ALBUMIN 20%W/V (BUMINATE 20%W/V)

Main information

  • Trade name:
  • ALBUMIN 20%W/V (BUMINATE 20%W/V)
  • Dosage:
  • 20 %w/v %w/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALBUMIN 20%W/V (BUMINATE 20%W/V)
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/001/001
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Albumin 20 %w/v (Buminate20%w/v)Human Albumin Solution, Solution forInfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Human albumin.

Solution containing 20 %ofprotein ofwhich atleast96 %ishuman albumin.

Each 100 mlcontainsatleast19.2g ofhuman albumin.

Theeffectiveoncoticpressureofthesolution isapproximately fourtimesthatofblood plasma.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Solution forinfusion

Glass(TypeIPh. Eur.)bottle, effectively sealed, containing 100 mlor50 mlofaclear, colourless, sterile, buffered

solution forinfusion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Restoration and maintenanceofcirculating blood volumewherevolumedeficiency hasbeen demonstrated, and useof

acolloid isappropriate.

Thechoiceofalbumin ratherthan artificialcolloid willdepend on theclinicalsituation oftheindividualpatient, based

on officialrecommendations.

4.2Posologyandmethodofadminstration

Theconcentration ofthealbumin preparation, dosageand infusion-rateshould beadjusted to thepatient’sindividual

requirements.

Posology

Thedoserequired dependson thesizeofthepatient, theseverity oftraumaorillnessand on continuing fluid and

protein losses. Measuresofadequacy ofcirculating volumeand notplasmaalbumin levelsshould beused to determine

thedoserequired.

Ifhuman albumin isto beadministered, haemodynamicperformanceshould bemonitoredregularly;thismay include:

arterialbloodpressureand pulserate

centralvenouspressure

pulmonary artery wedgepressure

urineoutput

electrolyte

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MethodofAdministration

Human Albumin can bedirectly administered by intravenousroute, oritcan also bediluted in an isotonicsolution

(e.g. 5 %Glucoseor0.9 %SodiumChloride).

Infusion rateshould beadjusted according to theindividualcircumstancesand theindication.

In plasmaexchangetheinfusion-rateshould beadjusted to therateofremoval.

4.3Contraindications

Hypersensitivity to albumin preparationsorto any oftheexcipients.

Thisproductisnotsuitableforprematureinfantsand dialysispatients.

4.4Special warningsandspecialprecautionsforuse

Ifallergicoranaphylacticreactionsoccur, theinfusion should bestopped immediately and appropriatetreatment

instituted. In thecaseofshock, thecurrentrecommendationsforshock treatmentshould beobserved.

Albumin should beused with caution in conditionswherehypervolaemiaand itsconsequencesorhaemodilutioncould

representaspecialrisk forthepatient. Examplesofsuch conditionsare:

Decompensated cardiacinsufficiency

Hypertension

Oesophagealvarices

Pulmonary oedema

Haemorrhagicdiathesis

Severeanaemia

Renaland post-renalfailure

Thecolloid-osmoticeffectofHuman Albumin 20%or25%isapproximately fourtimesthatofblood plasma.

Therefore, when concentrated albumin isadministered, caremustbetakento assureadequatehydration ofthepatient.

Patientsshould bemonitored carefully to guard againstcirculatory overload and hyperhydration.

20-25 %human albumin solutionsarerelatively lowin electrolytescompared to the4-5 %human albumin solutions.

When albumin isgiven, theelectrolytestatusofthepatientshould bemonitored (seesection 4.2)and appropriatesteps

taken to restoreormaintain theelectrolytebalance.

Albumin solutionsmustnotbediluted with WaterforInjectionsasthismay causehaemolysisinrecipients.

Ifcomparatively largevolumesareto bereplaced, controlsofcoagulation and haematocritarenecessary. Caremustbe

taken to ensureadequatesubstitution ofotherblood constituents(coagulation factors, electrolytes, plateletsand

erythrocytes).

Hypervolaemiamay occurifthedosageand rateofinfusion arenotadjusted to thepatient’scirculatory situation. At

thefirstclinicalsignsofcardiovascularoverload (headache, dyspnoea, jugularvein congestion), orincreased blood

pressure, raised centralvenouspressureand pulmonary oedema, theinfusion isto bestopped immediately.

Standard measuresto preventinfectionsresulting fromtheuseofmedicinalproductsprepared fromhuman blood or

plasmaincludesectionsofdonors, screening ofindividualdonationsand plasmapoolsforspecificmarkersofinfection

and theinclusion ofeffectivemanufacturing stepsfortheinactivation/removalofviruses. Despitethis, when medicinal

productsprepared fromhuman blood orplasmaareadministered, thepossibility oftransmitting infectiveagentscannot

betotally excluded. Thisalso appliesto unknown oremerging virusesand otherpathogens.

Thereareno reportsofvirustransmission withalbumin manufactured to European Pharmacopoeiaspecificationsby

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Itisstrongly recommended thatevery timethatAlbumin 20 %w/v (Buminate20%w/v)Human Albumin solution for

infusion isadministered to apatient, thenameand batch numberoftheproductarerecorded in orderto maintain alink

between thepatientand thebatch oftheproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

No specificinteractionsofhuman albumin with othermedicinalproductsareknown.

4.6Pregnancyandlactation

Thesafety ofhuman albumin forusein human pregnancy hasnotbeen established in controlled clinicaltrials.

