BALANCE 2.3% GLUCOSE, 1.75MMOL/L CALCIUM

Main information

  • Trade name:
  • BALANCE 2.3% GLUCOSE, 1.75MMOL/L CALCIUM
  • Dosage:
  • 2.3%/1.75mmol/l %v/v
  • Pharmaceutical form:
  • Soln for Peritoneal Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BALANCE 2.3% GLUCOSE, 1.75MMOL/L CALCIUM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0953/005/003
  • Authorization date:
  • 19-09-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0953/005/003

CaseNo:2066197

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

FreseniusMedicalCareDeutschlandGmbH

D-61346BadHomburg,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

balance2.3%glucose,1.75mmol/lcalcium,solutionforperitonealdialysis

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom17/11/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

balance2.3%glucose,1.75mmol/lcalcium,solutionforperitonealdialysis

2QUALITATIVEANDQUANTITATIVECOMPOSITION

balance2.3%glucose,1.75mmol/lcalciumisdeliveredinadoublechamberbag.Onechambercontainsthealkaline

lactatesolution,theotherchambercontainstheacidicglucose-basedelectrolytesolution.Mixingofbothsolutionsby

openingthemiddleseambetweenthetwochambersresultsintheneutralready-to-usesolution.

BEFORERECONSTITUTION

1litreofacidicglucosebasedelectrolytesolutioncontains:

Sodiumchloride 11.279g

Calciumchloridedihydrate 0.5145g

Magnesiumchloridehexahydrate 0.2033g

Glucose,anhydrous 45.46g

(asglucosemonohydrate)

1litreofalkalinelactatesolutioncontains:

Sodiumlactate7.85g

(assodiumlactatesolution)

AFTERRECONSTITUTION

1litreoftheneutralready-to-usesolutioncontains:

Sodiumchloride 5.640g

Sodiumlactate 3.925g

(assodiumlactatesolution)

Calciumchloridedihydrate 0.2573g

Magnesiumchloridehexahydrate 0.1017g

Glucose,anhydrous 22.73g

(asglucosemonohydrate)

mmol/l

1.75 mmol/l

mmol/l

101.5mmol/l

Lactate 35 mmol/l

Glucose 126.1mmol/l

Theoretical

osmolarity 401mOsm/l

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 2

3PHARMACEUTICALFORM

Solutionforperitonealdialysis

Doublechamberbagcontainingclearandcolourlessaqueoussolutions

4CLINICALPARTICULARS

4.1TherapeuticIndications

End-stage(decompensated)chronicrenalfailureofanyorigintreatedwithperitonealdialysis.

4.2Posologyandmethodofadministration

Dosage

Thissolutionisindicatedexclusivelyforintraperitonealuse.

Themodeoftherapy,frequencyofadministration,anddwelltimerequiredwillbespecifiedbytheattendingphysician.

Unlessotherwiseadvised,patientswillreceiveaninfusionof2000mlsolutionperexchangefourtimesaday.Aftera

dwelltimebetween2and10hoursthesolutionwillbedrained.

Adjustmentofdosage,volumeandnumberofexchangeswillbenecessaryforindividualpatients.

Ifpainduetoabdominaldistensionoccursatthecommencementofperitonealdialysis,thesolutionvolumeper

exchangeshouldbetemporarilyreducedto500-1500ml.

Inlargepatients,andifresidualrenalfunctionislost,anincreasedvolumeofdialysissolutionwillbenecessary.In

thesepatients,orpatientswhotoleratelargervolumes,avolumeof2500-3000mlsolutionperexchangemaybegiven.

Ifamachineisusedforintermittentorcontinuouscyclicperitonealdialysis,theuseoflargerbagsisrecommended

providingmorethanonesolutionexchange.

Inchildrenthesolutionvolumeperexchangeshouldbereducedaccordingtoage,heightandbodyweight(30-40ml/kg

bodyweight).

Therearenospecialdosagerecommendationsforelderlypatients.

