DIANEAL PD4 GLUCOSE 1.36 % W/V (13.6 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS

Main information

  • Trade name:
  • DIANEAL PD4 GLUCOSE 1.36 % W/V (13.6 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS
  • Dosage:
  • 13.6 Mg/Ml
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIANEAL PD4 GLUCOSE 1.36 % W/V (13.6 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/084/001A
  • Authorization date:
  • 03-06-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DianealPD4Glucose1.36%w/v(13.6mg/ml),Solutionforperitonealdialysis.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

mmol/l

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

SolutionforPeritonealDialysis.

Aclearcolourlesstopaleyellow,solutioninPVCcontainers,whichmayhaveanintegraladministrationsetand

drainagebag.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DianealPD4isindicatedwheneverperitonealdialysisisemployed,including:

Acuteandchronicrenalfailure.

Severewaterretention.

Electrolytedisorders.

Drugintoxication,whenamoreadequatetherapeuticalternativeisnotavailable.

DianealPD4isparticularlyusefulforthecontrolofserumcalciumandphosphatelevelsinrenalfailurepatients

AnhydrousGlucose 1.36% w/v 13.60 g/L

GlucoseMonohydrate 1.50% w/v 15.00 g/L

SodiumChloride 0.538% w/v 5.38 g/L

SodiumLactate 0.448% w/v 4.48 g/L

CalciumChlorideDihydrate 0.0184% w/v 184.00 mg/L

MagnesiumChlorideHexahydrate 0.0051% w/v 51.00 mg/L

132.00

1.25

0.25

95.00

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4.2Posologyandmethodofadministration

Administration

DIANEALPD4isintendedforintraperitonealadministrationonly.Notforintravenousadministration.

Peritonealdialysissolutionsmaybewarmedto37°Ctoenhancepatientcomfort.However,onlydryheat(forexample,

heatingpad,warmingplate)shouldbeused.Solutionsshouldnotbeheatedinwaterduetoanincreasedriskof

contamination.Solutionsshouldnotbeheatedinamicrowaveovenduetothepotentialfordamagetothecontainer

andpatientinjuryordiscomfort.

Aseptictechniqueshouldbeemployedthroughouttheperitonealdialysisprocedure.

Donotadministerifthesolutionisdiscoloured,cloudy,containsparticulatematterorshowsevidenceofleakage,orif

sealsarenotintact.

Thedrainedfluidshouldbeinspectedforthepresenceoffibrinorcloudiness,whichmayindicatethepresenceof

peritonitis.

Forsingleuseonly.

Posology:

Themodeoftherapy,frequencyoftreatment,exchangevolume,durationofdwellandlengthofdialysisshouldbe

selectedbytheattendingphysician.

Adults

Patientsoncontinuousambulatoryperitonealdialysis(CAPD)typicallyperform4cyclesperday(24hours).Patients

onautomatedperitonealdialysis(APD)typicallyperform4-5cyclesatnightandupto2cyclesduringtheday.Thefill

volumedependsonbodysize,usuallyfrom2.0to2.5litres.

Paediatricpatients(i.e.,newbornto18yearsofage)

800to1400ml/m2percycleuptoamaximumamountof2000ml,astolerated,isrecommended.Fillvolumesof500

to1000ml/m2arerecommendedinchildrenlessthan2yearsofage.

Asthepatient’sbodyweightbecomesclosertotheidealdryweight,loweringtheglucoseconcentrationofDIANEAL

isrecommended.

Toavoidtheriskofseveredehydration,hypovolaemiaandtominimisethelossofproteins,itisadvisabletoselectthe

peritonealdialysissolutionwiththelowestosmolarityconsistentwithfluidremovalrequirementsforeachexchange.

4.3Contraindications

DIANEALiscontraindicatedinpatientswith:

pre-existingseverelacticacidosis,

uncorrectablemechanicaldefectsthatpreventeffectivePDorincreasetheriskofinfection,

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4.4Specialwarningsandprecautionsforuse

Peritonealdialysisshouldbedonewithcautioninpatientswith:

abdominalconditions,includingdisruptionoftheperitonealmembraneanddiaphragmbysurgery,from

congenitalanomaliesortraumauntilhealingiscomplete,abdominaltumors,abdominalwallinfection,hernias,

fecalfistula,colostomyoriliostomy,frequentepisodesofdiverticulitis,inflammatoryorischemicbowel

disease,largepolycystickidneys,orotherconditionsthatcompromisetheintegrityoftheabdominalwall,

abdominalsurface,orintra-abdominalcavity

otherconditionsincludingrecentaorticgraftreplacementandseverepulmonarydisease.

EncapsulatingPeritonealSclerosis(EPS)isconsideredtobeaknown,rarecomplicationofperitonealdialysis

therapy.EPShasbeenreportedinpatientsusingperitonealdialysissolutionsincludingsomepatientsusing

DIANEALPD4aspartoftheirPDtherapy.