However, clinicalexperiencewith albumin suggeststhatno harmfuleffectson thecourseofpregnancy, oron the

foetusand theneonateareto beexpected.

No animalreproduction studieshavebeen performed with thisproduct.

However, human albumin isanormalconstituentofhuman blood.

4.7Effectsonabilitytodriveandusemachines

No effectson ability to driveand usemachineshavebeen observed.

4.8Undesirableeffects

Mild reactionssuch asflush, urticaria, feverand nauseaoccurrarely. Thesereactionsnormally disappearrapidly when

theinfusion rateisslowed down ortheinfusion isstopped. In isolated cases, severereactionsasshock may occur. In

thesecases, theinfusion should bestopped and an appropriatetreatmentshould beinitiated.

Forsafety with respectto transmissibleagents, see4.4.

4.9Overdose

Hypervolaemiamay occurifthedosageand rateofinfusion aretoo high. Atthefirstclinicalsignsofcardiovascular

overload (headache, dyspnoea, jugularvein congestion), orincreased blood pressure, raised centralvenouspressureand

pulmonary oedema, theinfusion should bestoppedimmediately and thepatient’shaemodynamicparameterscarefully

monitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:plasmasubstitutesand plasmaprotein fractions, ATCcode:B05AA01.

Human albumin accountsquantitatively formorethan halfofthetotalprotein in theplasmaand representsabout10 %

oftheprotein synthesisactivity oftheliver.

Physicochemicaldata:Human Albumin 4-5%ismildly hypooncoticto normalplasma. Human Albumin 20 or25%has

acorresponding hyperoncoticeffect.

Themostimportantphysiologicalfunctionsofalbumin resultsfromitscontribution to oncoticpressureoftheblood

and transportfunction. Albumin stabilisescirculating blood volumeand isacarrierofhormones, enzymes, medicinal

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5.2Pharmacokineticproperties

Undernormalconditionstheexchangeablealbumin poolis4-5 g/kg bodyweight, ofwhich 40 to 45%ispresent

intravascularly and 55 to 60%in theextravascularspace. Increased capillary permeability willalteralbumin kinetics

and abnormaldistribution may occurin conditionssuch assevereburnsorsepticshock.

Undernormalconditionstheaveragehalf-lifeofalbumin isabout19 days. Thebalancebetweensynthesisand

breakdown isnormally achieved by feed-back regulation. Elimination ispredominantly intracellularand dueto

lysosomeproteases.

In healthy subjects, lessthan 10%ofinfused albumin leavestheintravascularcompartmentduring thefirsttwo hours

followinginfusion. Thereisconsiderableindividualvariation in theeffecton plasmavolume. In somepatientsthe

plasmavolumecan remain increased forsomehours.However, in critically illpatients, albumin can leak outofthe

vascularspacein substantialamountsatan unpredictablerate.

5.3Preclinical safetydata

Human Albumin isanormalconstituentofhuman plasma.

In animals, singledosetoxicity testing isoflittlerelevanceand doesnotpermittheestimation oftoxicorlethaldoses

orofadose-effectrelationship.

Repeated dosetoxicity isimpracticaldueto thedevelopmentofantibodiesin animalmodels.

To date, human albumin hasnotbeen reported to beassociated with embryo-foetaltoxicity, oncogenicormutagenic

potential.

No signsofacutetoxicity havebeen described in animalmodels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Stabilizers:

Sodiumoctanoate(16 mmol/1)

Sodiumacetyltryptophonate(16 mmol/l)

PH-adjusters:

Sodiumhydrogen carbonate

Sodiumchloride7.6-9.4 g/L

Sodiumhydroxide

Hydrochloricacid dilute

Waterforinjections

Aluminiumcontent:morethan 200 micrograms/l

6.2Incompatibilities

Human Albumin mustnotbemixed with othermedicinalproducts(excepttherecommended diluents), wholeblood

and packed red cells.

6.3ShelfLife

Irish Medicines Board

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6.4Special precautionsforstorage

Do notstoreabove25°C.

Do notfreeze.

Keepthecontainerin theoutercarton in orderto protectfromlight.

6.5Natureandcontentsofcontainer

Albumin 20%w/v (Buminate20%w/v)Human Albumin Solution isfilled in rubbercapped glassTypeIPh. Eurvials.

Theproductissupplied in singlepacksof50 mlor100 mlvials. .

6.6Instructionsforuseandhandling

Thesolution can bedirectly administered by theintravenousrouteoritcan also bediluted in an isotonicsolution (e.g.

5 %Glucoseor0.9%SodiumChloride).

Albumin solutionsmustnotbediluted with WaterforInjectionsasthismay causehaemolysisinrecipients.

Iflargevolumesareadministered, theproductshould bewarmed to roomorbody temperaturebeforeuse.

Thesolution should beclearorslightly opalescent. Do notusesolutionswhich arecloudy orhavedeposits. Thismay

indicatethattheprotein isunstableorthatthesolution hasbecomecontaminated.

Oncethecontainerhasbeen opened, thecontentsshould beused immediately. Any unused productshould bedisposed

ofin accordancewith localrequirements.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd,

Caxton Way,

Thetford,

Norfolk, IP24 3SE,

United Kingdom.

8MARKETINGAUTHORISATIONNUMBER

PA167/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1977

Dateoflastrenewal:1 st

April2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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