Peritonealdialysissolutionswithahighglucoseconcentration(2.3%or4.25%)areusedwhenthebodyweightis

abovethedesireddryweight.Thewithdrawaloffluidfromthebodyincreasesinrelationtotheglucoseconcentration

oftheperitonealdialysissolution.Thesesolutionsshouldbeusedcautiouslytohandletheperitonealmembranewith

care,topreventdehydrationandinordertokeeptheglucoseburdenaslowaspossible.

Dialysisusingtheprescribeddosesshouldbeperformeddaily.Peritonealdialysisisalong-termtherapyinvolving

repeatedadministrationsofsinglesolutions.

balance2.3%glucose,1.75mmol/lcalciumcontains22.73gglucosein1000mlsolution.

Methodanddurationofadministration

Forstaysafebalance,thesolutionbagisfirstwarmeduptobodytemperature.Theheatingwillbeperformedwitha

heatingplate.Thetimeforheatingisabout120minutesfora2000mlbagatatemperatureof22ºC.Detailscanberead

intheinstructionmanualoftheheatingplate.Amicrowaveovenmustnotbeusedduetotheriskoflocaloverheating.

Thesolutionsinthetwochambersmustbemixedbeforeuse.Forthestep-by-stepinstructionforusepleaseseeSection

6.6.

Dependingonphysician'sinstructions,thedoseshoulddwellintheperitonealcavityfor2to10hours(equilibrium

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 3

Dependingontherequiredosmoticpressure,balance2.3%glucose,1.75mmol/lcalciumcanbeusedsequentiallywith

otherperitonealdialysissolutionswithlowerorhigherglucosecontent(i.e.withlowerorhigherosmolarity).

Beforeperformingperitonealdialysisathomethepatientmustbetrainedappropriately,mustpracticethetechnique

andbeshowntobeproficient.Thetrainingshouldbeperformedbyqualifiedpersonnel.Theattendingphysicianmust

ensurethatthepatientmastersthehandlingtechniquessufficientlybeforebeingdischargedtocarryoutperitoneal

dialysisathome.Incaseofanyproblemsoruncertaintytheattendingphysicianshouldbecontacted.

Peritonealdialysisshouldbecontinuedforaslongasrenalfunctionsubstitutiontherapyisrequired.

4.3Contraindications

Forthisspecificperitonealdialysissolution

balance2.3%glucose,1.75mmol/lcalciummustnotbeusedinpatientswithseverehypokalaemiaandsevere

hypercalcaemia.

Forperitonealdialysisingeneral

Peritonealdialysisshouldnotbecommencedifanyofthefollowingarepresent:

recentabdominalsurgeryorinjury,ahistoryofabdominaloperationswithfibrousadhesions,abdominalburns,

bowelperforation,

extensiveinflammatoryconditionsoftheabdominalskin(dermatitis),

inflammatoryboweldiseases(Crohn'sdisease,ulcerativecolitis,diverticulitis),

peritonitis,

internalorexternalabdominalfistula,

umbilical,inguinalorotherabdominalhernia,

intra-abdominaltumours,

ileus,

pulmonarydisease(especiallypneumonia),

sepsis,

lacticacidosis,

extremehyperlipidaemia,

inrarecasesofuraemia,whichcannotbemanagedbyperitonealdialysis,

cachexiaandsevereweightloss,particularlyincaseswhereingestionofadequateproteinisnotguaranteed,

patientswhoarephysicallyormentallyincapableofperformingperitonealdialysisasinstructedbythephysician.

Ifanyoftheabovementioneddisordersdevelopsduringtheperitonealdialysis,theattendingphysicianwillhaveto

decideonhowtoproceed.

