CAPD/ DPCA 18

Main information

  • Trade name:
  • CAPD/ DPCA 18
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CAPD/DPCA 18
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0953/002/001
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CAPD/DPCA18,SolutionforPeritonealDialysis

2QUALITATIVEANDQUANTITATIVECOMPOSITION

mmol/l

Ca++ 1.25 mmol/l

Mg++ 0.50 mmol/l

102.50 mmol/l

(S)-lactate 35.00 mmol/l

Glucose 235.80 mmol/l

Theoreticalosmolarity 509.00mosm/l

Forexcipients,seeSection6.1

3PHARMACEUTICALFORM

SolutionforPeritonealDialysis.

Clearcolourlesstoslightlyyellowsolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseinpatientswithend-stage(decompensated)chronicrenalfailureofanyoriginwhichcanbetreatedwith

peritonealdialysis.

4.2Posologyandmethodofadministration

Dosage

CAPD/DPCA18isexclusivelyindicatedforintraperitonealuse.

1litrecontains:

Sodiumchloride 5.786g

Sodium-(S)-lactatesolution 7.85g

equivalentto3.925gsodium-(S)-lactate

Calciumchloridex2HO 0.1838g

Magnesiumchloridex6HO 0.1017g

Glucosemonohydrate 46.75g

equivalentto42.5g/lanhydrousglucoseandupto2.1g/lfructose 2

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Continuousambulatoryperitonealdialysis(CAPD)

Unlessotherwiseprescribed,patientswillreceive2,000mlsolutionperexchangefourtimesaday(correspondingtoa

dailydoseof8,000ml).Afteradwelltimebetween2and10hoursthesolutionwillbedrained.

Adjustmentofdosagewillbenecessaryforindividualpatients.

Ifpainduetoabdominaldistensionoccursatthecommencementofperitonealdialysistreatment,thesolutionvolume

perexchangeshouldbereduced.

Childrenreceive500and1,500ml(30–40ml/kgbodyweight)ofthesolutionpertreatment,dependingonweight.

Inlargeadultsand/orpatientswhotoleratehighervolumes,andifresidualrenalfunctionislost,thevolumetobe

administeredisincreasedto2,500–3,000ml.

Automatedperitonealdialysis(APD)

Ifamachine(sleep.safecycler)isusedforintermittentorcontinuouscyclicperitonealdialysis,largervolumesbags

(5,000ml)providingmorethanonesolutionexchangeareused.Thecyclerperformsthesolutionexchangesaccording

tothemedicalprescriptionstoredinthesleep.safecycler.

Peritonealdialysisisalongtermtherapyinvolvingrepeatedadministrationbythesamemethod.

Methodanddurationofadministration

Patientsshouldbeproficientatperformingperitonealdialysisbeforeperformingitathome.Thetrainingshouldbe

performedbyqualifiedpersonnel.Theattendingphysicianmustensurethatthepatientmastersthehandlingtechniques

sufficientlybeforethepatientperformsperitonealdialysisathome.Incaseofanyproblemsoruncertaintytheattending

physicianshouldbecontacted.

Dialysisusingtheprescribeddosesshouldbeperformeddaily.

Peritonealdialysisshouldbecontinuedforaslongasrenalfunctionsubstitutiontherapyisrequired.

Continuousambulatoryperitonealdialysis(CAPD)

Theready-to-usesolutionisfirstwarmedtobodytemperature.Forbagswithavolumeupto3,000mlthisshouldbe

doneusinganappropriateheatertray.Theheatingtimefora2,000mlbagwithastartingtemperatureof22°Cis

approx.120min.Thetemperaturecontrolisdoneautomaticallyandissetto39°C ±

1°C.Moredetailedinformation

canbeobtainedfromtheoperatinginstructionsofthebagwarmer.Useofmicrowavesisnotrecommendedduetherisk

oflocaloverheating.

Theappropriatedoseisinfusedintheperitonealcavityusingaperitonealcatheterover5-20minutes.Dependingon

physician'sinstructions,thedoseshoulddwellintheperitonealcavityfor2-10hours(equilibriumtime),andthenbe

drained.Dependingontherequiredosmoticpressure,CAPD/DPCA18canbeusedsequentiallywithotherperitoneal

dialysissolutionswithlowerglucosecontent(i.e.withlowerosmolarity).

