BICAVERA

Main information

  • Trade name:
  • BICAVERA Soln for Peritoneal Dialysis 2.3% %w/ v
  • Dosage:
  • 2.3% %w/ v
  • Pharmaceutical form:
  • Soln for Peritoneal Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BICAVERA Soln for Peritoneal Dialysis 2.3% %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0953/004/003
  • Authorization date:
  • 28-11-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

bicaVera2.3%Glucose,Solutionforperitonealdialysis

2QUALITATIVEANDQUANTITATIVECOMPOSITION

bicaVera2.3%glucoseisdeliveredinadouble-chamberbag.Onechambercontainsthealkalinehydrogencarbonate

carbonatesolution;theotherchambercontainstheacidicglucose-basedelectrolytesolution.Mixingofbothsolutions

byopeningthemedianseambetweenthetwochambersresultingintheready-to-usesolution.

BEFORERECONSTITUTION

1litreofacidicglucosebasedelectrolytesolutioncontains:

activesubstances:

Sodiumchloride 11.57 g

Calciumchloridedihydrate 0.5145g

Magnesiumchloridehexahydrate 0.2033g

Glucosemonohydrate 50.0 g

(equivalenttoglucose) 45.46 g

198.0 mmol/l

mmol/l

mmol/l

Chloride 209.0 mmol/l

1litreofalkalinehydrogencarbonatesolutioncontains:

activesubstances:

Sodiumhydrogencarbonate 5.88 g

70.0 mmol/l

70.0 mmol/l

AFTERRECONSTITUTION

1litreoftheready-to-usesolutioncontains

activesolution:

Sodiumchloride 5.786 g

Sodiumhydrogencarbonate 2.940 g

Calciumchloridedihydrate 0.2573g

Magnesiumchloridehexahydrate 0.1017g

Glucosemonohydrate 25.0 g

(equivalenttoglucose) 22.73 g

134.0 mmol/l

1.75 mmol/l

mmol/l

Chloride 104.5 mmol/l

HydrogenCarbonate 34.0 mmol/l

Glucose 126.1 mmol/l

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 1

3PHARMACEUTICALFORM

Solutionforperitonealdialysis

Clearandcolourlesssolution.

Theoreticalosmolarity:401mosm/l

≈7.40

4CLINICALPARTICULARS

4.1TherapeuticIndications

End-stage(decompensated)chronicrenalfailureofanyorigintreatedwithperitonealdialysis.

4.2Posologyandmethodofadministration

Dosage

bicaVera2.3%glucoseisexclusivelyindicatedfortheintraperitonealuse.

Themodeoftherapy,frequencyofadministration,anddwelltimerequiredwillbespecifiedbytheattendingphysician.

Continuousambulatoryperitonealdialysis(CAPD)

Unlessotherwiseadvised,patientswillreceiveaninfusionof2000mlsolutionperexchangefourtimesaday.Aftera

dwelltimebetween2and10hoursthesolutionwillbedrained.

bicaVera2.3%glucosecontains22.73gglucosein1000mlsolution.Accordingtothedosageinstructionupto45.5g

glucosearesuppliedtothebodywitheachbag.

Adjustmentofdosagewillbenecessaryforindividualpatients.

Ifdilationpainoccursatthecommencementofperitonealdialysis,thesolutionvolumeperexchangeshouldbeinitially

reducedto500-1500ml.

Inlargepatients,andifresidualrenalfunctionislost,anincreaseddoseofdialysiswillbenecessary.Inthesepatients,

orpatientswhotoleratelargervolumes,adoseof2500mlsolutionperexchangemaybegiven.

Inchildrenthesolutionvolumeperexchangeshouldbereducedaccordingtoage,size,andbodyweight(30–40ml/kg

bodyweight).

Automatedperitonealdialysis(APD)

Ifamachine(sleepsafecycler)isusedforintermittentorcontinuouscyclicperitonealdialysislargervolumebags

(3000ml)providingmorethanonesolutionexchangeareused.Thecyclerperformsthesolutionexchangesaccording

tothemedicalprescriptionstoredinthesleepsafecycler.

Peritonealdialysissolutionswithahighglucoseconcentration(2.3%or4.25%)areusedwhenthebodyweightis

abovethedesireddryweight.Thewithdrawaloffluidfromthebodyincreasesinrelationtotheglucoseconcentration

oftheperitonealdialysissolution.Thesesolutionsshouldbeusedcautiouslytotreattheperitonealmembranewithcare

topreventdehydrationandinordertokeeptheglucoseburdenaslowaspossible.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 2

Methodanddurationofadministration

Patientsshouldproficientatperformingperitonealdialysisbeforeperformingitathome.Thetrainingshouldbe

performedbyqualifiedpersonnel.Theattendingphysicianmustensurethatthepatientmastersthehandlingtechniques

sufficientlybeforethepatientperformsperitonealdialysisathome.Incaseofanyproblemsoruncertaintytheattending

physicianshouldbecontacted.