4.4Specialwarningsandprecautionsforuse

Thissolutionmayonlybeadministeredaftercarefulbenefit-riskassessmentin:

lossofelectrolytesduetovomitingand/ordiarrhoea(atemporarychangetoaperitonealdialysissolutioncontaining

potassiummightthenbecomenecessary).

hypercalcaemia,e.g.duetotheadministrationofcalcium-containingphosphatebindersand/orvitaminD(a

temporaryorpermanentchangetoaperitonealdialysissolutionwithalowercalciumconcentrationshouldbe

considered).

patientsreceivingdigitalistherapy:Regularmonitoringoftheserumpotassiumlevelismandatory.Severe

hypokalaemiamaynecessitatetheuseofapotassium-containingdialysissolutiontogetherwithdietarycounselling.

patientswithlargepolycystickidneys.

Theeffluentshouldbecheckedforclarityandvolume.Turbidity,whichmayormaynotbeaccompaniedbyabdominal

pain,orabdominalpainaloneareindicatorsofperitonitis.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 4

adequatedietorsupplementationshouldbeensured.

Thetransportcharacteristicsoftheperitonealmembranemaychangeduringlong-termperitonealdialysisprimarily

indicatedbyalossofultrafiltration.Inseverecasesperitonealdialysismustbestoppedandhaemodialysiscommenced.

Regularmonitoringofthefollowingparametersisrecommended:

bodyweightfortheearlyrecognitionofover-anddehydration,

serumsodium,potassium,calcium,magnesium,phosphate,acidbasestatus,bloodgasesandbloodproteins,

serumcreatinineandurea,

parathormoneandotherindicatorsofbonemetabolism,

bloodsugar,

residualrenalfunctioninordertoadapttheperitonealdialysis.

Elderlypatients

Theincreasedincidenceofherniashouldbeconsideredinelderlypatientspriortothestartofperitonealdialysis.

Shelflifeoftheready-to-usesolution

Theready-to-usesolutionshouldbeusedimmediately,butwithinamaximumof24hoursaftermixing(seealso

Section6.3).

Handling(seealsoSection6.6)

Plasticcontainersmayoccasionallybedamagedduringtransportorstorage.Thiscanresultinacontaminationwith

growthofmicroorganismsinthedialysissolution.Thusallcontainersshouldbecarefullyinspectedfordamagepriorto

connectionofthebagandpriortouseoftheperitonealdialysissolution.Anydamage,evenminor,toconnectors,atthe

closure,containerweldsandcornersmustbenotedbecauseofpossiblecontamination.Damagedbagsorbagswith

cloudycontentshouldneverbeused.

Thissolutionmustonlybeusedifthesolutionfordialysisisclearandthecontainerundamaged.Anyunusedportionof

thesolutionistobediscarded.

Theoverwrapshouldonlyberemovedbeforeadministration.

Donotusebeforemixingthetwosolutions.

Asepticconditionsmustbemaintainedduringdialysateexchangeinordertoreducetheriskofinfection.

Thesolutionforperitonealdialysismustnotbeusedforintravenousinfusion.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theuseofthisperitonealdialysissolutioncanleadtoalossofefficacyofothermedicinalproductsiftheseare

dialysablethroughtheperitonealmembrane.Adoseadjustmentmightbenecessary.

Adistinctreductionoftheserumpotassiumlevelcanincreasethefrequencyofdigitalis-associatedadversereactions.

Potassiumlevelsmustbemonitoredparticularlycloselyduringconcurrentdigitalistherapy.

Theconcomitantadministrationofcalcium-containingmedicinalproductsorvitaminDmaycausehypercalcaemia.

Theuseofdiureticagentsmayhelpmaintainresidualdiuresis,butmayalsoresultinwaterandelectrolyteimbalances.

Indiabeticpatientsthedailydoseofinsulinororalhypoglycaemicmedicinalproductsmustbeadjustedtotakeaccount

oftheincreasedglucoseload.

4.6Pregnancyandlactation

Therearenoadequatedatafromuseofbalancesolutionsinanimalstudiesorinpregnantwomen.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 5

4.7Effectsonabilitytodriveandusemachines

balance2.3%glucose,1.75mmol/lcalciumhasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

balance2.3%glucose,1.75mmol/lcalciumisanelectrolytesolutionthecompositionofwhichissimilartoblood.In

additionthesolutionhasaneutralpHwhichissimilartothephysiologicalpHvalue.

