DECA DURABOLIN 100MG/ML, SOLUTION FOR INJECTION (A

Main information

  • Trade name:
  • DECA DURABOLIN 100MG/ML, SOLUTION FOR INJECTION (A
  • Dosage:
  • 100 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECA DURABOLIN 100MG/ML, SOLUTION FOR INJECTION (A
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0261/003/001
  • Authorization date:
  • 29-08-1975
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0261/003/001

CaseNo:2036546

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OrganonLaboratoriesLimited

CambridgeSciencePark,MiltonRoad,CambridgeCB40FL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DecaDurabolin100mg/ml,SolutionforInjection(ampoule)

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/06/2007until28/08/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/06/2007 CRN 2036546 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DecaDurabolin100mg/ml,SolutionforInjection(ampoule)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontainsnandrolonedecanoate100mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Solutionforinjection.

Aclear,paleyellow,oilysolutionforinjection.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthemanagementoftherefractoryanaemiasassociatedwithsuchconditionsaschronicrenalfailure(including

patientsonhaemodialysis)aplasticanaemia,anaemiaduetocytotoxictherapyassociatedwithmalignantdisease.

4.2Posologyandmethodofadministration

Dosage

Adults:

Anaemiaofchronicrenalfailure:

Males: 200mgweekly

Females: 100mgweekly

Aplasticanaemia:

Theusualdoseis50to150mgweekly.

Anaemiaduetocytotoxictherapy:

Theusualdoseis200mgweeklycommencing2weekspriortothecourseofcytotoxictherapy.Thistreatmentshould

becontinuedthroughoutcytotoxictherapyandthereafterduringtherecoveryperioduntilthebloodcounthasreturned

tonormal.

Children:

Thereisinsufficientclinicalexperiencetopermitspecificrecommendations.

Administration

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4.3Contraindications

1.Useinwomenwhoarepregnantoratriskofbecomingpregnant.

2.Useinpatientswithknownorsuspectedprostaticortesticularcarcinomaormalemammary carcinoma.

3.Useinpatientsallergictopeanutsorsoya.

4.Knownhypersensitivitytotheactivesubstanceoranyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Anabolicsteroidsmayinterferewithgrowthinchildrenwithaccelerationofbonematuration.

Thisproductmayinducevirilisationinfemalepatients,particularlyinhighdosesandinhibitionofspermatogenesisin

males.

Thisproductshouldonlybeusedwithgreatcautioninpatientswithrenal,cardiacorliverdysfunction,orinthosewitha

historyofcoronaryarterydisease,epilepsyormigraine.

Alterationsinglucosetolerancemayoccur,requiringsurveillanceforlatentdiabetes,andpossiblechangesincontrolfor

diabeticpatients.

Fluidretentionmayoccur.

Theappearanceofunexplainedamenorrhoea,hypercalcaemiaorhypercalciuriarequiresdiscontinuationoftherapy.Patients

withskeletalmetastasesortheelderlyshouldbecarefullymonitored.

Thisproductshouldonlybeusedunderspecialistsupervisionandregularsurveillance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Anabolicsteroidsmayimproveglucosetoleranceanddecreasetheneedforinsulinorotherantidiabeticmedicinesin

diabetes.

Concurrentadministrationwithrifampicin,barbiturates,phenytoin,dichloralphenazone,phenylbutazone,

carbamazepinemaydecreaseitseffect.Usewithananticoagulantmayaltertheeffectofthelatter.

Concomitantusewithheparinshouldbeavoided.

4.6Pregnancyandlactation

Thismedicineiscontraindicatedduringpregnancybecauseofpossiblemasculinisationofthefoetus.Thereare

insufficientdataontheuseofthismedicineduringbreast-feedingtoassesspotentialharmtotheinfantorapossible

influenceonmilkproduction.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Dependentonthedose,frequencyandtotalperiodofadministrationofDeca-Durabolinthefollowingundesirable

effectsmayoccur(seealsoSection4.4):

*MedDRAversion7.1

Thetermsusedtodescribetheundesirableeffectsarealsomeanttoincludesynonymsandrelatedterms.

LivertumorshavebeenreportedoccasionallyonprolongedtreatmentwithorallyactiveC17-alpha-alkylatedanabolic

steroids.ArelationshipbetweenlivertumorsandnonC17-alpha-alkylatedanabolicsteroidssuchasNandroloneesters

appearstobehighlyunlikelybutcannotbeabsolutelyexcluded.

