Rubella virus live attenuated (wistar ra27/3 strain) 1000 CCID50, Varicella-zoster virus live attenuated (oka-strain) 1995.2623 PFU
Dosage form(s) Powder For Solution
Route(s) of administration Subcutaneous, Intramuscular
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J07 Vaccines
      1. J07B Viral vaccines
        1. J07BD Measles vaccines
          1. J07BD54 Measles, combinations with mumps, rubella and varicella, live attenuated
Company GLAXOSMITHKLINE INC
Current status Marketed
Current status date March 2, 2026

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.