Possibleadversereactionsmayresultfromtheperitonealdialysisitselformaybeinducedbytheperitonealdialysis

solution.

Potentialadversereactionsoftheperitonealdialysissolution

Metabolismandnutritiondisorders

Increasedbloodsugarlevels;hyperlipidaemia;increaseinbodyweightduetothecontinuousuptakeofglucosefrom

theperitonealdialysissolution.

Cardiacandvasculardisorders

Tachycardia;hypotension;hypertension.

Respiratory,thoracicandmediastinaldisorders

Dyspnoea.

Renalandurinarydisorders

Electrolytedisturbances,e.g.hypokalaemia(verycommon(>10%)),hypercalcaemiaincombinationwithanincreased

calciumuptake,e.g.bytheadministrationofcalcium-containingphosphatebinders.

Generaldisorders

Dizziness;oedema;disturbancesinhydrationindicatedeitherbyarapiddecrease(dehydration)orincrease

(overhydration)inbodyweight.Severedehydrationmightoccurwhenusingsolutionsofhigherglucoseconcentration.

Potentialadversereactionsofthetreatmentmode

Infectionsandinfestations

Peritonitis(verycommon(>10%));skinexitsiteandtunnelinfections(verycommon(>10%));inveryrarecases

sepsis(0.01%).

Respiratory,thoracicandmediastinaldisorders

Dyspnoeacausedbytheelevateddiaphragm;shoulderpain.

Gastrointestinaldisorders

Diarrhoea;constipation;hernia(verycommon(>10%));abdominaldistensionandsensationoffullness.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 6

Generalmalaise;redness,oedema,exudations,crustsandpainatthecatheterexitsite.

Peritonealdialysisprocedurerelateddisorders

Cloudyeffluent;in-andoutflowdisturbancesofthedialysissolution.

Peritonitisisindicatedbyacloudyeffluent.Laterabdominalpain,fever,andgeneralmalaisemaydevelopor,invery

rarecases,sepsis.Thepatientshouldseekmedicaladviceimmediately.Thebagwiththecloudyeffluentshouldbe

closedwithasterilecapandassessedformicrobiologicalcontaminationandwhitebloodcellcount.

Incaseofskinexitsiteandtunnelinfectionstheattendingphysicianshouldbeconsultedassoonaspossible.

4.9Overdose

Noemergencysituationsinconnectionwithoverdosehavebeenreported.

Excessiveinflowofdialysissolutioniseasilydrainedintoanemptybag.However,ifbagexchangeshavebeencarried

outtoofrequentlyortoorapidly,statesofdehydrationand/orelectrolytedisturbancescanoccurwhichnecessitate

immediatemedicalattention.Ifanexchangehasbeenforgotten,thenasarulethedwelltimesofthenextbagsshould

bereducedinsuchawaythatthetotalamountofdialysissolutionrequiredperday(e.g.4x2000ml)isachieved.

Incorrectbalancingcanleadtohyper-ordehydrationandelectrolytedisturbances.

Themostlikelyconsequenceofanoverdosagewithbalance2.3%glucose,1.75mmol/lcalciumisdehydration.

Underdosage,interruptionoftreatmentordiscontinuationoftreatmentmayleadtolife-threateninghyperhydrationwith

peripheraloedemaandcardiacdecompensationand/orothersymptomsofuraemia,whichmayendangerlife.

Thegenerallyacceptedrulesforemergencycareandintensivetherapymustbeapplied.Thepatientmayrequire

immediatehaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Solutionforperitonealdialysis

ATCcode:B05DB

balance2.3%glucose,1.75mmol/lcalciumisalactate-buffered,glucose-containingelectrolytesolutionindicatedfor

intraperitonealadministrationforthetreatmentofend-stagerenalfailureofanyorigin.

