ACCUSOL 35 POTASSIUM 2MMOL/L

Main information

  • Trade name:
  • ACCUSOL 35 POTASSIUM 2MMOL/L
  • Dosage:
  • 2 mMol.
  • Pharmaceutical form:
  • Solution for Haemofiltration
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACCUSOL 35 POTASSIUM 2MMOL/L
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/123/001
  • Authorization date:
  • 28-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Accusol35Potassium2mmol/l

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Equivalenttothefollowingioniccomposition:

The5000mloffinalsolutionresultsfrommixing3750mlofsolution‘A’with1250mlofsolution‘B’.

ThepHofthefinalsolutionisbetween7.0-7.5.

Forafulllistofexcipients,seesection6.1.

Thenumber“35”inthenamespecifiesthebufferconcentrationofthesolution(bicarbonate=35mmol/l.)

3PHARMACEUTICALFORM

Composition Per1000ml

Accusol35

Largechamber‘A’

Calciumchloridedihydrate 0.343g

Magnesiumchloridehexahydrate 0.136g

Sodiumchloride 7.66g

Potassiumchloride 0.199g

Glucosemonohydrate 1.47g

Smallchamber‘B’

Sodiumbicarbonate 12.9g

Finalsolutionaftermixing Per1000ml

Accusol35

Calciumchloridedihydrate 0.257g

Magnesiumchloridehexahydrate 0.102g

Sodiumchloride 6.14g

Potassiumchloride 0.149g

Glucoseanhydrous 1.0g

Sodiumbicarbonate 2.94g

IonicCompositionofFinalSolution Per1000ml

Accusol35

Calcium(Ca ++

1.75mmol

Magnesium(Mg ++

0.5mmol

Sodium(Na +

140mmol

Potassium(K +

2mmol

Chloride(Cl -

111.5mmol

GlucoseAnhydrous 5.55mmol

Bicarbonate(HCO

35mmol

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Accusol35isasterile,nonpyrogenic,clearandcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Accusol35isindicatedforthetreatmentofacuteandchronicrenalfailure,assubstitutionsolutioninhaemofiltration

andhaemodiafiltration,andasdialysissolutioninhaemodialysisandhaemodiafiltration.

4.2Posologyandmethodofadministration

Forhaemofiltration,haemodialysisandhaemodiafiltration.

Accusol35assubstitutionsolution

Theamountofsubstitutionsolutiontobeadministeredinadultsisdeterminedbytheultrafiltrationrateandissetfor

eachindividualcasetoensureanadequateelectrolytefluidbalance.

Adults:

-Chronicrenalfailure:7to35ml/kg/hr,

-Acuterenalfailure:20to35ml/kg/hr,

Elderly:asforadults

Thesefluidvolumerecommendationsmaybeadjustedbytheprescribingphysicianaccordingtothepatient’sclinical

status.

Accusol35canbeadministeredintotheextracorporealbloodcircuiteitherinpre-and/orpost-dilutionmodeaccording

tothephysician’sprescription.

Accusol35asdialysissolution

Theprescriptionandamountofdialysissolutiondependuponthemodeoftherapy,frequencyanddurationoftreatment

andwillbeselectedbytheprescribingphysicianaccordingtothepatient’sclinicalstatus.

Administration:

Haemodialysis:viathedialysiscompartmentofthedialyser.

Haemofiltration:viathearterialorvenousbloodline.Theready-to-useAccusol35solutionisobtainedbymixingthe

solutioncontainedinthelargechamber‘A’withthesolutioncontainedinthesmallchamber‘B’afteropeningthe

peel-seal.Forinstructionsforuseandhandling,pleaserefertosection6.6.

4.3Contraindications

Solutiondependentcontraindications

-Hypokalaemia,ifnosimultaneousadaptedpotassiumsupplementation

-Metabolicalkalosis

Haemofiltration/haemodialysis/haemodiafiltrationdependentcontraindicationduetothetechnicalprocedureitself:

-Renalfailurewithincreasedhypercatabolismincaseswhereuraemicsymptomscannolongerberelievedby

haemofiltration

-Inadequatebloodflowfromvascularaccess.

