Varicella Virus Vaccine Live
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about VARIVAX Refrigerated. It does not
contain all the available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has weighed the risks
of you being given VARIVAX Refrigerated against the benefits they expect it will have
If you have any concerns about being given this vaccine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What VARIVAX Refrigerated is used for
VARIVAX Refrigerated is a vaccine used to help prevent chickenpox (varicella). It
can be given to children 12 months of age and older, teenagers and adults who are
Chickenpox is an infectious disease caused by the varicella-zoster virus, or otherwise
known as varicella virus. It occurs in millions of people around the world each year,
most often in children 5 to 9 years of age. Chickenpox is easily passed from one person
to another. It is commonly spread from person to person through the air by sneezing
or coughing. Once a person is infected, it usually takes about 2 to 3 weeks before
symptoms of the infection start.
Symptoms of chickenpox include mild headache, moderate fever and general discomfort.
These are followed by a rash of itchy, little red spots which usually start on the
chest, stomach or back, but can appear anywhere on the body. There may be only a few
spots or groups of spots, or even hundreds of spots that develop over the next 3 to
5 days. The spots will change into clear blisters filled with fluid which then become
cloudy, break open, dry, scab and heal, usually within 5 to 20 days.
Although chickenpox is generally a fairly harmless infection, it may be associated
with serious complications and/or rarely death. In children, the most common complications
are bacterial skin infections. Less frequent but very serious complications include
pneumonia, inflammation of the brain (encephalitis), Reye syndrome (which causes brain
and liver damage), and death. Severe disease and serious complications are more likely
to occur in teenagers and adults.
VARIVAX Refrigerated contains a weakened strain of living varicella virus. This strain
of live virus causes either mild or no symptoms of infection.
It is not known whether VARIVAX Refrigerated will prevent chickenpox if it is given
after you have been exposed to the natural varicella virus. Therefore, vaccination
before exposure is the best way to help protect against infection and possible serious
Groups of people who would particularly benefit from being vaccinated with VARIVAX
Refrigerated include those who have not been infected with chickenpox before and either:
work in jobs where they are at high risk of being infected,
are parents of young children, or
live in the same household as someone who has a poor immune system (such as people
with organ transplants, certain cancers, and HIV/AIDS) and has not had chickenpox
How it works
VARIVAX Refrigerated works by causing your body to produce its own protection against
chickenpox. It does this by making disease-fighting substances called antibodies to
fight the varicella virus. If a vaccinated person comes into contact with live virus,
the body is usually ready to destroy it.
Your doctor will use the official recommendations to decide the number of doses needed
and when to get them. At least one injection of VARIVAX Refrigerated is needed to
help protect against chickenpox in children aged 12 months to 12 years. In persons
aged 13 years and older, a second injection is required after the first injection.
After vaccination with VARIVAX Refrigerated, most people will produce enough antibodies
against the varicella virus. However, as with all vaccines, 100% protection against
chickenpox cannot be guaranteed.
The chance of a severe reaction from VARIVAX Refrigerated is very small, but the risks
from not being vaccinated are very serious.
Before you are given VARIVAX Refrigerated
When you or your child must not be given it
Do not have VARIVAX Refrigerated if:
you have an allergy to VARIVAX Refrigerated or any of the ingredients listed at the
end of this leaflet
you have a serious allergy to the antibiotic, neomycin
Symptoms of an allergic reaction may include swelling of the face, lips, tongue, throat,
difficulty in breathing, or hives.
you are pregnant or intend to become pregnant
VARIVAX Refrigerated is not recommended to be given to pregnant women. Also women
of child-bearing age should avoid falling pregnant for 3 months after vaccination.
you are being treated with medicines which decrease the body's immune system such
as corticosteroids (eg. prednisone), cyclosporin, cancer medicines
have diseases which decrease the body's immune system, such as blood disorders, cancers
of the blood cells or lymph system (eg. leukaemia, lymphoma) and HIV/AIDS
you have a family history of immune deficiency
you have tuberculosis (TB) which is not being currently treated
you have an infection with a high temperature
the expiry date on the pack has passed.
