| ROTARIX® Rotavirus Vaccine, live attenuated CONSUMER MEDICINE INFORMATION LEAFLET What is in this leaflet? Please read this leaflet carefullybefore your child receivesROTARIX vaccine.This leaflet answers somecommon questions aboutROTARIX. It does not contain allof the available information.It does not take the place of talkingto your doctor or pharmacist.All medicines and vaccines haverisks and benefits. Your doctorhas weighed the expected benefitsof your child having ROTARIX against the possible risks.If you have any concerns aboutyour child having this vaccine,ask your doctor or pharmacist.Keep this leaflet with thevaccine.You may need to read it again. What is ROTARIX usedfor? ROTARIX is a viral vaccine thathelps to protect your child againstgastro-enteritis (diarrhoea andvomiting) caused by rotavirusinfection.Rotavirus infection is the mostcommon cause of severediarrhoea in infants and youngchildren. Rotavirus is easilyspread by hand-to-mouth contactwith stool from an infected person.Most children with rotavirusdiarrhoea recover on their own.Some children become very ill withsevere vomiting, diarrhoea andlife-threatening loss of fluids thatrequires hospitalisation. Rotavirusinfections are responsible forhundreds of thousands of deathsworldwide every year especially indeveloping countries, wherenutrition and health care are notoptimal.When a person is given thevaccine, the immune system (thebody’s natural defences) will makeantibodies against the mostcommonly occurring types ofrotavirus. These antibodiesprotect against disease caused bythese types of rotavirus.As with all vaccines, ROTARIXmay not completely protect allpeople who are vaccinated againstthe infections it is intended toprevent. The vaccine will notprotect against gastro-enteritiscaused by other types of viruses ororganisms.ROTARIX is not addictive. ROTARIXROTARIX should not begiven if: • your child has previously hadan allergic reaction toROTARIX or any of theingredients listed toward theend of this leaflet. (See“Ingredients”) Signs of anallergic reaction include itchyskin rash, shortness ofbreath and swelling of theface or tongue. • Your child has a severeinfection with hightemperatureIt might be necessary topostpone the vaccinationuntil recovery. A minorinfection such as a coldshould not be a problem, buttalk to your doctor first. • your child has diarrhoea oris vomiting. It might benecessary to postpone thevaccination until recovery. • the expiry date (EXP) printedon the pack has passed. • the packaging is torn orshows signs of tampering. Tell your doctor if: • your child is allergic to foods,dyes, preservatives or anyother medicines.In these cases, your doctor candetermine the right time ofvaccination for your child. • your child is taking anyprescription or OTC (overthe-counter) medicines. Some vaccines may beaffected by other vaccines ormedicines. Your doctor,nurse or pharmacist will beable to tell you what to do ifROTARIX is to be given withanother vaccine or medicine. • your child has a history ofchronic gastrointestinaldisease. How is ROTARIX given? The doctor or nurse will administerthe recommended dose of ROTARIX to your child. THE VACCINE WILL BE GIVENORALLY. How much is given ROTARIX is given as a 1 mL liquiddose. How it is given ROTARIX is given into the mouth. Under no circumstance should thisvaccine be given by injection. When will it be given? Your child will receive two doses ofthe vaccine. Each dose will begiven on a separate occasion withan interval of at least 4 weeksbetween the two doses. The firstdose will be given between 6 and14 weeks of age and the seconddose must be given by 24 weeksof age.There are no restrictions on yourchild’s consumption of food orliquids, including breast milk, eitherbefore or after vaccination.In the unlikely event that an infantspits out or regurgitates most of thevaccine dose, a single replacementdose may be given at the samevaccination visit.It is important that you follow theinstructions of your doctor or nurseregarding return visits for thefollow-up dose. IF A DOSE IS MISSED If you forget to go back to yourdoctor at the scheduled time, askyour doctor for advice. After having ROTARIX Things you must do If you are in close contact witha recently vaccinatedbaby/child, ensure your handsare washed thoroughly: • after changing nappies • before eating or handlingfood. What are the sideeffects? Check with your doctor as soonas possible if you think yourchild is experiencing any sideeffects or allergic reactions dueto having ROTARIX, even if theproblem is not listed below. Like other medicines, ROTARIX can cause some side-effects. Ifthey occur, they are most likely tobe minor and temporary.However, some may be seriousand need medical attention.The most commonly reported sideeffectsare: • loss of appetite, irritability,fever, fatigue, diarrhoea,vomiting, regurgitation of food,flatulence, abdominal pain,crying, disturbed sleep,sleepiness and constipation. Rarely reported side-effects are: • chest infection, hoarseness,runny nose, dermatitis, rashand muscle cramp. Tell your doctor immediately if you notice any of the following: • Wheezing, swelling of thelips/mouth, difficulty inbreathing, hayfever, lumpyrash (hives) or fainting.These could be symptoms ofan allergic reaction. This is not a complete list of allpossible side-effects. Others mayoccur in some people and theremay be some side-effects not yetknown.Tell your doctor or pharmacist ifyou notice any side effects fromyour child’s vaccine which are notmentioned here. Do not be alarmed by this list ofpossible side-effects. Your child may not experience any ofthem. How do I storeROTARIX? ROTARIX is usually stored at thedoctor’s clinic or surgery, or at thepharmacy. But if you need to store ROTARIX always: • Keep ROTARIX in therefrigerator stored between+2 C and +8 C. Do not store itin the bathroom, or leave it inthe car. Avoid exposing the vaccine to sunlight. HEAT CANDESTROY THE VACCINE. • Keep the vaccine out of thereach of children. • Keep ROTARIX in the originalpack until it is time for it to begiven. Ask your pharmacist what to dowith any left over ROTARIX that has expired or has not beenused. Product Description What ROTARIX looks like ROTARIX is supplied as a whitishpowder in a single dose glass vialwith a separate pre-filled syringe ofsolvent and an adapter (transferdevice) which allows easy transferof the solvent into the vialcontaining the powder for mixingthe vaccine. Ingredients The active ingredient of ROTARIXis live attenuated human rotavirus RIX4414 strain.ROTARIX also contains sucrose,dextran 40, sorbitol, amino acids,Dulbecco\\\\\\\'s Modified Eagle Medium(DMEM), calcium carbonate,xanthan gum and water forinjections.The manufacture of this productincludes exposure to bovinederived materials.No evidence exists that any caseof vCJD (considered to be thehuman form of bovine spongiformencephalopathy) has resulted fromthe administration of any vaccineproduct. Supplier Your ROTARIX is supplied by:GlaxoSmithKline Australia Pty Ltd1061 Mountain HighwayBoroniaVictoria, 3155Australia. Where to go for furtherinformation Pharmaceutical companies are notin a position to give people anindividual diagnosis or medicaladvice. Your doctor or pharmacistis the best person to give youadvice on the treatment of yourcondition. Include the followingwhere appropriate: You may alsobe able to find general informationabout your disease and itstreatment from patient informationgroups and product specificorganisations eg. asthmafoundationThis leaflet was prepared on 22February 2007The information provided appliesonly to: ROTARIX®.®ROTARIX is a trademark of theGlaxoSmithKline Group ofCompanies.ROTARIX: AUST R 116532This leaflet is subject to copyright
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