Ifperitonitisoccurs,thechoiceanddosageofantibioticsshouldbebasedupontheresultsofidentificationand

sensitivitystudiesoftheisolatedorganism(s)whenpossible.Priortoidentificationoftheinvolvedorganism(s),

broadspectrumantibioticsmaybeindicated.

Patientswithconditionsknowntoincreasetheriskoflacticacidosis[e.g.,acuterenalfailure,inbornerrorsof

metabolism,treatmentwithdrugssuchasmetforminandnucleoside/nucleotidereversetranscriptaseinhibitors

(NRTIs)]shouldbemonitoredforoccurrenceoflacticacidosisbeforethestartoftreatmentandduring

treatmentwithlactate-basedperitonealdialysissolutions.

Whenprescribingthesolutiontobeusedforanindividualpatient,considerationshouldbegiventothepotential

interactionbetweenthedialysistreatmentandtherapydirectedatotherexistingillnesses.Serumpotassium

levelsshouldbemonitoredcarefullyinpatientstreatedwithcardiacglycosides.

Anaccuratefluidbalancerecordmustbekeptandtheweightofthepatientcarefullymonitoredtoavoidover-or

underhydrationwithsevereconsequencesincludingcongestiveheartfailure,volumedepletionandshock.

Significantlossesofprotein,aminoacidsandwatersolublevitaminsmayoccurduringperitonealdialysis.

Replacementtherapyshouldbeprovidedasnecessary.

Patientsreceivinglowcalciumsolutionshouldhavetheircalciumlevelsmonitoredforthedevelopmentof

hypocalcaemiaorworseningofhypercalcaemia.Inthesecircumstances,adjustmentstothedosageofthe

phosphatebindersand/orvitaminDanalogsshouldbeconsideredbythephysician.

Theuseof5or6litresofsolutioninasingleCAPDorAPDexchangeisnotrecommendedduetopotentialfor

overinfusion.

OverinfusionofDIANEALPD4solutionsintotheperitonealcavitymaybecharacterisedbyabdominal

distension/abdominalpainand/orshortnessofbreath.

TreatmentofDIANEALPD4overinfusionistodrainthesolutionfromtheperitonealcavity.

ExcessiveuseofDIANEALPD4peritonealdialysissolutionwithahigherglucoseconcentrationduringa

peritonealdialysistreatmentmayresultinexcessiveremovalofwaterfromthepatient.

PotassiumisomittedfromDIANEALPD4solutionsduetotheriskofhyperkalaemia.

Insituationsinwhichthereisanormalserumpotassiumlevelorhypokalaemia,theadditionofpotassium

chloride(uptoaconcentrationof4mEq/l)maybeindicatedtopreventseverehypokalaemiaandshould

bemadeaftercarefulevaluationofserumandtotalbodypotassium,onlyunderthedirectionofa

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Serumelectrolyteconcentrations(particularlybicarbonate,potassium,magnesium,calciumandphosphate),blood

chemistry(includingparathyroidhormone)andhaematologicalparametersshouldbemonitoredperiodically.

Indiabeticpatientsbloodglucoselevelsshouldberegularlymonitored,andthedosageofinsulinorother

treatmentforhyperglycaemiashouldbeadjusted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NointeractionstudieshavebeenconductedwithDIANEALPD4.Thebloodconcentrationofdialysabledrugsmaybe

reducedbyperitonealdialysis.

Plasmalevelsofpotassium,calciumandmagnesiuminpatientsusingcardiacglycosidesmustbecarefullymonitored,

asthereisariskofdigitalisintoxication.Potassiumsupplementsmaybenecessary.

4.6Fertility,pregnancyandlactation

ThereisnoclinicalexperiencewithDIANEALPD4duringpregnancyandlactation.Nodataareavailablefromanimal

studies.Therisk-benefitmustbeassessed.

Seesection4.4.

Whenassessingperitonealdialysisasamodeoftherapyduringadvancedpregnancy,thebenefitstothepatientmustbe

weighedagainstthepossiblecomplications.

4.7Effectsonabilitytodriveandusemachines

Endstagerenaldisease(ESRD)patientsundergoingperitonealdialysismayexperienceundesirableeffects,which

couldaffecttheabilitytodriveorusemachines(e.g.Malaise,Hypovolaemia).

4.8Undesirableeffects

Adversereactionsfrompostmarketingexperiencearelistedbelow.

Theadversedrugreactionslistedinthissectionaregivenfollowingtherecommendedfrequencyconvention:very

common:10%;common:1%and<10%;uncommon:0.1%and<1%;veryrare:<0.01%,notknown(cannotbe

estimatedfromavailabledata).

SystemOrganClass Preferredterm Frequency

METABOLISMAND

NUTRITIONAL

DISORDERS Hypokalaemia

Fluidretention

Hypervolaemia

Hypovolaemia

Hyponatraemia

Dehydration

Hypochloraemia Notknown

VASCULARDISORDERS Hypertension

Hypotension Notknown

RESPIRATORY,

THORACIC,AND

MEDIASTINAL

DISORDERS Dyspnoea Notknown

GASTROINTESTINAL

DISORDERS Sclerosingencapsulating

peritonitis

Peritonitis

Peritonealcloudyeffluent

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Otherundesirableeffectsofperitonealdialysisrelatedtotheprocedure:Fungalperitonitis,bacterialperitonitis,catheter

relatedinfection,catheterrelatedcomplication.

