DEXTRAN 70

Main information

  • Trade name:
  • DEXTRAN 70
  • Dosage:
  • 6/5 %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEXTRAN 70
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/028/001A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dextran70IntravenousInfusionBP6.0%w/vinGlucoseIntravenousInfusionBP5.0%w/v.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1000mlcontains:

Forexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionforinfusion.

Aclear,colourless,sterile,aqueoussolutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofearlystagesofvenousthrombosis.

Asaplasmavolumeexpanderintreatmentofhypovolaemicshock,haemorrhagictraumaticburns.

Prophylaxisofpostoperativethromboembolism.

4.2Posologyandmethodofadministration

Dosage

Thedosageisdependentupontheage,weightandclinicalconditionofthepatient.

Asplasmavolumeexpander

Usualdoseis500to1500ml,dependingontheindividualresponse.Thisdoseshouldnotbeexceeded

exceptinunusualcircumstances.

Forprophylaxisofpostoperativethromboembolism/treatmentofearlystagesofvenousthrombosis

Theusualdoseis500mlbeforesurgery,ifnecessaryfollowedby500mldailyoneveryotherday.

Administration

Dextran70/Dextran70forInjection 60.0 g

Anhydrousglucose 50.0 g

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2039934 page number: 1

4.3Contraindications

Dextran70iscontraindicated:

Inpatientswithseverecongestiveheartfailureorcardiacdecompensation,thrombocytopeniaorinthosewith

anuriaorsevereoliguria

Inpatientshypersensitivetodextrans.

4.4Specialwarningsandprecautionsforuse

Lessseveresideeffects,suchasurticaria,nausea,vomiting,fever,jointpainsandflushingmayoccur.

Overloadingofthecirculationwithensuingcardiacdistressandpulmonaryoedemamayoccurwiththisproduct.It

shouldthereforebegivenwithcautiontopatientsvulnerabletovascularoverloadingeg.congestivecardiacfailureand

renaldisease.

Excessiveuseofthisproductmayleadtoahemorrhagediathesisandprolongedbleeding,duetointerferencewith

plateletfunctionandplasmaclottingfactors.Itshouldnotbeusedinconjunctionwithheparin.

Thepresenceofdextraninbloodmayinterferewithbloodgrouptryingwhencarriedoutbyenzymaticmethods.

Thissolutionishyperosmoticanddehydrationshouldbecorrectedbeforeoratleastduringdextraninfusion.

Dextraninfusionsproduceaprogressivedilutiontooxygencarryingcapacitycoagulationfactorsandplasmaproteins.

Deficienciesshouldbecorrectedandfluidandelectrolytebalancedmaintained.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Theproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.

Anaphylacticreactionsinthemotherhavebeenreportedtocauseanoxicbraindamagewhichresultedindeathofthe

foetusinanumberofcases.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Maygiverisetosevereanaphylactoidreactionsusuallyinthefirstfewminutesofinfusionparticularlyinpatients

withahistoryofasthmaorallergy.Patientsshouldbecarefullysupervisedandappropriateresuscitatorymeasures

shouldbeimmediatelyavailable.

4.9Overdose

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2039934 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Polysaccharideofwhich50%ofanintravenousdoseisexcretedinurinewithin24hours.Theremainderisslowly

metabolisedinlivertocarbondioxideandwater.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Sodiumhydroxide

Hydrochloricacid,concentrated

6.2Incompatibilities

Donottransfusebloodthroughthesamegivingset.

Donotuseadditivesunlesscompatibilityisknown.

6.3ShelfLife

Unopened:2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aclear,collapsiblePVCcontainer,effectivelysealed,availablein500mlor1000mlvolumes.Eachcontaineris

sealedintoahighdensitypolyethyleneorpolypropyleneoverpouch.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlessthesolutionisclearandthecontainerisundamaged.

Discardanyunusedportion.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2039934 page number: 3

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0167/028/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:1 st

April1983

Dateoflastrenewal:1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2039934 page number: 4