Automatedperitonealdialysis(APD)

Theconnectorsoftheprescribedsleepsafesolutionbagsareinsertedinthefreesleep.safetrayportsandthen

automaticallyconnectedtothesleepsafetubingsetbythecycler.Thecyclerchecksthebarcodesofthesolutionbags

andgivesanalarmwhenthebagsdonotcomplytotheprescriptionstoredinthecycler.Afterthischeckthetubingset

canbeconnectedtothepatient’scatheterextensionandthetreatmentbestarted.Thesleepsafesolutionis

automaticallywarmeduptobodytemperaturebythesleep.safecyclerduringtheinflowintotheabdominalcavity.

Dwelltimesandselectionofglucoseconcentrationsarecarriedoutaccordingtothemedicalprescriptionstoredinthe

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4.3Contraindications

Forthisspecificperitonealdialysissolution

CAPD/DPCA18mustnotbeusedinpatientswithlacticacidosis,severehypokalaemia,severehypocalcaemia,

hypovolaemiaandarterialhypotension.

Duetothecontentoffructose,thismedicinalproductisunsuitableforpatientswithfructoseintolerance(hereditary

fructoseintolerance).Anon-recognisedhereditaryfructoseintolerancemustbeexcludedpriortoadministrationto

babiesandinfants.

Forperitonealdialysistreatmentingeneral

Aperitonealdialysistreatmentshouldnotbecommencedinthefollowingcircumstances:

recentabdominalsurgeryorinjury,ahistoryofabdominaloperationswithfibrousadhesions,severe

abdominalburns,abdominalperforation

extensiveinflammationoftheabdominalskin(dermatitis),

inflammatoryboweldiseases(Crohn'sdisease,ulcerativecolitis,diverticulitis),

localisedperitonitis,

internalorexternalabdominalfistula,

umbilical,inguinalorotherabdominalhernia,

intra-abdominaltumours,

ileus,

pulmonarydisease(especiallypneumonia),

sepsis,

extremehyperlipidaemia,

inrarecasesofuraemia,whichcannotbemanagedbyperitonealdialysis,

cachexiaandsevereweightloss,particularlyincasesinwhichanadequateproteinsupplementationisnot

guaranteed

patientswhoarephysicallyormentallyincapableofperformingPDasinstructedbythephysician.

4.4Specialwarningsandprecautionsforuse

CAPD/DPCA18shouldonlybeadministeredaftercarefulbenefit-riskassessmentin:

lossofelectrolytesduetovomitingand/ordiarrhoea(atemporarychangetoaperitonealdialysissolution

containingpotassiummightthenbecomenecessary).

○hyperparathyroidism:Thetherapyshouldcomprisetheadministrationofcalcium-containingphosphatebinders

and/orvitaminDtoensureadequateenteralcalciumsupply.

hypocalcaemia:Achangetoaperitonealdialysissolutionwithahighercalciumconcentrationmustbeconsidered

incaseanadequateenteralsupplywithcalciumbycalcium-containingphosphatebindersand/orvitaminDisnot

possible.

digitalistherapy:Regularmonitoringoftheserumpotassiumlevelismandatory.Severehypokalaemiamay

necessitatetheuseofapotassium-containingdialysissolutionaswellasdietarycounseling.

Peritonealdialysissolutionswithahighglucoseconcentration(2.3%or4.25%)shouldbeusedcautiouslytotreatthe

peritonealmembranewithcare,topreventdehydrationandtoreducetheglucoseload.

Alossofproteins,aminoacids,andvitamins(especiallywater-solublevitamins)isunavoidableduringperitoneal

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Thetransportcharacteristicsoftheperitonealmembranemaychangeduringlong-termperitonealdialysisprimarily

indicatedbyalossofultrafiltration.Inseverecasesperitonealdialysismustbestoppedandhaemodialysiscommenced.

Themonitoringofthefollowingparametersisrecommended:

bodyweightfortheearlyrecognitionofover-hydrationanddehydration,

serumsodium,potassium,calcium,magnesium,phosphate,acidbasebalanceandblood

proteins,

serumcreatinineandurea,

bloodsugar,

parathyroidhormoneandotherindicatorsofbonemetabolism,

residualrenalfunctioninordertoadapttheperitonealdialysistreatment.

