GAMBROSOL TRIO 40

Main information

  • Trade name:
  • GAMBROSOL TRIO 40
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAMBROSOL TRIO 40
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0953/008/002
  • Authorization date:
  • 22-07-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gambrosoltrio40,solutionforperitonealdialysis.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Gambrosoltrio40isfilledinathree-compartmentbag.

Twosmallercompartments(AandB)eachcontain50%glucosesolutionandsodiumchloride(NaCl)andalargerthird

compartment(C)theelectrolytesolution.AfterbreakingthefrangiblepinbetweencompartmentsAandCand

thoroughlymixingthetwofluidsaPDsolutioncontaining1.5%glucosewillbeproduced.Similarlymixingthe

contentsofcompartmentsBandCwillproduceaPDsolutioncontaining2.5%glucose.Finallybybreakingboth

frangiblepinsandmixingthecontentsofallthreecompartmentswillproduceasolutioncontaining3.9%glucose.

BEFORERECONSTITUTION

Each1000mlcontains:

GlucosecompartmentsAandB

ElectrolytecompartmentC

AFTERRECONSTITUTION

TheglucosecompartmentsAor/andBaremixedwiththeelectrolytecompartmentCtogivethefollowing

reconstitutedsolutions:

Activeingredients:

Glucoseanhydrous 500.0g

(asglucosemonohydrate 550.0g)

Sodiumchloride 5.38g

Activeingredients:

Sodiumchloride 5.38g

SodiumlactateS-(+)anhydrous 4.72g

(as60%m/msolution) (7.87g)

Calciumchloridedihydrate 0.209g

Magnesiumchloridehexahydrate 0.054g

MixcompartmentsAandC Reconstitutedsolution40L(Light)

MixcompartmentsBandC Reconstitutedsolution40M(Medium)

MixcompartmentsA,BandC Reconstitutedsolution40H(High)

Reconstitutedsolutionmmol/l L M H

SodiumNa + 133 132 131mmol/l

CalciumCa ++ 1.38 1.35 1.31mmol/l

MagnesiumMg ++ 0.26 0.25 0.24mmol/l

ChlorideCl - 95.4 95.2 95.2mmol/l

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Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionsforperitonealdialysis.

Clearandcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofacuteandchronicrenalfailure.Treatmentofexcessivefluidretentionandcertaintypesofsevere

electrolyteimbalance(e.g.hyperkalemia)notamenabletoothertherapy.Treatmentofintoxicationwithdialysable

substances.

4.2Posologyandmethodofadministration

Forintraperitonealadministration

Themodeoftherapy,frequencyoftreatment,exchangevolume,durationofdwellandlengthofdialysisare

individuallydecidedbytheresponsiblephysician.

Theaveragefrequencyis3to5timesaday.Thefillvolumedependsonbodysize,usuallyfrom2,0to2,5litresfor

adults.Therearenodatafromclinicalstudiesinpaediatricpatients.

Theglucoseconcentrationinthesolutionischosenaccordingtothepatient'sultrafiltrationneedsandshouldbekeptas

lowaspossible.

Theintraperitonealadministrationrequirestheuseofaspecialcatheterandasuitableadministrationsetenablingthe

connectionbetweenthesolutionbagandthepatient'scatheter.

Modeofpreparation

Itisnecessarytowarmupthesolutiontobodytemperaturebeforeuseusingthespecialheaterprovided.

Priortopreparingforadministrationensurethatallthesolutionsareclearandallthesealsintact,washthehands,clean

theworkingareawithadisinfectantandplacethesolutionbagontheworkingarea.Topreparesolutionsreadyforuse

itisnecessarytoremovetheoverwrapping.Dependingontheinformationprovidedbythephysicianthenimmediately

thefrangiblepin(s)mustbebrokenbetweenthemainelectrolytebag(compartmentC)andoneorbothoftheglucose

solutioncompartments(compartmentAand/orB).Allowtheglucosesolutiontoflowintothemainelectrolytebag.

