DOBUTAMINE-HAMELN 250 MG/50 ML AMPOULE

Main information

  • Trade name:
  • DOBUTAMINE-HAMELN 250 MG/50 ML AMPOULE
  • Dosage:
  • 5 Mg/Ml
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOBUTAMINE-HAMELN 250 MG/50 ML AMPOULE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0971/002/001
  • Authorization date:
  • 04-11-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dobutamine-hameln 250 mg/50 mlampoule, solution forinfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolution contains5mg Dobutamineequivalentto 5.6mg DobutamineHCl.Each 50mlampoulecontains

250mg Dobutamineequivalentto 280mg DobutamineHydrochloride.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Solution forinfusion.

Aclear, colourlessoralmostcolourlesssolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dobutamineisindicated foradultswho requireinotropicsupportinthetreatmentoflowoutputcardiacfailure

associated with myocardialinfarction, open heartsurgery orcardiomyopathies.Dobutamineisalso indicated for

adultswith cardiogenicorsepticshock who arenotseverely hypotensive.Dobutaminecan increaseormaintain

cardiacoutputduring positiveend expiratory pressure(PEEP)ventilation.

Dobutaminemay also beused forcardiacstresstesting in caseswhereexercisestresstesting isnotfeasibleor

inadequate.

4.2Posologyandmethodofadminstration

Dueto itsshorthalf-lifedobutaminehasto beadministered by continuousintravenousinfusion.

DobutamineHameln 250 mg/50 mlmay bediluted ifwanted. Diluentsmaybe5 %glucosesolution, 0.9 %sodium

chloridesolution, Ringer-lactateor0.45 %sodiumchloridein 5 %glucosesolution.

Note:DobutamineHameln 250 mg/50 mlmay notbemixed with 5%sodiumbicarbonatesolution orany other

strong alkalinesolution. Dueto therisk ofincompatibility DobutamineHameln 250 mg/50 mlisnotrecommended

to bemixed in thesameinfusion asothermedicalsubstances.

DobutamineHameln 250 mg/50 mlshould notbeused in solutionsforintravenousinfusion containing both

sodiummetabisulphiteand ethanol. Sulphiteisavery reactivesubstance. Otherdrugsmay notbeadded to the

solution. In caseofconcomitantadministration ofotherdrugsdifferentvenouscathetersshould beused (c.f. 6.2.

Incompatibilities).

Thesolution forinfusion should beprepared underasepticconditionsimmediately beforeuse. Theprepared

solution should beused within 24 h ordiscarded. Thediluted solution hasto beprotected fromlightand stored in

therefrigerator. In principle, only clearand colourlesssolutionsshould beused. Aslightpink discolouration,

which may deepen with time, resultsfromaslightoxidation ofthedrug, butthereisno relevantlossofpotency

during therecommended storagetimein caseofadherenceto therecommended precautionsforstorage.

Therapeuticdosage:

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should beadjusted according to thepatient'sresponseasdetermined by heartrate, blood pressure, urineflow, and

ifpossible, by measurementofcardiacoutput, centralvenouspressureand pulmonary capillary wedgepressure.

Thereisevidencethatpartialtolerancedevelopswith continuousinfusionsfor72 hoursormore, thereforehigher

dosesmay benecessary to maintain thesameeffects.

Itisrecommended thattreatmentwith dobutamineshould bediscontinued gradually.

Dosagein adults:

Mostpatientswillrespond satisfactorily to dosesranging from2.5 to 10µg/kg/min. Occasionally, however, adose

aslowas0.5µg/kg/min willelicitaresponse. Rarely, adoseashigh as40µg/kg/min isrequired.

Dosagein children:

Thesafety and efficacy ofdobutamineforusein children havenotbeen established.

Thenecessary infusion ratedependson theresponseofthepatientand theoccurrenceofpossibleadverseevents.

Therateofinfusion isincreased at10-30 minutesintervalsuntilthedesired haemodynamiceffectsareachieved or

undesired effectspreventafurtherincreasein dose.

Theduration ofthetreatmentdependson theclinicalneeds. Cautionhasto beexercised in casethedoseexceeds

10µg/kg/min orthetreatmentduration islongerthan 72 hours.