Itismandatorytomonitorforturbidityoftheeffluent,decreasedeffluentvolume,andabdominalpainastheymaybe

indicatorsofperitonitis.

Additionofmedicationtotheperitonealdialysissolution:

Theadditionofmedicationtotheperitonealdialysissolutionisgenerallynotrecommendedbecauseoftheriskof

contaminationandofincompatibilitybetweentheperitonealdialysissolutionandthemedication.Itmustbecarriedout

underasepticconditions.Afterthoroughmixingandcheckingfortheabsenceofanyturbiditytheperitonealdialysis

solutionmustbeusedimmediately(nostorage).

Handling

Plasticcontainersmayoccasionallybedamagedduringtransportorstorage.Thiscanresultinacontaminationwith

growthofmicroorganismsinthedialysissolution.Thusallcontainersshouldbecarefullyinspectedfordamagepriorto

connectionofthebagandpriortouseoftheperitonealdialysissolution.Anydamage,evenminor,toconnectors,atthe

closure,containerweldsandcorners,mustbenotedbecauseofpossiblecontamination.

Damagedbagsorbagswithcloudycontentshouldneverbeused!

Onlyusetheperitonealdialysissolutionifcontainerandsealareundamaged.

Asepticconditionsmustbemaintainedduringdialysateexchangeinordertoreducetheriskofinfections.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theuseofthisperitonealdialysissolutioncanyieldtoalossofefficacyofothermedicationifthesearedialysable

throughtheperitonealmembrane.Adoseadjustmentmightbecomenecessary.

Adistinctreductionoftheserumpotassiumlevelcanincreasethefrequencyofdigitalis-associatedadversereactions.

Specialattentionandmonitoringisrequiredinthecaseofhyperparathyroidism.Therapyshouldincludethe

administrationofcalcium-containingphosphatebindersand/orvitaminDtoensureadequateenteralcalciumsupply.

Useofdiureticagentsmayhelpmaintainresidualrenalfunction,butmayalsoresultinwaterandelectrolyte

imbalances.

Indiabeticsthedailydoseofbloodsugarreducingmedicationmustbeadjustedtotheincreasedglucoseintake.

4.6Pregnancyandlactation

Noadequateorwell-controlledstudieswithCAPD/DPCA18havebeenperformedinpregnantorlactatingwomen.No

animalreproductivetoxicitystudieshavebeenpreformed.PeritonealdialysiswithCAPD/DPCA18isnot

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thelikelyrisktothemotherorthechild.

4.7Effectsonabilitytodriveandusemachines

Noeffectsontheabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

Possiblesideeffectsmayresulteitherfromthetechniqueoftheperitonealdialysisitselformaybeinducedbythe

dialysissolution.

Potentialadversereactionsoftheperitonealdialysissolutionare:

hyperparathyroidismmaydeveloporbeaggravated,

electrolytedisturbances,e.g.hypokalaemia,hypocalcaemia,

○disturbancesinfluidbalance.Arapidlossinbodyweight,dropinbloodpressureand/ortachycardiamightindicate

dehydration;oedema,hypertensionandpossiblydyspnoeamightindicateover-hydration,

increasedbloodsugarlevels,

hyperlipidaemiaordeteriorationofpre-existinghyperlipidaemia,

increaseofbodyweight.

Potentialsideeffectsofthetreatmentmodeare:

peritonitis,indicatedbycloudydialysate.Later,abdominalpain,feverandmalaise(generallyfeelingunwell)may

developor,inveryrarecases,generalisedbloodpoisoning(sepsis).

skinexitsiteinfectionortunnelinfectionofthecatheterindicatedbyredness,swelling,pain,weepingorscabs.In

caseofanysignofinfectiontheattendingphysicianmustbeconsultedimmediately.

inandoutflowdisturbancesofthedialysissolution,

diarrhoeaorobstipation,

dyspnoeacausedbytheelevateddiaphragm,

hernia,

abdominaldistensionandfeelingoffullness(abdominalpain),

shoulderpain.

4.9Overdose

Anyexcessofdialysissolutionwhichhasflowedintotheperitonealcavitycaneasilybedrainedintothedrainagebag.

