FLOLAN 0.5MG INJECTION
Active substance: EPOPROSTENOL SODIUM
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3
10000000107880 GSK-ITA-Parma-ITPAR United Kingdom-GBR Flolan 1
10000000107880
Package leaflet: Information for the user
Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
epoprostenol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - eepthisleaflet.Youmayneedto K readitagain. - fyouhaveanyfurtherquestions,ask I yourdoctororpharmacistornurse. - hismedicinehasbeenprescribedfor T youonly.Donotpassitontoothers. Itmayharmthem,eveniftheirsigns ofillnessarethesameasyours. - fyougetanysideeffects,talkto I yourdoctororpharmacistornurse. This includes any possible side effects notlistedinthisleaflet. What is in this leaflet: 1 WhatFlolanisandwhatitisusedfor 2 hatyouneedtoknowbeforeyou W takeFlolan 3 HowtotakeFlolan 4 Possible side effects 5 HowtostoreFlolan 6 ontentsofthepackandother C information
surroundingtissue.Ifitdoes,theskin couldbedamaged.Thesymptomsof this are: enderness t . urning b . . tinging s welling s edness. r This may be followed by blistering and sheddingoftheskin.Whileyouare beingtreatedwithFlolanitisimportant thatyouchecktheinjectionarea. Contact the hospital immediately for adviceiftheareabecomessore,painful or swollen or you notice any blistering orshedding. Effect of Flolan on blood pressure and heart rate Flolancancauseyourhearttobeat fasterorslower.Alsoyourblood pressurecanbecometoolow.Whileyou arebeingtreatedwithFlolanyourheart rateandbloodpressurewillbechecked. The symptoms of low blood pressure include dizziness and fainting. Tell your doctor if you get these symptoms.Yourdosemayneedtobe reducedoryourinfusionstopped. Other medicines and Flolan Tell your doctor or pharmacist if youaretaking,haverecentlytaken ormighttakeanyothermedicines, including medicines obtained without a prescription. SomemedicinesmayaffecthowFlolan works,ormakeitmorelikelythatyoull havesideeffects.Flolancanalsoaffect how some other medicines work if taken atthesametime.Theseinclude: edicinesusedtotreat high blood m pressure edicinesusedtoprevent blood m clots edicinesusedtodissolve blood m clots edicinestotreatinflammation or m pain(alsocalledNSAIDs) igoxin(usedtotreatheart disease). d Tell your doctor or pharmacist if you are takinganyofthese. Pregnancy and breast-feeding Ifyouarepregnantorbreast-feeding, think you may be pregnant or are planningtohaveababy,askyour doctor or pharmacist for advice before taking this medicine as your symptoms couldworsenduringpregnancy. It is not known whether the ingredientsofFlolancanpassinto breast-milk.You should stop breastfeeding your child during treatment with Flolan. Driving and using machines Yourtreatmentmayhaveaneffecton theabilitytodriveorusemachinery. Dont drive or use machines unless yourefeelingwell. FlolancontainsSodium.
Pulmonary arterial hypertension Yourfirsttreatmentwillbegiventoyou inahospital.Thisisbecauseyourdoctor needs to monitor you and find the best doseforyou. YouwillstartwithaninfusionofFlolan. Thedosewillbeincreased,untilyour symptomsarerelieved,andanyside effectsaremanageable.Oncethebest dosehasbeenfound,apermanenttube (line)willbefittedintooneofyour veins.Youcanthenbetreatedusingan infusionpump. Kidney dialysis YouwillbegivenaninfusionofFlolan forthedurationofyourdialysis. Using Flolan at home (only for treatment of Pulmonary Arterial Hypertension) Ifyouaretreatingyourselfathome, your doctor or nurse will show you how toprepareanduseFlolan.Theywill also advise you how to stop treatment ifnecessary.StoppingFlolanmustbe donegradually.Itisveryimportant that you follow all their instructions carefully. Flolancomesasapowderinaglass vial.Beforeuse,thepowderneedsto bedissolvedintheliquidprovided.The liquiddoesnotcontainapreservative. Ifyouhaveanyoftheliquidleftover,it mustbethrownaway. Looking after the injection line Ifyouhavebeenfittedwithalineinto a vein it is very important to keep this areaclean,otherwiseyoucouldget aninfection.Yourdoctorornursewill show you how to clean your line and theareaaroundit.Itisveryimportant that you follow all of their instructions carefully. If you take more Flolan than you should Seek urgent medical attention if you think you have used or been given too muchFlolan.Symptomsofoverdosemay includeheadache,nausea,vomiting, fastheartrate,warmthortingling,or feeling like you might pass out (feeling faint/dizziness). If you forget to take Flolan Donottakeadoubledosetomakeup foraforgottendose. If you stop taking Flolan StoppingFlolanmustbedonegradually. Ifthetreatmentisstoppedtooquickly youmaygetserioussideeffects, includingdizziness,feelingweakand breathingdifficulties.Ifyouhave problems with the infusion pump or injectionlinethatstops,orprevents treatmentwithFlolan,contact your doctor, nurse or hospitalimmediately. Ifyouhaveanyfurtherquestionsonthe useofthismedicine,askyourdoctoror pharmacistornurse.
