DIANEAL PD1 GLUCOSE 3.86% W/V (38.6 MG/ML) SOLUTIO

Main information

  • Trade name:
  • DIANEAL PD1 GLUCOSE 3.86% W/V (38.6 MG/ML) SOLUTIO
  • Dosage:
  • 3.86 %w/v
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIANEAL PD1 GLUCOSE 3.86% W/V (38.6 MG/ML) SOLUTIO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/017/002
  • Authorization date:
  • 18-12-1979
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DianealPD1Glucose3.86%w/v38.6mg/mlSolutionforPeritonealDialysis.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

OnelitreofPeritonealDialysisSolutioncontains:

Thisprovides:

Forafulllistexcipients,seesection6.1.

3PHARMACEUTICALFORM

Solutionforperitonealdialysis.

Aclear,colourless,sterileaqueoussolution,packedinPVCcontainers,eachcontainedinasealedplasticoverpouch.

Thecontainermaybefittedwithanintegraldrainage/administrationset.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DianealPD1isindicatedwheneverperitonealdialysisisemployed,including:

Acuteandchronicrenalfailure.

Severewaterretention.

ElectrolyteDisorders.

Drugintoxication,whenamoreadequatetherapeuticalternativeisnotavailable.

4.2Posologyandmethodofadministration

Administration

DIANEALPD1isintendedforintraperitonealadministrationonly.Notforintravenousadministration.

Peritonealdialysissolutionsmaybewarmedto37°Ctoenhancepatientcomfort.However,onlydryheat(forexample,

heatingpad,warmingplate)shouldbeused.Solutionsshouldnotbeheatedinwaterduetoanincreasedriskof

contamination.Solutionsshouldnotbeheatedinamicrowaveovenduetothepotentialfordamagetothecontainer

AnhydrousGlucose 38.60 g

whichmaybepresentasGlucoseMonohydrate 42.00 g

SodiumChloride 5.67 g

Sodiumlactate 3.92 g

CalciumChlorideDihydrate 257.00 mg

MagnesiumChlorideHexahydrate 152.00 mg

Sodium 132.00 mmol

Calcium 1.75 mmol

Magnesium 0.75 mmol

Chloride 102.00 mmol

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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,

documentedlossofperitonealfunctionorextensiveadhesionsthatcompromiseperitonealfunction

4.4Specialwarningsandprecautionsforuse

Peritonealdialysisshouldbedonewithcautioninpatientswith:

abdominalconditions,includingdisruptionoftheperitonealmembraneanddiaphragmbysurgery,fromcongenital

anomaliesortraumauntilhealingiscomplete,abdominaltumors,abdominalwallinfection,hernias,fecalfistula,

colostomyoriliostomy,frequentepisodesofdiverticulitis,inflammatoryorischemicboweldisease,largepolycystic

kidneys,orotherconditionsthatcompromisetheintegrityoftheabdominalwall,abdominalsurface,orintra-abdominal

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otherconditionsincludingrecentaorticgraftreplacementandseverepulmonarydisease.

EncapsulatingPeritonealSclerosis(EPS)isconsideredtobeaknown,rarecomplicationofperitonealdialysistherapy.EPS

hasbeenreportedinpatientsusingperitonealdialysissolutionsincludingsomepatientsusingDIANEALPD1aspartof

theirPDtherapy.

Ifperitonitisoccurs,thechoiceanddosageofantibioticsshouldbebasedupontheresultsofidentificationandsensitivity

studiesoftheisolatedorganism(s)whenpossible.Priortoidentificationoftheinvolvedorganism(s),broadspectrum

antibioticsmaybeindicated.

Patientswithconditionsknowntoincreasetheriskoflacticacidocis[e.g.,acuterenalfailure,inbornerrorsofmetabolism,

treatmentwithdrugssuchasmetforminandnucleoside/nucleotidereversetranscriptaseinhibitors(NRTIs)]shouldbe

monitoredforoccurrenceoflacticacidosisbeforethestartoftreatmentandduringtreatmentwithlactate-basedperitoneal

dialysissolutions.

Whenprescribingthesolutiontobeusedforanindividualpatient,considerationshouldbegiventothepotentialinteraction

betweenthedialysistreatmentandtherapydirectedatotherexistingillnesses.Serumpotassiumlevelsshouldbe

monitoredcarefullyinpatientstreatedwithcardiacglycosides.

Anaccuratefluidbalancerecordmustbekeptandtheweightofthepatientcarefullymonitoredtoavoidover-orunder

hydrationwithsevereconsequencesincludingcongestiveheartfailure,volumedepletionandshock.

Significantlossesofprotein,aminoacidsandwatersolublevitaminsmayoccurduringperitonealdialysis.Replacement

therapyshouldbeprovidedasnecessary.