An i.v. drip chamberorothersuitablemeteringdeviceisessentialforcontrolling therateofflowin dropsper

minute. High concentrationsshouldonly begiven with an infusion pump to ensureaccuratedosing.

Thefollowing tablemay serveasaguidefortherateofinfusion perkg body weightand minute.

* 250 mg dobutaminein 1 litresolution

** 500 mg dobutaminein 1 litresolution or250mg dobutaminein 500mlsolution

*** 1000 mgdobutaminein 1 litresolution, or250 mg dobutaminein250 mlsolution

**** 250 mgdobutaminein 50 mlsolution.

Thefinalvolumeadministered should bedetermined by thefluid requirementsofthepatient. Concentrationsas

high as5,000µg/ml(5 mg/ml)havebeen used in patientson arestricted fluid intake.

Dosageforcardiacstresstesting:

Therecommendeddosageisan incrementalincreasein infusion ratesfrom5µg/kg/min to 10, 20, 30 and a

maximumof40µg/kg/min, each dosebeing infused for3 minutes.In addition atropinemay beadded during

furtherinfusionofthepeak dosein caseofnotachieving an endpointwith dobutaminealone. ContinuousECG

monitoring isessentialand theinfusion terminatedin theeventofST-segmentdepression of>0.2 mV(2 mm)

measured 80 msaftertheJpoint,aST-segmentelevation of>0.1 mV(1 mm)in patientswithouthistory of

myocardialinfarction, orany significantcardiacarrhythmias.

Theinfusion should also beterminated iftheheartratereaches85%oftheage-predicted maximum, systolicblood

Delivery rate(ml/min/kg)atconcentrationsofinfusion solution of

250

µg/ml* 500

µg/ml** 1000

µg/ml*** 5000

µg/ml****

infusion rate

(µg/kg/min)

0.002 0.001 0.0005 0.0001

0.004 0.002 0.0010 0.0002

0.010 0.005 0.0025 0.0005

0.020 0.010 0.0050 0.0010

0.030 0.015 0.0075 0.0015

10.0 0.040 0.020 0.0100 0.0020

12.5 0.050 0.025 0.0125 0.0025

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newcardiacwallmotion abnormalities, severechestpain orany non-tolerableadverseeffectoccurs.

Thedobutaminestresstestshould only beundertaken in units, wherepersonnelspecially trained in resuscitation

and resuscitationequipmentincluding adefibrillatorareimmediately available.

4.3Contraindications

Hypersensitivity to dobutamineorsodiummetabisulphite. Mechanicalobstruction ofventricularfilling oroutflow.

Hypovolaemia. Non-controllableseriousventriculararrhythmias.

In addition forcardiacstresstest:unstableangina, uncontrolled hypertension, uncontrolled arrhythmias(including

uncontrolled atrialfibrillation), known severeventriculararrhythmias, electrolyteimbalanceand severeanaemia.

4.4Special warningsandspecialprecautionsforuse

Dobutamineshould only beused in specialistunitsin which adequatefacilitiesareavailableforpatient

surveillanceand themonitoring ofresponses. During dobutamineinfusionsheartrate, cardiacrhythm(by ECG),

blood pressure, urineflowand infusion rateshould bemonitored continuously and, ifpossiblecardiacoutput,

centralvenouspressureand pulmonary capillary wedgepressurebecontrolled.

Thedobutaminestresstestshould only beundertaken in units, wherepersonnelspecially trained in resuscitation

and resuscitationequipmentincluding adefibrillatorareimmediately available.

Dobutaminemay causeamarked increasein heartrateorblood pressure, especially systolicpressure. Patientswith

pre-existing hypertension appearto beatgreaterrisk ofdeveloping ahypertensiveresponse. Ifan undueincrease

in heartrateorsystolicblood pressureoccursorifan arrhythmiaisprecipitated thedoseofdobutamineshould be

reduced orthedrug should bediscontinued temporarily.

Dobutaminemay precipitateorexacerbateventricularectopicactivity, rarely ithascaused ventriculartachycardia

orfibrillation. Becausedobutaminefacilitatesatrioventricularconduction, patientswith atrialflutterorfibrillation

may develop rapid ventricularresponsesand thereforeshould bedigitalised priorto administrationofdobutamine.

