DEXTRAN 40

Main information

  • Trade name:
  • DEXTRAN 40
  • Dosage:
  • 10/5 %w/v %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEXTRAN 40
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/026/001A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dextran40IntravenousInfusionBP10%w/vinGlucoseIntravenousInfusionBP5.0%w/v.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1000mlcontains:

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforInfusion.

Aclear,colourless,sterile,aqueoussolutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dextran40isusedforearlyfluidreplacementorforplasmavolumeexpansionintheadjunctivetreatmentofcertain

typesofshock,orinimpendingshockwhenwholebloodorfluidproductsarenotavailable,includingshockresulting

fromburns,surgery,haemorrhageortrauma,inwhichcirculatingvolumedeficitispresent.Itshouldnotreplaceother

formsoftherapyknowntobeofvalueinthetreatmentofshock.

Itmaybeusedtoimprovebloodflowandtissuefunctioninconditionsassociatedwithlocalischaemiae.g.peripheral

limbischaemia.

Itisalsousedasaprimingfluideitherasasoleagentorasanadditiveinpumpoxygenatorsduringextra-corporal

circulation.

4.2Posologyandmethodofadministration

Dosage

Therecommendeddosageisdependantupontheage,weightandclinicalconditionofthepatient.

Hypovolaemicshock

Theusualdoseis500to1000ml,dependingonindividualresponse.Thisdoseshouldnotbeexceededexceptin

unusualcircumstances.Recommendeddosagetochildrenis10ml/kgandtobabies5ml/kg.

Toimprovebloodflowandtissuefunctioninburnsandconditionsassociatedwithlocalischaemia

Theusualdoseis500mlpriortosurgeryand500mlduringsurgery.Dosagedependsonindividualpatient

Dextran40/Dextran40forInjection 100 g

Anhydrousglucose 50 g

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2043488 page number: 1

Inextracorporealperfusion

ThedoseofDextran40IntravenousInfusionBPwilldependuponthevolumeneededtoprimethepumpoxygenator.

Usually,atotaldoseof10-20mlperkgofbodyweightisaddedtotheperfusioncircuit.ThetotalDextran

concentrationshouldnotexceed3%andthiscanbelimitedandcontrolledbyaddingotherprimingfluids.

Administration

Thesolutionisforadministrationbyintravenousinfusiononly.

4.3Contraindications

Dextran40IntravenousInfusionBPiscontraindicatedinthepresenceofthrombocytopenia,severecongestiveheart

failure,renaldiseasewithsevereoliguriaoranuriaandwherethereisknownhypersensitivitytoDextran,andin

patientsreceivingheparinorlowmolecularweightheparins(seebelow).

4.4Specialwarningsandprecautionsforuse

Dextran40IntravenousInfusionBPmaygiverisetoanaphylactoidreactions,usuallyinthefirstfewminutesof

infusion,particularlyinpatientswithahistoryofasthmaorallergy.Patientsshouldbecarefullysupervisedand

appropriateresuscitatorymeasuresshouldbeimmediatelyavailable.Lessseveresideeffectssuchasurticaria,nausea,

vomiting,fever,jointpainsandflushingmayalsooccur.

Overloadingofthecirculationwithensuingcardiacdistressandpulmonaryoedemamayoccurwiththisproduct.It

shouldthereforebegivenwithcautiontopatientsvulnerabletovascularoverloadinge.g.congestivecardiacfailureand

renaldisease.

Dextran40maygiverisetorenalimpairmentresultingfromtubulardamageormorerarelyacuteglomerulo-nephritis.

Thedangeroftheformerisincreasedinthedehydrated/oliguricstate,andtheproductshouldnotbeusedifdiuresisis

lessthan1500ml/24hr.

Excessiveuseofthisproductmayleadtoahaemorrhagicdiathesisandprolongedbleeding,duetointerferencewith

plateletfunctionandplasmaclottingfactors.Itshouldnotbeusedinconjunctionwithheparinorlowmolecular

weightheparins.