K
D00055LEA
1 What Flolan is and what it is used for
Flolancontainstheactivesubstance epoprostenol which belongs to a group ofmedicinescalledprostaglandin,which stops blood from clotting and widens thebloodvessels. Flolanisusedtotreatalungcondition calledpulmonaryarterialhypertension. This is where the pressure is high in the bloodvesselsinthelungs.Flolanwidens the blood vessels to lower the blood pressureinthelungs. Flolanisusedtopreventbloodclotting during kidney dialysis when heparin cannotbeused.
FRONT PAGE
TYPE SIZE: 8/9.5 HORIZONTAL SCALE: 100%
2 What you need to know before you take Flolan
Do not take Flolan f you are allergictoFlolanoranyof i the other ingredients of this medicine (listedinsection6). fyouhaveheart failure. i fyoustarttodevelopabuild-up i of fluid in your lungs causing breathlessness after starting this treatment. Ifyouthinkanyoftheseapplytoyou, dont take Flolan until you have checked withyourdoctor. Warnings and precautions BeforeyouaregivenFlolanyourdoctor needs to know: fyouhaveanyproblemswith i bleeding. Skin damage at the injection site Flolanisinjectedintoavein.Itis important that the medicine does not leak out of the vein into the
Page 1 of 2
4 Possible side effects
Likeallmedicines,thismedicine cancausesideeffects,althoughnot everybodygetsthem. Tellyourdoctorornurseimmediately, as these may be signs of infection of the blood or low blood pressure or serious bleeding: oufeelthatyourheartisbeating Y faster,oryouhavechestpainor shortnessofbreath. oufeeldizzyorfeelfaint,especially Y onstanding. ouhavefeversorchills. Y ouhavemorefrequent,orlonger Y periodsofbleeding.
3 How to take Flolan
Alwaystakethismedicineexactlyas yourdoctororpharmacisthastoldyou. Check with your doctor or pharmacist if youarenotsure. Yourdoctorwilldecidehowmuch Flolanisrightforyou.Theamountyou aregivenisbasedonyourbodyweight, andyourtypeofillness.Yourdosemay be increased or decreased depending on howwellyourespondtotreatment. Flolanisgivenbyslowinfusion(drip) intoavein.
Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
epoprostenol
DOSAGE AND ADMINISTRATION INFORMATION ONLY Please refer to the Summary of Product Characteristics for complete prescribing information INFORMATION FOR HEALTHCARE PROFESSIONALS Renal Dialysis There is only one pack available for use in renal dialysis: ne0.5mgpowdervialandonesolventvial O Reconstitution: 1. seonlythesolventprovidedforreconstitution U 2. ithdrawapproximately10mLofthesolventintoasterilesyringe,injectitintothevialcontaining0.5mgfreeze-driedFlolanpowderandshakegently W until the powder has dissolved 3. rawuptheresultingFlolansolutionintothesyringe,re-injectitintotheremainingvolumeofthesolventandmixthoroughly. D Thissolutionisnowreferredtoastheconcentratedsolutionandcontains10,000nanogrampermLFlolan.Onlythisconcentratedsolutionissuitablefor furtherdilutionpriortouse.When0.5mgFlolanpowderisreconstitutedwith50mLofthesolvent,thefinalinjectionhasapHofapproximately10.5and asodiumioncontentofapproximately56mg. Dilution: Theconcentratedsolutionisnormallyfurtherdilutedbeforeuse.Itmaybedilutedwithsodiumchloride0.9%w/vsolution,providedaratioof 6volumesofsodiumchloride0.9%w/vsolutionto1volumeofconcentratedsolutionisnotexceedede.g.50mLofconcentratedsolutionfurther dilutedwithamaximumof300mLsodiumchloride0.9%w/vsolution. OthercommonintravenousfluidsareunsatisfactoryforthedilutionoftheconcentratedsolutionastherequiredpHisnotattained.Flolansolutions arelessstableatlowpH. Todilutetheconcentratedsolution,drawitupintoalargersyringeandthenattachthesterilefilterprovidedtothesyringe. Dispensetheconcentratedsolutiondirectlyintothechoseninfusionsolutionusingfirmbutnotexcessivepressure;thetypicaltimetakenforfiltration of50mLofconcentratedsolutionis70seconds.Mixwell. Thefilterunitmustbeusedonceonlyandthendiscarded. Whenreconstitutedanddilutedasdirectedabove,FlolaninfusionsolutionshaveapHofapproximately10andwillretain90%oftheirinitialpotency forapproximately12hoursat25C. . . . Calculation of infusion rate: The infusion rate may be calculated from the following formula: dosage(nanogram/kg/min)xbodyweight(kg) concentrationofsolution(nanogram/mL) Infusionrate(mL/h)=Infusionrate(mL/min)x60 Foradministrationusingapumpcapableofdeliveringsmallvolumeconstantinfusions,suitablealiquotsofconcentratedsolutionmaybedilutedwith sterilesodiumchloride0.9%w/vsolution. Infusionrate (mL/min) =
