FINOCAR

Main information

  • Trade name:
  • FINOCAR Film Coated Tablet 5 Milligram
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FINOCAR Film Coated Tablet 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0585/027/001
  • Authorization date:
  • 26-10-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Finocar5mgFilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains5mgfinasteride.

Excipient(s):Eachfilm-coatedtabletcontains79mglactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Coatedlightbluesphericalbiconvextabletswith7mmdiameter.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Finasterideisindicatedforthetreatmentandcontrolofbenignprostatichyperplasia(BPH)inpatientswithanenlarged

prostate(prostatevolumeaboveca.40ml)to:

-causeregressionoftheenlargedprostate,improveurinaryflowandimprovethesymptomsassociatedwithBPH

reducetheincidenceofacuteurinaryretentionandtheneedforsurgeryincludingtransurethralresectionofthe

prostate(TURP)andprostatectomy.

4.2Posologyandmethodofadministration

Oraluse.

Therecommendeddoseisone5mgtabletdaily(withorwithoutfood).Thetabletshouldbeswallowedwholeand

mustnotbedividedorcrushed(seesection6.6).

Evenifimprovementcanbeseenwithinashorttime,treatmentforatleast6monthsmaybenecessaryinorderto

assesswhetherabeneficialresponsehasbeenachieved.Thereafter,treatmentshouldbecontinuedlongterm.Therisk

ofacuteurinaryretentionisreducedwithinfourmonthsoftreatment.

Useinhepaticinsufficiency

Therearenodataavailableinpatientswithhepaticinsufficiency(seesection4.4).

Useinrenalinsufficiency

Dosageadjustmentsarenotnecessaryinpatientswithvaryingdegreesofrenalinsufficiency(withcreatinineclearance

aslowas9ml/min)asinpharmacokineticstudiesrenalinsufficiencywasnotfoundtoaffecttheeliminationof

finasteride.Finasteridehasnotbeenstudiedinpatientsonhaemodialysis.

Useintheelderly

Dosageadjustmentsarenotnecessaryalthoughpharmacokineticstudieshaveshownthattheeliminationrateof

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4.3Contraindications

Finocarisnotindicatedinwomenorchildren.

Finocariscontraindicatedinthefollowingsituations:

Hypersensitivitytofinasterideortoanyoftheexcipients.

Pregnancy-Useinwomenwhentheyareormaypotentiallybepregnant(seesection4.6Fertility,pregnancyand

lactation,"Exposuretofinasteride-risktomalefetus").

4.4Specialwarningsandprecautionsforuse

General

Toavoidobstructivecomplicationsitisimportantthatpatientswithlargeresidualurineand/orheavilydecreased

urinaryflowarecarefullycontrolled.Thepossibilityofsurgeryshouldbeanoption.

Patientswithlargeresidualurinevolumeand/orseverelydiminishedurinaryflowshouldbecarefullymonitoredfor

obstructiveuropathy.

Consultationwithanurologistshouldbeconsideredinpatientstreatedwithfinasteride.

Obstructionduetotrilobulargrowthpatternoftheprostateshouldbeexcludedbeforestartingtreatmentwith

finasteride.

Thereisnoexperienceinpatientswithhepaticinsufficiency.Cautionisadvisedinpatientswithimpairedhepatic

functionastheplasmalevelsoffinasteridemaybeincreasedinsuchpatients(seesection4.2).

Effectontheprostate-specificantigen(PSA)andprostatecancerdetection

Noclinicalbenefithasyetbeendemonstratedinpatientswithprostatecancertreatedwithfinasteride.

PatientswithBPHandelevatedserumprostatespecificantigen(PSA)weremonitoredincontrolledclinicalstudies

withserialPSAsandprostatebiopsies.IntheseBPHstudies,finsteridedidnotappeartoaltertherateofprostate

cancerdetection,andtheoverallincidenceofprostatecancerwasnotsignificantlydifferentinpatientstreatedwith

finasterideorplacebo.

Digitalrectalexaminationaswellasotherevaluationsforprostatecancerarerecommendedpriortoinitiatingtherapy

withfinasterideandperiodicallythereafter.SerumPSAisalsousedforprostatecancerdetection.Generallyabaseline

PSA>10ng/mL(Hybritech)promptsfurtherevaluationandconsiderationofbiopsy;forPSAlevelsbetween4and10

ng/mL,furtherevaluationisadvisable.ThereisconsiderableoverlapinPSAlevelsamongmenwithandwithout

prostatecancer.Therefore,inmenwithBPH,PSAvalueswithinthenormalreferencerangedonotruleoutprostate

cancerregardlessoftreatmentwithfinasteride.AbaselinePSA<4ng/mLdoesnotexcludeprostatecancer.