Dialysisusingtheprescribeddosesshouldbeperformeddaily.

Peritonealdialysisshouldbecontinuedforaslongasrenalfunctionsubstitutiontherapyisrequired.

Continuousambulatoryperitonealdialysis(CAPD)

Forthestep-by-stepinstructionforusepleasebereferredtoparagraph6.6,Specialprecautionsfordisposalofaused

medicinalproductorwastematerialsderivedfromsuchmedicinalproductandotherhandlingoftheproduct

Thesolutionbagisfirstwarmeduptobodytemperature.

Theheatingwillbeperformedwithaheatingplate.Thetimeforheatingisabout120minutesfora2000mlbagata

temperatureof22ºC.Detailscanbereadintheinstructionmanualoftheheatingplate.Amicrowaveovenmustnotbe

usedduetotheriskoflocaloverheating.

Thesolutionsinthetwochambersmustbemixedbeforeuse.Forthatpurposerollupthebagfromoneoftheupper

endsuntilthemiddleseamopens.Thesolutionsinthetwochambersaremixedautomatically.Thenrollupthebag

fromtheupperedge,untilthepeelseamofthelowertriangleiscompletelyopened.

Dependingonphysician'sinstructions,thedoseshoulddwellintheperitonealcavityfor2to10hours(equilibrium

time),andthenbedrained.Dependingontherequiredosmoticpressure,bicaVera2.3%glucosecanbeused

sequentiallywithotherperitonealdialysissolutionswithlowerorhigherglucosecontent(i.e.withlowerorhigher

osmolarity).

Automatedperitonealdialysis(APD)

Theconnectorsoftheprescribedsleepsafesolutionbagsareinsertedinthefreesleepsafetrayportsandthen

automaticallyconnectedtothesleepsafetubingsetbythecycler.Thecyclerchecksthebarcodesofthesolutionbags

andgivesanalarmwhenthebagsdonotcomplytotheprescriptionstoredinthecycler.Afterthischeckthetubingset

canbeconnectedtothepatient’scatheterextensionandthetreatmentbestarted.Thesleepsafesolutionis

automaticallywarmeduptobodytemperaturebythesleepsafecyclerduringtheinflowintotheabdominalcavity.

Dwelltimesandselectionofglucoseconcentrationsarecarriedoutaccordingtothemedicalprescriptionstoredinthe

cycler(formoredetailspleaserefertotheoperatinginstructionsofthesleepsafecycler).

4.3Contraindications

Forthisspecificperitonealdialysissolution

bicaVera2.3%glucosemustnotbeusedinpatientswithseverehypokalemia,severehypercalcemia,hypovolaemiaand

hypotension.

Forperitonealdialysisingeneral

Peritonealdialysisshouldnotbecommencedincaseof

recentabdominalsurgeryorinjury,ahistoryofabdominaloperationswithfibrousadhesions,severe

abdominalburns,bowelperforation,

extensiveinflammatoryconditionsoftheabdominalskin(dermatitis),

inflammatoryboweldiseases(Crohn'sdisease,ulcerativecolitis,diverticulitis),

localizedperitonitis,

internalorexternalabdominalfistula,

umbilical,inguinalorotherabdominalhernia,

intra-abdominaltumours,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 3

pulmonarydisease(especiallypneumonia),

sepsis,

extremehyperlipidemia,

inrarecasesofuremia,whichcannotbemanagedbyperitonealdialysis,

cachexiaandsevereweightloss,particularlyincasesinwhichtheingestionofadequateproteinisnot

guaranteed,

patientswhoarephysicallyormentallyincapableofperformingPDasinstructedbythephysician.

Ifanyoftheabovementioneddisordersdevelopsduringtheperitonealdialysis,theattendingphysicianhastodecide

onhowtoproceed.

Thisperitonealdialysissolutionmustnotbeusedforintravenousinfusion.

