PREVENAR 13®

Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed

Consumer Medicine Information

What is in this leaflet

This leaflet answers some commonquestions about Prevenar 13. It doesnot contain all the availableinformation. It does not take theplace of talking to your doctor, clinicnurse or pharmacist.

All vaccinations have benefits andrisks. Your doctor or clinic nurse hasweighed the risks of you or yourchild receiving Prevenar 13 againstthe benefits this vaccination isexpected to provide.

If you have any questions aboutthis vaccination, ask your doctor,clinic nurse or pharmacist.

Keep this leaflet. You may need toread it again.

What Prevenar 13 isused for

Prevenar 13 is a vaccine, which is atype of medicine that helps to protect(immunise) people from certaininfectious diseases. It does this bypreparing the body's defences to fightthe infection, before you catch thebacteria or virus.

Prevenar 13 is a mixture of the outersugar coating (polysaccharide) from13 different strains or serotypes ofbacteria called Streptococcuspneumoniae. Each serotype is joinedto a non-toxic protein to make itwork more effectively. Streptococcuspneumoniae bacteria are one of thecauses of

• meningitis (a serious braininfection that could cause deathor brain damage)

• bacteraemia (infection of theblood)

• pneumonia

• otitis media (an ear infection thatcan cause pain and temporaryhearing loss and may require youor your child to have an earoperation).

Prevenar 13 can protect against 13 ofthe strains of Streptococcuspneumoniae that can cause thesediseases. Prevenar 13 does notreplace the need for vaccination withHaemophilus influenzae type b (Hib)or meningococcal vaccines thatprotect against other importantcauses of meningitis.

You cannot catch any of the abovediseases from the vaccine itself,because it is not made with live orwhole bacteria.

As with all vaccines, 100%protection against the above diseasescannot be guaranteed.

Before you or yourchild is givenPrevenar 13

When you or your childshould not be givenPrevenar 13

You or your child should not begiven Prevenar 13 if you or yourchild have ever had an allergicreaction to pneumococcal ordiphtheria vaccines, or any of theingredients listed at the end of thisleaflet.

Symptoms of an allergic reactionmay include:

• shortness of breath, wheezing ordifficulty breathing

• swelling of the face, lips, tongueor other parts of the body

• rash, itching or hives on the skin.

Vaccination should be delayed ifyou or your child have a fever orinfection requiring a visit to thedoctor.

If you are not sure whether you oryour child should be given Prevenar13, talk to your doctor or clinicnurse. A mild illness without a raisedtemperature (such as a cold) is notusually a reason to delay vaccination.

Before giving Prevenar 13 makesure that the expiry date (EXP)printed on the pack has not beenpassed. If it has, use a new pack.

Prevenar 13 is not recommendedfor babies younger than 6 weeks ofage.

Before each Prevenar 13injection

You must tell the doctor or nurse

• if you suspect or know that you oryour child may be allergic toanything, including foods, anymedicines or other vaccines

• if you or your child have had areaction to an earlier dose ofPrevenar 13 vaccine

• if you or your child have anybleeding problems

• if you or your child are sick witha high fever

• if you or your child have aprevious history of interruption inbreathing after any vaccination.

In rare cases, the doctor or nurse maydecide that the risk of a further

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reaction may outweigh the benefitsof immunisation.

Tell your doctor if your baby wasborn prematurely

There is a higher risk of apnoea(temporarily stopping breathing)when vaccines are given topremature babies.

Tell your doctor or clinic nurse ifyou or your child are having anti-cancer therapy or have an HIVinfection or any other conditionthat affects the immune response.

Prevenar 13 may not be as effectivein individuals with reduced immuneresponsiveness due to various causessuch as these.

Tell your doctor or clinic nurse ifyou or your child have any otherdisease.

Prevenar 13 may not be suitable forindividuals with certain diseases.

Taking other medicines

Tell your doctor or nurse if you oryour child are taking any othermedicines, including medicines youbuy without a prescription from apharmacy, supermarket or healthfood shop, or if you or your childhave recently been given any othervaccine.

How Prevenar 13 isgiven

A doctor or a nurse will give thePrevenar 13 injection. The dose is 0.5mL injected into a muscle in thethigh or upper arm. Other vaccinesmight be given at the same time, butnot at the same injection site.

How many injections will begiven

Babies and young children up to 5years: The total number of injectionsrequired depends on how old yourchild is when they receive the firstdose of Prevenar 13. Normally, yourchild will receive four doses of thevaccine, at least 4 weeks apart,

starting at 6 weeks of age. Four is themaximum number of doses required.Each dose will be given on a separateoccasion. Your doctor or clinic nursewill tell you the correct vaccinationschedule for your child.

It is important to follow theinstructions from the doctor or clinicnurse so that your child completesthe course of injections.