Rinsetheglucosecompartment(s)bypressingthemixedsolutionbackintotheemptycompartment(s).Allowitto

finallyrunbackagainintothemaincompartment.ThePDsolutionisnowreadytouseandmustbeusedwithin18

Glucose 85 139 215mmol/l

CalculatedosmolaritymOsm/l 356 408 482

5.5-6.5 5.5-6.5 5.5-6.5

ReconstitutedsolutionmEq/l L M H

SodiumNa+ 133 132 131mEq/l

CalciumCa ++ 2.76 2.70 2.62mEq/l

MagnesiumMg ++ 0.52 0.50 0.48mEq/l

ChlorideCl - 95.4 95.2 95.2mEq/l

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4.3Contraindications

Thissolutionmustnotbeusedinpatientswithlacticacidosisandseverehypokalaemiaandseverhypocalcaemia.For

peritonealdialysistreatmentingeneral.

Aperitonealdialysistreatmentshouldnotbecommencedinthefollowingcircumstances:

recentabdominalsurgeryorinjury,ahistoryofabdominaloperationswithfibrousadhesions,severeabdominal

burns,abdominalperforation;extensiveinflammationoftheabdominalskin(dermatitis);

inflammatoryboweldiseases(Crohn’sdisease,ulcerativecolitis,diverticulitis);

localisedperitonitis;

internalorexternalabdominalfistula;

umbilical,inguinalorotherabdominalhernia;

intra-abdominaltumours;

ileus;

pulmonarydisease(especiallypneumonia);

sepsis;

extremehyperlipidemia;

inrarecasesofuremia,whichcannotbemanagedbyperitonealdialysis;

cachexiaandsevereweightloss,particularlyincasesinwhichanadequateproteinsupplementationisnot

guaranteed;

patientswhoarephysicallyormentallyincapableofperformingPDasinstructedbythephysician.

4.4Specialwarningsandprecautionsforuse

Itisgenerallynotadvisabletouseperitonealdialysisinadvancedpregnancy.

Anaccuratefluidbalancerecordmustbekeptandthebodyweightofthepatientshouldcarefullybemonitoredto

avoidover-orunderhydrationwithsevereconsequencesincludingcongestiveheartfailure,volumedepletionand

shock.

Inrenalfailurepatients,serumelectrolyteconcentrations(particularlybicarbonate,potassium,calcium,magnesium

andphosphate),bloodchemistry(includingparathyroidhormone)andhaemotologicalparametersshouldbe

evaluatedperiodically.

Replacementofproteins,aminoacidsandwater-solublevitaminsmaybenecessary,assignificantlossescantake

placeduringdialysis.

Innon-diabeticpatientsthedegreeofsusceptibilitytohyperglycaemiavariesasaresultofthecombinedeffectsof

intolerancetoglucosecausedbyuraemiaandtransperitonealabsorptionofglucose.

Inpatientswithdiabetesmellitusbloodglucoselevelsshouldbemonitoredandthedosageoftheinsulinorother

treatmentforhyperglycaemiaoftenneedtobeadjustedinordertomaintainglycaemiccontrol.Insulincanbe

administeredintraperitoneallyviathesolutionbag.

IncaseofsecondaryhyperparathyroidismasGambrosoltrio40contains1,35mmolcalciumperlitre,serum

parathormoneandtheotherindicatorsofbonemetabolismshouldbemonitoredperiodicallyandthetherapyshould

comprisetheadministrationofcalciumcontainingphosphatebindersand/oractivevitaminDmetabolitestoensure

adequateenteralcalciumsupply.

Dehydrationandhyperglycaemiamayoccurifthepatientdoesnotcomplywiththeprescriptionandbreaksboth

pinsateveryfluidexchange.Fluidretentionmayappearifthebreakingofthepin(s)isunsuccessfulandthe

intendedmixtureofthefluidvolumesdoesnottakeplace.

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thebloodconcentrationofdialysabledrugsmaybereducedbydialysis.Correctivetherapyshouldbeinstitutedif

necessary.

Plasmalevelsofpotassiuminpatientsusingcardiacglucosidesmustbecarefullymonitoredasthereisariskof

digitalisintoxication.Potassiumsupplementsmaybenecessary.

4.6Fertility,pregnancyandlactation

Peritonealdialysisduringpregnancyandlactationisnotadvised,buttherisksmustbeevaluatedbythephysician

accordingtoeachpatient'sstatus.

4.7Effectsonabilitytodriveandusemachines

Peritonealdialysishasnoreportedeffectontheabilitytodriveorusemachinery.

4.8Undesirableeffects

Undesirableeffectsofperitonealdialysisincludeprocedureandsolutionrelatedproblems.