If the vaccine is used after the expiry date has passed, it may not work.
If you are not sure whether you or your child should be given VARIVAX Refrigerated,
talk to your doctor.
Do not give VARIVAX Refrigerated to children under 12 months of age.
The safety and effectiveness of VARIVAX Refrigerated in children below the age of
12 months have not been established.
Before you or your child are given it
Tell your doctor if:
1. you are breast-feeding or plan to breast-feed
It is not known whether VARIVAX Refrigerated passes into breast milk. Your doctor
will discuss the possible risks and benefits of being given VARIVAX Refrigerated when
2. you have or have had any medical conditions
3. you have received blood or plasma transfusions or immune globulins within the past
Your doctor may decide to delay your injection of VARIVAX Refrigerated.
4. you have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you are
given an injection of VARIVAX Refrigerated.
Taking other medicines
Tell your doctor if you or your child are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
VARIVAX Refrigerated should not be given to people who are using the following:
medicines that decrease the immune system, such as corticosteroids (eg. prednisone)
cyclosporin, or cancer medicines
aspirin or other salicylate medicines.
Your doctor will advise you whether you are receiving any of these medicines.
Some medicines should not be used for 6 to 8 weeks after receiving VARIVAX Refrigerated.
aspirin or other salicylates.
A serious condition called Reye Syndrome has been reported following the use of aspirin
or other salicylate medicines during a natural chickenpox infection. Therefore, aspirin
or other salicylates should be avoided for 6 weeks following vaccination with VARIVAX
Your doctor will discuss with you the possible risks and benefits of having immune
globulin injections in the 2 months following vaccination with VARIVAX Refrigerated.
Use with other vaccines
VARIVAX Refrigerated can be given at the same time as M-M-R II (measles, mumps and
rubella virus vaccine live), oral polio vaccine, and diphtheria, tetanus and pertussis
vaccine. The injections should be given at different places on the body and using
separates syringes. Your doctor will decide if VARIVAX Refrigerated should be given
with other vaccines.
How VARIVAX Refrigerated is given
How much is given
The usual dose of VARIVAX Refrigerated is 0.5 mL. The dose of the vaccine is the same
VARIVAX Refrigerated can be given to persons 12 months of age and older. For children
aged 12 months to 12 years, at least one injection is given. Your doctor will use
the official recommendations to decide the number of doses needed and when to get
For persons who are first vaccinated at 13 years of age and older, a second injection
should be given 4 to 8 weeks after the first injection.
How it is given
VARIVAX Refrigerated is given as an injection just under the skin (subcutaneously)
of the upper arm by a doctor or trained nurse.
The vaccine should not be injected directly into veins (intravenously).
If you miss a dose
If you miss a scheduled dose, talk to your doctor and arrange another visit as soon
After you have been given VARIVAX Refrigerated
Things you must do
If you are 13 years of age or older, or your doctor tells you to have a second dose,
keep your follow-up appointment with your doctor or clinic.
It is important to have your follow-up injection of VARIVAX Refrigerated at the appropriate
time to make sure the vaccine has the best chance of providing protection against
the chickenpox virus.
If you are a woman of child-bearing age, avoid falling pregnant for 3 months after
If you are about to be injected with any immune globulin (including varicella zoster
globulin) and you have been injected with VARIVAX Refrigerated within the past 2 months,
tell your doctor.
If you or your child have been given VARIVAX Refrigerated , avoid coming into contact,
for six weeks, with a person who falls into one of the following categories:
people with a weakened immune system
pregnant women who have never had chickenpox
newborn babies whose mothers have never had chickenpox
These people may be at risk of catching chickenpox from you or your child.
Things you must not do
Do not take aspirin or other salicylate medicines for six weeks after being given
A serious condition called Reye Syndrome has been reported following the use of aspirin
or other salicylate medicines during a natural chickenpox infection.