4.4Specialwarningsandprecautionsforuse

bicaVera2.3%glucosemayonlybeadministeredaftercarefulbenefit-riskassessementin:

lossofelectrolytesduetovomitingand/ordiarrhoea(atemporarychangetoaperitonealdialysissolution

containingpotassiummightthenbecomenecessary.)

hypercalcemia,e.g.duetotheadministrationofcalcium-containingphosphatebinders:Atransientor

permanentchangetoaperitonealdialysissolutionwithalowercalciumconcentrationshouldbeconsidered.

digitalistherapy:Regularmonitoringoftheserumpotassiumlevelismandatory.Severehypokalemiamay

necessitatetheuseofapotassium-containingdialysissolutionbesidesdietarycounselling.

Thenaturalmetabolicacidosisduetorenalfailuremightnotbetotallycompensatedbythe34mmol/lbicarbonatelevel

ofthefinalsolution.Acidosismightbeassociatedwithundesirableeffectse.g.malnutrition.

Alossofproteins,aminoacids,andwater-solublevitaminsoccursduringperitonealdialysis.Toavoiddeficienciesan

adequatedietorsupplementationshouldbeensured.

Thetransportcharacteristicsoftheperitonealmembranemaychangeduringlong-termperitonealdialysisprimarily

indicatedbyalossofultrafiltration.Inseverecasesperitonealdialysismustbestoppedandhemodialysiscommenced.

Themonitoringofthefollowingparametersisrecommended:

bodyweightfortheearlyrecognitionofover-anddehydration,

serumsodium,potassium,calcium,magnesium,phosphate,acidbasestatusandbloodproteins

serumcreatinineandurea,

parathormoneandotherindicatorsofbonemetabolism,

bloodsugar,

residualrenalfunctioninordertoadapttheperitonealdialysis

Elderlypatients

Theincreasedincidenceofherniashouldbeconsideredinelderlypatientspriortothestartofperitonealdialysis.

Shelflifeoftheready-to-usesolution

Theready-to-usesolutionmustbeadministeredwithin24hoursaftermixing.

Handling

Plasticcontainersmayoccasionallybedamagedduringtransportorstorage.Thiscanresultinacontaminationwith

growthofmicroorganismsinthedialysissolution.Thusallcontainersshouldbecarefullyinspectedfordamagepriorto

connectionofthebagandpriortouseoftheperitonealdialysissolution.

Anydamage,evenminor,toconnectors,attheclosure,containerweldsandcornersmustbenotedbecauseofpossible

contamination.Damagedbagsorbagswithcloudycontentshouldneverbeused!

Onlyusetheperitonealdialysissolutionifcontainerandsealareundamaged.Incaseofdoubttheattendingphysician

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 4

Theoverwrapshouldonlyberemovedbeforeadministration.

Donotusebeforemixingthetwosolutions.

Asepticconditionsmustbemaintainedduringdialysateexchangeinordertoreducetheriskofinfection.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theuseofthisperitonealdialysissolutioncanleadtoalossofefficacyofotherdrugsifthesearedialysablethrough

theperitonealmembrane.Adoseadjustmentmightbenecessary.

Adistinctreductionoftheserumpotassiumlevelcanincreasethefrequencyofdigitalis-associatedadversereactions.

Potassiumlevelsmustbemonitoredparticularlycloselyduringconcurrentdigitalistherapy.

Theconcomitantadministrationofcalcium-containingdrugsaswellasvitaminDmaycausehypercalcaemia.

Theuseofdiureticagentsmayhelpmaintainresidualdiuresis,butmayalsoresultinwaterandelectrolyteimbalances.

Indiabeticpatientsthedailydoseofbloodsugarreducingmedicationmustbeadjustedtotheincreasedglucoseload.

4.6Pregnancyandlactation

TherearenoadequatedatafromuseofbicaVerasolutionsinanimalsstudiesorinpregnantwomen.

Cautionshouldbeexercisedwhenprescribingtopregnantwomenorduringlactationperiod.

4.7Effectsonabilitytodriveandusemachines

Whenusedasprescribednoimpairmentoftheabilitytodriveandtousemachinesisknown.

4.8Undesirableeffects

bicaVera2.3%glucoseisanelectrolytesolutionthecompositionofwhichissimilartoblood.

Inadditionthephysiologicalbufferbicarbonateisused.Ingeneralthesolutionistoleratedverywell.

Possibleadversereactionsmayresultfromtheperitonealdialysisitselformaybeinducedbytheperitonealdialysis

solution.

Potentialadversereactionsoftheperitonealdialysissolutionare

electrolytedisturbances,e.g.hypokalemia,hypercalcaemiaincombinationwithanincreasedcalciumuptake,

e.g.bytheadministrationofcalcium-containingphosphatebinders,

disturbancesinhydration.Arapiddecreaseinbodyweight,thedropinbloodpressureand/ortachycardiamay

indicatedehydration;oedema,hypertensionandpossiblydyspnoeamayindicateoverhydration.

increasedbloodsugarlevels,

hyperlipidemia

increaseinbodyweight.

