GELOFUSINE

Main information

  • Trade name:
  • GELOFUSINE Solution for Infusion 4 %w/v
  • Dosage:
  • 4 %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GELOFUSINE Solution for Infusion 4 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/038/001
  • Authorization date:
  • 14-10-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0179/038/001

CaseNo:2035401

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B.BraunMedicalLimited

3NaasRoadIndustrialPark,Dublin12,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Gelofusine,solutionforinfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom14/10/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gelofusine,solutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinfusion

Clear,colourlessorslightlyyellowish,aqueoussolutionwithapHof7.1-7.7andanosmolarityof274mOsm/l.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asaplasmavolumesubstituteforuseintheinitialmanagementofhypovolaemicshockduetobloodorplasmaloss,

dehydrationorperi-operativelossofcirculatingfluid.Thesolutioncanbeusedforhaemodilutionandasapriming

solutionforextracorporealcirculationsystemsandasacarriersolutionforinsulin.

Inthecontextofthereplacementofspecificcomponentsfollowingbloodloss,itisgenerallypossibletoavoidgiving

redcellsuntilthelossesamountto20%ofthetotalbloodvolume.Ifmorethan2,000-3,000mlofGelofusine are

infusedpre-andintraoperatively,itisrecommendedthattheserumproteinconcentrationbecheckedpost-operatively,

especiallyiftherearesignsoftissueoedema.

per500ml per1000ml

Gelofusinecontains:

Succinylatedgelatin(modifiedfluidgelatin) 20.00g 40.00g

Sodiumchloride 3.51g 7.01g

Sodiumhydroxide 0.68g 1.36g

Electrolytes

77.00mmol 154.00mmol

60.00mmol 120.00mmol

Physico-ChemicalProperties

Weightaveragemolecularweight(Mw) 30,000Daltons

Numberaveragemolecularweight(Mn) 23,200Daltons

7.4±0.3

Relativeviscosity(at37 o

Iso-electricpoint pH4.5±0.3

Colloidosmoticpressure(at37 o

mmH

33.3mmHg

Gelpoint

+3 o

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preparationmaybetheappropriatechoiceforfurthervolumeexpansion.

4.2Posologyandmethodofadministration

Thesolutionisadministeredintravenously.Dosagevolume,andrateofadministrationdependsupontheindividual

patientstate,circumstancesandhisresponse.Thedurationandquantityoftheinfusionistobedeterminedindividually

onthebasisofpulse,bloodpressure,peripheralperfusionanddiuresis.

Asageneralguide500mlmaybegiveninnotlessthan60minutes.Insevereacutebloodloss,500mlmaybeinfused

rapidlyuntilsignsofhypovolaemiaareimproved.Precautionsare:Pressureinfusion,seesection4.4,Specialwarnings

andPrecautionsforUseandfiguresattheendofthistext.Amaximumof2litresinadultsor30ml/kginchildren

shouldbeexceededonlyifbloodisunavailable.Insuchcases,anadequatehaematocritshouldbemaintained,and

dilutionaleffectsoncoagulationshouldbeavoided.

Incaseofpressureinfusion,allairshouldberemovedfromthecontainerusingeitheraventedgivingsetorthefiltered

ventingneedleprovided.

Ifthereisblood/fluidlossinexcessof1.5litresintheadult(i.e.greaterthan20%bloodvolume)bloodshouldusually

beadministeredaswellasGelofusine ®

.Thehaemodynamic,haematologicalandcoagulationsystemsshouldbe

monitored.

(Thehaematocritshouldnotfallbelow25%orinelderlypatientsbetternotbelow30%,andcoagulationdisorders

causedbydilutionshouldbeavoided).

4.3Contraindications

Useinuncontrolledcongestivecardiacfailureorincirculatoryoverload.

Knownhypersensitivitytotheactiveconstituent.

4.4Specialwarningsandprecautionsforuse

Allergicreactionsofvaryingseveritymayoccurduetohistaminerelease.Theirfrequencyandseverityisreportedas

beinggreaterinatopicpatients.Immediateresuscitativemeasuresshouldbeavailable.

Treatment:

TheGelofusine infusionshouldbestoppedimmediately.Furthertreatmentdependsontheseverityofthe

anaphylactoidreaction:

Alternativevolumereplacements.

Elevationofthelegs.

Administrationofoxygen.

Immediateadministrationofadrenaline/epinphrineparenterally(e.g.0.5-1mlofadrenaline/epinephrine1:1,000

intramuscularly,

repeatedifnecessary,every15minutesor5-10mlofadrenaline/epinephrine1:10,000slowlyintravenously).

Administrationofhigh-dosecorticosteroidsintravenously.

Antihistamines(e.g.chlorpheniramine10-20mgslowlyintravenously).

Calcium(cautioninpatientsbeingtreatedwithcardiacglycosides)intravenouslymaybenecessary.

Observationsandtreatmentofthemetabolicacidosis.

Gelofusine ®

shouldonlybeusedwithextremecautioninpatientswithseriouscardiovasculardisorders(including

hypertension,congestiveheartfailure,cardiogenicshock),pulmonaryfunctionalimpairment,renalfailure,

haemorrhagicdiathesesorsodiumorpotassiumdeficiency.Carefulandappropriatemonitoringshouldaccompany

administration.

Gelofusine ®

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Incaseofpressureinfusion,whichmightbenecessaryinvitalemergencies,allairmustberemovedfromthecontainer

andtheinfusionsetbeforethesolutionisadministered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AlthoughwatersolubledrugsmaybegiveninGelofusine ®

,experienceislimited.Electrolyteandcarbohydrate

solutionsmaybegiventogetherthroughthesamecannulaastheGelofusine solutionbutthisisnotpermittedforfat

emulsions.