The following information is intended for medical or healthcare professionals only:
3
10000000107880 GSK-ITA-Parma-ITPAR United Kingdom-GBR Flolan 1
Talk to your doctor or pharmacist or nurseaboutanyothersideeffects, includingthosenotlistedinthisleaflet. Very common side effects These may affect more than 1 in 10 people: eadache h awpain j ain p eingsick(vomiting) b eelingsick(nausea) f iarrhoea d ednessofyourface(flushing) r Common side effects These may affect up to 1 in 10 people: nfectionoftheblood(septicaemia) i eartbeatingfaster h lowheartbeat s owbloodpressure l leedingatvarioussitesandbruising b moreeasilythannormal,forexample from the nose or gums tomachdiscomfortorpain s hestpain c ointpain j eelinganxious,feelingnervous f ash r ainattheinjectionsite p Common side effects that may show up in blood tests ecreaseinthenumberofblood d platelets (cells that help the blood to clot) Uncommon side effects These may affect up to 1 in 100 people: weating s rymouth d Rare side effects These may affect up to 1 in 1,000 people: nfectionattheinjectionsite i Very rare side effects These may affect up to 1 in 10,000 people: eelingoftightnessaroundthechest f eelingtired,weak f eelingagitated f aleskin p ednessattheinjectionsite r veractivethyroidgland o lockageoftheinjectioncatheter b
Ifyouarenotusingacoldpouch,the solution can be stored in the pump: orupto12hoursat25C,ifithas f justbeenmadeup oramaximumof8hoursifitwas f made previously and has been stored at2-8C. Renal Dialysis OnceFlolanhasbeendissolvedand diluted,anyunusedsolutioncanbe storedat25Candusedwithin12hours.
. . .
6 Contents of the pack and other information
What Flolan contains The active substance is epoprostenol sodium.FlolanInjectioncomesin differentstrengths. Each vial contains either: .5mgepoprostenolsodium 0 .5mgepoprostenolsodium. 1 TheotheringredientsareMannitol, Glycine,SodiumChloride,Sodium HydroxideandWater. What Flolan looks like and contents of the pack Injection: Flolanisasolutionforinjectionmade upofpowderandsolution.Thepowder iswhiteoroff-whiteandthesolutionis clearandcolourless. TherearefourpacksofFlolanavailable for use in the treatment of pulmonary arterialhypertension,thecontentsof each pack include: ne0.5mgpowdervialandoneor O twosolventvialsandafilterunit. ne1.5mgpowdervialandoneor O twosolventvialsandafilterunit. ne0.5mgpowdervial. O ne1.5mgpowdervial. O Notallpacksizesareavailableinall markets. Marketing Authorisation Holder and Manufacturer MarketingAuthorisationHolder: GlaxoSmithKlineUK,StockleyParkWest, Uxbridge,MiddlesexUB111BT Manufacturer:GlaxoSmithKline ManufacturingS.p.A.,SanPolodi Torrile,Parma,Italy Other formats Tolistentoorrequestacopyofthis leafletinBraille,largeprintoraudio pleasecall,freeofcharge:
K
D00055LEA
BACK PAGE
TYPE SIZE: 8/9.5 HORIZONTAL SCALE: 100%
Other side effects Itisnotknownhowmanypeopleare affected: uildupoffluidinthelungs b (pulmonaryoedema) ncreaseinsugar(glucose)intheblood i
08001985000(UKOnly)
Please be ready to give the following information: Product name Referencenumber Flolan 0.5 mg and 1.5 mg injection P L10949/0310and PL10949/0312
5 How to store Flolan
Keepthismedicineoutofthesightand reachofchildren. Donotusethismedicineaftertheexpiry datewhichisstatedonthelabel. Donotstoreabove25C. StoreFlolaninadryplace. Storeintheoriginaloutercarton,to protectfromlight. Donotfreeze. Pulmonary arterial hypertension OnceFlolanpowderhasbeendissolved, anddiluted,itshouldideallybeused immediately.Ifyouarebeinggiven Flolanusinganinfusionpump,acold pouch may be used to maintain the temperatureofthesolution. Whenusingacoldpouch,thesolution can be stored in the pump for up to 24hoursat2-8Cifnecessary.The cold pouch must be regularly changed throughouttheday,tomaintainthe temperatureofthesolution.
