Deca-Durabolin Orgaject

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Nandrolone decanoate 25 mg/mL
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Nandrolone decanoate 25 mg/mL
Dosage:
25 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Nandrolone decanoate 25 mg/mL Excipient: Arachis oil Benzyl alcohol
Units in package:
Syringe, Orgaject, disposible 1 mL, 1 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Aspen Oss B.V
Therapeutic indications:
DECA-DURABOLIN can be used for the treatment of osteoporosis; for the palliative treatment of selected cases of disseminated mammary carcinoma in women and as an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance.
Product summary:
Package - Contents - Shelf Life: Syringe, Orgaject, disposible 1 mL - 1 mL - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-2792
Authorization date:
1969-12-31

NEW ZEALAND DATASHEET

DECA-DURABOLIN

Presentation

Each pre-filled syringe contains1mLof25 mg/mLnandrolonedecanoate.

Each pre-filled syringe contains1mLof50mg/mL nandrolonedecanoate.

Each pre-filled syringe isaffixed witha needle closedbyaneedleshieldof naturalrubberlatex

(Seewarningsand precautionsforuse).

Each ampoule contains1mlof50mg/mlnandrolonedecanoate.

Each mloftheyellow,oilysolution contains:

25 or50 mg nandrolone decanoate.

Uses

Actions

DECA-DURABOLINisan injectable anabolicpreparation. The pharmacologicallyactive substance is

nandrolone.The decanoate estergivesthepreparation a durationofactionofaboutthreeweeksafter

injection.

Nandroloneischemicallyrelated to the male hormone. Compared totestosterone,ithasan enhanced

anabolicand a reducedandrogenicactivity. Thishasbeendemonstratedinanimalbioassaysand

explained byreceptorbinding studies. Thelowandrogenicityofnandroloneisconfirmed in clinical

use.

In the human,DECA-DURABOLINhasbeen shown to positivelyinfluence calciummetabolismand to

increasebone massin osteoporosis.Inwomen withdisseminated mammarycarcinoma,DECA-

DURABOLINhasbeen reported to produce objective regressionsformanymonths.Furthermore,

DECA-DURABOLINhasa nitrogen-saving action.

Thiseffecton protein metabolismhasbeen established bymetabolicstudiesandisutilized

therapeuticallyinconditionswhere aproteindeficiencyexistssuchasduring chronicdebilitating

diseasesandaftermajorsurgeryandsevere trauma.In these conditions,DECA-DURABOLIN serves

asa supportiveadjunctto specifictherapiesanddietarymeasuresaswellasparenteralnutrition.

Androgeniceffects(e.g.virilisation)are relativelyuncommon atthe recommendeddosages.

Nandrolonelacksthe C17alpha-alkylgroupwhich isassociatedwith the occurrence ofliver

dysfunction and cholestasis.

Pharmacokinetics

Nandrolone decanoateisslowlyreleased fromthe injection siteintothebloodwith a half-life of6 days.

In the blood,the esterisrapidlyhydrolysed tonandrolonewitha half-life ofone hourorless. The half-

life forthe combinedprocessofhydrolysisofnandrolone decanoateandofdistribution and elimination

ofnandrolone is4.3hours.Nandroloneismetabolisedbytheliver.19-Norandrosterone,19-

noretiocholanoloneand 19-norepiandrosterone have beenidentified asmetabolitesin the urine.Itis

notknownwhetherthese metabolitesdisplaya pharmacologicalaction.

Indications

DECA-DURABOLINcanbeused forthetreatmentofosteoporosis;forthe palliative treatmentof

selectedcasesofdisseminated mammarycarcinoma inwomen andasanadjunctto specific

therapiesanddietarymeasuresinpathologicconditionscharacterizedbya negative nitrogen balance.

DosageAndAdministration

Adultsincludingelderly

Osteoporosis

50 mg every3weeks.

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ForThe Palliative TreatmentOfSelectedCasesOfDisseminatedMammaryCarcinoma In

Women

50 mg every2-3 weeks.

AsAnAdjunct ToSpecificTherapiesAndDietaryMeasuresInPathologicConditions

CharacterizedByANegative NitrogenBalance

25-50 mg every3weeks.

N.B. Foranoptimaltherapeuticeffectitisnecessaryto administeradequate amountsofvitamins,

mineralsand protein in acalorie-richdiet.

Paediatricpopulation:

Safetyandefficacyhave notbeen adequatelydetermined inchildren and adolescents.Pre-pubertal

children treatedwith Deca-Durabolin shouldbetreatedwith caution.

Methodof administration:

Deca-Durabolinshouldbe administered bydeep intramuscularinjection.

Contraindications

Pregnancy.

Knownorsuspected carcinoma ofthe prostateorbreastin the male.

Hypersensitivitytotheactive substanceortoanyofthe excipients,includingarachisoil. Deca-

Durabolin istherefore contraindicatedin patientsallergicto peanutsand soya (see Warningsand

Precautions).

EffectsonFertility:

In men,treatmentwithDeca-Durabolin canlead to fertilitydisordersbyrepressingsperm-formation.In

women treatmentwithDeca-Durabolin canlead to an infrequentorrepressed menstrualcycle.

