DECA DURABOLIN

Main information

  • Trade name:
  • DECA DURABOLIN
  • Dosage:
  • 50 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECA DURABOLIN
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0964/008/002
  • Authorization date:
  • 02-07-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0964/008/002

CaseNo:2082307

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0261/003/004.

NVOrganon

Kloosterstraat6,5349ABOss,Netherlands

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DecaDurabolin50mg/mlSolutionforInjection(syringe)

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom02/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 02/07/2010 CRN 2082307 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DecaDurabolin50mg/mlSolutionforInjection(syringe)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontainsnandrolonedecanoate50mg.

Excipients:Alsocontains0.1mlofBenzylalcoholandupto1mlofarachisoil.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinjection

Aclearpaleyellowtoyellowoilysterilesolutionforinjection.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofconditionsassociatedwithcatabolismandnegativenitrogenbalancesuchasdebility,burns,

osteoporosis,refractoryanaemiaandrenalfailure.

Asanadjunctinthemanagementofdisseminatedmammarycarcinomainthefemale.

4.2Posologyandmethodofadministration

Dosage

Adults:

Theusualinitialdoseis25to50mgonceever3weeks.Dosesof50mgonceevery3weeksmaybeusedinacuterenal

failure,osteoporosis,ormammarycarcinoma.

Children:

Dosagemaybevarieddependingonthestateofthechild,butshouldnotexceed0.5mg/kgbodyweightonceevery3

weeks.

Administration

Deepintramuscularinjection.

4.3Contraindications

Useinpatientswithcarcinomaofprostateortestes,orbreastcarcinomainthemale.

Useduringpregnancy.

Useinpatientsallergictopeanutsorsoya.

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4.4Specialwarningsandprecautionsforuse

Ifsignsofvirilisationdevelop,discontinuationofthetreatmentshouldbeconsidered,preferablyinconsultationwith

thepatient.

Thisproductshouldonlybeusedwithgreatcautioninpatientswithrenalfailure,cardiacorliverdysfunction,orin

thosewithahistoryofcoronaryarterydisease,epilepsy,hypertensionormigraine.Alterationsinglucosetolerance

mayoccur,requiringsurveillanceforlatentdiabetes,andpossiblechangesincontrolfordiabeticpatients.

Patientswithskeletalmetastasesofbreastcarcinomashouldbemonitored.Inthesepatientshypercalcaemiamay

developbothspontaneouslyandasaresultofanabolicsteroidtherapy.Thelattercanbeindicativeofapositivetumor

responsetothehormonaltreatment.

Nevertheless,thehypercalcaemiashouldfirstbetreatedappropriatelyandafterrestorationofnormalcalciumlevels

hormonetherapycanberesumed.

Fluidretentionmayoccur.

Whenusedinchildrenaccelerationofbonematurationmayoccurwithprematureepiphysealclosure.

Theuseofanabolicsteroidstoenhanceathleticabilitymaycarrysevereriskstotheuser’shealthandshouldbe

discouraged.

SinceDecaDurabolincontainsbenzylalcoholasanexcipient,itshouldnotbeusedinchildrenyoungerthan3years.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationwithrifampicin,barbiturates,phenytoin,dichloralphenazone,phenylbutazone,

carbamazepinemaydecreaseitseffect.Usewithananticoagulantmayaltertheeffectofthelatter.

Anabolicsteroidsmayimproveglucosetoleranceanddecreasetheneedforinsulinorotherantidiabeticmedicinesin

diabetics.

4.6Pregnancyandlactation

Thedrugmayproducevirilisationofoffspringofwomenreceivingthedrugduringpregnancy.Useistherefore

contraindicated,effectsofuseduringbreastfeedingareuncertainanduseshouldbeavoided.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Dependentonthedose,frequencyandtotalperiodofadministrationofDeca-Durabolinthefollowingundesirable

effectsmayoccur(seealsoSection4.4):

SystemOrganClass MedDRAterm*

Endocrinedisorders Virilism

Hirsutism

Metabolismandnutritiondisorders Hyperlipidaemia

Psychiatricdisorders Libidoincreased

Vasculardisorders Hypertension

Respiratory,thoracicandmediastinaldisorders Hoarseness

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*MedDRAversion7.1.