Page 2 of 2
This is a service provided by the Royal NationalInstituteofBlindPeople. This leaflet was last revised in 10/2012. Flolanisaregisteredtrademarkofthe GlaxoSmithKlinegroupofcompanies 2012GlaxoSmithKlinegroupof companies
Pulmonary arterial hypertension Therearefourpacksavailableforuseinthetreatmentofpulmonaryarterialhypertension,asfollows: ne0.5mgpowdervialandoneortwosolventvialsandafilterunit. O ne1.5mgpowdervialandoneortwosolventvialsandafilterunit. O ne0.5mgpowdervial. O ne1.5mgpowdervial. O Notallpacksizesareavailableinallmarkets. Initially,apackcontainingsolventmustbeused.DuringchronictherapywithFlolanthefinalconcentrationofsolutionmaybeincreasedbytheadditionof afurther0.5mgor1.5mgvialoffreeze-driedFlolan. Onlyvialsofthesameamountasthatincludedintheinitialstarterpackmaybeusedtoincreasethefinalconcentrationofsolution. Reconstitution: 1. seonlythesolventprovidedforreconstitution. U 2. ithdrawapproximately10mLofthesolventintoasterilesyringe,injectthecontentsofthesyringeintothevialcontainingFlolanpowderandshake W gentlyuntilthepowderhasdissolved. 3. rawuptheresultingFlolansolutionintothesyringe,re-injectitintotheremainingvolumeofthesolventandmixthoroughly. D Thissolutionisnowreferredtoastheconcentratedsolutionandcontainseither10,000(forthe0.5mgstrength)or30,000nanogrampermLFlolan(forthe 1.5mgstrength).Onlythisconcentratedsolutionissuitableforfurtherdilutionpriortouse.When0.5mgFlolanpowderisreconstitutedwith50mLofthe solvent,thefinalinjectionhasapHofapproximately10.5andasodiumioncontentofapproximately56mg. Dilution: Flolanmaybeusedeitherasconcentratedsolutionorinadilutedformforthetreatmentofpulmonaryarterialhypertension.Onlythesolventprovided maybeusedforthefurtherdilutionofreconstitutedFlolan.Sodiumchloride0.9%w/vsolutionmustnotbeusedwhenFlolanistobeusedforthe treatmentofpulmonaryarterialhypertension. Todilutetheconcentratedsolution,drawitupintoalargersyringeandthenattachthesterilefilterprovidedtothesyringe. Dispensetheconcentratedsolutiondirectlyintothesolventusingfirmbutnotexcessivepressure;thetypicaltimetakenforfiltrationof50mLof concentratedsolutionis70seconds.Mixwell. Thefiltermustbeusedonceonlyandthendiscarded. Concentrations commonly used in the treatment of pulmonary arterial hypertension are as follows: ,000nanogram/mLOnevialcontaining0.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 5 0,000nanogram/mLTwovialscontaining0.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 1 5,000nanogram/mLOnevialcontaining1.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 1 Calculation of infusion rate: The infusion rate may be calculated from the following formula: dosage(nanogram/kg/min)xbodyweight(kg) Infusionrate = (mL/min) concentrationofsolution(nanogram/mL) Infusionrate(mL/h)=Infusionrate(mL/min)x60 Higherinfusionrates,andtherefore,moreconcentratedsolutionsmaybenecessarywithlong-termadministrationofFlolan. Special precautions for storage Dontstoreabove25C. Keepcontainerintheoutercartontoprotectfromlight. Keepdry. Donotfreeze. Anycoldpouchusedmustbecapableofmaintainingthetemperatureofthereconstitutedsolution. Storebetween2and8Cforthefulladministrationperiod. Reconstitutionanddilutionshouldbecarriedoutimmediatelypriortouse. Thesolventcontainsnopreservative;consequentlyavialshouldbeusedonceonlyandthendiscarded. Thisleafletwaslastrevisedin10/2012. . FlolanisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies . . 2012GlaxoSmithKlinegroupofcompanies
10000000107880
10000000107880 GSK-ITA-Parma-ITPAR United Kingdom-GBR Flolan 1
10000000107880
Package leaflet: Information for the user
Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
epoprostenol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - eepthisleaflet.Youmayneedto K readitagain. - fyouhaveanyfurtherquestions,ask I yourdoctororpharmacistornurse. - hismedicinehasbeenprescribedfor T youonly.Donotpassitontoothers. Itmayharmthem,eveniftheirsigns ofillnessarethesameasyours. - fyougetanysideeffects,talkto I yourdoctororpharmacistornurse. This includes any possible side effects notlistedinthisleaflet. What is in this leaflet: 1 WhatFlolanisandwhatitisusedfor 2 hatyouneedtoknowbeforeyou W takeFlolan 3 HowtotakeFlolan 4 Possible side effects 5 HowtostoreFlolan 6 ontentsofthepackandother C information