FinasteridecausesadecreaseinserumPSAconcentrationsbyapproximately50%inpatientswithBPHeveninthe

presenceofprostatecancer.ThisdecreaseinserumPSAlevelsinpatientswithBPHtreatedwithfinasterideshouldbe

consideredwhenevaluatingPSAdataanddoesnotruleoutconcomitantprostatecancer.Thisdecreaseispredictable

overtheentirerangeofPSAvalues,althoughitmayvaryinindividualpatients.AnalysisofPSAdatafromover3000

patientsinthe4-year,double-blind,placebo-controlledfinasterideLong-TermEfficacyandSafetyStudy(PLESS)

confirmedthatintypicalpatientstreatedwithfinasterideforsixmonthsormore,PSAvaluesshouldbedoubledfor

comparisonwithnormalrangesinuntreatedmen.ThisadjustmentpreservesthesensitivityandspecificityofthePSA

assayandmaintainsitsabilitytodetectprostatecancer.

AnysustainedincreaseinPSAlevelsofpatientstreatedwithfinasterideshouldbecarefullyevaluated,including

considerationofnon-compliancetofinasteridetherapy.

PercentfreePSA(freetototalPSAratio)isnotsignificantlydecreasedbyfinasteride.TheratiooffreetototalPSA

remainsconstantevenundertheinfluenceoffinasteride.WhenpercentfreePSAisusedasanaidinthedetectionof

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Drug/laboratorytestinteractions

EffectonlevelsofPSA

SerumPSAconcentrationiscorrelatedwithpatientageandprostaticvolume,andprostaticvolumeiscorrelatedwith

patientage.WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSA

levelsdecreaseinpatientstreatedwithfinasteride.Inmostpatients,arapiddecreaseinPSAisseenwithinthefirst

monthsoftherapy,afterwhichtimePSAlevelsstabilizetoanewbaseline.Thepost-treatmentbaselineapproximates

halfofthepre-treatmentvalue.Therefore,intypicalpatientstreatedwithfinasterideforsixmonthsormore,PSA

valuesshouldbedoubledforcomparisontonormalrangesinuntreatedmen.Forclinicalinterpretation,see4.4"Special

warningsandprecautionsforuse","Effectsonprostate-specificantigen(PSA)andprostatecancerdetection".

Breastcancerinmen

Breastcancerhasbeenreportedinmentakingfinasteride5mgduringclinicaltrialsandthepost-marketingperiod.

Physiciansshouldinstructtheirpatientstopromptlyreportanychangesintheirbreasttissuesuchaslumps,pain,

gynaecomastiaornippledischarge.

Pediatricuse

Finocarisnotindicatedforuseinchildren.

Safetyandeffectivenessinchildrenhavenotbeenestablished.

Lactose

Thetabletcontainslactosemonohydrate.Patientswithanyofthefollowinggeneticdeficienciesshouldnottakethis

drug:galactoseintolerance,totallactasedeficiencyorglucose-galactosemalabsorption.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nodruginteractionsofclinicalimportancehavebeenidentified.Finasterideismetabolizedprimarilyvia,butdoesnot

appeartoaffectsignificantlythecytochromeP450enzymesystem.Althoughtheriskforfinasteridetoaffectthe

pharmacokineticsofotherdrugsisestimatedtobesmall,itisprobablethatinhibitorsandinducersofcytochromeP450

3A4willaffecttheplasmaconcentrationoffinasteride.However,basedonestablishedsafetymargins,anyincrease

duetoconcomitantuseofsuchinhibitorsisunlikelytobeofclinicalsignificance.Finasteridedoesnotappeartoaffect

significantlythecytochromeP450-linkeddrugmetabolizingenzymesystem.Compoundswhichhavebeentestedin

manhaveincludedpropranolol,digoxin,glyburide,warfarin,theophylline,andantipyrineandnoclinicallymeaningful

interactionswerefound.

4.6Fertility,pregnancyandlactation

Pregnancy

Finasterideiscontraindicatedforuseinwomenwhentheyareormaypotentiallybepregnant(See4.3

"Contraindications").

BecauseoftheabilityoftypeII5-reductaseinhibitorstoinhibitconversionoftestosteronetodihydrotestosterone,

thesedrugs,includingfinasteride,maycauseabnormalitiesoftheexternalgenitaliaofamalefetuswhenadministered

toapregnantwoman.