Premature infants: Your child willreceive an initial course of threeinjections. The first injection may begiven as early as six weeks of agewith at least one month betweendoses. A fourth (booster) injection isrecommended at approximately 12months of age,

Children 6 - 17 years and adults: Onesingle dose.

Special populations: Individualsconsidered to be at a higher risk ofpneumococcal infection (such asthose with sickle cell disease or HIVinfection) may receive at least onedose of Prevenar 13. Your doctorwill advise the appropriatevaccination schedule.

If your child misses one ormore doses

If your child misses one or moredoses, talk to your doctor or clinicnurse.

Overdose

A trained doctor or nurse gives thisvaccination, so an overdose isunlikely to occur. An overdose wouldbe unlikely to harm you or yourchild.

Side Effects

Do not be alarmed by this list ofpossible side effects.

You or your child may notexperience any of them.

Tell your doctor or clinic nurse assoon as possible if you or yourchild are not well after receivingPrevenar 13.

Like all vaccines, Prevenar 13 maycause unwanted side effects Allmedicines including vaccines, canhave side effects. Sometimes they areserious, most of the time they are not.You or your child may need medicaltreatment for some side effects.

Tell your doctor or pharmacist ifyou notice any of the following andthey worry you:

Common side effects:

• local reaction around the injectionsite such as redness, itchiness,tenderness, pain or discomfortwhich may temporarily preventuse of the arm, warmth, burningor stinging, swelling, limitation ofarm movement or the formationof hard lumps or scars

• flushing or redness of the skin

• sleepiness

• disturbed sleep

• chills

• fatigue

• irritability

• fever

• headache

• loss of appetite

• vomiting

• diarrhoea

• skin rash, itchy spots or red lumpson the skin, also called hives

• itchiness, hives or rash over thebody

• joint or muscle pain

Uncommon side effects:

• crying

• nausea

• swelling of the glands in the neck,armpit or groin

These side effects are usually mild.

If any of the following happen, tellyour doctor or pharmacistimmediately or go to Accident andEmergency at your nearesthospital:

• allergic reaction such as rash,itching or hives on the skin,swelling of the face, lips, tongue

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or other parts of the body,shortness of breath or troublebreathing

• a seizure or convulsion, whichmay be accompanied by a veryhigh temperature. Symptoms mayinclude rapid uncontrollableshaking of the body, loss ofmuscle control, drooling, suddenchanges in mood or behaviour.

• rapid, shallow breathing, cold,clammy skin, a rapid, weak pulse,dizziness, weakness and fainting

• temperature higher than 39°C inbabies or young children

• temporary interruptions ofbreathing. In babies born veryprematurely (at or before 28weeks before gestation), longergaps than normal between breathsmay occur for 2 - 3 days aftervaccination

• your child is pale, limp and doesnot respond to you.

These are very serious side effects.You or your child may need urgentmedical attention or hospitalisation.

Other side effects not listed abovemay occur in some individuals. Tellyour doctor or pharmacist if younotice anything that is making youor your child feel unwell.

Ask your doctor or clinic nurse toanswer any questions you mayhave.

After receivingPrevenar 13

Storage

It is unlikely that you will be asked tostore Prevenar 13. If you are:

Keep this vaccine in therefrigerator at a temperaturebetween 2°C and 8°C where youngchildren cannot reach it.

Do not freeze it. If the vaccine hasbeen frozen it should not be used.

Keep Prevenar 13 in the originalpack until it is time to be given.

Product description

What it looks like

Prevenar 13 is a clear liquid withsediment, which after shaking willlook like a white coloured liquid(called a suspension).

Prevenar 13 is supplied as asuspension in 0.5 mL pre-filledsyringes in packs of 1 and 10.

Ingredients

Each 0.5 mL dose of Prevenar 13contains the following activeingredients:

• 30.8 micrograms ofpneumococcal purified capsularpolysaccharides

• 32 micrograms of CRM197protein

plus the following inactiveingredients:

• aluminium phosphate

• sodium chloride

• succinic acid

• polysorbate 80

• water for injections

The manufacture of this productincludes exposure to bovine derivedmaterials. No evidence exists thatany case of vCJD (considered to bethe human form of bovinespongiform encephalopathy) hasresulted from the administration ofany vaccine product.

Supplier

Prevenar 13 is supplied in Australiaby:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

WEST RYDE NSW 2114

Toll Free Number: 1800 675 229

Prevenar 13 is supplied in NewZealand by:

Pfizer New Zealand Ltd

PO Box 3998

Auckland

Toll Free Number: 0800 736 363

Australian registrationnumber

Prevenar 13 pre-filled syringes:AUST R 158450

Date of preparation

This leaflet was prepared in May2014.

® Registered Trade Mark

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