DOBUTAMINE-HAMELN 250 MG/ 5 ML AMPOULE

Main information

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

Documents

Localization

  • Available in:
  • DOBUTAMINE-HAMELN 250 MG/ 5 ML AMPOULE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0971/002/004
  • 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/5 mlampouleconcentrateforsolution forinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolution contains50mg Dobutamineequivalentto 56mg DobutamineHCl.Each 5mlampoulecontains250mg

Dobutamineequivalentto 280mg DobutamineHydrochloride.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Concentrateforsolution 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 casewhereexercisestresstesting isnotfeasibleor

inadequate.

4.2Posologyandmethodofadminstration

Dueto itsshorthalf-lifedobutaminehasto beadministered by continuousintravenousinfusion.

DobutamineHameln 50 mg/mlampoule.5 mlmay bediluted ifwanted.Diluentsmay be5 %glucosesolution, 0.9 %

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

Note:DobutamineHameln 50 mg/mlampoule.5 mlmay notbemixed with 5%sodiumbicarbonatesolution orany

otherstrong alkalinesolution. Dueto therisk ofincompatibility DobutamineHameln 50 mg/mlampoule. 5 mlisnot

recommended to bemixed in thesameinfusion asothermedicalsubstances.

DobutamineHameln 50 mg/mlampoule. 5 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 the

refrigerator. In principle, onlyclearand colourlesssolutionsshould beused. Aslightpink discolouration, which may

deepen with time, resultsfromaslightoxidation ofthedrug, butthereisno relevantlossofpotency during the

recommended storagetimein caseofadherenceto therecommended precautionsforstorage.

Therapeuticdosage:

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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, adoseas

lowas0.5µg/kg/min willelicitaresponse. Rarely, adoseashigh as40µg/kg/min isrequired.

Dosagein children:

Thesafety and efficacy ofdobutamineforusein children havenotbeen established.

Thenecessary infusion ratedependson theresponseofthepatientand theoccurrenceofpossibleadverseevents.The

rateofinfusion isincreased at10-30 minutesintervalsuntilthedesired haemodynamiceffectsareachieved or

undesired effectspreventafurtherincreasein dose.

Theduration ofthetreatmentdependson theclinicalneeds. Caution hasto beexercised in casethedoseexceeds10

µg/kg/min orthetreatmentduration islongerthan 72 hours.

An i.v. drip chamberorothersuitablemeteringdeviceisessentialforcontrolling therateofflowin dropsperminute.

High concentrationsshould only begiven with aninfusion 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. Concentrationsashigh as

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

Dosageforcardiacstresstesting:

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

of40µg/kg/min, each dosebeing infused for3 minutes.In addition atropinemay beadded during furtherinfusion of

thepeak dosein caseofnotachieving an endpointwith dobutaminealone. ContinuousECGmonitoring isessentialand

theinfusion terminated in theeventofST-segmentdepression of>0.2 mV(2 mm)measured 80 msaftertheJpoint, a

ST-segmentelevation of>0.1 mV(1 mm)in patientswithouthistory ofmyocardialinfarction, orany significant

cardiacarrhythmias.

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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cardiacwallmotion abnormalities, severechestpain orany non-tolerableadverseeffectoccur.

Thedobutaminestresstestshould only beundertaken in units, wherepersonnelspecially trained in resuscitation and

resuscitation equipmentincluding 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 adequatefacilitiesareavailableforpatientsurveillance

and themonitoring ofresponses. During dobutamineinfusionsheartrate, cardiacrhythm(by ECG), bloodpressure,

urineflowand infusion rateshould bemonitored continuously and, ifpossiblecardiacoutput, centralvenouspressure

and pulmonary capillary wedgepressurebecontrolled.

Thedobutaminestresstestshould only beundertaken in units, wherepersonnelspecially trained in resuscitation and

resuscitation equipmentincluding adefibrillatorareimmediately available.

Dobutaminemay causeamarked increasein heartrateorblood pressure, especially systolicpressure. Patientswith

pre-existing hypertension appearto beatgreaterrisk ofdeveloping ahypertensiveresponse. Ifan undueincreasein

heartrateorsystolicblood pressureoccursorifan arrhythmiaisprecipitated thedoseofdobutamineshould be

reduced orthedrug should bediscontinued temporarily.

Dobutaminemay precipitateorexacerbateventricularectopicactivity, rarely ithascaused ventriculartachycardiaor

fibrillation. Becausedobutaminefacilitatesatrioventricularconduction, patientswith atrialflutterorfibrillation may

develop rapid ventricularresponsesand thereforeshould bedigitalised priorto administration ofdobutamine.

Inotropicagents, including dobutamine, do notimprovehaemodynamicsin mostpatientswithmechanicalobstruction

thathinderseitherventricularfilling oroutflow, orboth. Inotropicresponsemay beinadequateinpatientswith

markedly reduced ventricularcompliance. Such conditionsarepresentin cardiactamponade, valvularaorticstenosis,

and idiopathichypertrophicsubaorticstenosis.