Exposuretofinasteride–risktomalefetus

Womenshouldnothandlecrushedorbrokentabletsoffinasteridewhentheyareormaypotentiallybepregnant

becauseofthepossibilityofabsorptionoffinasterideandthesubsequentpotentialrisktoamalefetus(see4.6

"Pregnancyandlactation","Pregnancy").Finasteridetabletsarecoatedandwillpreventcontactwiththeactive

ingredientduringnormalhandling,providedthatthetabletshavenotbeenbrokenorcrushed.

Smallamountsoffinasteridehavebeenrecoveredfromthesemeninsubjectsreceivingfinasteride5mg/day(see

sections5.2and5.3).Itisnotknownwhetheramalefetusmaybeadverselyaffectedifhismotherisexposedtothe

semenofapatientbeingtreatedwithfinasteride.Whenthepatient’ssexualpartnerisormaypotentiallybepregnant,

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Lactation

Finocarisnotindicatedforuseinwomen.Itisnotknownwhetherfinasterideisexcretedintohumanbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Finocarhasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Themostfrequentadversereactionsareimpotenceandreducedlibido.Theseadversereactionsoccurearlyinthe

courseoftherapyandresolvewithcontinuedtreatmentinthemajorityofpatients.

Theadversereactionsreportedduringclinicaltrialsand/orpost-marketingusearelistedinthetablebelow.

Frequencyofadversereactionsisdeterminedasfollows:

Verycommon(1/10),Common(1/100to<1/10)>,Uncommon(1/1,000to<1/100),Rare(1/10,000to<1/1,000),

Veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Thefrequencyofadversereactionsreportedduringpost-marketingusecannotbedeterminedastheyarederivedfrom

spontaneousreports.

Inaddition,thefollowinghasbeenreportedinclinicaltrialsandpost-marketinguse:malebreastcancer(see4.4

"Specialwarningsandprecautionsforuse").

Medicaltherapyofprostaticsymptoms(MTOPS)

TheMTOPSstudycomparedfinasteride5mg/day(n=768),doxazosin4or8mg/day(n=756),combinationtherapyof

finasteride5mg/dayanddoxazosin4or8mg/day(n=786),andplacebo(n=737).Inthisstudy,thesafetyand

tolerabilityprofileofthecombinationtherapywasgenerallyconsistentwiththeprofilesoftheindividualcomponents.

Theincidenceofejaculationdisorderinpatientsreceivingcombinationtherapywascomparabletothesumof

SystemOrganClass Frequency:adversereaction

Investigations Common:decreasedvolumeofejaculate

Cardiacdisorders Unknown:palpitation

Skinandsubcutaneoustissuedisorders Uncommon:rash

Unknown:pruritus,urticaria

Immunesystemdisorders Unknown:hypersensitivityreactionsincludingswellingofthelipsandface

Hepatobiliarydisorders Unknown:increasedhepaticenzymes

Reproductivesystemandbreastdisorders Common:impotence

Uncommon:ejaculationdisorder,breasttenderness,breastenlargement

Unknown:testicularpain

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OtherLong-TermData

Ina7-yearplacebo-controlledtrialthatenrolled18,882healthymen,ofwhom9060hadprostateneedlebiopsydata

availableforanalysis,prostatecancerwasdetectedin803(18.4%)menreceivingfinasterideand1147(24.4%)men

receivingplacebo.Inthefinasteridegroup,280(6.4%)menhadprostatecancerwithGleasonscoresof7-10detected

onneedlebiopsyvs.237(5.1%)menintheplacebogroup.Additionalanalysessuggestthattheincreaseinthe

prevalenceofhigh-gradeprostatecancerobservedinthefinasteridegroupmaybeexplainedbyadetectionbiasdueto

theeffectoffinasterideonprostatevolume.Ofthetotalcasesofprostatecancerdiagnosedinthisstudy,approximately

98%wereclassifiedasintracapsular(clinicalstageT1orT2)atdiagnosis.TheclinicalsignificanceoftheGleason7-10

dataisunknown.

LaboratoryTestFindings

WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSAlevelsare

decreasedinpatientstreatedwithfinasteride(seesection4.4"Specialwarningsandprecautionsforuse").

4.9Overdose

Singledosesoffinasterideupto400mgandmultipledosesofupto80mgdailyfor3monthsdidnotproduceanydose

relatedundesirableeffects.