-Ifthereisahighriskofhaemorrhageonaccountofsystemicanticoagulation

4.4Specialwarningsandprecautionsforuse

-Accusol35solutionmustonlybeusedbyorunderthedirectionofaphysicianexperiencedinhaemofiltration,

haemodialysisorhaemodiafiltrationtechniques,

-Whiteparticulateformationofcalciumcarbonatehasbeenobservedinthepre-dilutionandpost-dilutionCRRTlines

inassociationwiththeuseofAccusol35.Thereforeevery30minutesduringCRRTwithAccusol35,pre-andpost-

dilutionlinesshouldbecloselyinspectedtoverifythatthesolutioninthetubingisclearandwithoutparticles.Insome

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Ifprecipitateisobserved,theAccusol35solutionandCRRTtubinglinesmustbereplacedimmediatelyandthepatient

carefullymonitored.

-Fluidbalancemustbecarefullymonitored,

-Acid-basebalancemustbecarefullymonitored,

-Similarly,electrolytebalance(chloraemia,phosphataemia,calcaemia,magnesaemiaandnatraemia)shouldbe

monitoredregularlytodetectanypotentialimbalance,

-Kalaemiamustbemonitoredregularlybeforeandduringtreatment.Ifhypokalaemiaispresentorstartstodevelop,

supplementationofpotassiumand/orchangingtoasubstitutionsolutionwithhigherpotassiumconcentrationmaybe

required.Ifhyperkalaemiastartstodevelop,anincreaseinthefiltrationrateand/orchangingtoasubstitutionsolution

withalowerpotassiumconcentrationmaybeindicatedaswellasusualmeasuresofintensivecaremedicine,

-Bloodglucoselevelsmustbemonitoredclosely,especiallyindiabeticpatients,

-Incasetheinter-chamberpeel-sealisnotopenedandthesolutionofthesmallchamber“B”isgiven,alkalosismay

arise.Mostcommonclinicalsigns/symptomsofalkalosisarenausea,lethargy,headache,arrhythmia,respiratory

depression.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

WhenprescribingAccusol35Potassium2mmol/l,considerationshouldbegiventothepotentialinteractionsbetween

thistreatmentandotherconcomitanttherapiesrelatedtootherpre-existingconditions.

-Bloodconcentrationofothermedicinalproductsmaybealteredduringhaemodialysis,haemofiltrationand

haemodiafiltration.

-Plasmalevelsofpotassiuminpatientsusingcardiacglycosidesmustbecarefullymonitoredduetoanincreasedriskof

hypokalaemiaassociatedarrhythmias.

-VitaminDandmedicinalproductscontainingcalciumcanincreasetheriskofhypercalcaemia(egcalciumcarbonate

actingasachelatorofpotassium).

-Theadditionalsubstitutionofsodiumbicarbonatecanincreasetheriskofmetabolicalkalosis.

4.6Fertility,pregnancyandlactation

TherearenopreclinicalorclinicaldataontheuseofAccusol35duringpregnancyandlactation.Accusol35should

onlybeadministeredtopregnantandlactatingwomenifclearlyneeded.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Theundesirableeffectsreportedarebasedonadverseeventreportsfromclinicaltrials(see(1)below),whichwere

assessedbytheinvestigatortoberelatedtoAccusol,aswellasfromaliteraturereview(see(2)below).Noadverse

eventreportswerereportedfrompost-marketingexperience.

Thefrequencyhasbeenevaluatedbyusingthefollowingcriteria:verycommon(>1/10),common(>1/100,<1/10),

uncommon(>1/1,000,<1/100),rare(>1/10,000,<1/1,000)andveryrare(<1/10,000).

1)ClinicalTrials

2)Literaturereview

Theundesirableeffectsbelowlistedreflectthetypeofundesirableeffectsthatmaybereportedwithhaemofiltrationor

SystemOrganClass AdverseDrugReaction Frequency Procedure

related Solution

related

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-Potentialadversereactionsrelatedtothetreatmentmayincludenausea,vomiting,musclecramps,hypotension,

bleeding,clotting,infectionandairembolism.

