DEXEMEL 4%

Main information

  • Trade name:
  • DEXEMEL 4%
  • Dosage:
  • 40 Mg/Ml
  • Pharmaceutical form:
  • Solvent for Parenteral Use
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DEXEMEL 4%
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0675/002/001
  • Authorization date:
  • 27-07-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dexemel40g/litreSolventforintraperitonealuse.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Theoreticalosmolarity278(milliosmolesperlitre).

Electrolytesolutioncontentper1000ml:

Forexcipientsseesection6.1.

3PHARMACEUTICALFORM

Solventforintraperitonealuse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Dexemelisrecommendedasavehiclefortheadministrationviatheperitoneumofmedicinalproductscompatiblewith

thevehicleandshowntohavebeenusedsafelyandeffectivelybytheintraperitonealroute.

Seesection6.2.

4.2Posologyandmethodofadministration

ThePosologyandtechniqueapplieddependonthepharmaco-kineticattributesofthetherapeuticagentwhichhasbeen

dissolvedinDexemelandareindividuallydecidedbytheresponsiblephysician.

1Litre(approximately15ml/kg)maybeinstilledintotheperitonealcavitythriceweeklyviaasubcutaneously

implantedport/catheterdevice.

2Litres(approximately30ml/kg)maybeinstilleddailyintotheperitonealcavityviaaTenckhoffcatheterifdrained

Each1litrecontains:

Icodextrin 40.0 g

SodiumChloride 5.4 g

S(+)SodiumLactate(60%w/wsolution) 4.5 g

CalciumChloride 257.0 mg

MagnesiumChloride 51.0 mg

Sodium 133.0 mmol

Calcium 1.75 mmol

Magnesium 0.25 mmol

Chloride 96.0 mmol

Irish Medicines Board

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Thedosagefrequencyofthetherapeuticagentshouldbedeterminedbyitsknownpharmacokineticattributes.

Peritonealadministrationrequirestheuseofaspecificandadequateambulatorydrugdeliverysystem,permittingthe

connectionbetweentheDexemelbagandthepatient.

Toreducediscomfortonadministration,thesolutionmaybewarmedintheoversealedbagtoatemperatureof37°C

priortouse.Thisshouldbedoneusingadevicespeciallydesignedforthepurpose.

Iffluidistobedrainedout,drainageshouldbebygravityataratewhichthepatientfindscomfortable.

Thedrainedfluidshouldbeinspectedforthepresenceoffibrinorcloudiness,whichmayindicatethepresenceof

infection.

4.3Contraindications

Dexemelisnotrecommendedforuseinpatientswithaknownallergytostarchbasedpolymers,orinpatientswith

maltoseorisomaltoseintoleranceorinpatientswithglycogenstoragedisease.

Dexemelisalsocontraindicatedinpatientswithbowelobstruction.Thepresenceofabdominalfistulae,openwounds,

herniae,orotherconditionswhichcompromisetheintegrityoftheperitonealcavitymayalsocontraindicatetheuseof

Dexemel.

4.4Specialwarningsandprecautionsforuse

Dexemelisnotrecommendedforuseinchildren.

Aseptictechniqueshouldbeemployedthroughouttheprocedureofintraperitonealinstillationoffluidanddraining.

Bloodglucosemeasurementmustbedonewithaglucosespecificmethodtopreventmaltoseinterference.Glucose

dehydrogenasepyrroloquinolinequinone(GDHPQQ)-basedmethodshouldnotbeused.Itisrecommendedthat

referenceismadetotherelevantsectionoftheglucosetestkitproductleaflettoascertainthatinterferencewhileusing

Icodextrin-baseddialysistherapyisnotdescribed.

TheDexemelsolutionwhichistobeadministeredviatheperitoneumshouldbeusedwithcaution,aftercareful

evaluationofitspotentialrisksandbenefits,inpatientswithconditionswhichprecludenormalnutrition,withimpaired

respiratoryfunctionorwithhypokalaemiaorhypomagnesemia.

Inpatientswithclinicallysignificantcardiorespiratorydisease,carefulmonitoringtoavoidoverorunderhydration

usingfluidbalancerecordsandbodyweightshouldbeundertaken.

Bloodchemistry,haematologyandplasmaosmolalityshouldbemonitoredatregularintervals.