surroundingtissue.Ifitdoes,theskin couldbedamaged.Thesymptomsof this are: enderness t . urning b . . tinging s welling s edness. r This may be followed by blistering and sheddingoftheskin.Whileyouare beingtreatedwithFlolanitisimportant thatyouchecktheinjectionarea. Contact the hospital immediately for adviceiftheareabecomessore,painful or swollen or you notice any blistering orshedding. Effect of Flolan on blood pressure and heart rate Flolancancauseyourhearttobeat fasterorslower.Alsoyourblood pressurecanbecometoolow.Whileyou arebeingtreatedwithFlolanyourheart rateandbloodpressurewillbechecked. The symptoms of low blood pressure include dizziness and fainting. Tell your doctor if you get these symptoms.Yourdosemayneedtobe reducedoryourinfusionstopped. Other medicines and Flolan Tell your doctor or pharmacist if youaretaking,haverecentlytaken ormighttakeanyothermedicines, including medicines obtained without a prescription. SomemedicinesmayaffecthowFlolan works,ormakeitmorelikelythatyoull havesideeffects.Flolancanalsoaffect how some other medicines work if taken atthesametime.Theseinclude: edicinesusedtotreat high blood m pressure edicinesusedtoprevent blood m clots edicinesusedtodissolve blood m clots edicinestotreatinflammation or m pain(alsocalledNSAIDs) igoxin(usedtotreatheart disease). d Tell your doctor or pharmacist if you are takinganyofthese. Pregnancy and breast-feeding Ifyouarepregnantorbreast-feeding, think you may be pregnant or are planningtohaveababy,askyour doctor or pharmacist for advice before taking this medicine as your symptoms couldworsenduringpregnancy. It is not known whether the ingredientsofFlolancanpassinto breast-milk.You should stop breastfeeding your child during treatment with Flolan. Driving and using machines Yourtreatmentmayhaveaneffecton theabilitytodriveorusemachinery. Dont drive or use machines unless yourefeelingwell. FlolancontainsSodium.
Pulmonary arterial hypertension Yourfirsttreatmentwillbegiventoyou inahospital.Thisisbecauseyourdoctor needs to monitor you and find the best doseforyou. YouwillstartwithaninfusionofFlolan. Thedosewillbeincreased,untilyour symptomsarerelieved,andanyside effectsaremanageable.Oncethebest dosehasbeenfound,apermanenttube (line)willbefittedintooneofyour veins.Youcanthenbetreatedusingan infusionpump. Kidney dialysis YouwillbegivenaninfusionofFlolan forthedurationofyourdialysis. Using Flolan at home (only for treatment of Pulmonary Arterial Hypertension) Ifyouaretreatingyourselfathome, your doctor or nurse will show you how toprepareanduseFlolan.Theywill also advise you how to stop treatment ifnecessary.StoppingFlolanmustbe donegradually.Itisveryimportant that you follow all their instructions carefully. Flolancomesasapowderinaglass vial.Beforeuse,thepowderneedsto bedissolvedintheliquidprovided.The liquiddoesnotcontainapreservative. Ifyouhaveanyoftheliquidleftover,it mustbethrownaway. Looking after the injection line Ifyouhavebeenfittedwithalineinto a vein it is very important to keep this areaclean,otherwiseyoucouldget aninfection.Yourdoctorornursewill show you how to clean your line and theareaaroundit.Itisveryimportant that you follow all of their instructions carefully. If you take more Flolan than you should Seek urgent medical attention if you think you have used or been given too muchFlolan.Symptomsofoverdosemay includeheadache,nausea,vomiting, fastheartrate,warmthortingling,or feeling like you might pass out (feeling faint/dizziness). If you forget to take Flolan Donottakeadoubledosetomakeup foraforgottendose. If you stop taking Flolan StoppingFlolanmustbedonegradually. Ifthetreatmentisstoppedtooquickly youmaygetserioussideeffects, includingdizziness,feelingweakand breathingdifficulties.Ifyouhave problems with the infusion pump or injectionlinethatstops,orprevents treatmentwithFlolan,contact your doctor, nurse or hospitalimmediately. Ifyouhaveanyfurtherquestionsonthe useofthismedicine,askyourdoctoror pharmacistornurse.
