VARILRIX is a vaccine used to prevent chickenpox in children 9 months or older, adolescents, and adults. It contains a weakened form of the varicella-zoster virus. The vaccine works by causing the body to produce antibodies against the virus. Common mild side effects include redness, swelling or soreness at the injection site. More serious side effects like fever over 39°C or allergic reactions are rare. VARILRIX should be stored in the refrigerator between 2-8°C and kept out of reach of children.

1. VARILRIX®
Varicella vaccine
CONSUMER MEDICINE INFORMATION LEAFLET
who have lowered immunity BEFORE VACCINATION
WHAT IS IN THIS LEAFLET and have no history of
chickenpox.
VARILRIX SHOULD NOT BE
This leaflet answers some of GIVEN IF:
The vaccine works by causing the
the common questions about
body to produce its own
VARILRIX vaccine. It does you or your child has had an
protection (antibodies) against
not contain all the available allergic reaction to VARILRIX, or
this disease.
information. It does not take any ingredient contained in this
the place of talking to your vaccine. The ingredients in
Chickenpox is caused by a virus
doctor, nurse or pharmacist. VARILRIX are listed at the end
called the varicella-zoster virus.
of this leaflet. Signs of an
VARILRIX vaccine contains a
All medicines and vaccines allergic reaction may include
weakened form of the chickenpox
have risks and benefits. Your itchy skin rash, shortness of
(varicella-zoster) virus.
doctor has weighed the breath and swelling of the face
possible risks of you or your or tongue. VARILRIX can be
Chickenpox is a highly infectious
child having VARILRIX against used in people who have
disease, which usually causes an
the expected benefits. previously developed a skin
itchy, red rash with blisters. After
about 1 week, most of the blisters rash after applying the antibiotic
If you have any concerns ‘neomycin’ to the skin.
have normally crusted over. The
about VARILRIX talk to your
rash can appear on the face,
doctor, nurse or pharmacist. you are or think you may be
scalp, body, or in the mouth, eyes
pregnant, or if you intend to
and bottom. Other symptoms
Keep this leaflet with this can include fever, headaches, become pregnant within 3
vaccine. You may need to chills, and muscle and/or joint months of vaccination. Your
read it again aches and pains. Sometimes doctor will discuss with you the
risks of receiving VARILRIX
disease complications can occur
such as bacterial infection of the during pregnancy.
WHAT VARILRIX IS USED skin (often due to itching of the
FOR rash/crusts), inflammation of the you or your child has lowered
brain (varicella encephalitis), and immunity. This can occur in
persons:
VARILRIX is a vaccine used in lung infection (varicella
children aged 9 months or pneumonia). Complications are with inherited (or family
older, adolescents and adults not common and are mainly seen history of) immune
to prevent chickenpox. in children with lowered immunity, deficiency conditions
Groups who would benefit and sometimes in adults. with abnormal blood
mostly from vaccination conditions or blood protein
include: Full recovery from chickenpox (immunoglobulin) disorders
generally occurs; however, later with cancer
adults not immunised in life the virus can become active receiving or who have
(protected) against again. This condition is known as received certain drugs (ie
chickenpox, especially those shingles or Herpes zoster. cyclosporin, corticosteroids,
in ‘at-risk’ occupations such and cancer medicines)
as health care workers, receiving or who have
teachers and workers in received radiation therapy
child care centres with Human
adults not immunised, who Immunodeficiency Virus
are parents of young (HIV) infection
children
adults and children not you or your child has a severe
immunised, who live in the infection with a high
same house with people temperature. A minor infection
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2. such as a cold should not the immune system, such as IF A DOSE IS MISSED
be a problem, but talk to high-dose steroids. If a scheduled dose is missed, talk
your doctor or nurse about Some vaccines may be affected to your doctor or nurse and arrange
this before vaccination. by other vaccines or medicines. another visit as soon as possible.
