Consumer Medicine Information

VARIVAX^®

Varicella Virus Vaccine Live (Oka/Merck)

Single dose vial

What is in this leaflet

This leaflet answers some common questions about VARIVAX. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given VARIVAX against the benefits your doctor expects it will have for you.

If you have any concerns about being given this vaccine, ask your doctor.

Keep this leaflet. You may need to read it again.

What VARIVAX is used for

VARIVAX is a vaccine used to help prevent chickenpox. It can be given to children 12 months of age and above, teenagers and adults.

Chickenpox is easily passed from one person to another and occurs in millions of people worldwide each year, most often in children 5 to 9 years of age. It is primarily spread from person to person through the air by sneezing or coughing. Once a person has been infected, it usually takes about 2 to 3 weeks before symptoms 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 clusters 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 disease, 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's syndrome, and death. Severe disease and serious complications are more likely to occur in adolescents and adults.

Before you are given VARIVAX

When you or your child must not be given it

Do not have VARIVAX if:

you have an allergy to VARIVAX or any of the ingredients listed at the end of this leaflet
you have a blood disorder or any type of cancer that affects your immune system
you are taking any medicine that suppresses your immune system
you have any other disease that affects your immune system (such as AIDS)
you have active untreated tuberculosis
you currently have a fever of more than 38.5°C
you are or may potentially be pregnant (pregnancy should also be avoided for 3 months after vaccination)
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, talk to your doctor.

VARIVAX must not be given to children under 12 months of age. The safety and effectiveness of VARIVAX in these children have not been established.

Before you or your child are given it

Tell your doctor if:

you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes, especially gelatin or neomycin.
there is anyone who comes into close contact with the person being vaccinated who falls into one of the following categories, since these individuals may be at risk of catching chickenpox from the person who was vaccinated: individuals with a weakened immune system, pregnant women who never had chickenpox, newborn babies whose mothers never had chickenpox. Close association with these individuals should be avoided for up to 6 weeks.
you are breastfeeding or you intend to breastfeed, your doctor will decide if you should receive the vaccine.

If you have not told your doctor about any of the above, tell them before you or your child are given an injection of VARIVAX.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Medicines that fall under the category of salicylates such as Aspirin should not be taken for at least 6 weeks after vaccination with VARIVAX. If you are not sure if your medicine is within this class, ask your doctor or pharmacist.

Tell your doctor if you or your child are taking corticosteroids (e.g., prednisone). Your doctor will advise you if you or your child are taking any of these or other medicines that decrease the immune system, and the doctor will decide whether or not to give the vaccine.

Use with other vaccines

VARIVAX may be given at the same time as M-M-R^® II (measles, mumps, and rubella virus vaccine live), COMVAX^® (Haemophilus influenzae type b conjugate and hepatitis B vaccine), OPV (oral poliovirus vaccine), or DTaP (diphtheria, tetanus, acellular pertussis).

If VARIVAX is not given at the same time as M-M-R II, a 1-month interval between these 2 vaccines should be observed. Your doctor will decide the vaccination schedule.

The injections should be given at different places on the body and using separate syringes.

How VARIVAX is given

How much is given

VARIVAX is given to individuals 12 months of age and older. The dose of the vaccine is the same for everyone.

For persons who are first vaccinated at 13 years of age and older, a second dose should be given 4 to 8 weeks after the first dose.

How it is given

VARIVAX is given as an injection deep under the skin, usually in your upper arm or upper thigh by a doctor or trained nurse.

The vaccine should not be injected directly into veins (intravenously).

If you miss a dose

Talk to your doctor and arrange another visit as soon as possible.

After you have been given VARIVAX

Things you must do

If you require a second dose keep your follow-up appointment with your doctor or clinic.

It is important to have your follow-up dose of VARIVAX at the appropriate time to make sure the vaccine has the best chance of providing protection against the chickenpox virus.

Things to be careful of

Be careful driving or operating machinery until you know whether VARIVAX has affected you. VARIVAX should not normally interfere with your ability to drive a car or operate machinery.

Adverse Effects

Tell your doctor or nurse as soon as possible if you do not feel well during or after having had an injection of VARIVAX.

VARIVAX helps protect most people from chickenpox, but it may have unwanted adverse effects in a few people. All medicines and vaccines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

In children, teenagers and adults:

Tell your doctor if you have or your child has any of the following and they are troublesome or ongoing

local reaction around the injection site such as pain, soreness, tenderness, warmth, redness or swelling

These are the more common adverse effects of VARIVAX that may occur in children, teenagers and adults. For the most part these have been mild.

Other side effects have been reported and some of these were serious.

Tell your doctor if you notice any of the following and they worry you

skin rash, itching
hives or nettlerash (pinkish, itchy swellings on the skin), these may be signs of an allergic reaction
fever, tingling of the skin, shingles, or a chickenpox-like rash on the body or at the injection site
chest and/or ear infection
cough
nausea and/or vomiting
loss of appetite
abdominal pain
diarrhoea
constipation
irritability/fatigue/malaise
disturbed sleep
headache
muscle or joint pain, including stiff neck
dizziness
swollen lymph glands (in the neck, armpit or groin)
eye complaint

Tell your doctor immediately if you notice any of the following

difficulty walking
severe skin disorders, and skin infection
severe headache and sensitivity to light
inflammation of lung (Pneumonia/Pneumonitis)
seizure

These adverse effects are rare.

Other adverse 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 adverse effects. You may not experience any of them.

Storage

VARIVAX is usually stored in the doctor's surgery or clinic, or at the pharmacy. However if you need to store VARIVAX:

keep it where children cannot reach it
keep it in the refrigerator, but not in the door compartment
keep the injection in the original pack until it is time for it to be given.

Product description

What it looks like

VARIVAX is available in either a single dose carton containing a vial of vaccine and a vial of diluent or in a carton of 10 doses of vaccine with a corresponding carton containing 10 doses of diluent.. It is a clear colourless to pale yellow liquid. The vials are made up using a supplied diluent which contains sterile water for injection.

Ingredients

Active ingredient

Each 0.5 mL dose contains not less than 1350 plaque forming units of varicella virus (Oka/Merck).

Inactive ingredients

Sucrose, hydrolysed gelatin, urea, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic and potassium chloride. The product also contains residual components of MRC-5 cells and trace quantities of neomycin and bovine calf serum.

VARIVAX does not contain any preservatives.

Supplier

VARIVAX is supplied in New Zealand by:

Merck Sharp and Dohme (New Zealand) Limited
P O Box 99851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared in May 2008

CP-VRV-0308(290508)

INFORMATION FOR CONSUMERS