Consumer Medicine Information

VARILRIX

Live attenuated varicella vaccine

What Is In This Leaflet?

This leaflet answers some of the common questions about VARILRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having VARILRIX against the expected benefits.

If you have any concerns about VARILRIX talk to your doctor, nurse or pharmacist.

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

What Is VARILRIX Used For

VARILRIX is a vaccine used to prevent and immunise against the varicella virus, which causes chickenpox in infants (from the age of 9 months), children, adolescents and adults.

Varicella, commonly known as chickenpox, is a highly infectious viral infection, caused by varicella zoster virus.

Sufferers usually experience a rash, fever, loss of appetite, headache and sore throat. The spots of the rash are initially flat and become blisters with fluid in them which eventually forms a crust.

Some groups of people are at a higher risk of exposure to the varicella virus. Vaccination is recommended for these people:

• some healthcare workers
• school teachers
• people in contact with children
• children who have working mothers.

The virus can be spread by patients with chickenpox or the herpes zoster virus. The virus is spread through the air or direct contact with the lesions or blisters. It can also be transmitted from an infected mother to her unborn child.

Vaccination is the best way to protect against infection in the longer term. The risk of complications and death are greater in people whose immunity is impaired by illness or by treatment with drugs known as immunosuppressants.

VARILRIX will not protect a person if they are already infected with the varicella virus at the time of vaccination. VARILRIX may not prevent the disease in these people.

Before Receiving VARILRIX

When you must not have VARILRIX

• you have/your child has had an allergic reaction to VARILRIX, or any ingredient contained in this vaccine. The ingredients are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• you have/your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before being vaccinated.
• you or your child have a low white blood cell count or have problems with the immune system
• you/your child are sensitive to an antibiotic known as neomycin
• you are pregnant or plan to become pregnant 3 months after vaccination
• the expiry date printed on the pack has passed
• the packaging is torn or shows signs of tampering.

If you are not sure whether VARILRIX should be given, talk to your doctor or nurse.

Tell your doctor if:

• You are breast-feeding. It is not known if VARILRIX passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
• If you have/your child has had VARILRIX before and became unwell, tell your doctor or nurse before the dose is given.
• You have or your child has had a blood transfusion in the last 3 months
• You have/your child has any medical conditions, such as:
  • a bleeding disorder. Sometimes VARILRIX may need to be given differently in people with bleeding problems.
  • an immune deficiency condition (e.g. are HIV positive).
• You have/your child has allergies to any other medicines or substances, such as dyes, foods or preservatives.
• You have/your child has received another vaccine. VARILRIX can be given at the same time as other vaccines. VARILRIX will always be given separately from other injections.
• You are/your child is taking any prescription or OTC (over-the-counter) medicines or any medicine you have bought from a supermarket or health food shop.

Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if VARILRIX is to be given with another vaccine or medicine.

Varilrix can be given at the same time as a measles containing vaccine. If this is not possible an interval of at least one month should elapse before the measles containing vaccine is given.

Use In Children

VARILRIX is recommended for use in healthy infants (from the age of 9 months), children and adolescents.

Giving VARILRIX

The doctor or nurse will give VARILRIX as an injection. If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

How Much Is Given

From the age of 9 months up to and including 12 years of age: 1 dose

From 13 years and up, 2 doses should be given, with an interval of at least 6 weeks between the first and second dose.

How Is It Given

VARILRIX will be injected into the upper arm muscle in adults and older children, and into the thigh muscle in infants. The injection is given subcutaneously (under the skin).

The vaccine should never be given intravenously (into a vein) or intradermally (into the skin).

When It Will Be Given

VARILRIX is generally given as a single dose on an elected date. If a second dose is given, it will be administered 6 weeks after the first dose.

If A Dose Is Missed

If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

While You Are Getting VARILRIX

Things you must do

Keep your visits with the doctor or clinic. It is important VARILRIX doses are given at the correct times. This will ensure the best effect of the vaccine in protecting you (or your child) against varicella virus.

If you develop the chicken pox blisters within the first 4 weeks after vaccination, avoid contact with people who are immune suppressed (have problems with their immune system) for the duration of the rash.

Things to be careful of

Be careful driving or operating machinery until you know how VARILRIX affects you. VARILRIX should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or light-headedness. Make sure you know how you react to VARILRIX before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or light-headed.

Side Effects

Tell your doctor, nurse or pharmacist as soon as possible if you (or your child) do not feel well during or after having had a dose of VARILRIX.

VARILRIX helps protect most people from varicella virus, 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. Some side effects may need medical treatment.

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

Most unwanted effects with VARILRIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site such as tenderness, soreness and redness.

Mild effects

Tell your doctor if you notice any of the following that are troublesome or ongoing after vaccination:

• redness, swelling, a hard lump, soreness, bruising or itching around the injection site
• feeling generally unwell, fever, or headache
• loss of appetite, or feeling sick (nausea), vomiting, diarrhoea.

Serious effects

As with all vaccines given by injection there is a very small risk of serious allergic reaction. Contact your doctor immediately or go to the Accident and Emergency department of your nearest hospital if any of the following happens:

• swelling of limbs, face, eyes, inside of nose, mouth or throat
• shortness of breath, breathing or swallowing difficulties
• hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
• unusual tiredness or weakness that is sudden and severe, muscular aches and pains
• fever, headache, dizziness.

Allergy to VARILRIX is rare. Any such severe reactions will usually occur within the first few hours of vaccination.

Other side effects not listed above, can also occur during or soon after a dose of VARILRIX. Check with your doctor or nurse if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

VARILRIX is usually stored at the doctor's clinic or surgery, or at the pharmacy. But if you need to store VARILRIX always:

• Keep VARILRIX in the refrigerator stored between +2°C and +8°C . THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep VARILRIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over VARILRIX that has expired or has not been used.

Product Description

What It Looks Like

VARILRIX is a slightly pink-coloured pellet, which comes in a neutral, colourless glass vial. The solution used to dilute the pellet is clear and colourless and comes in ampoules and prefilled syringes.

Ingredients

• VARILRIX contains a live attenuated (weakened) strain of the varicella-zoster virus.

Varilrix also contains the following inactive inactive ingredients: human albumin (as a stabiliser), lactose, neomycin sulphate, polyalcohols and amino acids.

Varilrix meets the World Health Organisation requirements for biological substances and for varicella vaccines.

Further Information

VARILRIX is only available if prescribed by a doctor.

The vaccine comes in the following:

VARILRIX monodose vials in packs of 1

Diluent: glass ampoules or prefilled syringe, 0.5mL in packs of 1

Distributor

Distributed In New Zealand by:

GlaxoSmithKline
Private Bag 106600
Downtown Auckland

Ph: (09) 367 2900
Fax (09) 367 2910

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

Date of Preparation: 09/01, Version 1