ALBUMIN HUMAN 50G/ L

Main information

  • Trade name:
  • ALBUMIN HUMAN 50G/ L
  • Dosage:
  • 50 g/ l
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALBUMIN HUMAN 50G/L
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0521/002/001
  • Authorization date:
  • 14-07-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0521/002/001

CaseNo:2045324

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OctapharmaLimited

TheZenithBuilding,26SpringGardens,Manchester,M21AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AlbuminHuman50g/lOctapharma,solutionforInfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom14/07/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AlbuminHuman50g/lOctapharma,solutionforinfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Humanalbuminfromhumanplasmasource.

Solutioncontaining5%ofproteinofwhichatleast96%ishumanalbumin.

Each100mlcontains5ghumanalbumin.

AlbuminHuman50g/lisamildlyhypooncoticpasteurizedsolution.

Excipients:alsoincludessodium157.5mmol/litre

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforinfusion.

Aclear,slightlyviscousliquid;itisalmostcolourless,yellow,amberorgreensuppliedinTypeII(Ph.Eur.)glass

infusionbottles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Restorationandmaintenanceofcirculatingbloodvolumewherevolumedeficiencyhasbeendemonstrated,anduseof

acolloidisappropriate.

Thechoiceofalbuminratherthanartificialcolloidwilldependontheclinicalsituationoftheindividualbasedon

officialrecommendations.

4.2Posologyandmethodofadministration

Theconcentrationofthealbuminpreparation,dosageandtheinfusion-rateshouldbeadjustedtothepatient’s

individualrequirements.

Posology

Thedoserequireddependsonthesizeofthepatient,theseverityoftraumaorillnessandoncontinuingfluidand

proteinlosses.Measuresofadequacyofcirculatingvolumeandnotplasmaalbuminlevelsshouldbeusedto

determinedoserequired.

Ifhumanalbuministobeadministered,haemodynamicperformanceshouldbemonitoredregularly;thismayinclude;

arterialbloodpressureandpulserate

centralvenouspressure

pulmonaryarterywedgepressure

urineoutput

electrolytes

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 2

Thisproductissuitableforprematureinfantsanddialysispatients.

Methodofadministration

Humanalbumincanbedirectlyadministeredbytheintravenousroute.

Theinfusionrateshouldbeadjustedaccordingtotheindividualcircumstancesandtheindication.

Inplasmaexchangetheinfusionrateshouldbeadjustedtotherateofremoval.

4.3Contraindications

Hypersensitivitytoalbuminpreparationsortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Ifallergicoranaphylactic-typereactionsoccur,theinfusionshouldbestoppedimmediatelyandappropriatetreatment

instituted.Inthecaseofshock,thecurrentmedicalstandardsfortreatmentofshockshouldbeobserved.

Albuminshouldbeusedwithcautioninconditionswherehypervolaemiaanditsconsequencesorhaemodilutioncould

representaspecialriskforthepatient.

Examplesofsuchconditionsare:

Decompensatedcardiacinsufficiency

Oesophagealvarices

Pulmonaryoedema

Hypertension

Haemorrhagicdiathesis

Severeanaemia

Renalandpost-renalanuria

Thecolloid-osmoticeffectofhumanalbumin20%or25%isapproximatelyfourtimesthatofbloodplasma.Therefore,

whenconcentratedalbuminisadministered,caremustbetakentoassureadequatehydrationofthepatient.

Patientsshouldbemonitoredcarefullytoguardagainstcirculatoryoverloadandhyperhydration.

20%-25%humanalbuminsolutionsarerelativelylowinelectrolytescomparedtothe4-5%humanalbuminsolutions.

Whenalbuminisgiven,theelectrolytestatusofthepatientshouldbemonitored(seesection4.2)andappropriatesteps

takentorestoreandmaintaintheelectrolytebalance.

Albuminsolutionsmustnotbedilutedwithwaterforinjectionsasthismaycausehaemolysisinrecipients.

Ifcomparativelylargevolumesaretobereplaced,controlsofcoagulationandhaematocritarenecessary.Caremust

betakentoensureadequatesubstitutionofotherbloodconstituents(coagulationfactors,electrolytes,platelets,and

erythrocytes).

Hypervolaemiamayoccurifthedosageandtherateofinfusionarenotadjustedtothepatient’scirculatorysituation.

Atthefirstclinicalsignsofcardiovascularoverload(headache,dyspnoea,jugularveincongestion),orincreasedblood

pressure,raisedvenouspressureandpulmonaryoedema,theinfusionistobestoppedimmediately.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 3

plasmaincludeselectionofdonors,screeningofindividualdonationsandplasmapoolsforthespecificmarkersof

infectionandtheinclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Despitethis,when

medicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmittinginfective

agentscannotbetotallyexcluded.Thisalsoappliestounknownoremergingvirusesandotherpathogens.

TherearenoreportsofvirustransmissionswithalbuminmanufacturedtoEuropeanPharmacopoeiaspecificationsby

establishedprocesses.

ItisstronglyrecommendedthateverytimethatAlbuminHuman50g/lOctapharmaisadministeredtoapatient,the

nameandbatchnumberoftheproductarerecordedinordertomaintainalinkbetweenthepatientandthebatchofthe

product.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificinteractionsofhumanalbuminwithothermedicinalproductsareknown.

4.6Pregnancyandlactation

Thesafetyofhumanalbuminforuseinhumanpregnancyhasnotyetbeenestablishedincontrolledclinicaltrials.