K
D00055LEA
1 What Flolan is and what it is used for
Flolancontainstheactivesubstance epoprostenol which belongs to a group ofmedicinescalledprostaglandin,which stops blood from clotting and widens thebloodvessels. Flolanisusedtotreatalungcondition calledpulmonaryarterialhypertension. This is where the pressure is high in the bloodvesselsinthelungs.Flolanwidens the blood vessels to lower the blood pressureinthelungs. Flolanisusedtopreventbloodclotting during kidney dialysis when heparin cannotbeused.
FRONT PAGE
TYPE SIZE: 8/9.5 HORIZONTAL SCALE: 100%
2 What you need to know before you take Flolan
Do not take Flolan f you are allergictoFlolanoranyof i the other ingredients of this medicine (listedinsection6). fyouhaveheart failure. i fyoustarttodevelopabuild-up i of fluid in your lungs causing breathlessness after starting this treatment. Ifyouthinkanyoftheseapplytoyou, dont take Flolan until you have checked withyourdoctor. Warnings and precautions BeforeyouaregivenFlolanyourdoctor needs to know: fyouhaveanyproblemswith i bleeding. Skin damage at the injection site Flolanisinjectedintoavein.Itis important that the medicine does not leak out of the vein into the
Page 1 of 2
4 Possible side effects
Likeallmedicines,thismedicine cancausesideeffects,althoughnot everybodygetsthem. Tellyourdoctorornurseimmediately, as these may be signs of infection of the blood or low blood pressure or serious bleeding: oufeelthatyourheartisbeating Y faster,oryouhavechestpainor shortnessofbreath. oufeeldizzyorfeelfaint,especially Y onstanding. ouhavefeversorchills. Y ouhavemorefrequent,orlonger Y periodsofbleeding.
3 How to take Flolan
Alwaystakethismedicineexactlyas yourdoctororpharmacisthastoldyou. Check with your doctor or pharmacist if youarenotsure. Yourdoctorwilldecidehowmuch Flolanisrightforyou.Theamountyou aregivenisbasedonyourbodyweight, andyourtypeofillness.Yourdosemay be increased or decreased depending on howwellyourespondtotreatment. Flolanisgivenbyslowinfusion(drip) intoavein.
Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
epoprostenol
DOSAGE AND ADMINISTRATION INFORMATION ONLY Please refer to the Summary of Product Characteristics for complete prescribing information INFORMATION FOR HEALTHCARE PROFESSIONALS Renal Dialysis There is only one pack available for use in renal dialysis: ne0.5mgpowdervialandonesolventvial O Reconstitution: 1. seonlythesolventprovidedforreconstitution U 2. ithdrawapproximately10mLofthesolventintoasterilesyringe,injectitintothevialcontaining0.5mgfreeze-driedFlolanpowderandshakegently W until the powder has dissolved 3. rawuptheresultingFlolansolutionintothesyringe,re-injectitintotheremainingvolumeofthesolventandmixthoroughly. D Thissolutionisnowreferredtoastheconcentratedsolutionandcontains10,000nanogrampermLFlolan.Onlythisconcentratedsolutionissuitablefor furtherdilutionpriortouse.When0.5mgFlolanpowderisreconstitutedwith50mLofthesolvent,thefinalinjectionhasapHofapproximately10.5and asodiumioncontentofapproximately56mg. Dilution: Theconcentratedsolutionisnormallyfurtherdilutedbeforeuse.Itmaybedilutedwithsodiumchloride0.9%w/vsolution,providedaratioof 6volumesofsodiumchloride0.9%w/vsolutionto1volumeofconcentratedsolutionisnotexceedede.g.50mLofconcentratedsolutionfurther dilutedwithamaximumof300mLsodiumchloride0.9%w/vsolution. OthercommonintravenousfluidsareunsatisfactoryforthedilutionoftheconcentratedsolutionastherequiredpHisnotattained.Flolansolutions arelessstableatlowpH. Todilutetheconcentratedsolution,drawitupintoalargersyringeandthenattachthesterilefilterprovidedtothesyringe. Dispensetheconcentratedsolutiondirectlyintothechoseninfusionsolutionusingfirmbutnotexcessivepressure;thetypicaltimetakenforfiltration of50mLofconcentratedsolutionis70seconds.Mixwell. Thefilterunitmustbeusedonceonlyandthendiscarded. Whenreconstitutedanddilutedasdirectedabove,FlolaninfusionsolutionshaveapHofapproximately10andwillretain90%oftheirinitialpotency forapproximately12hoursat25C. . . . Calculation of infusion rate: The infusion rate may be calculated from the following formula: dosage(nanogram/kg/min)xbodyweight(kg) concentrationofsolution(nanogram/mL) Infusionrate(mL/h)=Infusionrate(mL/min)x60 Foradministrationusingapumpcapableofdeliveringsmallvolumeconstantinfusions,suitablealiquotsofconcentratedsolutionmaybedilutedwith sterilesodiumchloride0.9%w/vsolution. Infusionrate (mL/min) =