ThepresenceofDextraninbloodmayinterferewithbloodgrouptyping,whenenzymaticmethodsareused.

ThissolutionishyperosmoticanddehydrationshouldbecorrectedbeforeoratleastduringDextraninfusion.

Dextraninfusionsproduceaprogressivedilutionofoxygencarryingcapacity,coagulationfactorsandplasmaproteins.

Deficienciesshouldbecorrectedandfluidandelectrolytebalancemaintained.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusewithheparinorlowmolecularweightheparins(seeSection4.4above).

Dextran40IntravenousInfusionBPhasatendencytocrystallisewhenstoredatlowtemperatures.Storageshould

thereforebeataconstanttemperature,notexceeding25°C.Ifthesolutioniscloudyorcontainssedimentitshouldnot

beused.

Aswithallparenterals,compatibilitiesshouldbecheckedwhenadditivesareused.Alwaysdiscontinuedosageifan

adversereactionoccurs.

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4.6Pregnancyandlactation

SafeuseofDextran40duringpregnancyorlactationhasnotbeenestablishedandshouldnotbeusedunlessthe

potentialbenefitsoutweighthepossibleriskstothefoetusorneonate.

Anaphylacticreactions(seeotherundesirableeffects)duringpregnancyhavebeenreportedtocauseanoxicbrain

damagewhichhasresultedindeathofthefoetusinsomecases.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Mildurticarialreactions,rarelysevereanaphylactoidreactions,increaseinviscosityandspecificgravityofurine,

reversibletubularvacuolisation,increasedserumlevelsofaspartateoralaninetransaminasesandoccasionallytransient

acidosis.

Aswithanyprolongedinfusion,venousirritationandthrombophlebitismayoccurattheinjectionsite.

4.9Overdose

Intheeventofanaccidentaloverinfusion,treatmentshouldtemporarilybeeitherdiscontinuedorrateofinfusion

decreasedsignificantly,dependingonextentofoverinfusion.Thepatientshouldbeobservedforsymptomsandsigns

ofcardiorespiratorydecompensation,hepaticandrenalfunctions.Fluidandelectrolytebalanceshouldbecarefully

monitoredtogetherwithanyevidenceofbleedingdiathesis.Othersymptomaticandsupportivemeasuresshouldbe

provided.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Dextran40isknowntoenhancebloodflowbythefollowingmechanisms:

Increasingbloodvolume.

Decreasingtheviscosityoftheblood.

Reducingtheaggregationoftheerythrocytes,bycoatingthemandtherebymaintainingtheirelectronegative

charge.

Increasingcapillaryperfusionbycombinationsoftheforegoingaction.

Advantagesoverhomologousbloodandotherprimingfluidsasaprimerinpumpoxygenation:

Decreaseddestructionoferythrocytesandplatelets.

Maintenanceoftheelectronegativityoferythrocytesandplatelets.

5.2Pharmacokineticproperties

Whenadministeredtoapatientinshock,Dextran40mayincreasebloodvolume,bloodpressure,pulsepressure,

capillaryperfusion,centralvenouspressure,urinaryoutputanddecreaseheatrate,peripheralresistanceandmean

transittime.About70%oftheDextran40administeredisexcretedintheurinewithin24hoursofadministration.The

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5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Sodiumhydroxide

Hydrochloricacid,concentrated

6.2Incompatibilities

Donotuseadditivesunlesscompatibilityisknown.

Donotadministerbloodthroughthesamegivingset.

6.3ShelfLife

Unopened:2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aclear,collapsible,PVC,container,effectivelysealed,availablein500mlor1000mlvolumes.Thecontaineris

sealedinahighdensitypolyethyleneorpolypropyleneoverpouch.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

Discardanyunusedportion.

Donotreconnectpartiallyusedbags.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLimited,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1983

Dateoflastrenewal:1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2043488 page number: 5