However,clinicalexperiencewithalbuminsuggeststhatnoharmfuleffectsonthecourseofpregnancy,oronthe

foetusandtheneonatearetobeexpected.

Noanimalreproductionstudieshavebeenconductedwiththisproduct.

However,humanalbuminisanormalconstituentofhumanblood.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

Mildreactionssuchasflush,urticaria,hypotension,fever,andnauseaoccurrarely.Thesereactionsnormally

disappearrapidlywhentheinfusionrateissloweddownortheinfusionisstopped.Veryrarely,severereactionssuch

asshockmayoccur.Inthesecases,theinfusionshouldbestoppedandanappropriatetreatmentshouldbeinitiated.

Forsafetywithrespecttotransmissibleagents,see4.4.

4.9Overdose

Hypervolaemiamayoccurifthedosageandtherateofinfusionaretoohigh.Atthefirstclinicalsignsof

cardiovascularoverload(headache,dyspnoea,jugularveincongestion),orincreasedbloodpressure(raisedcentral

nervouspressureandpulmonaryoedema),theinfusionshouldbestoppedimmediatelyandthepatient’s

haemodynamicparameterscarefullymonitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:plasmasubstitutesandplasmafractions,

ATCcode:B05AA01

Humanalbuminaccountsquantitativelyformorethanhalfofthetotalproteinintheplasmaandrepresentsabout10%

oftheproteinsynthesisactivityoftheliver.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 4

25%hasacorrespondinghyperoncoticeffect.Themostimportantphysiologicalfunctionsofalbuminresultsfromits

contributiontooncoticpressureofthebloodandtransportfunction.Albuminstabilisescirculatingbloodvolumeand

isacarrierofhormones,enzymes,drugs,toxinsetc.

5.2Pharmacokineticproperties

Undernormalsituationsthetotalexchangeablealbuminpoolis4-5g/kgbodyweight,ofwhich40-45%ispresent

intravascularlyand55-60%intheextravascularspace.Increasedcapillarypermeabilitywillalteralbuminkineticsand

abnormaldistributionmayoccurinconditionssuchasevereburnsorsepticshock.

Undernormalconditionstheaveragehalf-lifeofalbuminisanaverageofabout19days.Thebalancebetween

synthesisandbreakdownisnormallyachievedbyfeed-backregulation.Eliminationispredominantlyintracellularand

duetolysosomeproteases.

Inhealthysubjects,lessthan10%ofinfusedalbuminleavestheintravascularcompartmentduringthefirst2hours

followinginfusion.Thereisconsiderableindividualvariationintheeffectonplasmavolume.Insomepatientsthe

plasmavolumecanremainincreasedforsomehours.However,incriticallyillpatients,albumincanleakoutofthe

vascularspaceinsubstantialamountsatanunpredictablerate.

5.3Preclinicalsafetydata

Humanalbuminisanormalconstituentofthehumanplasmaandactslikephysiologicalalbumin.

Inanimals,singledosetoxicitytestingisoflittlerelevanceanddoesnotpermittheevaluationoftoxicorlethaldoses

ofadose-effectrelationship.

Repeateddosetoxicitytestingisimpracticableduetothedevelopmentofantibodiestoheterologousproteininanimal

models.

Todate,humanalbuminhasnotbeenreportedtobeassociatedwithembryo-foetaltoxicity,oncogenicormutagenic

potential.Nosignsofacutetoxicityhavebeendescribedinanimal

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Octanoicacid/Caprylicacid(4.2mmol/litre)(max:0.08mmol/galbumin)

N-Acetyltryptophan(4.2mmol/litre)(max:0.08mmol/galbumin)

Sodiumchloride

Sodiumhydroxide

Hydrochloricacid,concentrated

Waterforinjections

Maximumlimitforaluminiumcontent:200microgramsperlitre.

Maximumsodiumchloridecontent:157.5mmol/litre(correspondingto3.6mg/mlsodiumions)

Maximumpotassiumioncontent:1.0mmol/litre.

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 5

6.3ShelfLife

Unopened: 3years.

Onceopened:Useimmediately

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotfreeze.

Storeintheoriginalcontainer.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

GlassTypeII(Ph.Eur.)infusionbottleswithbromobutylrubberstoppersTypeI(Ph.Eur.)

Packsizes:

1infusionbottlewith100ml

1infusionbottlewith250ml

Allinfusionbottlesareavailablesinglyorinpacksof10.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thesolutioncanbedirectlyadministeredbytheintravenousroute.

Albuminsolutionsmustnotbedilutedwithwaterforinjectionsasthismaycausehaemolysisinrecipients.

Iflargevolumesareadministered,theproductshouldbewarmedtoroomorbodytemperaturebeforeuse.

Thesolutionshouldbeclearorslightlyopalescent.Donotusesolutionswhicharecloudyorhavedeposits.Thismay

indicatethattheproteinisunstableorthatthesolutionhasbecomecontaminated.

Donotuseafterexpirydategivenonthelabel.

Oncetheinfusioncontainerhasbeenopenedthecontentshouldbeusedimmediately.

Anyunusedsolutionshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

OctapharmaLimited

6ElmCourt

Coventry

CV59RG

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 6

8MARKETINGAUTHORISATIONNUMBER

PA521/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14July1993

Dateoflastrenewal:14July2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 30/09/2008 CRN 2045324 page number: 7