ALBUMINATIV

Main information

  • Trade name:
  • ALBUMINATIV Solution for Infusion 40 Mg/ Ml
  • Dosage:
  • 40 Mg/ Ml
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALBUMINATIV Solution for Infusion 40 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0521/008/002
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0521/008/002

CaseNo:2065438

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

OctapharmaLimited

TheZenithBuilding,26SpringGardens,Manchester,M21AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Albuminativ40mg/ml,solutionforinfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/05/2009until09/10/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 08/05/2009 CRN 2065438 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Albuminativ40mg/ml,solutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Humanalbumin

Solutioncontaining4%ofproteinofwhichatleast96%ishumanalbumin.

Each100mlcontainsatleast3.84gofhumanalbumin.

Theproductisiso-oncotic.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Solutionforinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Restorationandmaintenanceofcirculatingbloodvolumewherevolumedeficiencyhasbeendemonstrated,anduseof

acolloidisappropriate.

Thechoiceofalbuminratherthanartificialcolloidwilldependontheclinicalsituationoftheindividualpatient,based

onofficialrecommendations.

4.2Posologyandmethodofadministration

Theconcentrationofthealbuminpreparation,dosageandtheinfusion-rateshouldbeadjustedtothepatient'sindividual

requirements.

Posology:

Thedoserequireddependsonthesizeofthepatient,theseverityoftraumaorillnessandoncontinuingfluidand

proteinlosses.Measuresofadequacyofcirculatingvolumeandnotonlyplasmaalbuminlevelsshouldbeusedto

determinethedoserequired.

Ifhumanalbuministobeadministered,haemodynamicperformanceshouldbemonitoredregularly;thismayinclude;

arterialbloodpressureandpulserate

centralvenouspressure

pulmonaryarterywedgepressure

urineoutput

electrolyte

haematocrit/haemoglobin

Thisproductissuitableforprematureinfantsanddialysispatients.

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Humanalbumincanbedirectlyadministeredbytheintravenousroute,oritcanalsobedilutedinanisotonicsolution

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

Theinfusionrateshouldbeadjustedaccordingtotheindividualcircumstancesandtheindication.

Inplasmaexchangetheinfusion-rateshouldbeadjustedtotherateofremoval.

4.3Contraindications

Hypersensitivitytoalbuminpreparationsortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Ifallergicoranaphylactic-typereactionsoccur,theinfusionshouldbestoppedimmediatelyandappropriatetreatment

instituted.Incaseofshock,thecurrentmedicalstandardsforshock-treatmentshouldbeobserved.

Albuminshouldbeusedwithcautioninconditionswherehypervolaemiaanditsconsequencesorhaemodilutioncould

representaspecialriskforthepatient.

Examplesofsuchconditionsare:

Decompensatedcardiacinsufficiency

Hypertension

Oesophagealvarices

Pulmonaryoedema

Haemorrhagicdiathesis

Severeanaemia

Renalandpost-renalanuria

Thecolloid-osmoticeffectofhumanalbumin20%or25%isapproximatelyfourtimesthatofbloodplasma.

Therefore,whenconcentratedalbuminisadministered,caremustbetakentoassureadequatehydrationofthepatient.

Patientsshouldbemonitoredcarefullytoguardagainstcirculatoryoverloadandhyperhydration.

20-25%humanalbuminsolutionsarerelativelylowinelectrolytescomparedtothe4-5%humanalbuminsolutions.

Whenalbuminisgiventheelectrolytestatusofthepatientshouldbemonitored(seesection4.2)andappropriatesteps

takentorestoreormaintaintheelectrolytebalance.

Albuminsolutionsmustnotbedilutedwithwaterforinjectionsasthismaycausehaemolysisinrecipients.

Ifcomparativelylargevolumesaretobereplaced,controlsofcoagulationandhaematocritarenecessary.Caremust

betakentoensureadequatesubstitutionofotherbloodconstituents(coagulationfactors,electrolytes,plateletsand

erythrocytes).

Hypervolaemiamayoccurifthedosageandrateofinfusionarenotadjustedtothepatient’scirculatorysituation.At

thefirstclinicalsignsofcardiovascularoverload(headache,dyspnoea,jugularveincongestion),orincreasedblood

pressure,raisedvenouspressureandpulmonaryoedema,theinfusionistobestoppedimmediately.

Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalproductspreparedfromhumanbloodor

plasmaincludeselectionofdonors,screeningofindividualdonationsandplasmapoolsforspecificmarkersof

infectionandtheinclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Despitethis,when

medicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmittinginfective

agentscannotbetotallyexcluded.Thisalsoappliestounknownoremergingvirusesandotherpathogens.

TherearenoreportsofvirustransmissionswithalbuminmanufacturedtoEuropeanPharmacopoeiaspecificationsby

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ItisstronglyrecommendedthateverytimethatAlbuminativ40mg/mlisadministeredtoapatient,thenameandbatch

numberoftheproductarerecordedinordertomaintainalinkbetweenthepatientandthebatchoftheproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificinteractionsofhumanalbuminwithothermedicinalproductsareknown.

4.6Pregnancyandlactation

Thesafetyofhumanalbuminforuseinhumanpregnancyhasnotbeenestablishedincontrolledclinicaltrials.

However,clinicalexperiencewithalbuminsuggeststhatnoharmfuleffectsonthecourseofpregnancy,oronthe

foetusandtheneonatearetobeexpected.

Noanimalreproductionstudieshavebeenconductedwiththisproduct.

