DECA DURABOLIN 25 MG / ML SOLUTION FOR INJECTION (

Main information

  • Trade name:
  • DECA DURABOLIN 25 MG / ML SOLUTION FOR INJECTION (
  • Dosage:
  • 25 Mg/Ml
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DECA DURABOLIN 25 MG / ML SOLUTION FOR INJECTION (
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0261/003/002
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0261/003/002

CaseNo:2036546

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OrganonLaboratoriesLimited

CambridgeSciencePark,MiltonRoad,CambridgeCB40FL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DecaDurabolin25mg/mlSolutionforInjection(ampoule)

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/06/2007until31/03/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DecaDurabolin25mg/mlSolutionforInjection(ampoule)

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontainsnandrolonedecanoate25mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

SolutionforInjection

1mlTypeIclearglass‘Ringsnap’ampoulecontainingaclearpaleyellowtoyellowoilysolution.

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.

Knownhypersensitivitytotheactivesubstanceortoanyoftheaboveexcipients.

4.4Specialwarningsandprecautionsforuse

Ifsignsofvirilisationdevelop,discontinuationofthetreatmentshouldbeconsidered,preferablyinconsultationwith

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Thisproductshouldonlybeusedwithgreatcautioninpatientswithrenalfailure,cardiacorliverdysfunction,orin

thosewithahistoryofcoronaryarterydisease,epilepsy,hypertensionormigraine.Alterationsinglucosetolerance

mayoccur,requiringsurveillanceforlatentdiabetes,andpossiblechangesincontrolfordiabeticpatients.

Patientswithskeletalmetastasesofbreastcarcinomashouldbemonitored.Inthesepatientshypercalcaemiamay

developbothspontaneouslyandasaresultofanabolicsteroidtherapy.

Thelattercanbeindicativeofapositivetumorresponsetothehormonaltreatment.

Nevertheless,thehypercalcaemiashouldfirstbetreatedappropriatelyandafterrestorationofnormalcalciumlevels

hormonetherapycanberesumed.

Fluidretentionmayoccur.

Whenusedinchildrenaccelerationofbonematurationoccurswithprematureepiphysealclosure.

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

Dysphonia

Gastrointestinaldisorders Nausea

Hepato-biliarydisorders Hepaticfunctionabnormal

Peliosishepatis

Skinandsubcutaneoustissuedisorders Acne

Rash

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*MedDRAversion7.1.

Thetermsusedtodescribetheundesirableeffectsarealsomeanttoincludesynonymsandrelatedterms.

LivertumorshavebeenreportedoccasionallyonprolongedtreatmentwithorallyactiveC17-alpha-alkylatedanabolic

steroids.ArelationshipbetweenlivertumorsandnonC17-alpha-alkylatedanabolicsteroidssuchasNandroloneesters

appearstobehighlyunlikelybutcannotbeabsolutelyexcluded.

4.9Overdose

Theacutetoxicityofnandrolonedecanoateinanimalsisverylow.TherearenoreportsofacuteoverdosagewithDeca-

Durabolininthehuman.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

NandrolonedecanoatehastheATCcode:A14AB01.

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-Durabolinservesasasupportiveadjuncttospecifictherapiesanddietarymeasuresas

wellasparenteralnutrition.

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

alpha-alkylgroupthatisassociatedwiththeoccurrenceofliverdysfunctionandcholestasis.

5.2Pharmacokineticproperties

Nandrolonedecanoateisslowlyreleasedfromtheinjectionsiteintothebloodwithahalf-lifeof6days.Intheblood,

theesterisrapidlyhydrolysedtoNandrolonewithahalf-lifeofonehourorless.Thehalf-lifeforthecombinedprocess

Musculoskeletal,connectivetissueandbone

disorders Epiphysesprematurefusion

Renalandurinarydisorders Urineflowdecreased

Reproductivesystemandbreastdisorders Benignprostatichyperplasia

Priapism

Penisenlarged

Enlargedclitoris

Oligomenorrhoea

Generaldisordersandadministrationsite

conditions Oedema

Injectionsitereaction

Investigations Highdensitylipoproteindecreased

Spermcountdecreased

Haemoglobinincreased

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metabolisedbytheliver.Themainexcretionproductsintheurineare19-Norandrosteroneand19-noretiocholanolone.

Itisnotknownwhetherthesemetabolitesdisplayapharmacologicalaction.

5.3Preclinicalsafetydata

Pharmacologicalstudiesinanimalsonthetoxicityafterrepeateddosing,genotoxicityandcarcinogenicitydidnot

indicateasafetyriskforhumans.Noanimaldataonreproductionareavailable.Theuseofandrogensindifferent

specieshasdemonstratedtoresultinmasculinisationoftheexternalgenitalsoffemalefoetuses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol

Arachisoil

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Theshelf-lifeexpirydateshallnotexceed5yearsfromthedateofmanufacture.

Theampoulesareintendedforsingleuseonly.Onceopened,anyunusedsolutionshouldbediscarded.

6.4Specialprecautionsforstorage

Storebelow25 °

C.Donotrefrigerate.

Keeptheampoulesintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

Boxesofthree1mlclearTypeIglassampoules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

OrganonLaboratoriesLimited

CambridgeSciencePark

MiltonRoad

CambridgeCB40FL

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1979

Dateoflastrenewal:01April2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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