GENTRAN 40 (DEXTRAN 40 INTRAVENOUS INFUSION BP 10%

Main information

  • Trade name:
  • GENTRAN 40 (DEXTRAN 40 INTRAVENOUS INFUSION BP 10%
  • Dosage:
  • 10/0.9 %w/v %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GENTRAN 40 (DEXTRAN 40 INTRAVENOUS INFUSION BP 10%
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/025/001A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gentran40(Dextran40IntravenousInfusionBP10%w/vinSodiumChlorideIntravenousInfusionBP0.9%w/v).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1000mlcontains:

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforInfusion.

Aclear,colourless,sterile,aqueoussolutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanadjunctinthetreatmentofhypovolaemicshock.

Prophylaxisofthromboembolicepisodesinsurgery.

Asadiluentinthepumpoxygenatorduringextra-corporealcirculation.

Toimprovebloodflowandtissuefunctioninburnsandconditionsassociatedwithlocalischaemia.

4.2Posologyandmethodofadministration

Dosage

Thedosageisdependentupontheage,weightandclinicalconditionofthepatient.

HypovolaemicShock

Adults

Usualdoseis500to1500ml,dependingonindividualresponse.Thisdoseshouldnotbeexceededexceptinunusual

circumstances.

PaediatricPatients

Children10ml/kg-Babies5ml/kg.

Prophylaxisofthromboembolicepisodes

500-1000mldailycommencingondayofsurgeryandcontinuingfor2-5dayspostoperatively.

Asdiluentinpumpoxygenator

Dextran40(Dextran40forInjection)100g

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043478 page number: 1

Toimprovebloodflowandtissuefunctioninburns/ischaemia

Usualdoseis500mlpriortosurgeryand500mlduringsurgery.Dosagedependsonindividualpatient’scircumstances

andresponse.

Administration

Intravenous.

4.3Contraindications

Useinpatientshypersensitivetodextrans.

Useinpatientswithseverecongestiveheartfailureorcardiacdecompensation,thrombocytopeniaorinthosewith

anuriaorsevereoliguria.

4.4Specialwarningsandprecautionsforuse

Overloadingofthecirculationwithensuingcardiacdistressandpulmonaryoedemamayoccurwiththisproduct.It

shouldthereforebegivenwithcautiontopatientsvulnerabletovascularoverloadinge.g.congestivecardiacfailureand

renaldisease.

Excessiveuseofthisproductmayleadtoahemorrhagicdiathesisandprolongedbleeding,duetointerferencewith

plateletfunctionandplasmaclottingfactors.Itshouldnotbeusedinconjunctionwithheparin.

Presenceofdextraninbloodmayinterferewithbloodgrouptyping,whenenzymaticmethodsareused.

Thisproductmaygiverisetorenalimpairmentresultingfromtubulardamageormorerarelyacuteglumerulo-

nephritis.Thedangeroftheformerisincreasedinthedehydrated/oliguricstate,andtheproductshouldnotbeusedif

diuresisislessthan1500ml/24hour.

Thissolutionishyperosmoticanddehydrationshouldbecorrectedbeforeoratleastduringdextraninfusions.

Dextraninfusionsproduceaprogressivedilutionofoxygencarryingcapacity,coagulationfactorsandplasmaproteins.

Deficienciesshouldbecorrectedandfluidandelectrolytebalancemaintained.

Discontinueifadversereactionoccurs.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notspecified.

4.6Pregnancyandlactation

Theproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.Anaphylacticreactions

inthemotherhavebeenreportedtocauseanoxicbraindamagewhichresultedinthedeathofthefoetusinanumberof

cases.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043478 page number: 2

4.8Undesirableeffects

Thisproductmaygiverisetosevereanaphylactoidreactions,usuallyinthefirstfewminutesofinfusion,particularlyin

patientswithahistoryofasthmaorallergy.Patientsshouldbecarefullysupervisedandappropriateresusitatory

measuresshouldbeimmediatelyavailable.Lessseveresideeffectssuchasurticaria,nausea,vomiting,fever,joint

painsandflushingmayoccur.

4.9Overdose

Notspecified.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Notapplicable.

5.2Pharmacokineticproperties

Lowmolecularweightpolysaccharide,70%ofwhichisexcretedinurinein24hours.Slowmetabolismofthe

remaindertocarbondioxideandwatertakesplaceintheliver.

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,PVCcontainereffectivelysealed,availablein500mlor1000mlvolumes.Thecontainerissealed

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043478 page number: 3

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

Discardanyunusedportion.

Donotreconnectpartiallyusedbags.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0167/025/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:1 st

April1983

Dateoflastrenewal:1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 15/11/2007 CRN 2043478 page number: 4