Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this vaccine, speak
to your doctor, nurse or pharmacist.
1. Why is my child or I being given VARIVAX Refrigerated?
2. What should I know before my child or I are given VARIVAX Refrigerated?
Do not receive VARIVAX Refrigerated if you or your child have ever had an allergic
reaction to VARIVAX Refrigerated or any of the ingredients listed at the end of the
CMI.
Talk to your doctor if you or your child have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before my child or I are given VARIVAX Refrigerated? in the full CMI.
3. What if my child or I are taking other medicines?
4. How is VARIVAX Refrigerated given?
The usual dose of VARIVAX Refrigerated is 0.5 mL. The dose of the vaccine is the same
for everyone.
VARIVAX Refrigerated is given as an injection just under the skin (subcutaneously)
of the upper arm by a doctor or trained nurse.
5. What should I know after my child or I are given VARIVAX Refrigerated?
|
Things you should 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.
If you are a woman of child-bearing age, avoid falling pregnant for 3 months after
vaccination
|
|
Things you should not do
|
Do not take aspirin or other salicylate medicines for six weeks after being given
VARIVAX Refrigerated.
|
|
Driving or using machines
|
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.
Be careful driving or operating machinery until you know whether VARIVAX Refrigerated
has affected you.
|
|
Looking after your medicine
|
It is unlikely that you would be asked to store VARIVAX Refrigerated. If you are,
keep it in the refrigerator, but not in the door compartment, until ready to use.
VARIVAX Refrigerated is stable for up to 24 months when stored in the refrigerator.
|
6. Are there any side effects?
Common side effects include: pain, soreness, swelling, itching, redness, bruising,
numbness, stiffness or a hard lump where you had the injection, fever, tingling of
the skin, irritability, swollen glands typically located in the neck, armpit or groin.
Serious side effects include: seizures or fits, severe skin conditions, skin infections,
allergic reactions, bruising more easily than normal, red or purple, flat, pinhead
spots under the skin; severe paleness, nausea, vomiting, chickenpox, difficulty walking.
For a complete list of side effects and more information, including what to do if
you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
Varicella virus vaccine live (live varicella vaccine)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VARIVAX Refrigerated. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VARIVAX Refrigerated.
Where to find information in this leaflet:
1. Why is my child or I being given VARIVAX Refrigerated?
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
healthy.
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.
What is chickenpox
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.
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 way exposure is the best to help protect against infection and possible serious
complications.
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
before.
How does it work
VARIVAX Refrigerated contains a weakened strain of living varicella virus. This strain
of live virus causes either mild or no symptoms of infection.
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.
2. What should I know before my child or I are given VARIVAX Refrigerated?
Warnings
Do not receive VARIVAX Refrigerated if:
you or your child have an allergy to VARIVAX Refrigerated or any of the ingredients
listed at the end of this leaflet
you or your child 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 or your child are pregnant or intend to become pregnant
you or your child are being treated with medicines which decrease the body's immune
system such as corticosteroids (e.g., prednisone), cyclosporin or cancer medicines
you or your child have diseases which decrease the body's immune system, such as blood
disorders, cancers of the blood cells or lymph system (e.g. leukaemia, lymphoma) and
HIV/AIDS
you or your child have a family history of immune deficiency
you or your child have tuberculosis (TB) which is not being currently treated
you or your child have an infection with a high temperature
If you are not sure whether you or your child should be given VARIVAX Refrigerated,
talk to your doctor.
Check with your doctor if you or your child:
are breast-feeding or plan to breast-feed
have or have had any serious medical conditions
have received blood or plasma transfusions or immune globulins within the past five
months
Your doctor may decide to delay your injection of VARIVAX Refrigerated.
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.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
VARIVAX Refrigerated is not recommended to be given to pregnant women. Also women
of child-bearing age should avoid becoming pregnant for 3 months after vaccination.
Check with your doctor if you or your child are pregnant or intend to become pregnant.
Breastfeeding
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
breast-feeding.
Talk to your doctor if you or your child are breastfeeding or intend to breastfeed.
Children
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.