Thecharacteristicofcontinuousambulatoryperitonealdialysis(CAPD)isthemoreorlesscontinuouspresenceof

usually2litresofdialysissolutionintheperitonealcavity.Thisdialysissolutionisreplacedbyfreshsolutionthreeto

fivetimesaday.

Thebasicprinciplebehindeveryperitonealdialysistechniqueistheuseoftheperitoneumasasemi-permeable

membraneallowingtheexchangeofsolutesandwaterbetweenthebloodandthedialysissolutionbydiffusionand

convectionaccordingtotheirphysico-chemicalproperties.

Theelectrolyteprofileofthesolutionisbasicallythesameasthatofphysiologicalserum,althoughithasbeenadapted

(e.g.thepotassiumcontent)foruseinuraemicpatientstoenablerenalfunctionsubstitutiontherapybymeansof

intraperitonealsubstancesandfluidexchange.

Substanceswhicharenormallyeliminatedwiththeurine,likeuraemicwasteproducts,suchasureaandcreatinine,

inorganicphosphate,uricacid,othersolutesandwater,areremovedfromthebodyintothedialysissolution.Thefluid

balancecanbemaintainedbytheadministrationofdifferentglucose-concentrationsinthesolution,effectingthefluid

removal(ultrafiltration).

Metabolicacidosissecondarytoend-stagerenalfailureiscounterbalancedbythepresenceoflactateinthesolution.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 7

5.2Pharmacokineticproperties

Uraemicwasteproducts(e.g.urea,creatinine,uricacid),inorganicphosphateandelectrolyteslikesodium,potassium,

calciumandmagnesiumareremovedfromthebodytothedialysissolutionbydiffusionand/orconvection.

Glucoseinthedialysateisusedasanosmoticagentinbalance2.3%glucose,1.75mmol/lcalcium.Itisslowly

absorbed,reducingthediffusiongradientbetweendialysissolutionandextracellularfluid.Theultrafiltrationis

maximalatthebeginningofthedwelltime,reachingapeakafterabouttwotothreehours.Laterabsorptionstartswith

aprogressivelossofultrafiltrate.Duringthedialysisperiodofsixhours60to80%ofdialysateglucoseisabsorbed.

Thetransferofcalciumdependsontheglucoseconcentrationinthedialysissolution,theeffluentvolume,theserum

ionisedcalciumandthecalciumconcentrationinthedialysissolution.Thehighertheglucoseconcentration,effluent

volumeandserumcalciumconcentration,andthelowercalciumconcentrationinthedialysissolution,thehigheristhe

calciumtransferfromthepatienttothedialysate.

5.3Preclinicalsafetydata

Nopreclinicaltoxicitystudieswithbalance2.3%glucose,1.75mmol/lcalciumhavebeencarriedout,butclinical

studieswithcomparablesolutionsforperitonealdialysishaveshownnomajorriskoftoxicity.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Hydrochloricacid

Sodiumhydroxide

Sodiumhydrogencarbonate

6.2Incompatibilities

Becauseoftheriskofincompatibilityandofcontaminationmedicinalproductsmustonlybeaddedwhenprescribedby

aphysician.

ThismedicinalproductshouldnotbeusedwithothermedicinalproductsexceptthosementionedinSection6.6.

6.3ShelfLife

Shelflifeaspackedforsale:2years.

Shelflifeaftermixing:Chemicalandphysicalin-usestabilityhasbeendemonstratedfor24hoursat20°C.

6.4Specialprecautionsforstorage

Donotstorebelow4°C

6.5Natureandcontentsofcontainer

Doublechamberbag:

Lactatesolution:glucose-basedelectrolytesolution=1:1

Doublechamberbagsystemconsistingofanon-PVCdoublechambersolutionbagwhichiswrappedinaprotective

bag,bothmadeofmultilayerpolyolefinefoils.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 8

Thestaysafebalancesystemcontainsthedoublechamberbagsystem,atubingsystemmadeofpolyolefines,asystem

connector(DISC)witharotableswitch(polypropylene)andadrainagebag,alsomadeofpolyolefinemultilayerfilm.