The following information is intended for medical or healthcare professionals only:
3
10000000107880 GSK-ITA-Parma-ITPAR United Kingdom-GBR Flolan 1
Talk to your doctor or pharmacist or nurseaboutanyothersideeffects, includingthosenotlistedinthisleaflet. Very common side effects These may affect more than 1 in 10 people: eadache h awpain j ain p eingsick(vomiting) b eelingsick(nausea) f iarrhoea d ednessofyourface(flushing) r Common side effects These may affect up to 1 in 10 people: nfectionoftheblood(septicaemia) i eartbeatingfaster h lowheartbeat s owbloodpressure l leedingatvarioussitesandbruising b moreeasilythannormal,forexample from the nose or gums tomachdiscomfortorpain s hestpain c ointpain j eelinganxious,feelingnervous f ash r ainattheinjectionsite p Common side effects that may show up in blood tests ecreaseinthenumberofblood d platelets (cells that help the blood to clot) Uncommon side effects These may affect up to 1 in 100 people: weating s rymouth d Rare side effects These may affect up to 1 in 1,000 people: nfectionattheinjectionsite i Very rare side effects These may affect up to 1 in 10,000 people: eelingoftightnessaroundthechest f eelingtired,weak f eelingagitated f aleskin p ednessattheinjectionsite r veractivethyroidgland o lockageoftheinjectioncatheter b
Ifyouarenotusingacoldpouch,the solution can be stored in the pump: orupto12hoursat25C,ifithas f justbeenmadeup oramaximumof8hoursifitwas f made previously and has been stored at2-8C. Renal Dialysis OnceFlolanhasbeendissolvedand diluted,anyunusedsolutioncanbe storedat25Candusedwithin12hours.
. . .
6 Contents of the pack and other information
What Flolan contains The active substance is epoprostenol sodium.FlolanInjectioncomesin differentstrengths. Each vial contains either: .5mgepoprostenolsodium 0 .5mgepoprostenolsodium. 1 TheotheringredientsareMannitol, Glycine,SodiumChloride,Sodium HydroxideandWater. What Flolan looks like and contents of the pack Injection: Flolanisasolutionforinjectionmade upofpowderandsolution.Thepowder iswhiteoroff-whiteandthesolutionis clearandcolourless. TherearefourpacksofFlolanavailable for use in the treatment of pulmonary arterialhypertension,thecontentsof each pack include: ne0.5mgpowdervialandoneor O twosolventvialsandafilterunit. ne1.5mgpowdervialandoneor O twosolventvialsandafilterunit. ne0.5mgpowdervial. O ne1.5mgpowdervial. O Notallpacksizesareavailableinall markets. Marketing Authorisation Holder and Manufacturer MarketingAuthorisationHolder: GlaxoSmithKlineUK,StockleyParkWest, Uxbridge,MiddlesexUB111BT Manufacturer:GlaxoSmithKline ManufacturingS.p.A.,SanPolodi Torrile,Parma,Italy Other formats Tolistentoorrequestacopyofthis leafletinBraille,largeprintoraudio pleasecall,freeofcharge:
K
D00055LEA
BACK PAGE
TYPE SIZE: 8/9.5 HORIZONTAL SCALE: 100%
Other side effects Itisnotknownhowmanypeopleare affected: uildupoffluidinthelungs b (pulmonaryoedema) ncreaseinsugar(glucose)intheblood i
08001985000(UKOnly)
Please be ready to give the following information: Product name Referencenumber Flolan 0.5 mg and 1.5 mg injection P L10949/0310and PL10949/0312
5 How to store Flolan
Keepthismedicineoutofthesightand reachofchildren. Donotusethismedicineaftertheexpiry datewhichisstatedonthelabel. Donotstoreabove25C. StoreFlolaninadryplace. Storeintheoriginaloutercarton,to protectfromlight. Donotfreeze. Pulmonary arterial hypertension OnceFlolanpowderhasbeendissolved, anddiluted,itshouldideallybeused immediately.Ifyouarebeinggiven Flolanusinganinfusionpump,acold pouch may be used to maintain the temperatureofthesolution. Whenusingacoldpouch,thesolution can be stored in the pump for up to 24hoursat2-8Cifnecessary.The cold pouch must be regularly changed throughouttheday,tomaintainthe temperatureofthesolution.