Use DuringPregnancyAndBreast-Feeding

Deca-Duraboliniscontra-indicatedin women whoare pregnant.

Pregnancy:

Thismedicineiscontraindicated during pregnancybecause ofpossible masculinizationofthe foetus.

There are noadequate data fromthe use ofDeca-Durabolininpregnantwomen.In viewofthe riskof

virilization ofthe fetus,Deca-Durabolin should notbeused during pregnancy.Treatmentwith Deca-

Durabolin shouldbediscontinuedwhenpregnancyoccurs.

Lactation:

There are noadequate data fromthe use ofDeca-Durabolinduringlactation.Therefore,Deca-

Durabolin shouldnotbeused during lactation.

EffectsOnAbilityToDriveAndUseMachines

Deca-Durabolinhasnoinfluenceon the abilityto driveanduse machines

WarningsAndPrecautions

Virilization:

Patientsshould be informed aboutthepotentialoccurrence ofsignsofvirilization.In particularsingers

andwomen with speechprofessionsshould be informed abouttheriskofdeepeningofthevoice.

Ifsignsofvirilisationdevelop,therisk/benefitratio hastobe newlyassessed withtheindividualpatient.

Deca-DurabolinA130424Version4 Page3

Medicalexamination:

Physiciansshould considermonitoringpatientsreceiving Deca-Durabolin before the startoftreatment,

atquarterlyintervalsforthefirst12 monthsandyearlythereafterforthe followingparameters:

Digitalrectalexamination (DRE)oftheprostate andPSAto excludebenign prostate

hyperplasiaora sub-clinical prostate cancer,

Hematocritandhemoglobinto excludepolycythemia.

Conditionsthatneedsupervision:

Patients,especiallytheelderly,with the following conditionsshouldbe monitored for:

Tumours–Mammarycarcinoma,hypernephroma,bronchialcarcinoma and skeletal

metastases.In these patientshypercalcemia maydevelop spontaneously,alsoduring

anabolicsteroid therapy.The lattercan be indicativeofa positivetumourresponse to

the hormonaltreatment.Nevertheless,the hypercalcemia should firstbetreated

appropriatelyandafterrestoration ofnormalcalciumlevels,hormone therapycanbe

resumed.

Pre-existingconditions–In patientswith pre-existingcardiac,renalorhepatic

insufficiency/diseaseanabolicsteroid treatmentmaycause complications

characterizedbyedema with orwithoutcongestiveheartfailure.In such cases

treatmentmustbe stoppedimmediately.

Patientswho experienced myocardialinfarction,cardiac-,hepatic-orrenal

insufficiency,hypertension,epilepsy,ormigraine shouldbe monitored due to the risk

ofdeteriorationorreoccurrenceofdisease.In suchcasestreatmentmustbe

stoppedimmediately.

Diabetesmellitus–Deca-Durabolincan improvethe glucose tolerance in diabetic

patients.

Anti-coagulant therapy–Deca-Durabolin can enhance theanti-coagulantactionof

coumarin-type agents.

Adverse events:

Ifanabolicsteroid-associated adverse reactionsoccur,treatmentwith Deca-Durabolin should be

discontinued and,upon resolution ofcomplaints,resumed withalowerdose.

(Mis)use in sports:

Patientswhoparticipateincompetitionsgoverned bytheWorld Anti-DopingAgency(WADA)should

consultthe WADA-code before using thisproductasDeca-Durabolin caninterfere withanti-doping

testing.The use ofanabolicsteroidsto enhance athleticabilitymaycarrysevere risksto the user's

healthand shouldbe discouraged.

Deca-Durabolin contains100 mg benzylalcoholpermLsolution and mustnotbe given topremature

babiesorneonates.Benzylalcoholmaycausetoxicreactionsandanaphylactoid reactionsininfants

and childrenup to 3yearsold.

Deca-Durabolin containsarachis(peanut)oiland should notbetaken/appliedbypatientsknown to be

allergicto peanut.Asthereisa possible relationship between allergytopeanutand allergyto soya,

patientswith soyaallergyshould also avoidDeca-Durabolin(see Contraindications).

The packaging ofthismedicinalproductcontainsnaturalrubberlatexwhich maycause allergic

reactions.

PaediatricPopulation:

Deca-DurabolinA130424Version4 Page4

In pre-pubertalchildren staturalgrowthandsexualdevelopmentshould bemonitored sinceanabolic

steroidsin generalandDeca-Durabolin in high dosagesmayaccelerate epiphysealclosure and

sexualmaturation.

Interactions

Enzyme-inducing agentsmaydecrease and enzyme-inhibitingdrugsmayincrease nandrolone levels.

Therefore,adjustmentofthe doseofDeca-Durabolinmaybe required.

Insulinand otheranti-diabeticmedicines:

Anabolicsteroidsmayimproveglucose tolerance anddecrease the needforinsulin orother

antidiabeticmedicinesin diabeticpatients. Patientswith diabetesmellitusshould therefore be

monitored especiallyatthebeginningorend oftreatmentand atperiodicintervalsduring Deca-

Durabolin treatment.