Particularcareshould beexercised when dobutamineisused in patientswith acutemyocardialinfarction becauseany

significantincreasein heartrateorexcessiveincreasesin arterialpressurethatoccurmay intensify ischaemiaand

causeanginalpain and ST-segmentelevation.

Aswithothercatecholaminesdobutaminecan also triggeran onsetofanginain patientswith ischaemicheartdisease

and consequently particularcareshould beexercised, when dobutamineisgiven to patientswith ischaemicheart

disease.

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. Unlikein

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 baselinevalues,

butrarelyintervention may berequired and reversibility may notbeimmediate.

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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 diabeticpatientstheglucoseconcentration

should becontrolled and theinsulin doseadjusted ifnecessary.

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

increasein dosenecessary.

DobutamineHameln 50 mg/mlAmp. 5 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 heart

rateand peripheralvasodilation.

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

outputand decreasesystemicperipheralresistanceand ventricularfilling pressuremorethan eitherdrug alone.

Concomitantuseofdobutamineand MAO-inhibitorsmay resultin marked increasesinblood pressureand heartrate

and in increased incidenceofarrhythmias. Even life-threatening adverseeffectsmay resultashypertensivecrisis,

cardiovascularcollapse, intracranialhaemorrhageand arrhythmias.

Concomitantadministration ofguanethidineand rauwolfiaalkaloidswith dobutaminemightresultin augmented

increasesin blood pressureand arrhythmiafrequency. Theophyllinewassupposed to increasetheheartrateresponse

in 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(temporal)

discontinuing oftheinfusion ofdobutaminein generalresultsin rapid return ofblood pressureto baselinevalues. In

rarecases, however, symptomatictreatmentmay berequiredand reversibility may notbeimmediate.

Occasionally aslightvasoconstriction hasbeen observed especially in patientspretreated with-blockers.

Occasionally supraventricularorventriculararrhythmias, primarily ventricularprematurebeats, may occurespecially

in patientswith pre-existing arrhythmias. In rarecasesdobutaminetreatmentwasassociated with atrialfibrillation and

seriousventriculararrhythmiasasventriculartachycardiaorfibrillation. Rapid ventricularresponsehasbeen observed

in patientswith atrialfibrillation oratrialflutter.

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

specificchestpain, palpitations, shortnessofbreath, tingling sensation orparaesthesia. In rarecasestremororflushing

havebeen observed.

Dobutaminemay induceamild reduction in serumpotassiumconcentrationsbutrarely hypokalaemiahasbeen

observed.

Administration ofdobutaminecan induceamild reduction in serumpotassiumconcentration, butrarely hypokalaemia

hasbeen induced.

Athigh dosesurinary urgency wasreported by somepatients.

Reactionssuggestiveofhypersensitivity including skin rash, fever, eosinophiliaand bronchospasmhavebeen reported

occasionally.

Pruritusofthescalp during infusion ofdobutaminehasbeen observed. In isolatescasesthrombocytopeniaand

petechialbleeding havebeen reported.

Localreactionsatthesiteoftheintravenousinfusion asphlebitishaveoccasionally been reported. Following

extravasation localinflammationshavebeen described and in isolated casesdermalnecroses(especially athigh

concentrationsoftheinfusion solution).

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

including anaphylaxisand life-threatening orlesssevereasthmaticepisodes.

During stresstest:

Theadverseeffectsseen during dobutaminestresstestarein principlethoseseen with therapeuticuse. However, the

incidenceofdose-related adverseeffectsisincreased. Chestpain, ST-segmentdeviations, dyspnoea, palpitations,

hypotension, cardiacarrhythmias(primarily atrialand ventricularprematurebeats)arecommon. Seriousventricular

arrhythmias, 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 other

drug-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, hydrochloricacid and waterforinjection.

6.2Incompatibilities

Dueto therisk ofincompatibilityDobutamineHameln 250 mg/5 mlisnotrecommended to bemixed in thesame

infusion asothermedicalsubstances.

DobutamineHameln 250 mg/5 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 outercontainer.

6.5Natureandcontentsofcontainer

1, 5 and 50 ampoulesmadeofcolourless, neutraltype1 Ph. Eur., each containing 5 mlsolution.

6.6Instructionsforuseandhandling

In caseofconcomitantadministrationofotherdrugsdifferentvenouscathetersshould beused (c.f. 6.2.

Incompatibilities).

DobutamineHameln 250 mg/5 mlmay only beused forintravenousinfusion afterdilution with suitablediluentsto a

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solution, Ringer-lactate, orasolution of0.45%sodiumchlorideand 5%glucosesolution.

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

PA971/2/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4 th

November2003

10DATEOFREVISIONOFTHETEXT

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