Thetermsusedtodescribetheundesirableeffectsarealsomeanttoincludesynonymsandrelatedterms.

LivertumorshavebeenreportedoccasionallyonprolongedtreatmentwithorallyactiveC17-alpha-alkylatedanabolic

steroids.ArelationshipbetweenlivertumorsandnonC17-alpha-alkylatedanabolicsteroidssuchasNandroloneesters

appearstobehighlyunlikelybutcannotbeabsolutelyexcluded.

4.9Overdose

Theacutetoxicityofnandrolonedecanoateinanimalsisverylow.TherearenoreportsofacuteoverdosagewithDeca-

Durabolininthehuman.

5PHARMACOLOGICALPROPERTIES

NandrolonedecanoatehastheATCcode:A14AB01.

5.1Pharmacodynamicproperties

Deca-Durabolinisaninjectableanabolicpreparation.ThepharmacologicallyactivesubstanceisNandrolone.The

decanoateestergivesthepreparationdurationofactionofaboutthreeweeksafterinjection.

Nandroloneischemicallyrelatedtothemalehormone.Comparedtotestosterone,ithasanenhancedanabolicand

reducedandrogenicactivity.Thishasbeendemonstratedinanimalbioassaysandexplainedbyreceptorbinding

studies.ThelowandrogenicityofNandroloneisconfirmedinclinicaluse.

Inthehuman,Deca-Durabolinhasbeenshowntopositivelyinfluencecalciummetabolismandtoincreasebonemass

inosteoporosis.Furthermore,Deca-Durabolinhasanitrogen-savingaction.

Thiseffectonproteinmetabolismhasbeenestablishedbymetabolicstudiesandisutilisedtherapeuticallyinconditions

whereaproteindeficiencyexistssuchasduringchronicdebilitatingdiseasesandaftermajorsurgeryandsevere

trauma.

Intheseconditions,Deca-Durabolinservesasasupportiveadjuncttospecifictherapiesanddietarymeasuresaswellas

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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Androgeniceffects(e.g.virilisation)arerelativelyuncommonattherecommendeddosages.NandrolonelackstheC17-

alpha-alkylgroupthatisassociatedwiththeoccurrenceofliverdysfunctionandcholestasis.

5.2Pharmacokineticproperties

Nandrolonedecanoateisslowlyreleasedfromtheinjectionsiteintothebloodwithahalf-lifeof6days.Intheblood,

theesterisrapidlyhydrolysedtoNandrolonewithahalf-lifeofonehourorless.Thehalf-lifeforthecombinedprocess

ofhydrolysisofNandrolonedecanoateandofdistributionandeliminationofNandroloneis4.3hours.Nandroloneis

metabolisedbytheliver.Themainexcretionproductsintheurineare19-Norandrosteroneand19-noretiocholanolone.

Itisnotknownwhetherthesemetabolitesdisplayapharmacologicalaction.

5.3Preclinicalsafetydata

Pharmacologicalstudiesinanimalsonthetoxicityafterrepeateddosing,genotoxicityandcarcinogenicitydidnot

indicateasafetyriskforhumans.Noanimaldataonreproductionareavailable.Theuseofandrogensindifferent

specieshasdemonstratedtoresultinmasculinisationoftheexternalgenitalsoffemalefoetuses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Arachisoil

6.2Incompatibilities

Intheabsenceofcompatibilitystudiesthismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

Aspackagedforsale:3years

Theproductmustbeusedimmediatelyafteropening.

6.4Specialprecautionsforstorage

Storebelow25 o

C.Donotrefrigerate.

Keepthesyringeintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

1mldisposableclearTypeIglasssyringewithaffixedneedle,thewholeblisterispackedinanoutercardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.

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7MARKETINGAUTHORISATIONHOLDER

NVOrganon

Kloosterstraat6

5349ABOss

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER

PA0964/008/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1979

Dateoflastrenewal:01April2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 02/07/2010 CRN 2082307 page number: 6