GENTRAN 70 (DEXTRAN 70 INTRAVENOUS INFUSION BP 6.0

Main information

  • Trade name:
  • GENTRAN 70 (DEXTRAN 70 INTRAVENOUS INFUSION BP 6.0
  • Dosage:
  • 6/0.9 %w/v %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GENTRAN 70 (DEXTRAN 70 INTRAVENOUS INFUSION BP 6.0
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/027/001A
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gentran70(Dextran70IntravenousInfusionBP6.0%w/vinSodiumChlorideIntravenousInfusionBP0.9%w/v).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1000mlcontains:

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforInfusion.

Aclear,colourless,sterile,aqueoussolutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dextran70isusedforearlyfluidreplacementorforplasmavolumeexpansionintheadjunctivetreatmentofcertain

typesofshock,orinimpendingshockwhenwholebloodorfluidproductsarenotavailable,includingshockresulting

fromburns,surgery,haemorrhageortrauma,inwhichcirculatingvolumedeficitispresent.Itshouldnotreplaceother

formsoftherapyknowntobeofvalueinthetreatmentofshock.

4.2Posologyandmethodofadministration

Dosage

Thedosageisdependentupontheage,weightandclinicalconditionofthepatient.

Hypovolaemicshock

Theusualdoseis500mlto1000mlinitially,followedby500mllaterifnecessary,dependingontheindividual

response.Thisdoseshouldnotbeexceededexceptinunusualcircumstances.Recommendeddosageinchildrenis10

ml/kgandinbabies5ml/kg.

Administration

Thesolutionisforadministrationbyintravenousinfusiononly.

4.3Contraindications

Dextran70IntravenousInfusionBPiscontraindicatedinthepresenceofthrombocytopenia,severecongestiveheart

failure,renaldiseasewithsevereoliguriaoranuria,wherethereisknownhypersensitivitytoDextran,andinpatients

Dextran70(Dextran70forInjection) 60 g

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2043496 page number: 1

4.4Specialwarningsandprecautionsforuse

Dextran70IntravenousInfusionBPmaygiverisetoanaphylactoidreactions,usuallyinthefirstfewminutesof

infusion,particularlyinpatientswithahistoryofasthmaorallergy.Patientsshouldbecarefullysupervisedand

appropriateresuscitatorymeasuresshouldbeimmediatelyavailable.

Lessseveresideeffectssuchasurticaria,nausea,fever,jointpainsandflushingmayalsooccur.

Overloadingofthecirculationwithensuingcardiacdistressandpulmonaryoedemamayoccurwiththisproductand

thepatientshouldbecarefullyobservedforsignsofvascularoverloading.Itshouldthereforebegivenwithcautionto

patientsvulnerabletovascularoverloadinge.g.congestivecardiacfailureandrenaldisease.

Dextran70maygiverisetorenalimpairmentresultingfromtubulardamageormorerarelyacuteglomerulo-nephritis.

Thedangeroftheformerisincreasedinthedehydrated/oliguricstate.Followingadministrationof500ml,ifno

increaseinurinaryoutputisobserved,theinfusionshouldbediscontinueduntiladequatediuresisisestablished.

Precautions

Excessiveuseofthisproductmayleadtoahaemorrhagicdiathesisandprolongedbleeding,duetointerferencewith

plateletfunctionandplasmaclottingfactors.Itshouldnotbeusedinconjunctionwithheparinorlowmolecular

weightheparins.

ThepresenceofDextraninbloodmayinterferewithbloodgrouptyping,whenenzymaticmethodsareused.

ThesolutionishyperosmoticanddehydrationshouldbecorrectedbeforeoratleastduringDextraninfusion.

Dextraninfusionsproduceaprogressivedilutionofoxygencarryingcapacity,coagulationfactorsandplasmaproteins.

Deficienciesshouldbecorrectedandfluidandelectrolytebalancemaintained.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Donotusewithheparinorlowmolecularweightheparins(seeSection4.4above).

Dextran70IntravenousInfusionBPhasatendencytocrystallisewhenstoredatlowtemperatures.Storageshould

thereforebeataconstanttemperaturenotexceeding25 o

C.Ifthesolutioniscloudyorcontainssedimentitshouldnot

beused.

Aswithallparenterals,compatibilitiesshouldbecheckedwhenadditivesareused.Alwaysdiscontinuedosageifan

adversereactionoccurs.

Thoroughandcarefulmixingofanyadditivesismandatory.Avoidstorageofsuchsolutions.

4.6Pregnancyandlactation

SafeuseofDextran70duringpregnancyorlactationhasnotbeenestablishedandshouldnotbeusedunlessthe

potentialbenefitsoutweighthepossibleriskstothefoetusorneonate.

Anaphylacticreactions(seesection4.8UndesirableEffects)duringpregnancyhavebeenreportedtocauseanoxic

braindamagewhichhasresultedindeathofthefoetusinsomecases.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

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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

Colloidalsolutionwhichholdsabout20mlofwaterpergramofdextran.

5.2Pharmacokineticproperties

Whenadministeredtoapatientinshock,Dextran70mayincreasebloodvolume,bloodpressure,pulsepressure,

capillaryperfusion,centralvenouspressure,urinaryoutputanddecreaseheatrate,peripheralresistanceandmean

transittime.About70%oftheDextran70administeredisexcretedintheurinewithin24hoursofadministration.The

remainderispartlyexcretedinthefaecesandpartlymetabolised.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydroxide

Hydrochloricacid,concentrated

Waterforinjections

6.2Incompatibilities

Donotadministerbloodthroughthesamegivingset.

Donotuseadditivesunlesscompatibilityisknown.

6.3ShelfLife

Unopened:2years.

6.4Specialprecautionsforstorage

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2043496 page number: 3

6.5Natureandcontentsofcontainer

Aclear,collapsible,PVCcontainereffectivelysealed,availablein500mlor1000mlvolumes.Thecontainerissealed

inahighdensitypolyethyleneorpolypropyleneoverpouch.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandthecontainerisundamaged.

Discardanyunusedportion.

Donotreconnectpartiallyusedbags.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLimited,

CaxtonWay,

Thetford,

Norfolk,

IP243SE,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0167/027/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:1 st

April1983

Dateoflastrenewal:1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2043496 page number: 4