Theundesirableeffectscommonlyobservedarementionedherebelow:

Frequenciesaredefinedasfollows:

Verycommon( >

1/10);common( >

1/100, <

1/10);uncommon( >

1/1000, <

1/100);rare( >

1/10.000, <

1/1000);veryrare

<

1/10.000).

Thosewhicharerelatedtotheprocedureincludeabdominalpain,bleeding,peritonitis(whichisfollowedbyabdominal

pain,cloudyeffluentandsometimesfever),infectionaroundthecatheter(signsofinflammation,rednessand

Undesirableeffects Frequency Procedure-

related Solution-

related

Metabolism and

nutritiondisorders Hyperglycaemia

Hypocalcaemia

Hypokalaemia

Ultrafiltrationdecrease

Lacticacidosis

Hypervolaemia Common

Common

Common

Common

Uncommon

Uncommon Yes

VasculardisordersHypertension Common Yes

Generaldisorders

andadministration

siteconditions Abdominalpain

Aesthenia

Shivering

Headache

Peritonitis Common

Uncommon

Uncommon

Uncommon

Uncommon Yes

Nervous system

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Thosewhicharegenerallyrelatedtoperitonealdialysissolutionsareseenlessfrequentlythanthoserelatedtothe

procedureandincludeweakness,fainting,tiredness,musclecramping,headache,respiratorysymptomsassociatedwith

pulmonaryoedemaandelectrolytedisturbances(e.g.;hypokalaemia,hypomagnesaemiaandhypocalcemia),diarrhoea

andconstipation.

Gambrosoltrio40maycauseorworsenhyperparathyroidism.

4.9Overdose

Anyexcessofdialysissolutionwhichhasflownintotheperitonealcavitycaneasilybedrainedintothedrainagebag.

Possibleconsequencesofoverdoseincludehypovolaemia,electrolytedisturbancesor(indiabeticpatients)

hyperglycaemia.

Managementofoverdose:

Hypovolaemiamaybemanagedbyfluidreplacementeitherorallyorintravenously,dependingonthedegreeof

dehydration.

Electrolytedisturbancesshallbemanagedaccordingtothespecificelectrolytedisturbanceverifiedbybloodtest.

Themostprobabledisturbance,hypokalaemia,maybemanagedbytheoralingestionofpotassiumorbyaddition

ofpotassiumchlorideintheperitonealdialysissolutionprescribedbythetreatingphysician.

Hyperglycaemia(indiabeticpatients)shallbemanagedbyadjustingtheinsuindoseaccordingtotheinsulinscheme

prescribedbythetreatingphysician.

Managementwhenthepatienthasnotusedthecorrectsolution:

TheelectrolytecompartmentCwithnoglucoseconcentrationhasbeendrainedintothepatient:thefluidshouldbe

drainedoutandanewbagpreparedandinfused.Theglucosesolutionaloneshouldneverbeeninfusedtothe

patient.

Alowerglucoseconcentrationthanintendedhasbeendrainedintothepatient:atthenextexchangethepatient

shoulduseahigherglucoseconcentration.

Ahigherglucoseconcentrationthanintendedhasbeendrainedintothepatient:atthenextexchangethepatient

shouldusealowerglucoseconcentration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroups:

L:Peritonealdialytics,Isotonicsolutions,ATCcodeB05DA00

M:Peritonealdialytics,Hypertonicsolutions,ATCcodeB05DB00

H:Peritonealdialytics,Hypertonicsolutions,ATCcodeB05DB00

ThecalciumdialysisconcentrationofGambrosoltrio40issetat1.35mmol/lwhichhasbeenshowntoreducetherisk

ofhypercalcaemiaduringtheconcomitanttreatmentwithcalcium-containingphosphatebindersand/orvitaminD.

Sterilesolution,freefrombacterialendotoxinsforintraperitonealadministrationbyperitonealdialysis.

Thelevelofelectrolyteinthereconstitutedsolutionsissimilartothephysiologicallevelinplasmaexceptfor

potassium,lactateandmagnesium.

Theosmolarityofthereconstitutedsolutionsisdependentontheglucoseconcentration.

Lactateisusedasanalkalisingbuffertocorrectand/ormaintaintheacid/basebalance.Theisomericformoflactatein

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5.2Pharmacokineticproperties

Intraperitoneallyadministeredglucose,buffer,electrolytesandwaterareabsorbedintothebloodandmetabolisedby

theusualpathways.