Things to be careful of
Be careful driving or operating machinery until you know whether VARIVAX Refrigerated
has affected you.
VARIVAX Refrigerated should not normally interfere with your ability to drive a car
or operate machinery. However, VARIVAX Refrigerated may cause tiredness or dizziness
in some people. Make sure you know how you react to VARIVAX Refrigerated before you
drive a car, operate machinery, or do anything else that could be dangerous if you
Tell your doctor or pharmacist as soon as possible if you or your child do not feel
well during or after having had a dose of VARIVAX Refrigerated.
VARIVAX Refrigerated helps protect most people from chickenpox, but it may have unwanted
side effects in a few people. All medicines and vaccines can have side effects. Sometimes
they are serious, most of the time they are not. You or your child may need medical
treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you or your child have any of the following and they are troublesome
pain, soreness, swelling, itching, redness, bruising, numbness, stiffness or a hard
lump where you had the injection
tingling of the skin
swollen glands typically located in the neck, armpit or groin
chickenpox-like rash on the body or at the injection site
These are the more common side effects of VARIVAX Refrigerated. For the most part
these have been mild.
Tell your doctor immediately if you or your child notice any of the following:
seizures or fits
severe skin conditions
bruising more easily than normal, red or purple, flat, pinhead spots under the skin;
shingles (herpes zoster)†, an infection which causes blisters and severe pain
drooping eyelid or sagging muscles on one side of the face, also called Bell's palsy
fever, chills, shortness of breath, cough, phlegm, difficulty breathing, wheezing
which may be symptoms of pneumonia or pneumonitis
inflammation of the brain (encephalitis†- symptoms include headache and fever, progressing
to hallucinations, confusion, paralysis of part or all of the body, disturbances of
behaviour, speech and eye movements, stiff neck, and sensitivity to light)
inflammation of the coverings of the brain and spinal cord (meningitis)†
†Can be from naturally occurring chickenpox or the vaccine in healthy individuals
or individuals with lowered immunity.
These may be serious side effects. You may need urgent medical attention. Serious
side effects are rare.
As with all vaccines given by injection, there is a very small risk of a serious allergic
Tell your doctor immediately or go to accident and emergency at your nearest hospital
if you notice any of the following:
skin rash, itchiness, or other severe skin reactions
pinkish, itchy swellings on the skin, also called hives or nettlerash
swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing
These are serious side effects. If you have them, you may have had a serious allergic
reaction to VARIVAX Refrigerated. You may need urgent medical attention or hospitalisation.
Most of these side effects occur within the first few hours of vaccination.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any
VARIVAX Refrigerated is usually stored in the doctor's surgery or clinic, or at the
pharmacy. However if you need to store VARIVAX Refrigerated:
Keep it where children cannot reach it.
Keep it in the refrigerator, but not in the door compartment.
VARIVAX Refrigerated is stable for up to 24 months when stored in the refrigerator.
Keep the injection in the original pack until it is time for it to be given.
What it looks like
VARIVAX Refrigerated is a white powder that comes in a glass vial. It is reconstituted
with a special diluent to make a solution suitable for injection.
Each 0.5 mL dose of VARIVAX Refrigerated contains a minimum of 1350 PFU (plaque forming
units) of Oka/Merck varicella virus (which is the weakened strain of varicella virus)
when reconstituted with the diluent and stored at room temperature for 150 minutes
(2 and a half hours).
hydrolysed porcine gelatin
monosodium glutamate monohydrate
dibasic sodium phosphate
monobasic potassium phosphate
Each dose contains trace amounts of neomycin and bovine (beef) serum.
The diluent contains water for injections.
The manufacture of this product includes exposure to bovine derived materials. No
evidence exists that any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
VARIVAX Refrigerated is supplied in Australia by:
bioCSL Pty Ltd
63 Poplar Road
PARKVILLE VIC 3052
This leaflet was prepared in August 2018.
Australian Register Numbers:
AUST R 90140
AUST R 115008