Inotropicagents, including dobutamine, do notimprovehaemodynamicsin mostpatientswithmechanical

obstruction thathinderseitherventricularfilling oroutflow, orboth. Inotropicresponsemay beinadequatein

patientswith markedly reduced ventricularcompliance. Such conditionsarepresentin cardiactamponade, valvular

aorticstenosis, and idiopathichypertrophicsubaorticstenosis.

Particularcareshould beexercised when dobutamineisused in patientswith acutemyocardialinfarction because

any significantincreasein heartrateorexcessiveincreasesin arterialpressurethatoccurmay intensify ischaemia

and causeanginalpain and ST-segmentelevation.

Aswithothercatecholaminesdobutaminecan also triggeran onsetofanginain patientswith ischaemicheart

diseaseand consequently particularcareshould beexercised, when dobutamineisgiven to patientswith ischaemic

heartdisease.

Particularcaution hasto beexercised when using dobutamineinpatientstreated with mono-aminoxidase(MAO)

inhibitorsand in patientswith phaeochromocytomaorwith hyper-thyroidismdueto theincreased catecholamine

levelsorsensitivity, which could resultin marked increasesinblood pressure, heartrateand higherincidencein

arrhythmias.

Somehaemodynamiceffectsofdobutaminemay bequantitatively orqualitatively differentin children compared

to adults. Heartrateand blood pressureincreasesappearto bemorefrequentand moreintensein children. Unlike

in adults, pulmonary capillary wedgepressuremay notbereduced in children, and itmay even increase, especially

in children underoneyearofage.Consequently, theuseofdobutaminein children should beclosely monitored.

Precipitousdecreasesinblood pressurehaveoccasionally been described in association with dobutaminetherapy.

Decreasing thedoseordiscontinuing theinfusion typically resultsin rapid return ofblood pressureto baseline

values, butrarely intervention may berequired and reversibility may notbeimmediate.

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(mean arterialpressurelessthan 70 mmHg).

Beforeadministration ofdobutaminehypovolaemiashould becorrected.

Ifarterialblood pressureremainslowordecreasesprogressively during administration ofdobutaminedespite

adequateventricularfilling pressureand cardiacoutput, consideration may begivento theconcomitantuseofa

peripheralvasoconstrictoragentasdopamineornoradrenaline.

Likeotherdrugswith-agonistactivity,dobutaminemay produceslightreductionsin serumpotassium

concentrationsand rarely hypokalaemiamay occur. Consideration should begivento monitoring serumpotassium

during dobutaminetherapy.

Dobutaminemay alterinsulin and glucoseplasmalevels. Consequently in diabeticpatientstheglucose

concentration should becontrolled and theinsulin doseadjusted ifnecessary.

During aprolonged continuousinfusion (48-72 h)adecreasein haemodynamicresponsemayoccur, which makes

an increasein dosenecessary.

DobutamineHameln 5 mg/mlAmp. 50 mlcontainssodiummetabisulphite. Thismay causeallergictypereactions

including anaphylaxisand life-threatening orlesssevereasthmaticepisodesin certain susceptibleindividuals. The

overallprevalenceofsulphitesensitivity in thegeneralpopulation isunknown butprobably low. Such sensitivity

seemsto occurmorefrequently in asthmaticthan in non-asthmaticpatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pretreatmentorconcomitantadministration of-receptorblocking drugsmay resultin decreasein inotropicand

chronotropiceffectsdueto competitivebinding to the-receptorandin predominanceofthe -mediated effects

resulting in peripheralvasoconstriction and increasein blood pressure.

Concomitantadministration of-blockersmay resultin predominanceofthe-agonisticeffectswith increasein

heartrateand peripheralvasodilation.

Peripheralvasodilators(e.g. nitrates, sodiumnitroprusside)in combination with dobutaminemayincreasecardiac

outputand decreasesystemicperipheralresistanceand ventricularfilling pressuremorethan eitherdrug alone.

