Consumer Medicine Information
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 VARILRIX IS USED FOR
VARILRIX is a vaccine used in children aged 9 months or older, adolescents and adults to prevent chickenpox. Groups who would benefit mostly from vaccination include:
adults not immunised (protected) against chickenpox, especially those in ‘at-risk’ occupations such as health care workers, teachers and workers in child care centres
adults not immunised, who are parents of young children
adults and children not immunised, who live in the same house with people who have lowered immunity and have no history of chickenpox.
The vaccine works by causing the body to produce its own protection (antibodies) against this disease.
Chickenpox is caused by a virus called the varicella-zoster virus. VARILRIX vaccine contains a weakened form of the chickenpox (varicella-zoster) virus.
Chickenpox is a highly infectious disease, which usually causes an itchy, red rash with blisters. After about 1 week, most of the blisters have normally crusted over. The rash can appear on the face, scalp, body, or in the mouth, eyes and bottom. Other symptoms can include fever, headaches, chills, and muscle and/or joint aches and pains. Sometimes disease complications can occur such as bacterial infection of the skin (often due to itching of the rash/crusts), inflammation of the brain (varicella encephalitis), and lung infection (varicella pneumonia). Complications are not common and are mainly seen in children with lowered immunity, and sometimes in adults.
Full recovery from chickenpox generally occurs; however, later in life the virus can become active again. This condition is known as shingles or Herpes zoster.
VARILRIX SHOULD NOT BE GIVEN IF:
you or your child has had an allergic reaction to VARILRIX, or any ingredient contained in this vaccine. Theingredients in VARILRIX 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. VARILRIX can be used in people who have previously developed a skin rash after applying the antibiotic ‘neomycin’ to the skin.
you are or think you may be pregnant, or if you intend to become pregnant within 3 months of vaccination.
Your doctor will discuss with you the risks of receiving VARILRIX during pregnancy.
you or your child has lowered immunity. This can occur in persons
- with inherited (or family history of) immune deficiency conditions
- with abnormal blood conditions or blood protein (immunoglobulin) disorders
- with cancer
- receiving or who have received certain drugs (ie cyclosporin, corticosteroids, and cancer medicines)
- receiving or who have received radiation therapy
- with Human Immunodeficiency Virus (HIV) infection
you or 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 vaccination.
the expiry (EXP) date printed on the pack has passed
the packaging is torn or shows signs of tampering.
If you are not sure whether you or your child should have VARILRIX, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for you or your child.
BEFORE VARILRIX IS GIVEN TELL YOUR DOCTOR OR NURSE 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.
you or your child has allergies to any other medicines or substances, such as dyes, foods or preservatives.
you or your child have received another vaccine within the last month.
you or your child have received a blood or plasma transfusion, or been given gamma globulin or other immunoglobulins within the last 3 months. VARILRIX may be less effective if given within 3 months of 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 the immune system, such as high-dose steroids.
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
HOW VARILRIX IS GIVEN
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
The dose is 0.5mL for infants (9 months or older), children, adolescents and adults.
HOW IS IT GIVEN
VARILRIX will be injected under the skin (subcutaneously) of the shoulder or thigh.
The vaccine should never be given intravenously.
WHEN IT IS GIVEN
VARILRIX is generally given to infants, 9 months or older, and children as a single dose on an elected date. Adults and adolescents aged 13 years and older are generally given two doses at least six weeks apart. Each dose is given at a separate visit.
The need for booster doses is uncertain at present.
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 USING VARILRIX
THINGS YOU MUST NOT DO:
Do not become pregnant for 3 months after receiving VARILRIX vaccination. Talk to your doctor as soon as possible, if you do become pregnant within this time.
THINGS YOU MUST DO:
Tell your doctor that you or your child has received VARILRIX if another vaccine is to be given within 1 month after vaccination.
Tell your doctor if you or your child develops a rash within 4 weeks after vaccination. Some individuals develop symptoms of mild chickenpox several weeks after vaccination with VARILRIX. While the rash lasts, you or your child should avoid contact with people who have low immunity.
Where possible, avoid contact with people who have lowered immunity for up to 6 weeks. The disease may be more serious in these people.
Tell your doctor if you or your child are to have a tuberculin skin test for tuberculosis within 4-6 weeks after vaccination. The vaccine may affect the results of the tuberculin skin test.
Tell your doctor if you or your child are to have another vaccine within 1 month after vaccination.
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 lightheadedness. 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 lightheaded.
Tell your doctor or nurse as soon as possible if you or your child do not feel or look well during or shortly after having had a dose of VARILRIX.
VARILRIX 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. 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. . However, some children develop symptoms of mild chickenpox several weeks after vaccination with VARILRIX
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
pain, fever, skin rash, itching, dry skin, swelling of the glands in the neck, armpit or groin
feeling generally unwell, sore throat, coughing, tiredness, runny nose, dizziness or headache
nausea, vomiting, diarrhoea, stomach pain/cramps, toothache or poor appetite
nervousness, inflammation of the eye lids (conjunctivitis)
pain in the joints or muscles, back pain.
MORE SERIOUS EFFECTS
Tell your doctor immediately if you notice any of the following:
fever greater than 39C
lung problems such as bronchitis, asthma and pharyngitis (sore throat and discomfort when swallowing)
infection of the middle ear that may cause earache and temporary hearing loss
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 casualty 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
Allergy to VARILRIX is rare. Any such severe reactions will usually occur within the first few hours of vaccination.
Other events that have been reported with VARILRIX include:
bacterial, viral or fungal infection
changes in sweat production and increased sputum
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 or your child has any other effects.
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. Do not store it in the bathroom, near the sink, or leave it in the car on hot days. Avoid exposing the vaccine to sunlight. The water diluent can be kept in a refrigerator or at room temperature. It must not be frozen.
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.
WHAT IT LOOKS LIKE
VARILRIX comes as a slightly cream to yellowish or pinkish coloured powder pellet in a glass vial. The clear sterile water diluent comes in prefilled syringes or ampoules. It is made into a clear peach to pink coloured liquid, before being injected by the doctor or nurse.
The active ingredient of VARILRIX is a live weakened varicella-zoster virus (Oka strain). Each 0.5mL dose contains not less than 10 3.3 plaque-forming units of the varicella-zoster virus.
Other inactive ingredients in 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.
VARILRIX is only available if prescribed by a doctor.
VARILRIX comes in the following:
a glass vial with sterile water diluent (prefilled syringe) in packs of 1 or 10 - AUST R 71007.
a glass vial with sterile water diluent (ampoule) in packs of 1 or 10 - AUST R 71008.
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals S.A
rue de l'Institut 89,
1330 Rixensart, Belgium.
DISTRIBUTED IN AUSTRALIA BY
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia 3155 VIC
Date of Preparation:
22 January 2010
Published by MIMS/myDr May 2010
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