ACCUSOL 35

Main information

  • Trade name:
  • ACCUSOL 35
  • Pharmaceutical form:
  • Solution for Haemofiltration
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACCUSOL 35
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/122/001
  • Authorization date:
  • 28-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Accusol35

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Equivalenttothefollowingioniccomposition:

The5000mloffinalsolutionresultsfromthemixingof3750mlofsolution‘A’with1250mlofsolution‘B’.

ThepHofthefinalsolutionisbetween7.0-7.5

Forafulllistofexcipients,seesection6.1.

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

3PHARMACEUTICALFORM

Solutionforhaemofiltration,haemodialysisandhaemodiafiltration.

Composition Per1000ml

Accusol35

Largechamber‘A’

Calciumchloridedihydrate 0.343g

Magnesiumchloridehexahydrate 0.136g

Sodiumchloride 7.66g

Smallchamber‘B’

Sodiumbicarbonate 12.9g

Finalsolutionaftermixing Per1000ml

Accusol35

Calciumchloridedihydrate 0.257g

Magnesiumchloridehexahydrate 0.102g

Sodiumchloride 6.14g

Sodiumbicarbonate 2.94g

IonicCompositionofFinalSolution Per1000ml

Accusol35

Calcium(Ca ++

1.75mmol

Magnesium(Mg ++

0.5mmol

Sodium(Na +

140mmol

Chloride(Cl -

109.5mmol

Bicarbonate(HCO

35mmol

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4CLINICALPARTICULARS

4.1TherapeuticIndications

Accusol35isindicatedforthetreatmentofacuteandchronicrenalfailure,assubstitutionsolutioninhaemofiltration

andhaemodiafiltration,andasdialysissolutioninhaemodialysisandhaemodiafiltration.

Accusol35isprimarilyintendedforuseinpatientswithhyperkalaemia.

4.2Posologyandmethodofadministration

Forhaemofiltration,haemodialysisandhaemodiafiltration.

Accusol35assubstitutionsolution

Theamountofsubstitutionsolutiontobeadministeredinadultsisdeterminedbytheultrafiltrationrateandissetfor

eachindividualcasetoensureanadequateelectrolytefluidbalance.

Adults:

Chronicrenalfailure:7to35ml/kg/hr,

Acuterenalfailure:20to35ml/kg/hr,

Elderly:asforadults

Thesefluidvolumerecommendationsmaybeadjustedbytheprescribingphysicianaccordingtothepatient’sclinical

status.

Accusol35canbeadministeredintotheextracorporealbloodcircuiteitherinpre-and/orpost-dilutionmode

accordingtothephysician’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

-Hypokalaemia,ifnosimultaneousadaptedpotassiumsupplementation.

-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,

-Accusol35ispotassium-free.Kalaemiamustbemonitoredregularlybeforeandduringtreatment.Ifhypokalaemiais

presentorstartstodevelop,supplementationofpotassiumand/orchangingtoasubstitutionsolutionwithhigher

potassiumconcentrationmayberequired.Ifhyperkalaemiastartstodevelopanincreaseinthefiltrationratemaybe

indicatedaswellasusualmeasuresofintensivecaremedicine,

-Accusol35isglucose-free.Bloodglucoselevelsmustbemonitoredclosely,especiallyindiabeticpatients,

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

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

depression.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

WhenprescribingAccusol35,considerationshouldbegiventothepotentialinteractionsbetweenthistreatmentand

otherconcomitanttherapiesrelatedtootherpre-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/or

fluidimbalances: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,discard

thecontainer.

-Donotadministerunlessthesolutionisclear.

-Aseptictechniqueshouldbeobservedthroughoutthewholeprocedure.

-Concomitantdrugsmaybeaddedthroughthemedicationportinthelargerchamber.Drugcompatibilitymustbe

checkedbeforeadmixture.Addthemedicationandactivatetheinter-chamberpeel-sealimmediately.Theproduct

mustbeusedimmediatelyafteranydrugaddition.

-Afterremovaloftheoverpouch,immediatelyopentheinter-chamberpeel-sealtomixthetwosolutions.Ensurethe

peel-sealiscompletelyactivatedandthetwosolutionsarecompletelymixed.Connecttothepatientlineandactivate

theaccessport.Thesolutionmustbeusedwithin24hoursofmixing.

-Discardanyunusedremainingsolution.

-Forsingleuseonly.

-UseAccusol35onlywithadequateequipmentabletomonitorthetherapy

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay

Thetford

NorfolkIP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28April2006

Dateoflastrenewal:28April2010

10DATEOFREVISIONOFTHETEXT

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