FLEXBUMIN 200 G/ L SOLUTION FOR INFUSION

Main information

  • Trade name:
  • FLEXBUMIN 200 G/ L SOLUTION FOR INFUSION
  • Dosage:
  • 200 g/ l
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLEXBUMIN 200 G/L SOLUTION FOR INFUSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/128/001
  • Authorization date:
  • 24-08-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Flexbumin200g/lsolutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Flexbumin200g/lisasolutioncontaining200g/l(20%)oftotalproteinofwhichatleast95%ishumanalbumin.

Abagof100mlcontains20gofhumanalbumin.

Abagof50mlcontains10gofhumanalbumin

Thesolutionishyperoncotic

Excipients:

Sodium 130-160mmol/l

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinfusion.

Aclear,slightlyviscousliquid;itisalmostcolourless,yellow,amberorgreen.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Restorationandmaintenanceofcirculatingbloodvolumewherevolumedeficiencyhasbeendemonstrated,anduseof

acolloidisappropriate.

Thechoiceofalbuminratherthanartificialcolloidwilldependontheclinicalsituationoftheindividualpatient,based

onofficialrecommendations.

4.2Posologyandmethodofadministration

Theconcentrationofthealbuminpreparation,dosageandtheinfusionrateshouldbeadjustedtothepatient’s

individualrequirements.

Posology

Thedoserequireddependsonthesizeofthepatient,theseverityoftraumaorillnessandoncontinuingfluidand

proteinlosses.Measuresofadequacyofcirculatingvolumeandnotplasmaalbuminlevelsshouldbeusedtodetermine

thedoserequired.

Ifhumanalbuministobeadministered,haemodynamicperformanceshouldbemonitoredregularly;thismayinclude:

-arterialbloodpressureandpulserate

-centralvenouspressure

-pulmonaryarterywedgepressure(PCW-pressure)

-urineoutput

-electrolyte

-haematocrit/haemoglobin

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-clinicalsignsofincreasingintra-cranialpressure(e.g.headache)

MethodofAdministration

Flexbumin200g/lcanbedirectlyadministeredbytheintravenousroute,oritcanalsobedilutedinanisotonicsolution

(e.g.5%glucoseor0.9%sodiumchloride).

Theinfusionrateshouldbeadjustedaccordingtotheindividualcircumstancesandtheindication.

Inplasmaexchangetheinfusionrateshouldbeadjustedtotherateofremoval.

4.3Contraindications

Hypersensitivitytoalbuminpreparationsortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Suspicionofallergicoranaphylactictypereactionsrequiresimmediatediscontinuationoftheinjection.Incaseof

shock,standardmedicaltreatmentforshockshouldbeimplemented.

Albuminshouldbeusedwithcautioninconditionswherehypervolaemiaanditsconsequencesorhaemodilutioncould

representaspecialriskforthepatient.Examplesofsuchconditionsare:

-Decompensatedcardiacinsufficiency

-Hypertension

-Oesophagealvarices

-Pulmonaryoedema

-Haemorrhagicdiathesis

-Severeanaemia

-Renalandpost-renalanuria

Thecolloid-osmoticeffectofhumanalbumin200g/lor250g/lisapproximatelyfourtimesthatofbloodplasma.

Therefore,whenconcentratedalbuminisadministered,caremustbetakentoassureadequatehydrationofthepatient.

Patientsshouldbemonitoredcarefullytoguardagainstcirculatoryoverloadandhyperhydration.

200g/l–250g/lHumanalbuminsolutionsarerelativelylowinelectrolytescomparedtothe40–50g/lhuman

albuminsolutions.Whenalbuminisgiven,theelectrolytestatusofthepatientshouldbemonitored(seesection4.2

Posology)andappropriatestepstakentorestoreormaintaintheelectrolytebalance.

Flexbumincontains130-160mmol/lsodium.Tobetakenintoconsiderationbypatientsonacontrolledsodiumdiet.

Albuminsolutionsmustnotbedilutedwithwaterforinjectionsasthismaycausehaemolysisinrecipients.