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This is a service provided by the Royal NationalInstituteofBlindPeople. This leaflet was last revised in 10/2012. Flolanisaregisteredtrademarkofthe GlaxoSmithKlinegroupofcompanies 2012GlaxoSmithKlinegroupof companies
Pulmonary arterial hypertension Therearefourpacksavailableforuseinthetreatmentofpulmonaryarterialhypertension,asfollows: ne0.5mgpowdervialandoneortwosolventvialsandafilterunit. O ne1.5mgpowdervialandoneortwosolventvialsandafilterunit. O ne0.5mgpowdervial. O ne1.5mgpowdervial. O Notallpacksizesareavailableinallmarkets. Initially,apackcontainingsolventmustbeused.DuringchronictherapywithFlolanthefinalconcentrationofsolutionmaybeincreasedbytheadditionof afurther0.5mgor1.5mgvialoffreeze-driedFlolan. Onlyvialsofthesameamountasthatincludedintheinitialstarterpackmaybeusedtoincreasethefinalconcentrationofsolution. Reconstitution: 1. seonlythesolventprovidedforreconstitution. U 2. ithdrawapproximately10mLofthesolventintoasterilesyringe,injectthecontentsofthesyringeintothevialcontainingFlolanpowderandshake W gentlyuntilthepowderhasdissolved. 3. rawuptheresultingFlolansolutionintothesyringe,re-injectitintotheremainingvolumeofthesolventandmixthoroughly. D Thissolutionisnowreferredtoastheconcentratedsolutionandcontainseither10,000(forthe0.5mgstrength)or30,000nanogrampermLFlolan(forthe 1.5mgstrength).Onlythisconcentratedsolutionissuitableforfurtherdilutionpriortouse.When0.5mgFlolanpowderisreconstitutedwith50mLofthe solvent,thefinalinjectionhasapHofapproximately10.5andasodiumioncontentofapproximately56mg. Dilution: Flolanmaybeusedeitherasconcentratedsolutionorinadilutedformforthetreatmentofpulmonaryarterialhypertension.Onlythesolventprovided maybeusedforthefurtherdilutionofreconstitutedFlolan.Sodiumchloride0.9%w/vsolutionmustnotbeusedwhenFlolanistobeusedforthe treatmentofpulmonaryarterialhypertension. Todilutetheconcentratedsolution,drawitupintoalargersyringeandthenattachthesterilefilterprovidedtothesyringe. Dispensetheconcentratedsolutiondirectlyintothesolventusingfirmbutnotexcessivepressure;thetypicaltimetakenforfiltrationof50mLof concentratedsolutionis70seconds.Mixwell. Thefiltermustbeusedonceonlyandthendiscarded. Concentrations commonly used in the treatment of pulmonary arterial hypertension are as follows: ,000nanogram/mLOnevialcontaining0.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 5 0,000nanogram/mLTwovialscontaining0.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 1 5,000nanogram/mLOnevialcontaining1.5mgFlolanreconstitutedanddilutedtoatotalvolumeof100mLinsolvent. 1 Calculation of infusion rate: The infusion rate may be calculated from the following formula: dosage(nanogram/kg/min)xbodyweight(kg) Infusionrate = (mL/min) concentrationofsolution(nanogram/mL) Infusionrate(mL/h)=Infusionrate(mL/min)x60 Higherinfusionrates,andtherefore,moreconcentratedsolutionsmaybenecessarywithlong-termadministrationofFlolan. Special precautions for storage Dontstoreabove25C. Keepcontainerintheoutercartontoprotectfromlight. Keepdry. Donotfreeze. Anycoldpouchusedmustbecapableofmaintainingthetemperatureofthereconstitutedsolution. Storebetween2and8Cforthefulladministrationperiod. Reconstitutionanddilutionshouldbecarriedoutimmediatelypriortouse. Thesolventcontainsnopreservative;consequentlyavialshouldbeusedonceonlyandthendiscarded. Thisleafletwaslastrevisedin10/2012. . FlolanisaregisteredtrademarkoftheGlaxoSmithKlinegroupofcompanies . . 2012GlaxoSmithKlinegroupofcompanies
10000000107880
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