Thesleepsafebalancesystemcontainsthedoublechamberbagsystemandabagconnectorwhichconsistsof

polypropylene.

Thesafelockbalancesystemcontainsthedoublechamberbagsystemandasafelockconnectorwhichconsistsof

polycarbonate.

Packsizes:

staysafebalance

4bagseachcontaining1500ml

4bagseachcontaining2000ml

4bagseachcontaining2500ml

4bagseachcontaining3000ml

sleepsafebalance

4bagseachcontaining3000ml

2bagseachcontaining5000ml

2bagseachcontaining6000ml

safelockbalance

2bagseachcontaining5000ml

2bagseachcontaining6000ml

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Forsingleuseonly.Anyunusedportionofthesolutionistobediscarded.

Forstaysafebalance,firstwarmupthesolutionbagtobodytemperature.Forbagswithavolumeupto3000mlthis

shouldbedoneusinganappropriateheatertray.Theheatingtimefora2000mlbagwithastartingtemperatureof22°

Cisapprox.120min.Thetemperaturecontrolisdoneautomaticallyandissetto39°C ±

1°C.Moredetailed

informationcanbeobtainedfromtheoperatinginstructionsofthebagwarmer.Useofmicrowavesisnotrecommended

duetheriskoflocaloverheating.sleepsafebalanceandsafelockbalancebagsareappliedincombinationwitha

cycler.Warmingupisperformedautomaticallybytheheaterofthecycler.Afterwarmingthesolutionyoucanstart

withtheexchangeofthebags.

Instructionforuseofthestaysafebalancesystem:

1.Preparationofthesolution

Checkthewarmedsolutionbag(label,expirydate,clearnessofthesolution,bagandoverwrapnotdamaged,

integrityofpeelseams).

Placethebagonasolidsurface.

Opentheoverwrapofthebagandthepackagingofthedisinfectioncap.

Washyourhandswithanantimicrobialwashinglotion.

Rollupthebag,whichislyingontheouterwrappingfoil,fromoneofthesideedgesuntilthemiddleseamopens.

Thesolutionsinthetwochambersaremixedautomatically.

Nowrollupthebagfromtheupperedgeuntilthepeelseamofthelowertriangleiscompletelyopen.

Checkwhetherallpeelseamsarecompletelyopen.

Checkwhetherthesolutionisclearandthatthebagisnotleaking.

2.Preparationofthebagexchange

Hangthesolutionbagintheupperholeoftheinfusionpole,unrollthetubinglineofthesolutionbag,andplacethe

DISCintotheorganizer.Afterunrollingthetubinglinetothedrainagebag,hangthedrainagebaginthelowerholeof

theinfusionpoleandplacethedisinfectioncapintotheorganizer.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 9

DisinfectyourhandsandremovetheprotectioncapoftheDISC.

ConnectcatheterconnectortotheDISC.

3.Outflow

Openthecatheterextensionclamp.Theoutflowstarts.

Position (

4.Flush

AftercompletionofoutflowfillthetubebetweensolutionbagandDISCcompletelywithfluidbyflushingfresh

solutionintothedrainagebag(approx.5seconds).

Position ((

5.Inflow

Startinflowbyturningthecontrolswitchto

Position *)(

6.Safetystep

ClosethecatheterextensionbyintroducingthePinintothecatheterconnector.

Position((((

7.Disconnection

Removeprotectioncapfromthenewdisinfectioncapandscrewittotheoldone.

ScrewthecatheterconnectorofftheDISCandscrewthecatheterconnectortothenewdisinfectioncap.

8.ClosureoftheDISC

ClosetheDISCwiththeopenendoftheprotectioncapoftheuseddisinfectioncap,whichisplacedintheright

holeoftheorganizer.

9.Checkthedraineddialysateforclarityandweightandiftheeffluentiscleardiscardit.