Ifcomparativelylargevolumesaretobereplaced,controlsofcoagulationandhaematocritarenecessary.Caremustbe

takentoensureadequatesubstitutionofotherbloodconstituents(coagulationfactors,electrolytes,plateletsand

erythrocytes).

Hypervolaemiamayoccurifthedosageandrateofinfusionarenotadjustedtothepatient’scirculatorysituation.At

thefirstclinicalsignsofcardiovascularoverload(headache,dyspnoea,jugularveincongestion),orincreasedblood

pressure,raisedvenouspressureandpulmonaryoedema,theinfusionistobestoppedimmediately.

Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalproductspreparedfromhumanbloodor

plasmaincludeselectionofdonors,screeningofindividualdonationsandplasmapoolsforspecificmarkersof

infectionandtheinclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Despitethis,when

medicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmittinginfective

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TherearenoreportsofvirustransmissionswithalbuminmanufacturedtoEuropeanPharmacopoeiaspecificationsby

establishedprocesses.

ItisstronglyrecommendedthateverytimethatFlexbumin200g/lisadministeredtoapatient,thenameandbatch

numberoftheproductarerecordedinordertomaintainalinkbetweenthepatientandthebatchoftheproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificinteractionsofhumanalbuminwithothermedicinalproductsareknown.

4.6Fertility,pregnancyandlactation

ThesafetyofFlexbumin200g/lforuseinhumanpregnancyhasnotbeenestablishedincontrolledclinicaltrials.

However,clinicalexperiencewithalbuminsuggeststhatnoharmfuleffectsonthecourseofpregnancy,oronthe

foetusandtheneonatearetobeexpected.

NoanimalreproductionstudieshavebeenconductedwithFlexbumin200g/l.

Experimentalanimalstudiesareinsufficienttoassessthesafetywithrespecttoreproduction,developmentofthe

embryoorfoetus,thecourseofgestationandperi-andpostnataldevelopment.

However,humanalbuminisanormalconstituentofhumanblood.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

Frequencyhasbeenevaluatedusingthefollowingcriteria:verycommon(1/10),common(1/100to<1/10),

uncommon(1/1,000to<1/100),rare(1/10,000to<1/1,000),andveryrare(<1/10,000),notknown(cannotbe

estimatedfromtheavailabledata).

Incasesofseverereactions,theinfusionshouldbestoppedandanappropriatetreatmentshouldbeinitiated.

Inpost-marketingsurveillancethefollowingadverseeventshavebeenreported.TheseeventsarelistedbyMedDRA

SystemOrganClass,thenbyPreferredTerminorderofseverity.

ImmuneSystemDisorders:Anaphylacticreactions,Hypersensitivity/Allergicreactions

NervousSystemDisorders:Headache

CardiacDisorders:Tachycardia

VascularDisorders:Hypotension

Respiratory,Thoracic,andMediastinalDisorders:Dyspnea

GastrointestinalDisorders:Vomiting,Dysguesia

Very

common Common Uncommon Rare Veryrare

Immunesystem

disorders anaphylacticshock

Gastrointestinal

disorders nausea

Skinand

subcutaneous

tissuedisorders flushing,skin

rash

Generaldisorders

andadministration

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GeneralDisordersandAdministrationSiteConditions:Chills

TherearenodataavailableonadversereactionsfromcontrolledclinicaltrialsconductedwithAlbumin(Human).

Forsafetywithrespecttotransmissibleagents,see4.4.

4.9Overdose

Hypervolaemiamayoccurifthedosageandrateofinfusionaretoohigh.Atthefirstclinicalsignsofcardiovascular

overload(headache,dyspnoea,jugularveincongestion),orincreasedbloodpressure,raisedcentralvenouspressureand

pulmonaryoedema,theinfusionshouldbestoppedimmediatelyandthepatient’shaemodynamicparameterscarefully

monitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:plasmasubstitutesandplasmaproteinfractions

ATCcode:B05AA01.