Incaseoftoofrequentortoorapidexchanges,dehydrationand/orelectrolytedisturbancesmightresultwhich

necessitatesimmediateemergencytreatment.

Ifoneormoreofthedailyexchangeshavebeenforgottenortheadministeredvolumeofsolutionwastoolow,over-

hydrationandelectrolytedisturbancesmayoccur.

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup

Group:Solutionforperitonealdialysis

ATC:B05DB

CAPD/DPCA18representsalactate-buffered,glucose-containingelectrolytesolutionindicatedforintraperitoneal

administrationforthetreatmentofend-stagerenalfailureofanyoriginbycontinuousambulatoryperitonealdialysis

(CAPD).Thecalciumdialysisconcentrationofthisperitonealdialysissolutionissetat1.25mmol/lwhichhasbeen

showntoreducetheriskofhypercalcaemiaduringtheconcomitanttreatmentwithcalcium-containingphosphate

bindersand/orvitaminD.

Thecharacteristicofcontinuousambulatoryperitonealdialysis(CAPD)isthemoreorlesscontinuouspresenceof

usually2litresofdialysissolutionintheperitonealcavitywhichisreplacedbyfreshsolutionthreetofivetimesaday.

Thebasicprinciplebehindeveryperitonealdialysistechniqueistheuseoftheperitoneumasasemipermeable

membraneallowingtheexchangeofsolutesandwaterbetweenthebloodandthedialysissolutionbydiffusionand

convectionaccordingtotheirphysico-chemicalproperties.

Theelectrolyteprofileofthesolutionisbasicallythesameasthatofphysiologicalserum,althoughithasbeenadapted

(e.g.thepotassiumcontent)foruseinuraemicpatientstoenablerenalfunctionsubstitutiontherapybymeansof

intraperitonealsubstanceandfluidexchange.Substanceswhicharenormallyeliminatedwiththeurine,suchasurea,

creatinine,inorganicphosphate,uricacid,othersolutesandwater,areremovedfromthebodyintothedialysissolution.

Itshouldbeborneinmindthatmedicationmayalsobeeliminatedduringdialysis,andthatadoseadjustmentmaythus

benecessary.

Individualparameters(suchaspatientsize,bodyweight,laboratoryparameters,residualrenalfunction,ultrafiltration)

mustbeusedtodeterminethedoseandcombinationofsolutionsrequiredwithdifferingosmolarity(glucosecontent),

potassium,sodium,andcalciumconcentrations.Theefficacyoftherapyshouldberegularlymonitoredonthebasisof

theseparameters.

Peritonealdialysissolutionswithahighglucoseconcentration(2.3%or4.25%)areusedwhenthebodyweightis

abovethedesireddryweight.Thewithdrawaloffluidfromthebodyincreasesinrelationtotheglucoseconcentration

oftheperitonealdialysissolution.

5.2Pharmacokineticproperties

Uraemicretentionproductssuchasurea,creatinine,anduricacid,inorganicphosphate,andelectrolytessuchas

sodium,potassium,calciumandmagnesiumareremovedfromthebodyintothedialysissolutionbydiffusionand/or

convection.

DialysateglucoseusedasanosmoticagentinCAPD/DPCA18isslowlyabsorbeddecreasingthediffusiongradient

betweendialysissolutionandextracellularfluid.Ultrafiltrationismaximalatthebeginningofthedwelltimereaching

apeakafterabout2to3hours.Laterabsorptionstartswithaprogressivelossofultrafiltrate.After4hoursthe

ultrafiltrateaverages100mlwitha1.5%,400mlwitha2.3%,and800mlwitha4.25%glucosesolution.60to80%

ofdialysateglucoseareabsorbed.

L-lactateusedasthebufferingagentisalmostcompletelyabsorbedaftera6-hourdwelltime.Inpatientswithanormal

hepaticfunctionL-lactateisrapidlymetaboliseddemonstratedbynormalvaluesofintermediatemetabolites.