Potentialsideeffectsofthetreatmentmodeare

peritonitis,indicatedbycloudyeffluent.Laterabdominalpain,fever,andmalaise(generalfeelingunwell)may

developor,inveryrarecases,generalisedbloodpoisoning(sepsis).Thepatientshouldvisittheattending

physicianimmediately.Thebagwiththecloudyeffluentshouldbeclosedwithasterilecapandbroughtalong

forfurtherevaluation.

skinexitsiteinfectionortunnelinfectionofthecatheterindicatedbyredness,oedema,pain,exudationsor

crusts.Theattendingphysicianshouldbeconsultedassoonaspossible.

in-andoutflowdisturbancesofthedialysissolution,

diarrhoeaorconstipation,

dyspnoeacausedbytheelevateddiaphragm,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 5

abdominaldilatationandsensationoffullness,

shoulderpain.

4.9Overdose

Anyexcessofdialysissolutioninfusedintheperitonealcavitycaneasilybedrainedinthedrainagebag.Incaseoftoo

frequentexchangesdehydrationand/orelectrolytedisturbancesmightresultwhichnecessitateimmediatemedical

attention.

Ifoneormoreofthedailyexchangesaremissedoratoosmallsolutionvolumehasbeenadministered,overhydration

andelectrolytedisturbancesmaydevelop.

Interruptionordiscontinuationoftreatmentmayresultinlife-threateningoverhydrationanduraemia.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup

Group: Solutionforperitonealdialysis

ATC: B05DB

Theelectrolyteprofileofthesolutionisbasicallythesameasthatofphysiologicalserum.Ithasbeenadapted(e.g.the

potassiumcontent)foruseinuraemicpatients,toenablerenalreplacementtherapybymeansofintraperitoneal

substanceandfluidexchange.Substanceswhicharenormallyeliminatedwiththeurine,suchasurea,creatinine,and

water,areremovedfromthebodyintothedialysissolution.Itshouldbeborneinmindthattherapeuticsubstancesmay

alsobeeliminatedduringdialysis,andthatadoseadjustmentmaybenecessary.

Individualparameters(patientsizeandbodyweight,laboratoryparameters,residualrenalfunction,ultrafiltration,

requireddialysisdose)mustbeconsideredtodeterminetheadequatedoseandthecombinationofsolutionswith

differingosmolarity(glucoseconcentration),andpotassium,sodium,andcalciumconcentrations.Theefficacyof

therapyshouldberegularlymonitoredonthebasisoftheseparameters.

bicaVera2.3%glucosecontainsbicarbonate-thephysiologicalbuffer-insteadoflactateoracetate.

5.2Pharmacokineticproperties

Noanimalstudieshavebeenperformedwiththeintraperitonealapplicationofbicarbonate-containingbicaVera

solutions.ClinicalstudiesinpatientsonbicaVerahaveshownthatdialysatebicarbonateequilibrateswithblood

bicarbonatewithinatwo-hourdwelltime.

5.3Preclinicalsafetydata

Preclinicaldatarevealednospecialhazardforhumansbasedonsafetypharmacology,singledosetoxicityandrepeated

dosetoxicity.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hydrochloricacid

Sodiumhydroxide

Carbondioxide

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 6

6.2Incompatibilities

Drugsmustbeaddedunderasepticconditionsonlywhenmedicallyprescribed.

Becauseoftheriskofincompatibilitybetweenthedialysissolutionandtheaddeddrugsonlythefollowingdrugsmay

beaddeduptothementionedconcentrationifindicatedbytheattendingphysician:heparin1000I.U./l,insulin20

I.U./l,vancomycin1000mg/l,teicoplanin400mg/l,cefazolin500mg/l,ceftazidime250mg/l,gentamycin8mg/l.

Afterthoroughmixingandcheckingfortheabsenceofanyturbiditytheperitonealdialysissolutioncontainingother

drugsmustbeusedimmediately(nostorage).

6.3ShelfLife

Shelflifewithinthecontainer:2years

Shelflifeoftheready-to-usesolutionpreparedasdescribedinsection6.6,Specialprecautionsfordisposalofaused

medicinalproductorwastematerialsderivedfromsuchmedicinalproductandotherhandlingoftheproductand

withoutanyadditionaldrugs:24hours

6.4Specialprecautionsforstorage

Donotstorebelow4°C.