Humanalbuminaccountsquantitativelyformorethanhalfofthetotalproteinintheplasmaandrepresentsabout10%

oftheproteinsynthesisactivityoftheliver.

Physico-chemicaldata:Humanalbumin200g/lor250g/lhasahyperoncoticeffect.

Themostimportantphysiologicalfunctionsofalbuminresultfromitscontributiontotheoncoticpressureoftheblood

anditstransportfunction.Albuminstabilisescirculatingbloodvolumeandisacarrierofhormones,enzymes,

medicinalproductsandtoxins.

5.2Pharmacokineticproperties

Undernormalconditions,thetotalexchangeablealbuminpoolis4-5g/kgbodyweight,ofwhich40to45%ispresent

intravascularlyand55to60%intheextravascularspace.Increasedcapillarypermeabilitywillalteralbuminkinetics

andabnormaldistributionmayoccurinconditionssuchassevereburnsorsepticshock.

Undernormalconditionstheaveragehalflifeofalbuminisabout19days.Thebalancebetweensynthesisand

breakdownisnormallyachievedbyfeed-backregulation.Eliminationispredominantlyintracellularanddueto

lysosomeproteases.

Inhealthysubjects,lessthan10%ofinfusedalbuminleavestheintravascularcompartmentduringthefirsttwohours

followinginfusion.Thereisconsiderableindividualvariationintheeffectonplasmavolume.Insomepatientsthe

plasmavolumecanremainincreasedforsomehours.However,incriticallyillpatients,albumincanleakoutofthe

vascularspaceinsubstantialamountsatanunpredictablerate.

5.3Preclinicalsafetydata

Humanalbuminisanormalconstituentofhumanplasmaandactslikephysiologicalalbumin.

Inanimals,singledosetoxicitytestingisoflittlerelevanceanddoesnotpermittheevaluationoftoxicorlethaldoses

orofadose-effectrelationship.Repeateddosetoxicitytestingisimpracticableduetothedevelopmentofantibodiesto

heterologousproteininanimalmodels.

Todate,humanalbuminhasnotbeenreportedtobeassociatedwithembryo-foetaltoxicity,oncogenicormutagenic

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Nosignsofacutetoxicityhavebeendescribedinanimalsmodels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride 4.3g/l

Sodiumcaprylate 2.7g/l

Sodiumacetyltryptophanate 4.3g/l

Waterforinjections

Totalamountofsodiumions 130–160mmol/l

6.2Incompatibilities

Humanalbuminmustnotbemixedwithothermedicinalproducts(exceptthosementionedin6.6),wholebloodand

packedredcells.Furtherhumanalbuminshouldnotbemixedwithproteinhydrolysates(e.g.parenteralnutrition)or

solutionscontainingalcoholsincethesecombinationsmaycausetheproteinstoprecipitate.

6.3Shelflife

2years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotfreeze.

Keepthebagintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

50or100mlofsolutioninapolyethylenebag,withaninfusionport(polyethylene).

Packsizes: 24x50ml(2boxesof12or24singleunits)

12x100ml(2boxesof6or12singleunits)

1x50ml(singleunit)

1x100ml(singleunit)

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Thesolutioncanbedirectlyadministeredbytheintravenousroute,oritcanalsobedilutedinanisotonicsolution(e.g.

5%glucoseor0.9%sodiumchloride).

Albuminsolutionsmustnotbedilutedwithwaterforinjectionsasthismaycausehaemolysisinrecipients.

Iflargevolumesareadministered,theproductshouldbewarmedtoroomorbodytemperaturebeforeuse.

Donotusesolutionswhicharecloudyorhavedeposits.Thismayindicatethattheproteinisunstableorthatthe

solutionhasbecomecontaminated.

Useonlyifthesealisintact.Discardincaseofleak

Oncethecontainerhasbeenopened,thecontentsshouldbeusedimmediately.Anyunusedproductshouldbedisposed

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7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd

CaxtonWay

Thetford

Norfolk

IP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/128/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24thAugust2007.

Dateoflastrenewal:13thOctober2011

10DATEOFREVISIONOFTHETEXT

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