DuringGelofusine infusionstheresultsofthefollowingclinicalchemistrytestsmaybeunreliable:

Bloodsugar.

ESR.

Specificgravityofurine.

Protein.

Biuret.

Fattyacids.

Cholesterol.

Fructose.

Sorbitoldehydrogenase.

Thelowcalciumcontentdoesnotgiverisetoclottinginthegivingsetwhencitratedbloodprecedesand/orfollows

administration.

4.6Pregnancyandlactation

Thereisverylittleinformationavailableontheuseofplasmasubstitutesinpregnantorlactatingwomen.No

embryotoxiceffecthas,however,hithertobeenobserved,butthereisasmallriskofsevereanaphylactoidreactions.

Aswithalldrugs,thebenefitsandrisksofuseshouldbeassessedinthelightofthepatientscondition:Under

thesecircumstancesthispreparationshouldonlybeprescribedwhenthepotentialadvantageoutweighsthe

potentialrisktothefoetus.

Gelofusine ®

maybeusedintheinitialtreatmentofbloodlossduringpregnancywhereplasmavolumereplacementis

needed.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Anaphylactoid/anaphylacticreactionscanoccurasaresultofGelofusine ®

administration(see4.4Specialwarnings

andprecautions).

4.9Overdose

Gelofusine ®

shouldbegivenwithcaretopatientswhoaresusceptibleofcirculatoryoverloading(e.g.severe

congestivecardiacfailureorrenalfailurewitholiguriaoranuria)sinceexcessivevolumesmaygiverisetocirculatory

overloadandelectrolyteimbalance.

Treatment:

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adiureticmaybegiventopromotefluidloss.

Decreasedurinaryoutputsecondarytoshockisnotacontraindicationunlessthereisnoimprovementinurineoutput

aftertheinitialdoseofGelofusine®.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Isotonicsterileandpyrogen-free4%solutionofsuccinylatedgelatinin0.9%NaCl.Ithasavolumeeffectcomparable

tothevolumeinfused,andthereforedoesnothaveanintrinsicvolumeexpandereffect.

TheinfusionofGelofusine increasestheplasmavolume.Thisproducesanincreaseinvenousreturn,cardiacoutput,

arterialbloodpressureandperipheralperfusion.TheosmoticdiuresisinducedbyGelofusine hasasubstantialeffect

onthemaintenanceofrenalfunctioninshock.

ThecombinationofthefollowingeffectsofaGelofusine infusionproducesanimprovedoxygensupplytothe

tissues:

HaemodilutionwithGelofusine,whichhasarelativeviscositysimilartoplasma,reducestherelativeviscosity

oftheblood.Whengivenintheinitialmanagementofhypovolaemicshocktheoverallresultisaconsiderably

improvedpatternofbloodflowwithanincreasedcardiacoutput.

TheGelofusine infusionreducesthehaematocritandtherebytheoxygen-carryingcapacityoftheblood.

However,thereductioninbloodviscosityandthepositivechangesinthemicrocirculationreducetheworkloadofthe

heart,sothatthecardiacoutputcanbeincreasedwithoutanyincreaseinmyocardialoxygenconsumption.Theoverall

effectoftheGelofusine infusion,takingintoaccountthisincreaseincardiacoutputistoincreasetheoxygentransport

(ifthehaematocritdoesn’tsinkbelowabout25%orinelderlypatientsbetternotbelowmorethan30%).

Furthermore,thecolloidosmoticpropertiesofGelofusine preventorreducethepossibilityofinterstitial

oedema,whichmaylimittheoxygensupplytothetissues.

5.2Pharmacokineticproperties

Gelofusine hasbeenshowntohaveamulti-phaseeliminationcurvefromthebloodcirculation,withahalf-lifeof

about4hoursinthefirstphaseandaclearvolumeeffectofabout5hours.

Itappearsthatsome75%oftheinfusedgelatinmoleculesareexcretedthroughthekidneysandabout15%inthe

faeces.Inanimalexperimentsretentioninthereticulo-endothelialsystemfor24-48hourshasbeendemonstrated.The

fractionwhichisnotdirectlyexcretedisbrokendownbyproteolysis.Thisbreakdownprocessissoeffectivethatthere

isnoaccumulationeveninrenalfailure.

Thedoseadministeredisalwaysdeterminedbythegoalofanadequatecirculation.Thisappliesevenwhenrenal

excretionisreduced.

5.3Preclinicalsafetydata

ToxicologicalinvestigationswithGelofusineshowedittobewelltolerated,somuchsothatthemaximumdosageis

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

Gelofusinehasalowcalciumcontent(max0.4mmol/1)andthereforewillnotcauseclottingofbloodorplasma.

6.3ShelfLife

Shelflifeofthemedicinalproductaspackagedforsale:

3years.

Shelflifeafterfirstopeningthecontainer:

Theproductshouldbeusedimmediatelyafteropening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotrefrigerateorfreeze.

Donotuseunlessthesolutionisclearandcontainerisintact.

Anyunusedsolutionistobediscarded.

Onlyunopenedcontainersofproductshouldbeused.

6.5Natureandcontentsofcontainer

Gelofusineisavailableinthefollowingcontainersandpacksizes:

1x10semi-flexiblepolyethylenebottlesof500ml.

Eachboxcontains10filteredventingneedles.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

BBraunMedicalLimited

3NaasRoadIndustrialPark

Dublin12

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14October1992

Dateoflastrenewal: 14October2007

10DATEOFREVISIONOFTHETEXT

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