Theuseof5or6litresofsolutioninasingleCAPDorAPDexchangeisnotrecommendedduetopotentialforoverinfusion.

OverinfusionofDIANEALPD1solutionsintotheperitonealcavitymaybecharacterisedbyabdominaldistension/abdominal

painand/orshortnessofbreath.

TreatmentofDIANEALPD1overinfusionistodrainthesolutionfromtheperitonealcavity.

ExcessiveuseofDIANEALPD1peritonealdialysissolutionwithahigherglucoseconcentrationduringaperitonealdialysis

treatmentmayresultinexcessiveremovalofwaterfromthepatient.

PotassiumisomittedfromDIANEALPD1solutionsduetotheriskofhyperkalaemia.

Insituationsinwhichthereisanormalserumpotassiumlevelorhypokalaemia,theadditionofpotassiumchloride(up

toaconcentrationof4mEq/l)maybeindicatedtopreventseverehypokalaemiaandshouldbemadeaftercareful

evaluationofserumandtotalbodypotassium,onlyunderthedirectionofaphysician.

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

(includingparathyroidhormone)andhaematologicalparametersshouldbemonitoredperiodically.

Indiabeticpatientsbloodglucoselevelsshouldberegularlymonitored,andthedosageofinsulinorothertreatmentfor

hyperglycaemiashouldbeadjusted.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NointeractionstudieshavebeenconductedwithDIANEALPD1.Thebloodconcentrationofdialysabledrugsmaybe

reducedbyperitonealdialysis.

Plasmalevelsofpotassium,calciumandmagnesiuminpatientsusingcardiacglycosidesmustbecarefullymonitored,

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4.6Fertility,pregnancyandlactation

ThereisnoclinicalexperiencewithDIANEALPD1duringpregnancyandlactation.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

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 Generalisedoedema

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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

SolutionsforPeritonealDialysis(codeATC:B05DB00).

Forpatientswithrenalfailure,peritonealdialysisisaprocedureforremovingtoxicsubstancesproducedbynitrogen

metabolismandnormallyexcretedbythekidneysandforaidingtheregulationoffluidandelectrolyteaswellasacid

basebalances.

Thisprocedureisaccomplishedbyadministeringperitonealdialysisfluidthroughacatheterintotheperitonealcavity.

Transferofsubstancesbetweenthedialysisfluidandpatientsperitonealcapillariesismadeacrosstheperitoneal

membraneaccordingtotheprinciplesofosmosisanddiffusion.

Afterafewhoursofdwelltimethesolutionissaturatedwithtoxicsubstancesandmustbechanged.Withtheexception

oflactate,presentasabicarbonateprecursor,electrolyteconcentrationsinthefluidhavebeenformulatedinanattempt

tonormaliseplasmaelectrolyteconcentrations.Nitrogenouswasteproducts,presentinhighconcentrationintheblood,

crosstheperitonealmembrane,intothedialysingfluid.Glucoseproducesasolutionhyperosmolartotheplasma,

creatinganosmoticgradientwhichfacilitatesfluidremovalfromtheplasmatothesolution,necessarytocompensate

fortheoverhydrationobservedinchronicrenalfailurepatients.

5.2Pharmacokineticproperties

SITECONDITIONS Malaise

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5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections.

6.2Incompatibilities

Noformalclinicaldruginteractionstudieshavebeenperformed.

Compatibilitiesshouldbecheckedwhenadditivesareused.Admixedsolutionsshouldbeusedimmediately

6.3Shelflife

Unopened:2years.

Opened:Forimmediateuse.Discardanyunusedsolution.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

ThefluidishermeticallysealedinsideabagmanufacturedfrommedicalgradeplasticisedPVC,designatedPL-146.

Thebagisfittedwithaportforconnectiontoasuitableadministrationset.Oralternativelythebagmaybeconnected

toanintegraladministrationsetandemptydrainagebag.Thebagisalsofittedwitharesealableinjectionportforthe

additionofmedicationtothesolutionpriortoadministration,ifappropriate.

Thebagisthensealedinsideanoverpouchmanufacturedfromhighdensitypolyethyleneorpolypropylene.

Containersizes:1.5litres,2litres,2.5litres,3litresand5litres.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Fordetailsontheconditionsofadministrationseesection4.2.

DetailedinstructionontheCAPDexchangeproceduresisgiventopatientsbymeansofspecialisedtraining,andinthe

leaflet.

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7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd

CaxtonWay

Thetford

Norfolk,IP243SE

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA167/17/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:18 th

December1979

Dateoflastrenewal:30 th

September2009

10DATEOFREVISIONOFTHETEXT

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