Dexemelremainsintheperitonealcavitylongerthansalineorglucosesolutions.Thepharmacokineticattributesofthe

therapeuticagentdissolvedinDexemelmustbetakenintoaccountbytheprescribingphysicianwhenassessingtherisk

benefitofanysubstancegivenbythisroute.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.However,bloodconcentrationsofdialysabledrugsmaybereducedbyperitonealdialysis.Corrective

therapyshouldbeinstitutedifnecessary.Inpatientsusingcardiacglycosides,plasmalevelsofpotassiumandcalcium

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4.6Pregnancyandlactation

Animalstudiesontheeffectsoficodextrinareinsufficientwithrespecttoeffectsonembryonal/foetaldevelopmentand

lactation.

TherearenoadequatedatafromtheuseofDexemelinpregnantwomen.

Dexemelshouldnotbeusedduringpregnancyorwhilebreastfeedingunlessclearlynecessary.

WomenofchildbearingpotentialshouldbetreatedwithDexemelonlywhenadequatecontraceptiveprecautionshave

beentaken.

4.7Effectsonabilitytodriveandusemachines

Noeffectsonabilitytodriveandusemachineshavebeenobserved.

4.8Undesirableeffects

UndesirableeffectsassociatedwithDexemelhaveincludedperitonitisrelatedtotheadministrationprocedureand

abdominalpain.Inpatientsreceivingicodextrin7.5%solutionaspartofaperitonealdialysisregimenandonmulti

therapytherehavebeencommonreportsofskinreactions,includingrashandpruritiswhicharegenerallymildor

moderateinseverity.Occasionallytheserasheshavebeenassociatedwithexfoliation.Intheeventofthisoccurring

anddependingontheseverity,Dexemelshouldbewithdrawnatleasttemporarily.

4.9Overdose

Nodataareavailableontheeffectsofoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:V07AB.

Icodextrinisan 1-4linkedglucosepolymerwhichwhenadministeredintraperitoneallyasa4%solutioniscapable

ofmaintainingaconstantreservoiroffluidwithintheperitonealcavityforaperiodof24to48hours.

TheclinicalexperiencewithDexemelislimited.Todate105patientshavebeenstudied.Inthesestudies5-

fluorouracil(atdifferentdoses)aloneandincombinationwithfolinicacidhavebeenadministeredinDexemel.

5.2Pharmacokineticproperties

Whengivenintraperitoneallythepolymerislargelyretainedwithintheperitonealcavity.Someabsorptionoccursfrom

theperitoneumintothesystemiccirculationwhereitismetabolisedbyamylasetosmalleroligosaccharides,ultimately

maltoseandbymaltasetoglucose.Steadystateplasmalevelsof1.98mg/mlhavebeenmeasuredforoligomersof

glucoseunitsgreaterthan7andmaltoselevelsof0.14mg/ml.

5.3Preclinicalsafetydata

Pre-clinicaldatarevealnospecifichazardforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

Irish Medicines Board

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Carcinogenicitystudieswiththeproductarenotfeasiblebutcarcinogeniceffectsareunlikelygiventhechemicalnature

ofthemolecule,itslackofpharmacologicaleffect,lackoftargetorgantoxicity,andnegativeresultsinmutagenicity

studies.

Areproductiontoxicitystudyinratsdemonstratednoeffectonfertilityorembryofoetaldevelopment.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

WaterforInjections

SodiumhydroxideorHydrochloricacidq.s.torequiredpH

6.2Incompatibilities

Noneknown.

Arangeofantibioticsincludingvancomycin,cephazolin,ampicillin/flucloxacillin,ceftazidime,gentamycin,

amphotericin;insulin;and5FUhaveshownnoevidenceofincompatibilitywitha7.5%solutionoficodextrin.

SomemedicinalproductsthatmaybedissolvedinDexemelmayinteractwiththePVCbag.

6.3ShelfLife

2years.

FollowingadmixtureofmedicinalproductswithDexemelthesolutionshouldbeusedimmediatelyandanyunused

solutionshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Donotrefrigerateorfreeze.

6.5Natureandcontentsofcontainer

1L,1.5Land2.0LflexiblePVCbags.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotstoreabove30°C.Donotrefrigerateorfreeze.

7MARKETINGAUTHORISATIONHOLDER

Innovataplc

1MereWay

Ruddington

Nottingham,NG116JS

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA0675/002/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27 th

July2001

Dateoflastrenewal:6 th

January2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/11/2007 CRN 2043438 page number: 5