Nospecifictreatmentinconnectionwithoverdosingoffinasteridecanberecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Testosterone,5reductaseinhibitor,ATCcode:G04CB01

Finasterideisacompetitiveinhibitorofhuman5reductasetypeIIwithwhichitgraduallyformsastableenzyme

complex.Theconversionofthiscomplexisveryslow(t

=30days).Invitroandinvivoithasbeenfoundthat

finasterideisaspecifictypeII5reductaseinhibitor.Theenzymeconvertstestosteroneintothemorepotentandrogen

dihydrotestosterone(DHT).Theprostateglandand,consequently,alsothehyperplasicprostatetissuearedependenton

theconversionoftestosteronetoDHTfortheirnormalfunctionandgrowth.Finasteridehasnoaffinityforthe

androgenreceptor

ClinicalstudiesshowarapidreductionoftheserumDHTlevelsof70%,whichleadstoareductionofprostate

volume.After3months,areductionofapprox.20%inthevolumeoftheglandoccurs,andtheshrinkingcontinues

andreachesapprox.27%after3years.Markedreductiontakesplaceintheperiurethralzoneimmediatelysurrounding

theurethra.Urodynamicmeasurementshavealsoconfirmedasignificantreductionofdetrusorpressureasaresultof

thereducedobstruction.

Significantimprovementsinmaximumurinaryflowrateandsymptomshavebeenobtainedafteracoupleofweeks,

comparedwiththestartoftreatment.Differencesfromplacebohavebeendocumentedat4and7months,respectively.

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Effectsoffouryearstreatmentwithfinasterideonincidenceofacuteurineretention,needforsurgery,symptomscore

andprostatevolume:

InclinicalstudiesofpatientswithmoderatetoseveresymptomsofBPH,anenlargedprostateondigitalrectal

examinationandlowresidualurinaryvolumes,finasteridereducedtheincidenceofacuteretentionofurinefrom7/100

to3/100overfouryearsandtheneedforsurgery(TURPorprostatectomy)from10/100to5/100.Thesereductions

wereassociatedwitha2pointimprovementinQUASI-AUAsymptomscore(range0-34),asustainedregressionin

prostatevolumeofapproximately20%andasustainedincreaseinurinaryflowrate.

Medicaltherapyofprostaticsymptoms

TheMedicalTherapyofProstaticSymptoms(MTOPS)Trialwasa4-to6-yearstudyin3047menwithsymptomatic

BPHwhowererandomisedtoreceivefinasteride5mg/day,doxazosin4or8mg/day*,thecombinationoffinasteride5

mg/dayanddoxazosin4or8mg/day*,orplacebo.TheprimaryendpointwastimetoclinicalprogressionofBPH,

definedasa4pointconfirmedincreasefrombaselineinsymptomscore,acuteurinaryretention,BPH-relatedrenal

insufficiency,recurrenturinarytractinfectionsorurosepsis,orincontinence.Comparedtoplacebo,treatmentwith

finasteride,doxazosin,orcombinationtherapyresultedinasignificantreductionintheriskofclinicalprogressionof

BPHby34(p=0.002),39(p<0.001),and67%(p<0.001),respectively.Themajorityoftheevents(274outof351)that

constitutedBPHprogressionwereconfirmed 4pointincreasesinsymptomscore;theriskofsymptomscore

progressionwasreducedby30(95%CI6to48%),46(95%CI25to60%),and64%(95%CI48to75%)inthe

finasteride,doxazosin,andcombinationgroups,respectively,comparedtoplacebo.Acuteurinaryretentionaccounted

for41ofthe351eventsofBPHprogression;theriskofdevelopingacuteurinaryretentionwasreducedby67

(p=0.011),31(p=0.296),and79%(p=0.001)inthefinasteride,doxazosin,andcombinationgroups,respectively,

comparedtoplacebo.Onlythefinasterideandcombinationtherapygroupsweresignificantlydifferentfromplacebo

*Titratedfrom1mgto4or8mgastoleratedovera3-weekperiod.

5.2Pharmacokineticproperties

Absorption

Thebioavailabilityoffinasterideisapprox.80%.Peakplasmaconcentrationsarereachedapprox.2hoursafterintake,

andabsorptioniscompleteafter6-8hours.

Distribution

Bindingtoplasmaproteinsisapprox.93%.

Clearanceandvolumeofdistributionareapprox.165ml/min(70-279ml/min)and76l(44-96l),respectively.

Accumulationofsmallamountsoffinasterideisseenonrepeatedadministration.Afteradailydoseof5mgthelowest

steady-stateconcentrationoffinasteridehasbeencalculatedtobe8-10ng/ml,whichremainsstableovertime.

Biotransformation

Finasterideismetabolisedintheliver.FinasteridedoesnotsignificantlyaffectcytochromeP450enzymesystem.Two

metaboliteswithlow5a-reductase-inhibitingeffectshavebeenidentified.