6.5Natureandcontentsofcontainer

Doublechamberbag:

Bicarbonatesolution:glucose-basedelectrolytesolution=Theratioshouldbe1:1

Staysafe:

Thestaysafesystemisprovidedasadoublebagsystemconsistingofanon-PVCsolutionbagmadeofamultilayer

polyolefinefoil,containingthegasbarrier,atubingsystemalsomadeofpolyolefines,asystemconnector(DISC,

polypropy-lene),adrainagebagandanouterbag,alsomadeofpolyolefinemultilayerfilm.

Sleepsafe:

Thesleepsafesystemisprovidedasasinglebagsystemconsistingofanon-PVCsolutionbagmadeofamultilayer

polyolefinefoil,containingthegasbarrier,atubingsystem,abagconnectorbothalsomadeofpolyolefinesandan

injectionportmadeofpolyolefine/syntheticrubber.

Bothstaysafeandsleepsafesystemarewrappedupinapolyolefine/polyester-laminatedfilm.

PackSizes:

4bagsof1500mleach

4bagsof2000mleach

4bagsof2500mleach

4bagsof3000mleach

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Staysafesystem:

Thesolutionbagisfirstwarmedtobodytemperature.Thisshouldbedonebyusinganappropriateheatertray.The

heatingtimefora2000mlbagwithastartingtemperatureof22°Cisapprox.120min.Moredetailedinformationcan

beobtainedfromtheoperatinginstructionsofthebagwarmer.Theuseofmicrowavestowarmthesolutionisnot

recommendedduetotheriskoflocaloverheating.Afterwarmingthesolutionyoucanstartwiththeexchangeofthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 7

1.Preparationofthesolution

Placethebagonasolidground

Opentheoverwrapofthebagandsealofthedisinfectioncap.

Controlthesolutionbag(label,expirydate,clearnessofthesolution,integrityofthebag)

Washyourhandswithanantimicrobialwashinglotion.

Rollupthebagfromoneoftheupperendsuntilthemiddleseamopens.Thesolutionsinthetwochambersare

mixedautomatically.

Thenrollupthebagfromtheupperedge,untilthepeelseamofthelowertriangleiscompletelyopened.

Theready-to-usesolutionshouldbeusedwithinamaximumof24hoursaftermixing!

2.Preparationofthebagexchange

Hangthesolutionbagontheupperhookoftheinfusionpole,unrollthetubinglineofthesolutionbag,and

placetheDISCintotheorganizer.Afterunrollingthetubinglinetothedrainagebag,hangthedrainagebagon

thelowerhookoftheinfusionpoleandplacethedisinfectioncapintotheorganizer.

Placecatheteradapterintotheorganizer.

DisinfectyourhandsandremovetheprotectioncapoftheDISC.

ConnectcatheteradaptertotheDISC.

3.Outflow

Openthecatheterclamp.Theoutflowstarts.

Position

4.Flush

Flushthedrainagebagwithfreshsolution(approx.5seconds)

Position

5.Inflow

Connectthesolutionbagwiththecatheter.

Position ○◑

6.Securitystep

ClosethecatheteradapterbyputtinginthePIN

Position

7.Disconnection

RemovethecatheteradapterfromtheDISCandscrewthenewdisinfectioncaptothecatheteradapter

8.ClosureoftheDISC

ClosetheDISCwiththeopenendoftheprotectioncapoftheuseddisinfectioncap,whichisplacedinthe

rightholeoftheorganizer.

9.Checkthedraineddialysateanddisposeofit.

Sleepsafesystem

(forthesetupofthesleepsafesystempleaserefertoitsoperatinginstructions):

InstructionforuseofthesleepsafebicaVerasystem:

Preparationofthesolution

Placethebagonasolidground

Opentheoverwrapofthebagandsealofthedisinfectioncap.

Controlthesolutionbag(label,expirydate,clearnessofthesolution,integrityofthebag)

Washyourhandswithanantimicrobialwashinglotion.

Rollupthebagfromoneoftheupperendsuntilthemiddleseamopens.Thesolutionsinthetwochambersare

mixedautomatically.

Thenrollupthebagfromtheupperedge,untilthepeelseamofthelowertriangleiscompletelyopened.

Theready-to-usesolutionshouldbeusedwithinamaximumof24hoursaftermixing!

Unrolltubingofbag.

Removetheprotectioncap.

Insertconnectorinfreesleepsafetrayport.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 8

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareDeutschlandGmbH

D-61346BadHomburg

Germany

8MARKETINGAUTHORISATIONNUMBER

PA0953/004/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28November2003

Dateoflastrenewal:14May2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/09/2007 CRN 2041678 page number: 9