4.9Overdose

Possibleconsequencesofoverdoseincludehypervolaemia,hypovolaemia,electrolytedisturbancesor(indiabetic

patients)hyperglycaemia.

Managementofoverdose:

Hypervolaemiamaybemanagedbyusinghypertonicperitonealdialysissolutionsandfluidrestriction.

Hypovolaemiamaybemanagedbyfluidreplacementeitherorallyorintravenously,dependingonthedegreeof

dehydration.

Electrolytedisturbancesshallbemanagedaccordingtothespecificelectrolytedisturbanceverifiedbybloodtest.The

mostprobabledisturbance,hypokalaemia,maybemanagedbytheoralingestionofpotassiumorbytheadditionof

potassiumchlorideintheperitonealdialysissolutionprescribedbythetreatingphysician.

Hyperglycaemia(indiabeticpatients)shallbemanagedbyadjustingtheinsulindoseaccordingtotheinsulinscheme

prescribedbythetreatingphysician.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Forpatientswithrenalfailure,peritonealdialysisisaprocedureforremovingtoxicsubstancesproducedbynitrogen

metabolismandnormallyexcretedbythekidneys,andforaidingtheregulationoffluidandelectrolyteaswellasacid

basebalances.

Thisprocedureisaccomplishedbyadministeringperitonealdialysisfluidthroughacatheterintotheperitonealcavity.

Transferofsubstancesbetweenthedialysisfluidandthepatient’speritonealcapillariesismadeacrosstheperitoneal

membraneaccordingtotheprinciplesofosmosisanddiffusion.Afterafewhoursofdwelltime,thesolutionis

Diarrhoea

Nausea

Constipation

Abdominalpain

Abdominaldistension

Abdominaldiscomfort

SKINAND

SUBCUTANEOUS

DISORDERS Stevens-Johnsonsyndrome

Urticaria

Rash(includingpruritic,

erythematousandgeneralised)

Pruritus Notknown

MUSCULOSKELETAL,

CONNECTIVETISSUE

DISORDERS Myalgia

Musclespasms

Musculoskeletalpain Notknown

GENERALDISORDERS

ANDADMINISTRATIVE

SITECONDITIONS Generalisedoedema

Pyrexia

Malaise

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Withexceptionoflactate,presentasabicarbonateprecursor,electrolyteconcentrationsinthefluidhavebeen

formulatedinanattempttonormaliseplasmaelectrolyteconcentrations.Nitrogenouswasteproducts,presentinhigh

concentrationintheblood,crosstheperitonealmembraneintothedialysingfluid.Glucoseproducesasolution

hyperosmolartotheplasma,creatinganosmoticgradientwhichfacilitatesfluidremovalfromtheplasmatothe

solution,necessarytocompensatefortheover-hydrationobservedinchronicrenalfailurepatients.

5.2Pharmacokineticproperties

Intraperitoneallyadministeredglucoseisabsorbedintothebloodandmetabolisedbytheusualpathways.

5.3Preclinicalsafetydata

Notappropriate.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections.

6.2Incompatibilities

Noformalclinicaldruginteractionstudieshavebeenperformed.

Compatibilitiesshouldbecheckedwhenadditivesareused.Admixedsolutionsshouldbeusedimmediately.

6.3Shelflife

Theshelflifeoftheproductaspackagedforsaleis24months

12months(formedicinalproductmanufacturedatAlliston,CanadaandNorthCove,USAonly).

Theproduct,onceremovedfromitsoverpouch,shouldbeusedimmediately.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

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6.5Natureandcontentsofcontainer

ThefluidishermeticallysealedinsideabagmanufacturedfrommedicalgradeplasticisedPVC,designatedPL-146.

Thebagisfittedwithaportforconnectiontoasuitableadministrationset,oralternativelythebagmaybeconnectedto

anintegraladministrationsetandemptydrainagebag.Thebagisalsofittedwitharesealablelatexinjectionportfor

theadditionofmedicationtothesolutionpriortoadministration,ifappropriate.

Thebagisthensealedinsideanoverpouchmanufacturedfromhighdensitypolyethyleneorpolypropylene.

Containersizes:1500ml,2000ml,2500ml,3000ml,5000ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Fordetailsontheconditionsofadministrationseesection4.2.

DetailedinstructionontheCAPDexchangeproceduresisgiventopatientsbymeansofspecialisedtraining,andinthe

leaflet.

Discardanyunusedremainingsolution.

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLimited

CaxtonWay

Thetford

Norfolk

IP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA167/84/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:3 rd

June1993

Dateoflastrenewal:7 th

September2009

10DATEOFREVISIONOFTHETEXT

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