VARILRIX®Varicella vaccineCONSUMER MEDICINE INFORMATION LEAFLET                          who have lowered immunity        ...
such as a cold should not           the immune system, such as       IF A DOSE IS MISSED   be a problem, but talk to      ...
THINGS TO BE CAREFUL               MILD EFFECTS                                shortness of breath,OF:                    ...
Keep VARILRIX in the             FURTHER INFORMATION   original pack until it is time   for it to be given.              V...
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Varilrix cmi version_4.0


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VARILRIX е ваксина, предназначена за деца на възраст от 9 и повече месеца, юноши и възрастни
за предотвратяване на варицелата.

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Varilrix cmi version_4.0

  1. 1. VARILRIX®Varicella vaccineCONSUMER MEDICINE INFORMATION LEAFLET who have lowered immunity BEFORE VACCINATIONWHAT IS IN THIS LEAFLET and have no history of chickenpox. VARILRIX SHOULD NOT BEThis leaflet answers some of GIVEN IF: The vaccine works by causing thethe common questions about body to produce its ownVARILRIX vaccine. It does you or your child has had an protection (antibodies) againstnot contain all the available allergic reaction to VARILRIX, or this disease.information. It does not take any ingredient contained in thisthe place of talking to your vaccine. The ingredients in Chickenpox is caused by a virusdoctor, nurse or pharmacist. VARILRIX are listed at the end called the varicella-zoster virus. of this leaflet. Signs of an VARILRIX vaccine contains aAll medicines and vaccines allergic reaction may include weakened form of the chickenpoxhave risks and benefits. Your itchy skin rash, shortness of (varicella-zoster) has weighed the breath and swelling of the facepossible risks of you or your or tongue. VARILRIX can be Chickenpox is a highly infectiouschild having VARILRIX against used in people who have disease, which usually causes anthe expected benefits. previously developed a skin itchy, red rash with blisters. After about 1 week, most of the blisters rash after applying the antibioticIf you have any concerns ‘neomycin’ to the skin. have normally crusted over. Theabout 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 symptomsKeep this leaflet with this can include fever, headaches, become pregnant within 3vaccine. You may need to chills, and muscle and/or joint months of vaccination. Yourread 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 theFOR 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 (varicellachildren aged 9 months or pneumonia). Complications are with inherited (or familyolder, adolescents and adults not common and are mainly seen history of) immuneto prevent chickenpox. in children with lowered immunity, deficiency conditionsGroups who would benefit and sometimes in adults. with abnormal bloodmostly from vaccination conditions or blood proteininclude: 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 1
  2. 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 VARILRIXIf you are not sure whether vaccination. Talk to your doctor asyou or your child should The doctor or nurse will give soon as possible, if you do becomehave VARILRIX, talk to your VARILRIX as an injection. If you pregnant within this or nurse. Do not have any concerns about how this vaccine is to be given, talk THINGS YOU MUST DO:give this vaccine to anyoneelse; your doctor has to your doctor, nurse or Tell your doctor that you or yourprescribed it specifically for pharmacist. child has received VARILRIX ifyou or your child. another vaccine is to be given HOW MUCH IS GIVEN within 1 month afterBEFORE 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 underis not known if VARILRIX of mild chickenpox several the skin (subcutaneously) of thepasses into breast milk, weeks after vaccination with shoulder or thigh.however the vaccine is not VARILRIX. While the rashexpected to cause problems in lasts, you or your child should The vaccine should never bebreast-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 2
  3. 3. THINGS TO BE CAREFUL MILD EFFECTS shortness of breath,OF: breathing or swallowingBe careful driving or operating Tell your doctor if you difficultiesmachinery until you know how notice any of the following hives, itching (especially ofVARILRIX affects you. that are troublesome or the hands or feet), reddeningVARILRIX should not normally ongoing after vaccination: of skin (especially aroundinterfere with your ability to the ears), or severe skindrive a car or operate redness, swelling, a hard reactionsmachinery. But in some lump, soreness, bruising unusual tiredness orpeople vaccination can cause or itching around the weakness that is sudden anddizziness or lightheadedness. injection site severeMake sure you know how you pain, fever, skin rash,react to VARILRIX before you itching, dry skin, swelling Allergy to VARILRIX is a car or operate of the glands in the neck, Any such severe reactions willmachinery, or do anything that armpit or groin usually occur within the first fewcould 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 fungalTell your doctor or nurse as poor appetite infectionsoon as possible if you or nervousness, migraineyour child do not feel or inflammation of the eye changes in sweatlook well during or shortly lids (conjunctivitis) production and increasedafter having had a dose of pain in the joints or sputumVARILRIX. muscles, back pain. Other side effects not listed above,VARILRIX helps protect most can also occur during or soon afterpeople from chickenpox, but it MORE SERIOUS EFFECTS a dose of VARILRIX. Check withmay have unwanted side your doctor or nurse if you oreffects in a few people. All Tell your doctor your child has any other effects.medicines and vaccines can immediately if you noticehave side effects. Sometimes any of the following:they are serious; most of the STORAGEtime they are not. Some side fever greater than 39 Ceffects may need medical lung problems such as bronchitis, asthma and VARILRIX is usually stored at thetreatment. pharyngitis (sore throat doctor’s clinic or surgery, or at the and discomfort when pharmacy. But if you need toAsk your doctor, nurse or swallowing) store VARILRIX always:pharmacist to answer any infection of the middle earquestions you may have. Keep VARILRIX in the that may cause earache and temporary hearing refrigerator stored betweenMost unwanted effects with loss +2 C and +8 C. Do not store itVARILRIX 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 toother vaccines, generally risk of serious allergic sunlight. The water diluent canoccur 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 notdevelop symptoms of mild casualty department of your be frozen.chickenpox several weeksafter vaccination with nearest hospital if any of the following happens: Keep the vaccine out of theVARILRIX swelling of limbs, face, reach of children. eyes, inside of nose, mouth or throat 3
  4. 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 whatto do with any left over VARILRIX comes in the following:VARILRIX that has expired - a glass vial with sterile wateror has not been used. diluent (prefilled syringe) in packs of 1 or 10 - AUST RPRODUCT DESCRIPTION 71007. - a glass vial with sterile waterWHAT IT LOOKS LIKE diluents (ampoule) in packs ofVARILRIX comes as a slightly 1 or 10 – AUST R 71008cream to yellowish or pinkishcoloured powder pellet in a Not all pack sizes may beglass vial. The clear sterile marketed.water diluent comes inprefilled syringes or ampoules.It is made into a clear peach MANUFACTURERto pink coloured liquid, beforebeing injected by the doctor or GlaxoSmithKline Biologicals S.Anurse. rue de lInstitut 89, 1330 Rixensart, Belgium.INGREDIENTSThe active ingredient of DISTRIBUTED IN AUSTRALIA BYVARILRIX is a live weakened GlaxoSmithKline Australia Pty Ltdvaricella-zoster virus (Oka Level 4, 436 Johnston Street,strain). Each 0.5mL dose Abbotsford, Victoria 3067contains not less than 103.3plaque-forming units of thevaricella-zoster virus. Date of Preparation: 21 January 2011Other inactive ingredients in Version 4.0the vaccine are: amino acidsfor injection, human albumin,lactose, neomycin sulphate,and polyalcohols.The manufacture of thisproduct includes exposure tobovine derived materials. Noevidence exists that any caseof vCJD (considered to bethe human form of bovinespongiform encephalopathy)has resulted from theadministration of any vaccineproduct.VARILRIX does not containsucrose, gluten, tartrazine orany other azo dyes. 4