Anti-coagulanttherapy:

HighdosesofDeca-Durabolinmayenhance the anti-coagulantactionofcoumarin-type agents.

Therefore close monitoringofprothrombin time andifnecessarya dose reductionofthe anti-

coagulantisrequired during therapy.

ACTHorcorticosteroids:

The concurrentadministration ofanabolicsteroidswithACTHorcorticosteroidsmayenhance oedema

formations;thusthese active substancesshould be administered cautiously,particularlyin patientwith

cardiacorhepaticdiseaseorinpatientpredisposed tooedema.

Laboratorytestinteractions

Anabolicsteroidsmaydecrease levelsofthyroxine-binding globulin resultingindecreased totalT4

serumlevelsandincrease resin uptake ofT3 and T4.Free thyroid hormone levelsremain unchanged,

however,andthereisno clinicalevidence ofthyroid dysfunction

RecombinantHuman Erythropoietin:

Combination ofDeca-Durabolin (50-100mg/week)with rhEPO(recombinanthuman erythropoietin),

especiallyin females,mayenablea reduction oftheerythropoietin dose toreduceanaemia.

AdverseEffects

Due to the natureofDeca-Durabolin,side effectscannotbe quicklyreversedbydiscontinuing

medication.Injectablesin general,maycause alocalreaction attheinjection site.

Dependenton the dose,frequencyand totalperiodofadministration ofDeca-Durabolin thefollowing

undesirableeffectsmayoccur.

SystemOrganClass MedDRAterm*

Endocrine disorders Virilism

Metabolismand nutrition disorders Hyperlipidaemia

Psychiatricdisorders Libidoincreased

Vasculardisorders Hypertension

Respiratory,thoracicandmediastinal

disorders Dysphonia

Gastrointestinaldisorders Nausea

Deca-DurabolinA130424Version4 Page5

SystemOrganClass MedDRAterm*

Hepatobiliarydisorders Hepaticfunction abnormal

Peliosishepatis

Skin andsubcutaneoustissue

disorders Acne

Rash

Pruritus

Hirsutism

Musculoskeletaland connective

tissue disorders Epiphysespremature fusion

Renaland urinarydisorders Urine flowdecreased

Reproductive systemand breast

disorders Benign prostatichyperplasia

Priapism

Penisenlarged

Enlarged clitoris

Oligomenorrhoea

Amenorrhoea

Spermcountdecreased

Generaldisordersand administration

site conditions Oedema

Injectionsite reaction

Investigations Highdensitylipoproteindecreased

Haemoglobin increased

Injury,poisoning andprocedural

complications Intentionalmisuse

*MedDRAversion15.0.

The termsused to describetheundesirableeffectsaboveare also meanttoinclude synonymsand

related terms.

Paediatricpopulation:

The followingundesirableeffectshavebeen reportedin pre-pubertalchildren using androgens:

precocioussexualdevelopment,an increased frequencyoferections,phallicenlargementand

premature epiphysealclosure.

Highdosages,prolonged treatmentand/ortoo frequentadministration maycause:

Virilisationwhichappearsin sensitivewomen ashoarseness,acne,hirsutismand increase oflibido;

and in girlsasan increase ofpubichairandclitoralhypertrophy.Hoarsenessmaybe the first

symptomofvocalchangewhich mayendin along-lasting,sometimesirreversible deepening ofthe

voice.

Amenorrhoea.

Inhibition ofspermatogenesis.

Premature epiphysealclosure.

Fluid retention.

Deca-DurabolinA130424Version4 Page6

Overdosage

The acute toxicityofnandrolone decanoateinanimalsisverylow.There are no reportsofacute

overdosagewith DECA-DURABOLINin the human.

PharmaceuticalPrecautions

List of Excipients

The ampoulesandorgajectscontain,apartfromthe active ingredient,benzylalcoholandarachis

(peanut)oil.

Incompatibilities

In viewoftheprescribedwayofadministration,chemicalinteractionofthe activeingredientwithother

substancescanbeleftoutofconsideration.

Shelf-Life

DECA-DURABOLINmaybe useduntilthe expirationdateindicated onthepackage.

Orgajects3years

Ampoules5years

SpecialPrecautionsForStorage

DECA-DURABOLINshouldbe stored at8°Cto 25°C,protected fromlight.Keep containerin the

originalcarton.

Sinceanopened ampoulecannotbe resealedin suchawaytofurtherguarantee the sterilityofthe

contents,the solution should beusedimmediately.

Medicine Classification

Prescription Medicine.

Package Quantities

Orgajectscontaining 1mlofoilysolutionwith 25mg*or50mgnandrolone decanoate.

Ampoulescontaining 1mlofoilysolutionwith50mg*nandrolone decanoate.

*Notcommerciallyavailable

Name AndAddress

MerckSharp &Dohme (NZ)Ltd

POBox99851

Newmarket

Auckland1149

Tel:0800500 673

DateOf Preparation

24April2013

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