However,humanalbuminisanormalconstituentofhumanblood.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

AdversereactionsforAlbuminativ200mg/mlarerare.Thesereactionsnormallydisappearrapidlywhentheinfusion

rateissloweddownortheinfusionisstopped.Incaseofseverereactions,theinfusionshouldbestoppedandan

appropriatetreatmentshouldbeinitiated.

ThefollowingadversereactionshavebeenobservedforAlbuminativ200mg/mlduringthepostmarketingphase.

Verycommon(>1/10);common(.1/100,<1/10);uncommon(>1/1,00,<1/100);rare(>1/10,000,<1/1000);veryrare

(<1/10,000)

SystemOrganClass Rare VeryRare

Cardiacdisorders tachycardia

bradycardia

Gastrointestinaldisorders nausea

Generaldisordersand

administrationsite

conditions Pyrexia

chills

Immunesystemdisorders anaphylacticreaction

hypersensitivity anaphylacticshock

Nervoussystemdisorders headache

Psychiatricdisorders confusionalstate

Respiratory,thoracicand

mediastinaldisorders dyspnoea

Skinandsubcutaneous

tissuedisorders Urticaria

angioneuroticoedema

rasherythematosus

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Forinformationonviralsafetysee4.4.

4.9Overdose

Hypervolaemiamayoccurifthedosageandrateofinfusionaretoohigh.Atthefirstclinicalsignsofcardiovascular

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

andpulmonaryoedema,theinfusionshouldbestoppedimmediatelyandthepatient’shaemodynamicparameters

carefullymonitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:plasmasubstitutesandplasmaproteinfractions,ATCcode:B05AA01

Humanalbuminaccountsquantitativelyformorethanhalfofthetotalproteinintheplasmaandrepresentsabout10%

oftheproteinsynthesisactivityoftheliver.

Physico-chemicaldatahuman:Humanalbumin4-5%ismildlyhypooncotictonormalplasma.Humanalbumin20or

25%hasacorrespondinghyperoncoticeffect.

Themostimportantphysiologicalfunctionsofalbuminresultfromitscontributiontooncoticpressureofthebloodand

transportfunction.Albuminstabilisescirculatingbloodvolumeandisacarrierofhormones,enzymes,medicinal

productsandtoxins.

5.2Pharmacokineticproperties

Undernormalconditions,thetotalexchangeablealbuminpoolis4-5g/kgbodyweightofwhich40-45%ispresent

intravascularlyand55-60%intheextravascularspace.Increasedcapillarypermeabilitywillalteralbuminkineticsand

abnormaldistributionmayoccurinconditionssuchassevereburnsorsepticshock.

Undernormalconditions,theaveragehalf-lifeofalbuminisabout19days.Thebalancebetweensynthesisand

breakdownisnormallyachievedbyfeed-backregulation.Eliminationispredominantlyintracellularanddueto

lysosomeproteases.

Inhealthysubjects,lessthan10%ofinfusedalbuminleavestheintravascularcompartmentduringthefirst2hours

followinginfusion.Thereisconsiderableindividualvariationintheeffectonplasmavolume.Insomepatientsthe

plasmavolumecanremainincreasedforsomehours.However,incriticallyillpatients,albumincanleakoutofthe

vascularspaceinsubstantialamountsatanunpredictablerate.

5.3Preclinicalsafetydata

Humanalbuminisanormalconstituentofhumanplasmaandactslikephysiologicalalbumin.

Inanimals,singledosetoxicitytestingisoflittlerelevanceanddoesnotpermittheevaluationoftoxicorlethaldoses

orofadose-effectrelationship.Repeateddosetoxicitytestingisimpracticableduetothedevelopmentofantibodiesto

heterologousproteininanimalmodels.

Todate,humanalbuminhasnotbeenreportedtobeassociatedwithembryo-foetaltoxicity,oncogenicormutagenic

Vasculardisorders hypotension hypertension

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Nosignsofacutetoxicityhavebeendescribedinanimalmodels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumcaprylate(1.3mg/ml)

SodiumhydroxideorHydrochloricacid(topH7)

Sodiumchloride

Waterforinjections

Maximumaluminiumcontent:notmorethan200micrograms/litre

Maximumsodiumcontent:notmorethan145mmol/l(or3.34mg/ml)

6.2Incompatibilities

Albuminativ40mg/mlshouldnotbemixedwithothermedicinalproducts,wholebloodorpackedredcells.

Albuminativ40mg/mlcanbedilutedwiththefollowinginfusionsolutions:Sodiumchloride0.9%,Glucose5%and

10%,RingerandRingeracetate.

6.3ShelfLife

3years.

Oncethecontainerhasbeenopenedthecontentsmustbeusedimmediately.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Anyunusedsolutionmustbediscardedowingtotheriskofbacterialcontamination.

Donotuseaftertheexpirydategivenonthelabel.

Donotfreeze.

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6.5Natureandcontentsofcontainer

Glassbottles,typeIIglass(Ph.Eur),of500mlstopperedwithpurecoatstoppersandsealedwithapull-offcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Thesolutioncanbedirectlyadministeredbytheintravenousroute.Albuminsolutionsshouldnotbedilutedwithwater

forinjectionsasthismaycausehaemolysisinrecipients.

Iflargevolumesareadministered,theproductshouldbewarmedtoroomorbodytemperaturebeforeuse.

Thesolutionshouldbeclearorslightlyopalescent.Donotusesolutionswhicharecloudyorhavedeposits.Thismay

indicatethattheproteinisunstableorthatthesolutionhasbecomecontaminated.

Oncethecontainerhasbeenopened,thecontentsshouldbeusedimmediately.

Anyunusedproductshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

OctapharmaLimited

TheZenithBuilding

26SpringGardens

ManchesterM21AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA521/8/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June1995

Dateoflastrenewal:10October2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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