-Potentialadversereactionsrelatedtotheproductmayincludemetabolicalkalosis,electrolytedisturbancesand/orfluid

imbalances:hypophosphataemia,hypoglycaemia,hypo-andhypervolaemia,hypo-andhypertension.

4.9Overdose

Overdoseshouldnotoccurifthefluidandelectrolytebalancesaremonitoredregularlyasrecommendedinsection4.4.

Overdosemayleadtohypervolaemiaandelectrolytedisturbances.Thesesymptomscanbecorrectedbyadjustingthe

ultrafiltrationrateandthevolumeofsolutionadministered.

Electrolyteimbalancesshouldbemanagedaccordingtothespecificelectrolytedisturbance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Haemofiltrates,ATCcode:B05ZB

Accusol35ispharmacologicallyinactive.Thesolutionconsistsofionsthatarepresentatconcentrationssimilarto

physiologicallevelinplasma.

Assubstitutionsolution,Accusol35providesacontinuoussourceofelectrolytesandwaterforhydrationandactsasan

alkalinisingagent.

Asdialysissolution,Accusol35removesmetabolicwasteproductsfromthebloodandhelpstomanagetheserum

electrolytesand/orfluidimbalances.

5.2Pharmacokineticproperties

NotrelevantastheactiveingredientsofAccusol35arepharmacologicallyinactiveandneartophysiologicalplasma

concentrations

5.3Preclinicalsafetydata

TherearenopreclinicaldataconsideredrelevanttoclinicalsafetybeyonddataincludedinothersectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections,

Hydrochloricacid(pHadjuster),

Sodiumhydroxide(pHadjuster).

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6.

6.3Shelflife

Shelflife

1yearwhenstoredintheoverpouch.

Shelflifeaftermixing

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6.4Specialprecautionsforstorage

Donotstorebelow4°Cand25°C.

6.5Natureandcontentsofcontainer

Accusol35isstoredinanonPVCtwo-chamberbagmadeofacoextrudedfilmofPolypropylene,Polyamideanda

blendofPolypropylene,SEBSandPolyethylene(Clear-Flex).Apeel-sealseparatesthetwochambers.

Thelargechamber‘A’isfittedwithamedicationportandthesmallchamber‘B’isfittedwithanaccessportfor

connectiontoasuitableadministrationset.

Thetwo-chamberbagispresentedinaprotectivetransparentoverpouchmadeofcopolymers.

Thevolumeofthecontaineraftermixingis5000ml(3750mlinthelargechamberand1250mlinthesmallchamber).

Accusol35isavailableas2x5000mlperbox.

6.6Specialprecautionsfordisposalandotherhandling

-Checktheintegrityoftheproduct.Ifthesealisopenedprematurely,donotusethebag.Incaseofdamage,discardthe

container.

-Donotadministerunlessthesolutionisclear.

-Aseptictechniqueshouldbeobservedthroughoutthewholeprocedure.

-Concomitantdrugsmaybeaddedthroughthemedicationportinthelargerchamber.Drugcompatibilitymustbe

checkedbeforeadmixture.Addthemedicationandactivatetheinter-chamberpeel-sealimmediately.Theproductmust

beusedimmediatelyafteranydrugaddition.

-Afterremovaloftheoverpouch,immediatelyopentheinter-chamberpeel-sealtomixthetwosolutions.Ensurethe

peel-sealiscompletelyactivatedandthetwosolutionsarecompletelymixed.Connecttothepatientlineandactivate

theaccessport.Thesolutionmustbeusedwithin24hoursofmixing.

-Discardanyunusedremainingsolution.

-Forsingleuseonly.

UseAccusol35onlywithadequateequipmentabletomonitorthetherapy

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay

Thetford

NorfolkIP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/123/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28April2006

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10DATEOFREVISIONOFTHETEXT

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