Calciummasstransferdependsonthedialysissolutionglucoseconcentration,theeffluentvolume,theserumionised

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volumeandtheserumionisedcalciumconcentration,andthelowerthecalciumconcentrationinthedialysissolution,

thehigheristhecalciumtransferfromthepatienttothedialysate.IthasbeenestimatedthatatypicalCAPDschedule

ofthree1.5%andone4.25%glucose-containingbagsperdaywouldremoveupto160mgcalciumperdayenablinga

higherintakeoforalcalciumcontainingdrugsandvitaminDwithouttheriskofhypercalcaemia.

5.3Preclinicalsafetydata

NopreclinicaltoxicitystudieswithCAPD/DPCA18havebeencarriedout,butclinicalstudieswithcomparable

solutionsforperitonealdialysishaveshownnomajorriskoftoxicity.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydrochloricacid

Sodiumhydroxide

Waterforinjections

6.2Incompatibilities

Becauseoftheriskofincompatibilityandofcontaminationmedicinalproductsmustonlybeaddedwhenprescribedby

aphysician(seealsoSection4.4under“Additionofmedicationtotheperitonealdialysissolution”).

6.3ShelfLife

2years

Shelflifeafterfirstopening:Thecontentmustbeusedimmediately.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

staysafe:

Thestaysafesystemisprovidedasadoublebagsystemconsistingofanon-PVCsolutionbagmadeofamultilayer

polyolefinefoil,atubingsystemalsomadeofpolyolefines,asystemconnector(DISC,polypropylene),adrainagebag

andanouterbag,alsomadeofpolyolefinemultilayerfilm.

sleepsafe:

Thesleepsafesystemisprovidedasasinglebagsystemconsistingofanon-PVCsolutionbagmadeofamultilayer

polyolefinefoil,atubingsystem,abagconnectorbothalsomadeofpolyolefinesandaninjectionportmadeof

polyolefine/syntheticrubber.

Packsizes:

staysafe sleepsafe

6bagsof1,500mleach 2bagsof5,000mleach

4bagsof2,000mleach

4bagsof2,500mleach

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

(seealsoSection4.2and4.4)

Staysafesystem:

Sleepsafesystem(forthesetupofthesleep.safesystempleaserefertoitsoperatinginstructions):

1.Preparationofthesolution

Checkthesolutionbag(label,expirydate,clearnessofthesolution,bag,andoverwrapnotdamaged).

Placethebagonasolidsurface.

Opentheoverwrapofthebag.

1.Checkthesolutionbag(label,theexpirydateandensure

thatthesolutionisclear)–opentheouterwrapandpackage

ofthedisinfectioncap.

2.Cleanhandswithanantimicrobialwashingsolution.

3.PlacetheDISCintotheorganiser(suspendsolutionbag

fromtheupperholeoftheinfusionpole–unrolltheline

“solutionbag-DISC”–placetheDISCintotheorganiser–

afterwardsplacedrainagebagintolowerholderofthe

infusionpole).

4.Placecatheteradapterintotheorganiser.

5.Disinfectyourhandsandremoveprotectioncapofthe

DISC

6.ConnectcatheteradaptertotheDISC:

7.Openingcatheterclamp–position

8.Flush-position“ ”-flush

offreshdialysatetothe

drainagebag(approx.5

seconds)

9.Inflow–position“ ○◑”–

connectionbetweensolution

bagandcatheter.

10.Securitystep–position

”–automatedclosing

ofthecatheteradapterwith

thePIN.

11.Disconnection(remove

catheteradapterfromDISC

part)–screwcatheter

adaptertothenew

disinfectioncap.

12.ClosetheDISCwiththe

openendoftheprotection

cap(whichisplacedinthe

rightholeoftheorganiser)

13.Checkingthedrained

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Checkwhetherthesolutionisclearandthatthebagisnotleaking.

2.Unrolltubing(1)ofbag.

3.Removetheprotectioncap.

4.Insertconnectorinfreesleepsafetrayport.

5.Thebagisnowreadyforusewiththesleepsafeset.

Whenaddingdrugs,useaseptictechnique,mixthoroughlyandaftercheckingfortheabsenceofanyturbidity,which

mayoccurduetoincompatibilities,theperitonealdialysissolutionmustbeusedimmediately.

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareDeutschlandGmbH

D-61346BadHomburg

Germany

8MARKETINGAUTHORISATIONNUMBER

PA0953/002/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

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