Close Contact with High Risk People
In rare circumstances, it is possible to catch chickenpox, including severe chickenpox,
from a person who has been vaccinated with VARIVAX Refrigerated. This may occur in
persons who have not previously been vaccinated or had chickenpox, as well as persons
who fall into one of the following categories:
individuals with a weakened immune system
pregnant women who never had chickenpox
newborn babies whose mothers never had chickenpox.
Whenever possible, individuals who have been vaccinated with VARIVAX Refrigerated
should attempt to avoid close contact, for up to 6 weeks following the vaccination,
with anyone who falls into one of the categories above. Tell your doctor if there
is anyone who falls into one of the categories above and is expected to be in close
contact with the person being vaccinated.
3. What if my child or I are taking other medicines?
Tell your doctor, nurse or pharmacist if you or your child have been given any other
vaccines or are taking any other medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy, supermarket or health food
shop.
VARIVAX Refrigerated should not be given to people who are using the following:
medicines that decrease the immune system, such as corticosteroids (e.g., prednisone) cyclosporin, or cancer medicines
aspirin or other salicylate medicines.
Talk to your doctor if you or your child are taking any of these medicines.
Some medicines should not be used for 6 to 8 weeks after receiving VARIVAX Refrigerated.
These include:
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
Refrigerated.
immune globulins.
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.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you or your child are taking and if these affect VARIVAX Refrigerated.
4. How is VARIVAX Refrigerated given?
How much is given
The usual dose of VARIVAX Refrigerated is 0.5 mL. The dose of the vaccine is the same
for everyone.
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
them.
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 is VARIVAX Refrigerated 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).
5. What should I know after my child or I are given VARIVAX Refrigerated?
Things you should 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
vaccination.
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 should not do
Do not take aspirin or other salicylate medicines for six weeks after being given
VARIVAX Refrigerated.
A serious condition called Reye Syndrome has been reported following the use of aspirin
or other salicylate medicines during a natural chickenpox infection.
Driving or using machines
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 are tired.
Looking after your vaccine
It is unlikely that you will be asked to store VARIVAX Refrigerated. 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.
Do not freeze VARIVAX Refrigerated
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.
6. Are there any side effects?
VARIVAX Refrigerated helps protect most people from chickenpox, but it may have unwanted
side effects in a few people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Common side effects
|
Common side effects
|
What to do
|
|
pain, soreness, swelling, itching, redness, bruising, numbness, stiffness or a hard
lump where you had the injection
fever
tingling of the skin
irritability
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.
|
Speak to your doctor if you or your child have any of these common side effects and
they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
seizures or fits
severe skin conditions
skin infections
allergic reactions
bruising more easily than normal, red or purple, flat, pinhead spots under the skin;
severe paleness
nausea
vomiting
chickenpox
difficulty walking
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)#
stroke
#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
reaction.
skin rash, itchiness, or other severe skin reactions
pinkish, itchy swellings on the skin, also called hives
swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing
or breathing
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.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you or your child feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this vaccine.
7. Product details
This vaccine is only available with a doctor's prescription.
What VARIVAX Refrigerated contains
|
Active ingredient
(main ingredient)
|
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).
|
|
Other ingredients
(inactive ingredients)
|
sucrose
hydrolysed porcine gelatin*
sodium chloride
monosodium glutamate monohydrate
dibasic sodium phosphate
monobasic potassium phosphate
potassium chloride
urea
*contains sulfites
|
|
Potential allergens
|
neomycin
|
Each dose contains trace amounts of bovine (beef) serum.
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.
Do not take this vaccine if you are allergic to any of these ingredients.
What VARIVAX Refrigerated looks like
VARIVAX REFRIGERATED is a white powder that comes in a glass vial. It is reconstituted
with a special diluent (water for injections) to make a solution suitable for injection.
Australian Register Numbers:
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial (AUST
R 90140)
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with prefilled
diluent syringe (AUST R 115008)
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with sterile
diluent vial (AUST R 337387)
Who sponsors VARIVAX Refrigerated
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113
Who distributes VARIVAX Refrigerated
Seqirus (Australia) Pty Ltd
Melbourne, Victoria
Australia
This leaflet was prepared in July 2023.
(S-WPPI-V210-I-ref-032023)
RCN: 000025626-AU
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights
reserved.