Glucoseismetabolised(1gofglucose=4calories)intoCO

andH

Formalinteractionstudieshavenotbeenperformed.

5.3Preclinicalsafetydata

ThereisnodataofrelevancetotheprescriberthathavenotbeenincludedelsewhereintheSummaryoftheProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlucosecompartmentAandB:

Hydrochloricacidconcentrated(37%)(forpHadjustment),waterforinjections.

ElectrolytecompartmentC:

Sodiumhydroxide(forpHadjustment),waterforinjections.

6.2Incompatibilities

Incompatibilitieshavenotbeenstudied.

Additivesmaybeincompatible.Whenindoubt,apharmacistshouldbeconsultedpriortotheadditionofdrug.When

introducingadditives,useaseptictechnique,mixthoroughlyanduseimmediately.

6.3Shelflife

Aspackedforsale:18months.

Afterreconstitutionandbeforeopening:18hours.

Afteropening:forimmediateandsingleuse.

Fromamicrobiologicalpointofview,theproductshouldbeusedimmediately.Ifnotusedimmediately,in-usestorage

timesandconditionspriortousearetheresponsibilityoftheuser.

6.4Specialprecautionsforstorage

Donotstorebelow4 o

6.5Natureandcontentsofcontainer

ThecontainermadeofPolyvinylChloride(PVC)isathreecompartmentbag.Theelectrolytesolutioncompartment(C)

isfittedwithaninjectionportfordrugadmixtureafterreconstitutionatthetopsideandatthebottomanotherportfor

theconnectiontothepatientwithasuitableset(tubingorconnectors).Thebagisoverwrappedwithatransparent

overpouchmadeofmultilayercopolymers.

Typeofpackaging

Singlebagwithconnector:System10

Singlebagwithtubing:System100

Doublebagwithconnector:Gemini10

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Sizeofpackaging

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalandotherhandling

Gambrosoltrioperitonealdialysissolutionsareintendedforintra-peritonealadministrationonly.

Priortopreparingforadministration,inspectvisuallythebagforparticulatematters,colorationordamageofcontainer

andensurethatallthesolutionsareclearandallthesealsintact.Discardanysolutionpresentingdefects.Washthe

hands,cleantheworkingareawithaspecificdisinfectantprescribedbythephysicianandplacethesolutionbagonthe

workingarea.

Topreparesolutionsreadyforuseitisnecessarytomixthecontentsofoneorbothofthesmallercompartments

containingglucosewiththeelectrolytesolutioninthelargercompartment.Thefrangiblepin(s)betweenthecorrect

compartment(s)(Aand/orB)mustbebrokenandtheglucosesolution(s)allowedtoflowintotheelectrolytesolutionin

compartmentC.Theglucosecompartment(s)arethenrinsedbypressingthemixedsolutionbackintothesmaller

compartment(s)beforebeingallowedtorunbacktothelargecompartment.ThePDsolutionisthenreadyforuse.

Recommendationshowtobreakthefrangiblepin(s)

Breakoffapinletitsinkandsettleinthebottomofthebagbeforeopeningthepatientinflowtubing.Thepinwill

remainthereunlessthebagisshaken.

TheadditionofanyothermedicinetoGambrosoltrio40mustonlybemadetothefinalsolutionaftermixingwhen

readyforuseinperitonealdialysis.

Aseptictechniquemustbeappliedduringconnection/disconnectionofthelines.

Whenusingthebagwiththeconnector,itisrecommendedthat,priortodisconnection,theexternalsurfacesofthe

line/bagconnectorshouldbedisinfected.Afterremovingtheprotectivecaponthenewbag,disinfectantshouldalsobe

appliedtotheinterioroftheconnector.

Anyunusedsolutionorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

DetailedinstructionontheCAPDexchangeprocedureisgiventopatientsbymeansoftraining,inaspecialised

trainingcentre,priortohomeuse.

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareDeutschlandGmbH

61346BadHomburgv.d.H.

Germany

8MARKETINGAUTHORISATIONNUMBER

PA953/8/2

System10 System100 Gemini10 Gemini100

4x2000ml 4x2000ml 4x2000ml 4x2000ml

4x2500ml 4x2500ml 4x2500ml 4x2500ml

3x3000ml 3x3000ml 3x3000ml 3x3000ml

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Dateoffirstauthorisation:07July2000

Dateoflastrenewal:30April2009

10DATEOFREVISIONOFTHETEXT

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