Concomitantuseofdobutamineand MAO-inhibitorsmay resultin marked increasesinblood pressureand heart

rateand in increased incidenceofarrhythmias. Even life-threatening adverseeffectsmay resultashypertensive

crisis, cardiovascularcollapse,intracranialhaemorrhageand arrhythmias.

Concomitantadministration ofguanethidineand rauwolfiaalkaloidswith dobutaminemightresultin augmented

increasesin blood pressureand arrhythmiafrequency. Theophyllinewassupposed to increasetheheartrate

responsein onestudy.

Concomitantadministration ofdobutamineand ACE-inhibitors(e.g. captopril)may resultin an increasein cardiac

outputaccompanied by increased myocardialoxygen consumption, occurrenceofchestpain and arrhythmiashave

been reported with thiscombination.

Concurrentuseofdobutamineand dopamineincreasessystemicarterialpressuremoremarkedly and preventsthe

increasein ventricularfilling pressureseen with dopaminealone.

Concomitantuseofdobutamineand peripheralvasoconstrictoragentsasnoradrenalineincreasessystemicarterial

blood pressuremoremarkedly.

According toanimalstudiesvolatileanaesthetics, especially cyclopropaneand halothane, may interactwith

dobutamine, giving riseto ventriculararrhythmias.

Addition ofatropinesulphateenhancestheincreasesin heartrateinduced by dobutamineand may counteractthe

deceleration in heartrateoccasionally observed in dobutaminestresstesting.

Pretreatmentwith acalciumchlorideload wasfound to decreasetheinotropiceffectsofdobutaminein onestudy.

Dobutaminemay increasetheclearanceoflidocainein patientswith severeheartfailureaccording to onestudy.

Dobutaminemay interferewith thedetectionofchloramphenicolby HPLC.

4.6Pregnancyandlactation

Asthereareno adequatedataon thesafety ofdobutaminein human pregnancy, anditisnotknown whether

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outweigh thepotentialrisksto thefoetusand thereareno safertherapeuticalternatives.

Itisnotknown, whetherdobutamineisexcreted in milk, so caution should beexercised. Ifdobutaminetreatment

ofthemotherisrequired duringlactation, breastfeeding shouldbediscontinued fortheduration oftreatment.

4.7Effectsonabilitytodriveandusemachines

Dueto theshortduration ofaction ofdobutamineno effectson theability to driveoruseofmachinesisto be

expected shortly aftertheend oftheinfusion.

4.8Undesirableeffects

Therapeuticuse:

An increasein heartrateby 5 to 15 beatsperminuteand in systolicblood pressureby 10-20 mmHg havebeen

noted frequently. Morepronounced increasesin heartrateand blood pressure(especially in patientswith

preexisting hypertension)havebeen reported occasionally.

Precipitousdecreasesinblood pressurehaveoccasionally been reported. Decreasing theinfusionrateor

(temporary)discontinuing oftheinfusion ofdobutaminein generalresultsin rapid return ofbloodpressureto

baselinevalues. In rarecases,however, symptomatictreatmentmay berequired and reversibility may notbe

immediate.

Occasionally aslightvasoconstriction hasbeen observed especially in patientspretreated with-blockers.

Occasionally supraventricularorventriculararrhythmias, primarily ventricularprematurebeats, may occur

especially in patientswith preexisting arrhythmias. In rarecasesdobutaminetreatmentwasassociated withatrial

fibrillation and seriousventriculararrhythmiasasventriculartachycardiaorfibrillation. Rapid ventricularresponse

hasbeen observed in patientswith atrialfibrillation oratrialflutter.

Thefollowing adverseeffectshavebeen reported in 1-3%ofpatients:nausea, vomiting, headache, anginalpain,

non-specificchestpain, palpitations, shortnessofbreath, tingling sensation orparaesthesia. In rarecasestremoror

flushing havebeen observed.

Dobutaminemay induceamild reduction in serumpotassiumconcentrationsbutrarely hypokalaemiahasbeen

observed.

Administration ofdobutaminecan induceamild reduction in serumpotassiumconcentration, butrarely

hypokalaemiahasbeen induced.

Athigh dosesurinary urgency wasreported by somepatients.

Reactionssuggestiveofhypersensitivity including skin rash, fever, eosinophiliaand bronchospasmhavebeen

reported occasionally.

