FINASTERIDE PFIZER 5 MG FILM-COATED TABLETS

Main information

  • Trade name:
  • FINASTERIDE PFIZER 5 MG FILM-COATED TABLETS
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FINASTERIDE PFIZER 5 MG FILM-COATED TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0822/033/001
  • Authorization date:
  • 05-08-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FinasteridePfizer5mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onefilm-coatedtabletcontains5mgfinasteride.

Excipient:lactosemonohydrate(97.5mg).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Bluecoloured,circular,biconvex,bevelededgedfilm-coatedtabletsdebossedwith‘E’ononesideand‘61’onthe

otherside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FinasteridePfizer5mgisindicatedforthetreatmentandcontrolofbenignprostatichyperplasia(BPH)to:

-causeregressionoftheenlargedprostate,improveurinaryflowandimprovethesymptomsassociatedwithBPH,

-reducetheincidenceofacuteurinaryretentionandreduceneedforsurgeryincludingtransurethralresectionofthe

prostate(TURP)andprostatectomy.

FinasteridePfizershouldbeadministeredinpatientswithanenlargedprostate(prostatevolumeaboveca.40ml).

4.2Posologyandmethodofadministration

FinasteridePfizerisfororaluseonly.

Dosageinadults

Therecommendeddosageisone5mgtabletdailywithorwithoutfood.Thetabletshouldbeswallowedwholeand

mustnotbedividedorcrushed(seesection6.6).

Eventhoughimprovementcanbeseenwithinashorttime,treatmentforatleast6monthsmaybenecessaryinorderto

determineobjectivelywhetherasatisfactoryresponsetotreatmenthasbeenachieved.

Dosageintheelderly

Dosageadjustmentsarenotnecessaryalthoughpharmacokineticstudieshaveshownthattheeliminationrateof

finasterideisslightlydecreasedinpatientsovertheageof70.

Dosageinhepaticinsufficiency

Thereisnodataavailableinpatientswithhepaticinsufficiency(seesection4.4).

Dosageinrenalinsufficiency

Dosageadjustmentsarenotnecessaryinpatientswithvaryingdegreesofrenalinsufficiency(startingfromcreatinine

clearanceaslowas9ml/min)asinpharmacokineticstudiesrenalinsufficiencywasnotfoundtoaffecttheelimination

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4.3Contraindications

FinasteridePfizerisnotindicatedforuseinwomenorchildren.

FinasteridePfizeriscontraindicatedinthefollowing:

Hypersensitivitytoanycomponentofthisproduct.

Pregnancy–Useinwomenwhentheyareormaypotentiallybepregnant(see4.6Pregnancyand

lactation,Exposuretofinasteride–risktomalefetus).

4.4Specialwarningsandprecautionsforuse

General:

Toavoidobstructivecomplicationsitisimportantthatpatientswithlargeresidualurineand/orheavilydecreased

urinaryflowarecarefullycontrolled.Thepossibilityofsurgeryshouldbeanoption.

Effectsonprostate-specificantigen(PSA)andprostatecancerdetection:

Noclinicalbenefithasyetbeendemonstratedinpatientswithprostatecancertreatedwithfinasteride.Patientswith

BPHandelevatedserumprostatespecificantigen(PSA)weremonitoredincontrolledclinicalstudieswithserialPSAs

andprostatebiopsies.IntheseBPHstudies,finasteridedidnotappeartoaltertherateofprostatecancerdetection,and

theoverallincidenceofprostatecancerwasnotstatisticallydifferentinpatientstreatedwithfinasterideorplacebo.

Digitalrectalexaminationsaswellasotherevaluationsforprostatecancerarerecommendedpriortoinitiatingtherapy

withfinasterideandperiodicallythereafter.SerumPSAisalsousedforprostatecancerdetection.Generallyabaseline

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

ng/ml,furtherevaluationisadvisable.ThereisconsiderableoverlapinPSAlevelsamongmenwithandwithout

prostatecancer.Therefore,inmenwithBPH,PSAvalueswithinthenormalreferencerangedonotruleoutprostate

cancer,regardlessoftreatmentwithfinasteride.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

prostatecancer,noadjustmenttoitsvalueisnecessary.

Drug/laboratorytestinteractions

EffectonlevelsofPSA

SerumPSAconcentrationiscorrelatedwithpatientageandprostaticvolume,andprostaticvolumeiscorrelatedwith

patientage.WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSA

levelsdecreaseinpatientstreatedwithfinasteride.Inmostpatients,arapiddecreaseinPSAisseenwithinthefirst

monthsoftherapy,afterwhichtimePSAlevelsstabilizetoanewbaseline.Thepost-treatmentbaselineapproximates

halfofthepre-treatmentvalue.Therefore,intypicalpatientstreatedwithfinasterideforsixmonthsormore,PSA

valuesshouldbedoubledforcomparisontonormalrangesinuntreatedmen.Forclinicalinterpretation,see4.4Special

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Breastcancerinmen

Breastcancerhasbeenreportedinmentakingfinasteride5mgduringclinicaltrialsandinthepost-marketingperiod.