Elimination

Theplasmahalflifeisameanof6hours(4-12hours)(inmen>70years:8hours,range6–15hours).

Followingadministrationofradioactivelylabelledfinasteride,approx.39%(32–46%)ofthedosewasexcretedinthe

urineintheformofmetabolites.Virtuallynounchangedfinasteridewasrecoveredintheurine.Approx.57%(51–

64%)ofthetotaldosewasexcretedinthefaeces.

Intheelderly,theeliminationrateoffinasterideissomewhatdecreased.Half-lifeisprolongedfromameanhalf-lifeof

approximately6hoursinmenaged18-60yearsto8hoursinmenagedmorethan70years.Thisisofnoclinical

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Inpatientswithrenalimpairment(creatinineclearanceabove9ml/min),nochangesintheeliminationoffinasteride

havebeenseen(seesection4.2).Proteinbindingalsodidnotdifferinpatientswithrenalimpairment.Aportionofthe

metaboliteswhichisnormallyexcretedrenallywasexcretedinthefaeces.Itthereforeappearsthatfaecalexcretion

increasescommensuratetothedecreaseinurinaryexcretionofmetabolites.Dosageadjustmentinnon-dialysedpatients

withrenalimpairmentisnotnecessary.

Therearenodataavailableinpatientswithhepaticinsufficiency.

Finasteridehasbeenfoundtocrosstheblood-brainbarrier.Smallamountsoffinasteridehavebeenrecoveredinthe

seminalfluidoftreatedpatients.

5.3Preclinicalsafetydata

Currentstudiesrelatingtogeneraltoxicity,genotoxicityandcarcinogenicitydidnotdemonstrateanyspecialrisksto

humans.

Reproductiontoxicologystudiesonmaleratshavenotrevealeddecreasedprostaticandseminalvesicularweights,

reducedsecretionfromaccessorysexglandsandareductionoffertilityindex(causedbythepharmacologicaleffectsof

finasteride).Theclinicalrelevanceofthesefindingsisunknown.

Aswithother5-alpha-reductaseinhibitors,feminisationofmaleratfoetuseshasbeenobservedwithadministrationof

finasterideduringpregnancy.Whenfinasteridewasadministeredtoprimatesduringpregnancy,noevidenceof

feminisationofmalefoetuseswasobservedwithexposureinbloodwellinexcessofexpectedlevelsviahuman

seminalfluid.Itisunlikelythatmalefoetuseswillbenegativelyaffectedbytransferenceoffinasterideviaseminal

fluid.

Inanimaldevelopmentalstudies,dose-dependenthypospadiaswereobservedinthemaleoffspringofpregnantrats

givenfinasterideatdosesrangingfrom100µg/kg/dayto100mg/kg/day,atanincidenceof3.6%to100%.

Additionally,pregnantratsproducedmaleoffspringwithdecreasedprostaticandseminalvesicularweights,delayed

preputialseparation,transientnippledevelopmentanddecreasedanogenitaldistance,whengivenfinasterideatdoses

belowtherecommendedhumandose.Thecriticalperiodduringwhichtheseeffectscanbeinducedhasbeendefinedin

ratsasdays16-17ofgestation.

ThechangesdescribedaboveareexpectedpharmacologicaleffectsofTypeII5alpha-reductaseinhibitors.

Manyofthechanges,suchashypospadias,observedinmaleratsexposedinuterotofinasteridearesimilartothose

reportedinmaleinfantswithageneticdeficiencyofTypeII5alpha-reductase.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore

Lactosemonohydrate

Cellulosemicrocrystalline

Maizestarch,pre-gelatinised

Docusatesodium

Sodiumstarchglycolate(typeA)

Silica,colloidalanhydrous

Sodiumstearylfumarate

Film-coating

ALBUMOPADRYII31F58914white(hypromellose,lactosemonohydrate,titaniumdioxide(E171),

macrogol4000,sodiumcitratedihydrate(E331))

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6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

TransparentPVC/PVDC/Alblister

Sizeofbox:10,15,28,30,50,100tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Pregnantwomenorwomenwhocouldpotentiallybepregnantmaynottouchthecrushedorbrokentabletsofthe

preparationFinocar(cf.Item4.3Contraindicationsand4.6Fertility,pregnancyandlactation).

7MARKETINGAUTHORISATIONHOLDER

PLIVAPharmaLimited

VisionHouse

BedfordRoad

Petersfield

Hampshire

GU323QB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA585/27/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26thOctober2007

Dateoflastrenewal:18thFebruary2011

10DATEOFREVISIONOFTHETEXT

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