4.9Overdose

Theacutetoxicityofnandrolonedecanoateinanimalsisverylow.TherearenoreportsofacuteoverdosagewithDeca-

Durabolin"100"inman.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

DECA-DURABOLIN"100"isahighdosageformofnandrolonedecanoatedesignedespeciallyforadjuvanttherapyin

SystemOrganClass MedDRAterm*

Endocrinedisorders Virilism

Hirsutism

Metabolismandnutritiondisorders Hyperglycaemia

Hyperlipidaemia

Psychiatricdisorders Libidoincreased

Vasculardisorders Hypertension

Respiratory,thoracicandmediastinaldisorders Hoarseness

Dysphonia

Gastrointestinaldisorders Nausea

Hepato-biliarydisorders Hepaticfunctionabnormal

Peliosishepatis

Skinandsubcutaneoustissuedisorders Acne

Rash

Pruritus

Musculoskeletal,connectivetissueandbone

disorders Epiphysesprematurefusion

Renalandurinarydisorders Urineflowdecreased

Reproductivesystemandbreastdisorders Benignprostatichyperplasia

Priapism

Penisenlarged

Enlargedclitoris

Oligomenorrhoea

Generaldisordersandadministrationsite

conditions Oedema

Injectionsitereaction

Investigations Highdensitylipoproteindecreased

Spermcountdecreased

Haemoglobinincreased

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chemicallyrelatedtotestosterone.Comparedtotestosterone,ithasanenhancedanabolicandareducedandrogenic

activity.Thishasbeendemonstratedinanimalbioassaysandexplainedbyreceptorbindingstudies.Thelow

androgenicityofnandroloneisconfirmedinclinicaluse.

Inanimals,nandrolonedecanoatepossessesanerythropoiesis-stimulatingeffectprobablybydirectlystimulatingthe

haematopoieticstemcellsinthebonemarrowandbyincreasingthereleaseoferythropoietin.Italsoaffordsprotection

againstthebonemarrowdepressioncausedbycytotoxicagents.

Inthehuman,DECA-DURABOLIN"100"stimulateserythropoiesisasdemonstratedbyrisesintheredbloodcell

mass,andinthehaemoglobinandhaematocritvalues.Thiseffectisutilisedtherapeuticallyinthetreatmentofanaemia

duetoadecreasedproductionoferythropoietin,bonemarrowdepressioninducedbychemotherapy,orhypoplasiaof

thestemcellsinthebonemarrow.Inthelattercondition(e.g.aplasticanaemia)theerythropoiesisresponseis

frequentlyaccompaniedbyapositiveeffectonleucopoiesisandthrombopoiesis.Androgeniceffects(e.g.virilisation)

arerelativelyuncommonattherecommendeddosages.NandrolonelackstheC17alpha-alkylgroupwhichisassociated

withtheoccurrenceofliverdysfunctionandcholestasis.

5.2Pharmacokineticproperties

Nandrolonedecanoateisslowlyreleasedfromtheinjectionsiteintothebloodwithahalf-lifeof6days.Intheblood,

theesterisrapidlyhydrolysedtonandrolonewithahalf-lifeofonehourorless.Thehalf-lifeforthecombinedprocess

ofhydrolysisofnandrolonedecanoateandofdistributionandeliminationofnandroloneis4.3hours.Nandroloneis

metabolisedbytheliver.19-Norandrosterone,19-noretiocholanoloneand19-norepiandrosteronehavebeenidentified

asmetabolitesintheurine.Itisnotknownwhetherthesemetabolitesdisplayapharmacologicalaction.

5.3Preclinicalsafetydata

Pharmacologicalstudiesinanimalsonthetoxicityafterrepeateddosing,genotoxicityandcarcinogenicitydidnot

indicateasafetyriskforhumans.Noanimaldataonreproductionareavailable.Theuseofandrogensindifferent

specieshasdemonstratedtoresultinmasculinisationoftheexternalgenitalsoffemalefetuses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Arachisoil,refined(peanutoil)

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Unopened:5years.

Theampoulesareintendedforsingleuseonly.

Onceopened,anyunusedsolutionshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Donotrefrigerate.

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6.5Natureandcontentsofcontainer

AclearTypeIglassampoulecontaining1mlofsolution,packedinboxesof3ampoules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

OrganonLaboratoriesLimited

CambridgeSciencePark

MiltonRoad

Cambridge

CB40FL

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA261/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29August1975.

Dateoflastrenewal:29August2005.

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/06/2007 CRN 2036546 page number: 6