Physiciansshouldinstructtheirpatientstopromptlyreportanychangesintheirbreasttissuesuchaslumps,pain,

gynaecomastiaornippledischarge.

Pediatricuse

FinasteridePfizerisnotindicatedforuseinchildren.

Safetyandeffectivenessinchildrenhavenotbeenestablished.

Lactose

Thetabletcontainslactosemonohydrate.Patientswithanyofthefollowinggeneticdeficienciesshouldnottakethis

drug:galactoseintolerance,totallactasedeficiencyorglucose-galactosemalabsorption.

Hepaticinsufficiency

Theeffectofhepaticinsufficiencyonthepharmacokineticsoffinasteridehasnotbeenstudied.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nodruginteractionsofclinicalimportancehavebeenidentified.Finasterideismetabolizedprimarilyvia,butdoesnot

appeartoaffectsignificantlythecytochromeP4503A4system.Althoughtheriskforfinasteridetoaffectthe

pharmacokineticsofotherdrugsisestimatedtobesmall,itisprobablethatinhibitorsandinducersofcytochromeP450

3A4willaffecttheplasmaconcentrationoffinasteride.However,basedonestablishedsafetymargins,anyincrease

duetoconcomitantuseofsuchinhibitorsisunlikelytobeofclinicalsignificance.Finasteridedoesnotappeartoaffect

significantlythecytochromeP450-linkeddrugmetabolizingenzymesystem.Compoundswhichhavebeentestedin

manhaveincludedpropanolol,digoxin,glyburide,warfarin,theophyllineandantipyrineandnomeaningful

interactionswerefound.

4.6Fertility,pregnancyandlactation

Pregnancy

FinasteridePfizeriscontraindicatedforuseinwomenwhentheyareormaypotentiallybepregnant(seesection4.3).

BecauseoftheabilityofthetypeII5-reductase-inhibitorstoinhibitconversionoftestosteronetodihydrotestosterone,

thesedrugs,includingfinasteride,maycauseabnormalitiesoftheexternalgenitaliaofamalefetuswhenadministered

toapregnantwoman(seesection5.3).

Exposuretofinasteride-risktomalefetus.

Womenshouldnothandlecrushedorbrokentabletsoffinasteridewhentheyareormaypotentiallybepregnant

becauseofthepossibilityofabsorptionoffinasterideandthesubsequentpotentialrisktoamalefetus(seesection6.6).

Finasteridetabletsarecoatedandwillpreventcontactwiththeactiveingredientduringnormalhandlingprovidedthat

thetabletshavenotbeenbrokenorcrushed.

Smallamountsoffinasteridehavebeenrecoveredfromthesemeninsubjectsreceivingfinasteride5mg/day.Itisnot

knownwhetheramalefetusmaybeadverselyaffectedifhismotherisexposedtothesemenofapatientbeingtreated

withfinasteride.Whenthepatient’ssexualpartnerisormaypotentiallybepregnant,thepatientisrecommendedto

minimiseexposureofhispartnertosemen.

Lactation:

FinasteridePfizerisnotindicatedforuseinwomen.

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4.7Effectsonabilitytodriveandusemachines

Therearenoknowndatatosuggestthatfinasterideaffectstheabilitytodriveorusemachines.

4.8Undesirableeffects

Themostfrequentadversereactionsareimpotenceanddecreasedlibido.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.

Inadditionthefollowinghasbeenreportedinclinicaltrialsandpost-marketinguse:malebreastcancer(seesection

4.4).

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

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

tolerabilityprofileofthecombinationtherapywasgenerallyconsistentwiththeprofilesoftheindividualcomponents.

Theincidenceofejaculationdisorderinpatientsreceivingcombinationtherapywascomparabletothesumof

incidencesofthisadverseexperienceforthetwomonotherapies.

