DIANEAL PD4 GLUCOSE 3.86 % W/ V (38.6 MG/ ML), SOLUTION FOR PERITONEAL DIALYSIS.

Main information

  • Trade name:
  • DIANEAL PD4 GLUCOSE 3.86 % W/ V (38.6 MG/ ML), SOLUTION FOR PERITONEAL DIALYSIS.
  • Dosage:
  • 3.86 %w/ v
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIANEAL PD4 GLUCOSE 3.86 % W/V (38.6 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/084/021A
  • Authorization date:
  • 03-06-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DianealPD4Glucose3.86%w/v(38.6mg/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 3.86% w/v 38.60 g/L

GlucoseMonohydrate 4.25% w/v 42.50 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.

DIANEAL3.86%glucose-containingsolutionisahighosmoticpressurefluidandusingitalonemaycause

dehydration.(Seesection4.4).

Toavoidtheriskofseveredehydration,hypovolaemiaandtominimisethelossofproteins,itisadvisabletoselectthe

peritonealdialysissolutionwiththelowestosmolarityconsistentwithfluidremovalrequirementsforeachexchange.

4.3Contraindications

DIANEALiscontraindicatedinpatientswith:

pre-existingseverelacticacidosis,

uncorrectablemechanicaldefectsthatpreventeffectivePDorincreasetheriskofinfection,

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4.4Specialwarningsandprecautionsforuse

Peritonealdialysisshouldbedonewithcautioninpatientswith:

1)abdominalconditions,includingdisruptionoftheperitonealmembraneanddiaphragmbysurgery,fromcongenital

anomaliesortraumauntilhealingiscomplete,abdominaltumors,abdominalwallinfection,hernias,fecalfistula,

colostomyoriliostomy,frequentepisodesofdiverticulitis,inflammatoryorischemicboweldisease,largepolycystic

kidneys,orotherconditionsthatcompromisetheintegrityoftheabdominalwall,abdominalsurface,orintra-

abdominalcavity

2)otherconditionsincludingrecentaorticgraftreplacementandseverepulmonarydisease.

EncapsulatingPeritonealSclerosis(EPS)isconsideredtobeaknown,rarecomplicationofperitonealdialysis

therapy.EPShasbeenreportedinpatientsusingperitonealdialysissolutionsincludingsomepatientsusing

DIANEALPD4aspartoftheirPDtherapy.

Ifperitonitisoccurs,thechoiceanddosageofantibioticsshouldbebasedupontheresultsofidentificationand

sensitivitystudiesoftheisolatedorganism(s)whenpossible.Priortoidentificationoftheinvolvedorganism(s),

broadspectrumantibioticsmaybeindicated.

Patientswithconditionsknowntoincreasetheriskoflacticacidocis[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

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PotassiumisomittedfromDIANEALPD4solutionsduetotheriskofhyperkalaemia.

Insituationsinwhichthereisanormalserumpotassiumlevelorhypokalaemia,theadditionofpotassium

chloride(uptoaconcentrationof4mEq/l)maybeindicatedtopreventseverehypokalaemiaand

shouldbemadeaftercarefulevaluationofserumandtotalbodypotassium,onlyunderthedirection

ofaphysician.

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

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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.

THORACIC,AND

MEDIASTINAL

DISORDERS

GASTROINTESTINAL

DISORDERS Sclerosingencapsulating

peritonitis

Peritonitis

Peritonealcloudyeffluent

Vomiting

Diarrhoea

Nausea

Constipation

Abdominalpain

Abdominaldistension

Notknown

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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Transferofsubstancesbetweenthedialysisfluidandthepatient’speritonealcapillariesismadeacrosstheperitoneal

membraneaccordingtotheprinciplesofosmosisanddiffusion.Afterafewhoursofdwelltime,thesolutionis

saturatedwithtoxicsubstancesandmustbechanged.

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

PA167/84/21

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:3 rd

June1993

Dateoflastrenewal:7 th

September2009

10DATEOFREVISIONOFTHETEXT

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