Your doctor, nurse or pharmacist
the expiry (EXP) date will be able to tell you what to do
printed on the pack has if VARILRIX is to be given with WHILE USING VARILRIX
passed another vaccine or medicine.
the packaging is torn or THINGS YOU MUST NOT DO:
shows signs of tampering. Do not become pregnant for 3
HOW VARILRIX IS GIVEN months after receiving VARILRIX
If you are not sure whether vaccination. Talk to your doctor as
you or your child should The doctor or nurse will give soon as possible, if you do become
have VARILRIX, talk to your VARILRIX as an injection. If you pregnant within this time.
doctor or nurse. Do not have any concerns about how
this vaccine is to be given, talk THINGS YOU MUST DO:
give this vaccine to anyone
else; your doctor has to your doctor, nurse or Tell your doctor that you or your
prescribed it specifically for pharmacist. child has received VARILRIX if
you or your child. another vaccine is to be given
HOW MUCH IS GIVEN within 1 month after
BEFORE VARILRIX IS The dose is 0.5mL for infants (9 vaccination.
months or older), children,
GIVEN TELL YOUR Tell your doctor if you or your
adolescents and adults.
DOCTOR OR NURSE IF: child develops a rash within 4
HOW IS IT GIVEN weeks after vaccination. Some
you are breast feeding. It individuals develop symptoms
VARILRIX will be injected under
is not known if VARILRIX of mild chickenpox several
the skin (subcutaneously) of the
passes into breast milk, weeks after vaccination with
shoulder or thigh.
however the vaccine is not VARILRIX. While the rash
expected to cause problems in lasts, you or your child should
The vaccine should never be
breast-fed babies. avoid contact with people who
given intravenously.
have low immunity.
you or your child has
WHEN IT IS GIVEN Where possible, avoid contact
allergies to any other
medicines or substances, In children from 9 months up to with people who have lowered
such as dyes, foods or and including 12 years, the immunity for up to 6 weeks.
appropriate time and number of The disease may be more
preservatives.
doses that will be given will be serious in these people.
determined by your doctor on the
you or your child have Tell your doctor if you or your
basis of appropriate official
received another vaccine child are to have a tuberculin
recommendations. Adults and
within the last month. skin test for tuberculosis within
adolescents aged 13 years and
older are generally given two 4-6 weeks after vaccination.
you or your child have The vaccine may affect the
doses at least six weeks apart.
received a blood or plasma results of the tuberculin skin
Each dose is given at a separate
transfusion, or been given test.
visit.
gamma globulin or other
immunoglobulins within the Tell your doctor if you or your
The need for booster doses is child are to have another
last 3 months. VARILRIX
uncertain at present. vaccine within 1 month after
may be less effective if
given within 3 months of vaccination.
these products.
you or your child are
having any prescription or
OTC (over-the-counter)
medicines. In particular,
mention use of any
medicines that suppress
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3. THINGS TO BE CAREFUL MILD EFFECTS shortness of breath,
OF: breathing or swallowing
Be careful driving or operating Tell your doctor if you difficulties
machinery until you know how notice any of the following hives, itching (especially of
VARILRIX affects you. that are troublesome or the hands or feet), reddening
VARILRIX should not normally ongoing after vaccination: of skin (especially around
interfere with your ability to the ears), or severe skin
drive a car or operate redness, swelling, a hard reactions
machinery. But in some lump, soreness, bruising unusual tiredness or
people vaccination can cause or itching around the weakness that is sudden and
dizziness or lightheadedness. injection site severe
Make sure you know how you pain, fever, skin rash,
react to VARILRIX before you itching, dry skin, swelling Allergy to VARILRIX is rare.
drive a car or operate of the glands in the neck, Any such severe reactions will
machinery, or do anything that armpit or groin usually occur within the first few
could be dangerous if you are feeling generally unwell, hours of vaccination.
dizzy or lightheaded. sore throat, coughing,
tiredness, runny nose,
Other events that have been
dizziness or headache
reported with VARILRIX
nausea, vomiting,
SIDE EFFECTS include:
diarrhoea, stomach
pain/cramps, toothache or bacterial, viral or fungal
Tell your doctor or nurse as poor appetite infection
soon as possible if you or nervousness, migraine
your child do not feel or inflammation of the eye changes in sweat
look well during or shortly lids (conjunctivitis) production and increased
after having had a dose of pain in the joints or sputum
VARILRIX. muscles, back pain.
