Details for: VARILRIX
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02241047 | VARILRIX | VARICELLA-ZOSTER VIRUS VACCINE LIVE ATTENUATED (OKA-STRAIN); WATER | 1995 PFU / 0.5 ML; 0.5 ML | POWDER FOR SOLUTION | SUBCUTANEOUS |
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
VARILRIX is a vaccine against chicken pox (varicella).
What it does
VARILRIX protects you against chicken pox (varicella) virus. It works by helping the body to make its own antibodies which protect you against the disease.
When it should not be used
You should not receive VARILRIX if:
- you have previously had an allergic reaction to VARILRIX, neomycin (an antibiotic), or any component contained in this vaccine. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
- you have previously had an allergic reaction to any other vaccine against chicken pox (varicella).
- you have any severe illness that weakens the immune system (such as blood disorders, leukemia or infections) (See also Warnings and Precautions).
- you have recently received or are still taking treatment that weakens the immune system (including high dose corticosteroids).
- you are pregnant. Furthermore, pregnancy should be avoided for one month after vaccination. During this time you should use an effective method of birth control to avoid pregnancy.
You should inform your doctor about the above conditions. Your doctor may decide if the vaccine can be given, if the allergy to neomycin is limited to a skin reaction (contact dermatitis) or the low white blood cell count is not evidence of inadequate immune response.
What the medicinal ingredient is
Each 0.5 mL dose of VARILRIX contains as active ingredient no less than 103.3 plaque-forming units (PFU) of the live attenuated Oka-strain of varicella-zoster virus.
What the non-medicinal ingredients are
The reconstituted vaccine contains the following nonmedicinal ingredients: amino acids, lactose, mannitol, sorbitol and water for injection. Residues: Neomycin sulphate.
What dosage form it comes in
VARILRIX is presented as a powder and diluent for solution
for injection.
The vaccine is provided as slightly cream to yellowish or
pinkish coloured powder in a monodose glass vial.
The sterile diluent (0.5 mL) is clear and colourless and
presented in ampoules or prefilled syringes*.
The colour of the reconstituted vaccine may vary from clear
peach to pink coloured solution.
*Format not available in Canada
Warnings and precautions
VARILRIX can be administered at the same time as any
other vaccine. Different injectable vaccines should be
administered at different injection sites.
Inactivated vaccines can be administered at any time in
relationship to VARILRIX.
If a measles vaccine cannot be administered at the same time
as VARILRIX, it is recommended that at least one month be
allowed between the administration of the two vaccines as it
is recognized that measles vaccination could effect the
effectiveness of VARILRIX.
Different injectable vaccines should always be administered
at different injection sites.
BEFORE you use VARILRIX talk to your doctor or
pharmacist if:
- you are or think you may be pregnant.
- you have or think you have had an allergic reaction previously to VARILRIX or any of its constituents.
- you have or think you have had an allergic reaction previously to another chickenpox vaccine.
- you have a history or family history of allergies.
- you have a weakened immune system. You should be closely monitored as the responses to the vaccine may not be sufficient to ensure a protection against the illness.
- you are due to have a skin test for possible tuberculosis. If this test is done within 6 weeks after receiving VARILRIX, the result may not be reliable.
- you have a severe infection with a high temperature (over 38°C). It might be necessary to postpone the vaccination until recovery. In healthy subjects the presence of minor infection such as a cold should not be a problem, but talk to your doctor first.
- you are taking any other medicine or have recently received any other vaccine.
- you are breastfeeding.
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.
High risk patients
VARILRIX should not be administered at the same time as
other live attenuated vaccines. Inactivated vaccines may be
administered at any time in relationship to VARILRIX given
that no specific contraindication has been established.
Interactions with this medication
In subjects who have received immune globulins or a blood
transfusion, vaccination should be delayed for at least three
months because of the likelihood of vaccine failure due to
passively acquired varicella antibodies.
You or your child should not take any aspirin or aspirin-like
products (also known as salicylates) for 6 weeks after
vaccination with VARILRIX as this may cause a serious
disease called Reye’s Syndrome which can affect all your
body organs.
Proper use of this medication
The vaccine must be administered by a health care
professional.
VARILRIX should not be mixed with any other vaccine in
the same syringe.
Make sure you finish the complete vaccination course. If not
you may not be fully protected against infection.
Usual Dose
VARILRIX will be injected under your skin
(subcutaneously).
The upper arm (deltoid region) is the preferred site of
injection. Your doctor may wipe the skin with alcohol or
other disinfecting agents and will let the skin dry before the
injection. VARILRIX must not be administered into your
blood vessels (intravascularly) or into your skin
(intradermally).
The doctor or nurse will inject the recommended dose of
vaccine. The appropriate number of injections that will be
given to children from the age of 12 months up to and
including 12 years of age will be determined by your doctor
or nurse on the basis of appropriate official
recommendations. Adolescents and adults from 13 years up
should receive 2 doses with an interval of at least 6 weeks
between each dose. In high risk patients additional doses of
vaccine might be required.
It is important to follow the instructions from the
doctor/nurse so that you complete the course of injections.
Administration
If you forget to go back to the doctor/nurse at the scheduled time, ask the doctor/nurse for advice.
Overdose
Side effects and what to do about them
Like all vaccines, VARILRIX may occasionally cause
unwanted effects.
As with all injectable vaccines, there is a 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
VARILRIX were as follows:
Very common
- Pain and redness at the injection site
Common
- Rash (spots and/or blisters)
- Swelling at the injection site
- Fever of 38°C or more (rectal)
Uncommon
- Upper respiratory tract infection
- Sore throat and discomfort when swallowing
- Swollen glands in the neck, armpit or groin
- Irritability
- Headache
- Sleepiness
- Cough, runny or blocked nose, sneezing (rhinitis)
- Nausea, vomiting
- Chickenpox-like rash
- Itching
- Painful, swollen joints
- Aching muscles, muscle tenderness or weakness, not caused by exercise
- Fever greater than 39.5°C (rectal)
- Tiredness (fatigue)
- Generally feeling unwell
Rare
- Discharge with itching of the eyes and crusty eyelids (conjunctivitis)
- Stomach pain or discomfort
- Diarrhea
- Hives (urticaria)
After the marketing of VARILRIX, the following additional side effects have been reported rarely:
- Shingles (herpes zoster)
- bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets
- Allergic reactions
- Fits or seizures
- 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
- 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
If these discomforts continue or become severe, tell the
doctor or nurse.
If you develop 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 VARILRIX, contact your doctor or
pharmacist.
How to store
VARILRIX should be stored in a refrigerator at 2 to 8°C.
The reconstituted vaccine may be kept for up to 90 minutes
at room temperature (25ºC) and 8 hours in the refrigerator (2
to 8ºC). If not used within these timeframes, the
reconstituted vaccine must be discarded.
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
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program 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.