Instructionforuseofthe3000mlsleepsafebalancesystem:

1.Preparationofthesolution

Checkthesolutionbag(label,expirydate,clearnessofthesolution,bagandoverwrapnotdamaged,integrityof

peelseams).

Placethebagonasolidsurface.

Opentheoverwrapofthebag.

Washyourhandswithanantimicrobialwashinglotion.

Rollupthebag,whichislyingontheouterwrappingfoil,fromoneofthesideedgesuntilthemiddleseamopens.

Thesolutionsinthetwochambersaremixedautomatically.

Nowrollupthebagfromtheupperedgeuntilthepeelseamofthelowertriangleiscompletelyopen.

Checkwhetherallpeelseamsarecompletelyopen.

Checkwhetherthesolutionisclearandthatthebagisnotleaking.

2.Unrolltubing(1)ofbag.

3.Removetheprotectioncap.

4.Insertbagconnectorinfreetrayportofthesleepsafecycler.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 10

Instructionforuseofthe5000mland6000mlsleepsafebalancesystem:

1.Preparationofthesolution

Checkthesolutionbag(label,expirydate,clearnessofthesolution,bag,andoverwrapnotdamaged,peelseams

intact).

Placethebagonasolidsurface.

Opentheoverwrapofthebag.

Washyourhandswithanantimicrobialwashinglotion.

Unfoldmiddlepeelseamandbagconnector.

Rollupthebag,whichislyingontheoverwrap,fromthediagonalendtowardsthebagconnector.Themiddle

peelseam(4)willopen.

Continueuntilthepeelseamofthesmallchamber(5)opensaswell.

Checkthatallpeelseamsarecompletelyopen.

Checkthatthesolutionisclearandthatthebagisnotleaking.

2.Unrolltubing(1)ofbag.

3.Removetheprotectioncap.

4.Insertbagconnectorinfreetrayportofthesleepsafecycler.

5.Thebagisnowreadyforusewiththesleepsafeset.

Instructionforuseofthesafelockbalancesystem:

1.Preparationofthesolution

Checkthesolutionbag(label,expirydate,clearnessofthesolution,bag,andoverwrapnotdamaged,peelseams

intact).

Placethebagonasolidsurface.

Opentheoverwrapofthebag.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 11

Unfoldmiddlepeelseamandbagconnector.

Rollupthebag,whichislyingontheoverwrap,fromthediagonalendtowardsthebagconnector.Themiddle

peelseam(4)willopen.

Continueuntilthepeelseamofthesmallchamber(5)opensaswell.

Checkthatallpeelseamsarecompletelyopen.

Checkthatthesolutionisclearandthatthebagisnotleaking.

2.Removeprotectivecapoftheconnector(1)fromtheconnectingline.

3.Connectlinestothebag.

4.Breaktheinnerlockbybendingthelineandthepinbymorethan90°tobothsides.

5.Thebagisnowreadyforuse.

Generalinstructionsapplicabletoallapplicationsystems:

Theready-to-usesolutionshouldbeusedimmediately,butifthisisnotpossiblewithinamaximumof24hoursafter

mixing(seealsoSection6.3).

Ifprescribed,medicinalproductsmaybeaddedtotheready-to-usesolutionthroughtheinjectionport(2)takinggreat

carenottointroduceanycontamination.

Onlythefollowingmedicinalproductsmaybeaddeduptothementionedconcentrationifindicatedbytheattending

physician:Heparin1000I.U./l,insulin20I.U./l,vancomycin1000mg/l,teicoplanin400mg/l,cefazolin500mg/l,

ceftazidim250mg/l,gentamycine8mg/l.Afterthoroughmixingandcheckingfortheabsenceofanyturbidityor

particlestheperitonealdialysissolutionmustbeusedimmediately(nostorage).

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareDeutschlandGmbH

D-61346BadHomburg

Germany

8MARKETINGAUTHORISATIONNUMBER

PA953/5/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19September2003

Dateoflastrenewal:17November2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/01/2010 CRN 2066197 page number: 12