Pruritusofthescalp during infusion ofdobutaminehasbeen observed. In isolated casesthrombocytopeniaand

petechialbleeding havebeen reported.

Localreactionsatthesiteoftheintravenousinfusion asphlebitishaveoccasionally been reported. Following

extravasation localinflammationshavebeen described and in isolated casesdermalnecroses(especially athigh

concentrationsoftheinfusion solution).

DobutamineHameln 5 mg/mlAmp. 50 mlcontainssodiummetabisulphite, which may causeallergictype

reactionsincluding anaphylaxisand life-threatening orlesssevereasthmaticepisodes.

During stresstest:

Theadverseeffectsseen during dobutaminestresstestarein principlethoseseen with therapeuticuse. However,

theincidenceofdose-related adverseeffectsisincreased. Chestpain, ST-segmentdeviations, dyspnoea,

palpitations, hypotension, cardiacarrhythmias(primarily atrialand ventricularprematurebeats)arecommon.

Seriousventriculararrhythmias, however, arerare.

Developmentofdynamiccardiacoutflowobstruction andofheartratedeceleration (afterinitialincrease)are

common. Hypertension hasbeen reported occasionally.

In rarecasescoronary spasms(withoutmyocardialnecrosis)havebeen induced and myocardialinfarctions, in part

occurring aftercessation oftheinfusion.

Otheradverseeffectsaschills, tremor, nausea, vomiting, flushing, headache, nervousnessand anxiety occur

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4.9Overdose

Thesymptomsofoverdosemay includeanorexia, nausea, vomiting, tremor, anxiety, palpitations, headache,

fatigue, shortnessofbreath and chestpain. Thepositiveinotropicand chronotropiceffectsofdobutaminemay

causehypertension, tachyarrhythmias, myocardialischaemiaand ventricularfibrillation. Hypotension may result

fromvasodilation.

Dueto theshortduration ofaction ofdobutamine, usually only areduction in infusion rateoratransientcessation

ofinfusion arenecessary untilstabilisation ofthepatient. Symptomatictreatmentshould beprovided isnecessary,

blood gasesandelectrolytescorrected.

Seriousventriculararrhythmiasmay betreated with lidocaineora-blocker(e.g. propranolol). Forced diuresis,

peritonealdialysisorcharcoalhaemoperfusionhavenotbeen establishedasbeneficial.

Ifdobutaminehydrochlorideisingested unpredictableabsorption may occur. Theuseofactivated charcoalis

recommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dobutaminefacilitatesatrioventricularconduction and shortenstheAV-noderecovery time. Dobutaminemay

enhanceorinduceectopicactivity.

Dobutamineincreases-asallinotropicagents-blood flowto poorly ventilated pulmonary areas. Theresulting

decreaseinarterialoxygen saturation, howeveriscompensated in generalby theincreasein oxygen delivery.

Dobutaminedoesnotacton dopaminergicreceptorsand hencedoesnotselectively dilaterenalorsplanchnic

vessels. However, dobutaminemay improverenalblood flow, glomerularfiltration rate, urinary outputand urinary

sodiumexcretion by increasing cardiacoutputand inducing vasodilatation.

5.2Pharmacokineticproperties

Following i.v. administration theonsetofaction ofdobutamineoccurswithin 2 minutes, peak effectsand steady

stateplasmaconcentrationswithin 10 minutesafterinitiation ofaparticularinfusion rate. Steady stateplasma

concentrationsarerelated linearly to theinfusion rate. Theeffectsofthedrug ceasesshortly afterdiscontinuation

oftheinfusion.

Itisnotknownifdobutaminecrossestheplacentaorisdistributed into milk.

Theplasmahalf-lifeisabout2 minutes. Theprincipalmetabolicpathwaysaremethylation by catecholamine-O-

methylase(COMT)and conjugation. Metabolitesareexcreted primarilyin urineand to aminorextentin bile. In

human urine, themajorexcretion productsaretheconjugatesofdobutamineand 3-O-methyl-dobutamine.

