ACCUSOL 35 POTASSIUM 4 MMOL/L

Main information

  • Trade name:
  • ACCUSOL 35 POTASSIUM 4 MMOL/L
  • Dosage:
  • 4 mMol.
  • Pharmaceutical form:
  • Solution for Haemofiltration
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACCUSOL 35 POTASSIUM 4 MMOL/L
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/123/002
  • Authorization date:
  • 28-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Accusol35Potassium4mmol/l

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Equivalenttothefollowingioniccomposition:

The5000mloffinalsolutionresultsfrommixing3750mlofsolution‘A’with1250mlofsolution‘B’.

ThepHofthefinalsolutionis7.4.

Forexcipients,seesection6.1.

Composition Per1000ml

Accusol35

Largechamber‘A’

Calciumchloridedihydrate 0.343g

Magnesiumchloridehexahydrate 0.136g

Sodiumchloride 7.66g

Potassiumchloride 0.398g

Glucosemonohydrate 1.47g

Smallchamber‘B’

Sodiumbicarbonate 12.9g

Finalsolutionaftermixing Per1000ml

Accusol35

Calciumchloridedihydrate 0.257g

Magnesiumchloridehexahydrate 0.102g

Sodiumchloride 6.14g

Potassiumchloride 0.298g

Glucoseanhydrous 1.0g

Sodiumbicarbonate 2.94g

IonicCompositionofFinalSolution Per1000ml

Accusol35

Calcium(Ca ++

1.75mmol

Magnesium(Mg ++

0.5mmol

Sodium(Na +

140mmol

Potassium(K +

4mmol

Chloride(Cl -

113.5mmol

GlucoseAnhydrous 5.55mmol

Bicarbonate(HCO

35mmol

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3PHARMACEUTICALFORM

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration.

Accusol35isasterile,nonpyrogenic,clearandcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Accusol35isindicatedforthetreatmentofacuteandchronicrenalfailure,assubstitutionsolutioninhaemofiltration

andhaemodiafiltration,andasdialysissolutioninhaemodialysisandhaemodiafiltration.

Accusol35,Potassium4mmol/lisprimarilyintendedforuseinpatientswithhypokalaemia.

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-useAccusol35solutionisobtainedbymixingthesolutioncontainedinthelargechamber‘A’withthe

solutioncontainedinthesmallchamber‘B’afteropeningthepeel-seal.Forinstructionsforuseandhandling,please

refertosection6.6.

4.3Contraindications

Solutiondependentcontraindications

-Hyperkalaemia.

-Metabolicalkalosis.

Haemofiltration/haemodialysis/haemodiafiltrationdependentcontraindicationduetothetechnicalprocedureitself:

-Renalfailurewithincreasedhypercatabolismincaseswhereuraemicsymptomscannolongerberelievedby

haemofiltration.

-Inadequatebloodflowfromvascularaccess.

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4.4Specialwarningsandprecautionsforuse

-Accusol35solutionmustonlybeusedbyorunderthedirectionofaphysicianexperiencedinhaemofiltration,

haemodialysisorhaemodiafiltrationtechniques,

-Whiteparticulateformationofcalciumcarbonatehasbeenobservedinthepre-dilutionandpost-dilutionCRRTlines

inassociationwiththeuseofAccusol35.Thereforeevery30minutesduringCRRTwithAccusol35,pre-andpost-

dilutionlinesshouldbecloselyinspectedtoverifythatthesolutioninthetubingisclearandwithoutparticles.Insome

casesprecipitationmaynotappearuntilseveralhoursafterthestartoftherapy.

Ifprecipitateisobserved,theAccusol35solutionandCRRTtubinglinesmustbereplacedimmediatelyandthepatient

carefullymonitored.

-Fluidbalancemustbecarefullymonitored,

-Acid-basebalancemustbecarefullymonitored,

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

monitoredregularlytodetectanypotentialimbalance,

-Kalaemiamustbemonitoredregularlybeforeandduringtreatment.Ifhypokalaemiaispresentorstartstodevelop,

supplementationofpotassiummayberequired.Ifhyperkalaemiastartstodevelop,anincreaseinthefiltrationrate

and/orchangingtoasubstitutionsolutionwithalowerpotassiumconcentrationmaybeindicatedaswellasusual

measuresofintensivecaremedicine,

-Bloodglucoselevelsmustbemonitoredclosely,especiallyindiabeticpatients,

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

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

depression.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

WhenprescribingAccusol35Potassium4mmol/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),

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1)ClinicalTrials

2)Literaturereview

Theundesirableeffectsbelowlistedreflectthetypeofundesirableeffectsthatmaybereportedwithhaemofiltrationor

haemodialysissolutions.

-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

SystemOrganClass AdverseDrugReaction Frequency Procedure

related Solution

related

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6.3Shelflife

Shelflife

1yearwhenstoredintheoverpouch.

Shelflifeaftermixing

Accusol35,onceremovedfromtheoverpouchandmixedshouldbeusedwithin24hours.

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-chamberpeelsealtomixthetwosolutions.Ensurethe

peel-sealiscompletelyactivatedandthetwosolutionsarecompletelymixed.Connecttothepatientlineandactivate

theaccessport.Thesolutionmustbeusedwithin24hoursofmixing.

-Discardanyunusedremainingsolution.

-Forsingleuseonly.

UseAccusol35onlywithadequateequipmentabletomonitorthetherapy

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay

Thetford

NorfoldIP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28April2006

Dateoflastrenewal:28April2010

10DATEOFREVISIONOFTHETEXT

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