Otherlong-termdata

Ina7yearplacebo-controlledtrialthatenrolled18,882healthymen,of9060hadprostateneedlebiopsydataavailable

foranalysis,prostatecancerwasdetectedin803(18.4%)menreceivingfinasterideand1147(24.4%)menreceiving

placebo.Inthefinasteridegroup,280(6.4%)menhadprostatecancerwithGleasonscoresof7-10detectedonneedle

biopsyvs237(5.1%)menintheplacebogroup.Additionalanalysessuggestthattheincreaseintheprevalenceofhigh-

gradeprostatecancerobservedinthefinasteridegroupmaybeexplainedbyadetectionbiasduetotheeffectof

finasterideonprostatevolume.Ofthetotalcasesofprostatecancerdiagnosedinthisstudy,approximately98%were

classifiedasintracapsular(clinicalstageT1orT2)atdiagnosis.TheclinicalsignificanceoftheGleason7-10datais

unknown.

Laboratorytestfindings

WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSAlevelsare

SystemOrganClass Frequency:adversereactions

Investigations Common:decreasedvolumeofejaculate

Cardiacdisorders Unknown:palpitation

Skinandsubcutaneoustissuedisorders Uncommon:rash

Unknown:pruritus,urticaria

Immunesystemdisorders Unknown:hypersensitivityreactionsincluding

swellingofthelipsandface

Hepatobiliarydisorders Unknown:increasedhepaticenzymes

Reproductivesystemandbreast

disorders Common:impotence

Uncommon:ejaculationdisorder,breast

tenderness,breastenlargement

Unknown:testicularpain

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4.9Overdose

Patientshavereceivedsingledosesoffinasterideupto400mgandmultipledosesupto80mg/daywithoutadverse

effects.Thereisnospecificrecommendedtreatmentofoverdoseoffinasteride.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Testosteron5-reductaseinhibitors

ATCcode:G04CB01

Finasterideisasynthetic4-azasteroid,aspecificcompetitiveinhibitoroftheintracellularenzymeType-II-5a-reductase.

Theenzymeconvertstestosteroneintothemorepotentandrogendihydrotestosterone(DHT).Theprostateglandand,

consequently,alsothehyperplasicprostatetissuearedependentontheconversionoftestosteronetoDHTfortheir

normalfunctionandgrowth.Finasteridehasnoaffinityfortheandrogenreceptor.

ClinicalstudiesshowarapidreductionoftheserumDHTlevelsof70%,whichleadstoareductiononprostate

volume.After3months,areductionofapprox.20%inthevolumeoftheglandoccurs,andtheshrinkingcontinuesand

reachesapproximately27%after3years.Markedreductiontakesplaceintheperiurethralzoneimmediately

surroundingtheurethra.Urodynamicmeasurementshavealsoconfirmedasignificantreductionofdetrusorpressureas

aresultofthereducedobstruction.

Significantimprovementsinmaximumurinaryflowrateandsymptomshavebeenobtainedafterafewweeks,

comparedwiththestartoftreatment.Differencesfromplacebohavebeendocumentedat4and7months,respectively.

Allefficacyparametershavebeenmaintainedovera3-yearfollow-upperiod.

Effectsoffouryearstreatmentwithfinasterideonincidenceofacuteurineretentionneedforsurgery,symptom-score

andprostatevolume:

InclinicalstudiesofpatientswithmoderatetoseveresymptomsofBPH,anenlargedprostateondigitalrectal

examinationandlowresidualurinaryvolumes,finasteridereducedtheincidenceofacuteretentionofurinefrom7/100

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

wereassociatedwitha2-pointimprovementinQUASI-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

constitutedBPHprogressionwereconfirmed4pointincreasesinsymptomscore;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.

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Inthisstudythesafetyandtolerabilityprofileofcombinedtreatmentwasbroadlysimilartotheprofileofeachofthe

drugstakenseparately.However,undesirableeffectsconcerningthe"nervoussystem"and"uro-genitalsystem"organ

classeswereobservedmorefrequentlywhenthetwodrugswereusedincombination(seesection4.8).

5.2Pharmacokineticproperties

Absorption:

Thebioavailabilityoffinasterideisapprox.80%.Peakplasmaconcentrationsarereachedapprox.2hoursafterdrug

intake,andabsorptioniscompleteafter6-8hours.

Distribution:

Bindingtoplasmaproteinsisapprox.93%.Clearanceandvolumeofdistributionareapprox.165ml/min(70-279

ml/min)and76l(44-96l),respectively.Accumulationofsmallamountsoffinasterideisseenonrepeated

administration.Afteradailydoseof5mgtheloweststeady-stateconcentrationoffinasteridehasbeencalculatedtobe

8-10ng/ml,whichremainsstableovertime.

Biotransformation:

Finasterideismetabolisedintheliver.FinasteridedoesnotsignificantlyaffectthecytochromeP450enzymesystem.

Twometaboliteswithlow5a-reductase-inhibitingeffectshavebeenidentified.

Elimination:

Theplasmahalf-lifeaverages6hours(4-12hours)(inmen>70yearsofage,8hours,range6-15hours).