5.3Preclinical safetydata

Acutetoxicity:

In themouseand rattheintravenousLD ofdobutaminewas100 mg/kg, in thedog 40 mg/kg. Attoxicdoses

immediatecollapseofshortduration wasobserved. Surviving animalsshowed hyperactivity with increased heart

and respiratory rates, mydriasisand salivation.

Repeated dosetoxicity:

Over14 daysratstolerated daily intravenousdosesof10 mg/kg dobutamine, dogsthoseof4x15 mg/kg/d or50

µg/kg/min continuously. Cardiotoxiceffectsin dogswereassociated with early ECG-signs.

In studiesover30daysdobutamineatdosesup to 24 mg/kg/d in dogsand up to 80 mg/kg/d in ratswasassociated

with dose-dependenthypertrophyoftheacinuscellsoftheparotid gland andwith myocardialdamageatthehigh

and to aminorextentmediumdoses. In ratsthehighestdosewasassociated with a100%lethality within 19 days.

At2 mg/kg/d in ratsand 1.4 mg/kg/d in dogsno toxiceffectswereseen.

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with increased amplitudes, flushing, vomiting, tremor, prostration and salivation)wereobserved butno otherdrug-

induced damage.

Mutagenicand carcinogenicactivity:

No studiesareavailable.

Reproduction toxicity:

Studiesin ratsand rabbitsrevealed no indicationsforateratogeniceffect. In impairmentofimplantation and pre-

and postnatalgrowthretardationswereobserved ratsatdobutaminedosestoxicto themothers. No influenceon

fertility wasseen in studiesin rats.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiummetabisulphite, sodiumchloride, hydrochloricacid and waterforinjection.

6.2Incompatibilities

Dueto therisk ofincompatibilityDobutamineHameln 250 mg/50 mlisnotrecommended to bemixed in thesame

infusion asothermedicalsubstances.

DobutamineHameln 250 mg/50 mlshould notbemixed oradministered simultaneously with:

alkalinesolutions(e.g. sodiumbicarbonate)and solutionscontaining both sodiummetabisulphiteand ethanol,

acyclovir, aminophylline, bretyliumtosylate, bumetanide, calciumchloride, calciumgluconate, cefamandolenafate,

cephalotinesodium, cephazolinesodium, diazepam, digoxin, ethacrynatesodium, furosemide, heparin sodium,

hydrocortisonesodiumsuccinate, insulin, magnesiumsulfate, penicillin, phenytoin, potassiumchloride, streptokinase,

verapamil.

Sodiummetabisulphiteisavery reactivesubstance. Thereforeadegradation ofthiamine(vitamin B)may bepossible.

6.3ShelfLife

Shelf-lifebeforefirstopening:

3 years.

Shelf-lifeafterfirstopening and/ordilution:

Fromthemicrobiologicalpointofview, thesolutionsordilutionsshould beused immediately. Ifnotused

immediately, in-usestoragetimesand conditionspriorto usearetheresponsibility oftheuserand would normally

notbelongerthan 24 hoursat2 to 8°C.

6.4Special precautionsforstorage

Storebelow25°C.Keepin theoutercontainer.

6.5Natureandcontentsofcontainer

1 and 5 ampoulesmadeofcolourless, neutraltype1 Ph. Eur. glasscontaining 50 mlsolution.

6.6Instructionsforuseandhandling

In caseofconcomitantadministrationofotherdrugsdifferentvenouscathetersshould beused (c.f. 6.2.

Incompatibilities).

DobutamineHameln 250 mg/50 mlmay bediluted ifwanted. Diluentsmay be5%glucosesolution, 0.9%sodium

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Thesolution forinfusion should beprepared underasepticconditionsimmediately beforeuse. In principle, only clear

and colourlesssolutionsshould beused. Aslightpink discolouration, which may deepen with time, resultsfroma

slightoxidation ofthedrug, butthereisno relevantlossofpotency during therecommended storagetimein caseof

adherenceto therecommended precautionsforstorage.

Any unused portion hasto bediscarded.

7MARKETINGAUTHORISATIONHOLDER

Hameln PharmaceuticalsGmbH

LangesFeld 13,

D-31789 Hameln

Germany

8MARKETINGAUTHORISATIONNUMBER

PA971/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

November2003

10DATEOFREVISIONOFTHETEXT

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