Other side effects not listed above,
VARILRIX helps protect most can also occur during or soon after
people from chickenpox, but it MORE SERIOUS EFFECTS a dose of VARILRIX. Check with
may have unwanted side your doctor or nurse if you or
effects in a few people. All Tell your doctor your child has any other effects.
medicines and vaccines can immediately if you notice
have side effects. Sometimes any of the following:
they are serious; most of the STORAGE
time they are not. Some side fever greater than 39 C
effects may need medical lung problems such as
bronchitis, asthma and VARILRIX is usually stored at the
treatment.
pharyngitis (sore throat doctor’s clinic or surgery, or at the
and discomfort when pharmacy. But if you need to
Ask your doctor, nurse or
swallowing) store VARILRIX always:
pharmacist to answer any
infection of the middle ear
questions you may have. Keep VARILRIX in the
that may cause earache
and temporary hearing refrigerator stored between
Most unwanted effects with
loss +2 C and +8 C. Do not store it
VARILRIX are mild and
in the bathroom, near the sink,
usually clear up within a few
As with all vaccines given by or leave it in the car on hot days.
days. These effects, as with
injection there is a very small Avoid exposing the vaccine to
other vaccines, generally
risk of serious allergic sunlight. The water diluent can
occur around the injection site.
reaction. Contact your doctor be kept in a refrigerator or at
. However, some children
immediately or go to the room temperature. It must not
develop symptoms of mild
casualty department of your be frozen.
chickenpox several weeks
after vaccination with nearest hospital if any of the
following happens: Keep the vaccine out of the
VARILRIX
swelling of limbs, face, reach of children.
eyes, inside of nose, mouth
or throat
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4. Keep VARILRIX in the FURTHER INFORMATION
original pack until it is time
for it to be given. VARILRIX is only available if
prescribed by a doctor.
Ask your pharmacist what
to do with any left over VARILRIX comes in the following:
VARILRIX that has expired - a glass vial with sterile water
or has not been used. diluent (prefilled syringe) in
packs of 1 or 10 - AUST R
PRODUCT DESCRIPTION 71007.
- a glass vial with sterile water
WHAT IT LOOKS LIKE diluents (ampoule) in packs of
VARILRIX comes as a slightly 1 or 10 – AUST R 71008
cream to yellowish or pinkish
coloured powder pellet in a Not all pack sizes may be
glass vial. The clear sterile marketed.
water diluent comes in
prefilled syringes or ampoules.
It is made into a clear peach MANUFACTURER
to pink coloured liquid, before
being injected by the doctor or GlaxoSmithKline Biologicals S.A
nurse. rue de l'Institut 89,
1330 Rixensart, Belgium.
INGREDIENTS
The active ingredient of DISTRIBUTED IN AUSTRALIA BY
VARILRIX is a live weakened GlaxoSmithKline Australia Pty Ltd
varicella-zoster virus (Oka Level 4, 436 Johnston Street,
strain). Each 0.5mL dose Abbotsford, Victoria 3067
contains not less than 103.3
plaque-forming units of the
varicella-zoster virus. Date of Preparation:
21 January 2011
Other inactive ingredients in Version 4.0
the vaccine are: amino acids
for injection, human albumin,
lactose, neomycin sulphate,
and polyalcohols.
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.
VARILRIX does not contain
sucrose, gluten, tartrazine or
any other azo dyes.
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