Afteradministrationofradioactivelylabelledfinasteride,approx.39%(32-46%)ofthegivendoseisexcretedinthe

urineintheformofmetabolites.Virtuallynounchangedfinasterideisrecoveredintheurine.Approximately57%(51-

64%)ofthetotaldoseisexcretedinthefaeces.

Finasteridehasbeenfoundtocrosstheblood-brainbarrier.Smallamountsoffinasteridehavebeenrecoveredinthe

seminalfluidoftreated.In2studiesofhealthysubjects(n=69)receivingfinasteride5mg/dayfor6-24weeks,

finasterideconcentrationsinsemenrangedfromundetectable(<0.1ng/ml)to10.54ng/ml.Inanearlierstudyusinga

lesssensitiveassay,finasterideconcentrationsinthesemenof16subjectsreceivingfinasteride5mg/dayrangedfrom

undetectable(<1.0ng/ml)to21ng/ml.Thus,basedona5-mlejaculatevolume,theamountoffinasterideinsemenwas

estimatedtobe50-to100-foldlessthanthedoseoffinasteride(5µg)thathadnoeffectoncirculatingDHTlevelsin

men(seealsosection5.3.).

Inpatientswithchronicrenalimpairment,whosecreatinineclearancerangedfrom9-55ml/min,thedispositionofa

singledoseof 14

C-finasteridewasnotdifferentfromthatinhealthyvolunteers(seesection4.2).Proteinbindingalso

didnotdifferinpatientswithrenalimpairment.Aportionofthemetaboliteswhichnormallyisexcretedrenallywas

excretedinthefaeces.Itthereforeappearsthatfaecalexcretionincreasescommensuratetothedecreaseinurinary

excretionofmetabolites.Dosageadjustmentinnon-dialysedpatientswithrenalimpairmentisnotnecessary.

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofrepeateddosetoxicity,

genotoxicity,andcarcinogenicpotential.Reproductiontoxicologystudiesinmaleratshavedemonstratedreduced

prostateandseminalvesicularweights,reducedsecretionfromaccessorygenitalglandsandreducedfertilityindex

(causedbytheprimarypharmacologicaleffectoffinasteride).Theclinicalrelevanceofthesefindingsisunclear.

Aswithother5-alpha-reductaseinhibitors,femininisationofmaleratfoetuseshasbeenseenwithadministrationof

finasterideinthegestationperiod.Intravenousadministrationoffinasteridetopregnantrhesusmonkeysatdosesupto

800ng/dayduringtheentireperiodofembryonicandfoetaldevelopmentresultedinnoabnormalitiesinmalefoetuses.

Thisdoseisabout60-120timeshigherthantheestimatedamountinsemenofamanwhohavetaken5mgfinasteride,

andtowhichawomancouldbeexposedviasemen.Thereproductivetoxicityisbelievedtobemediatedviathe

intendedinhibitionof5-reductase.Takenintoaccountthespeciesenzymedifferenceinsensitivitytofinasteride

inhibitionthemarginofpharmacologicalexposurewouldbeabout4times.Inconfirmationoftherelevanceofthe

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(AUC)ofmonkeyswasbeloworintherangeofthatofmenwhohavetaken5mgfinasteride,orapproximately1-2

milliontimestheestimatedmountoffinasterideinsemen)topregnantmonkeysresultedinexternalgenital

abnormalitiesinmalefoetuses.Nootherabnormalitieswereobservedinmalefoetusesandnofinasteride-related

abnormalitieswereobservedinfemalefoetusesatanydose.”

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core:

Lactosemonohydrate

Cellulose,microcrystalline

Sodiumstarchglycolate(TypeA)

Starchpregelatinised(maize)

Docusatesodium

Magnesiumstearate

Film-coating:

Hydroxypropylcellulose

Hypromellose

Titaniumdioxide

Talc

Indigocarminealuminiumlake(E132)

Ironoxideyellow(E172)

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

PVC/PE/PVDC/Aluminiumblister

Packsizes:10,14,15,20,28,30,45,50,60,90,98,100or120tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

WomenwhoarepregnantormaybecomepregnantmustnothandlecrushedorbrokenFinasteridetabletsbecauseof

thepossibilityofabsorptionoffinasterideandthesubsequentpotentialrisktoamalefoetus.Finasteridetabletshavea

filmcoating,whichpreventscontactwiththeactiveingredientprovidedthatthetabletshavenotbeenbrokenor

crushed.

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7MARKETINGAUTHORISATIONHOLDER

PfizerHealthcareIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA822/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5thAugust2011

10DATEOFREVISIONOFTHETEXT

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