GAMBROSOL TRIO 10

Main information

  • Trade name:
  • GAMBROSOL TRIO 10
  • Pharmaceutical form:
  • Solution for Dialysis
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAMBROSOL TRIO 10
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0953/008/001
  • Authorization date:
  • 22-07-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gambrosoltrio10,solutionforperitonealdialysis

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Gambrosoltrio10isfilledinathree-compartmentbag.

Twosmallercompartments(AandB)eachcontain50%glucosesolutionandsodiumchloride(NaCl)andalargerthird

compartment(C)theelectrolytesolution.AfterbreakingthefrangiblepinbetweencompartmentsAandCand

thoroughlymixingthetwofluidsaPDsolutioncontaining1.5%glucosewillbeproduced.Similarlymixingthe

contentsofcompartmentsBandCwillproduceaPDsolutioncontaining2.5%glucose.Finallybybreakingboth

frangiblepinsandmixingthecontentsofallthreecompartmentswillproduceasolutioncontaining3.9%glucose.

BEFORERECONSTITUTION

AFTERRECONSTITUTION

TheglucosecompartmentsAor/andBaremixedwiththeelectrolytecompartmentCtogivethefollowing

reconstitutedsolutions:

Each1000mlcontains:

GlucosecompartmentsAandB

Activeingredients:

Glucoseanhydrous 500.0g

(asglucosemonohydrate 550.0g)

Sodiumchloride 5.38g

ElectrolytecompartmentC

Activeingredients:

Sodiumchloride 5.38g

SodiumlactateS-(+)anhydrous 4.72g

(as60%m/msolution) (7.87g)

Calciumchloridedihydrate 0.271g

Magnesiumchloridehexahydrate 0.054g

MixcompartmentsAandC Reconstitutedsolution10L(Light)

MixcompartmentsBandC Reconstitutedsolution10M(Medium)

MixcompartmentsA,BandC Reconstitutedsolution10H(High)

Reconstitutedsolutionmmol/l L M H

SodiumNa + 133 132 131mmol/l

CalciumCa ++ 1.79 1.75 1.70mmol/l

MagnesiumMg ++ 0.26 0.25 0.24mmol/l

ChlorideCl - 96.2 96.0 96.0mmol/l

Lactate 41 40 39mmol/l

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Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionforperitonealdialysis.

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.

Modeofpreparations

Itisnecessarytowarmupthesolutiontobodytemperaturebeforeuseusingthespecialheaterprovided.

Priortopreparingforadministrationensurethatallthesolutionsareclearandallthesealsintact,washthehands,clean

theworkingareawithadisinfectantandplacethesolutionbagontheworkingarea.Topreparesolutionsreadyforuse

itisnecessarytoremovetheoverwrapping.Dependingontheinformationprovidedbythephysicianthenimmediately

thefrangiblepin(s)mustbebrokenbetweenthemainelectrolytebag(compartmentC)andoneorbothoftheglucose

solutioncompartments(compartmentsAand/orB).Allowtheglucosesolutiontoflowintothemainelectrolytebag.

Rinsetheglucosecompartment(s)bypressingthemixedsolutionbackintotheemptycompartment(s).Allowitto

finallyrunbackagainintothemaincompartment.ThePDsolutionisnowreadytouseandmustbeusedwithin18

CalculatedosmolaritymOsm/l 357 409 483

5.5-6.5 5.5-6.5 5.5-6.5

ReconstitutedsolutionmEq/l L M H

SodiumNa+ 133 132 131mEq/l

CalciumCa ++ 3.58 3.50 3.40mEq/l

MagnesiumMg ++ 0.52 0.50 0.48mEq/l

ChlorideCl - 96.2 96.0 96.0mEq/l

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4.3Contraindications

Thissolutionmustnotbeusedinpatientswithlacticacidosisandseverehypokalaemia.

Forperitonealdialysistreatmentingeneral

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),bloodchemistryandhaemotologicalparametersshouldbeevaluatedperiodically.

Replacementofproteins,aminoacidsandwater-solublevitaminsmaybenecessary,assignificantlossescantake

placeduringdialysis.

Innon-diabeticpatientsthedegreeofsusceptibilitytohyperglycaemiavariesasaresultofthecombinedeffectsof

intolerancetoglucosecausedbyuraemiaandtransperitonealabsorptionofglucose.

Inpatientswithdiabetesmellitusbloodglucoselevelsshouldbemonitoredandthedosageoftheinsulinorother

treatmentforhyperglycaemiaoftenneedtobeadjustedinordertomaintainglycaemiccontrol.Insulincanbe

administeredintraperitoneallyviathesolutionbag.

Dehydrationandhyperglycaemiamayoccurifthepatientdoesnotcomplywiththeprescriptionandbreaksboth

pinsateveryfluidexchange.Fluidretentionmayappearifthebreakingofthepin(s)isunsuccessfulandthe

intendedmixtureofthefluidvolumesdoesnottakeplace.

Aseptictechniqueshouldbeusedthroughouttheprocedure.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thebloodconcentrationofdialysabledrugsmaybereducedbydialysis.Correctivetherapyshouldbeinstitutedif

necessary.

Plasmalevelsofpotassiuminpatientsusingcardiacglucosidesmustbecarefullymonitoredasthereisariskof

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4.6Fertility,pregnancyandlactation

Peritonealdialysisduringpregnancyandlactationisnotadvised,buttherisksmustbeevaluatedbythephysician

accordingtoeachpatient'sstatus.

4.7Effectsonabilitytodriveandusemachines

Peritonealdialysishasnoreportedeffectontheabilitytodriveorusemachinery.

4.8Undesirableeffects

Undesirableeffectsofperitonealdialysisincludeprocedureandsolutionrelatedproblems.Theundesirableeffects

commonlyobservedarementionedherebelow:

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

secretion),catheterblockage,ileus,shoulderpain,herniaoftheabdominalcavity.

Thosewhicharegenerallyrelatedtoperitonealdialysissolutionsareseenlessfrequentlythanthoserelatedtothe

procedureandincludeweakness,fainting,tiredness,musclecramping,headache,respiratorysymptomsassociatedwith

pulmonaryoedemaandelectrolytedisturbances(e.g.;hypokalaemia,hypomagnesaemia),diarrhoeaandconstipation.

4.9Overdose

Anyexcessofdialysissolutionwhichhasflownintotheperitonealcavitycaneasilybedrainedintothedrainagebag.

Possibleconsequencesofoverdoseincludehypovolaemia,electrolytedisturbancesor(indiabeticpatients)

hyperglycaemia.

Managementofoverdose:

Hypovolaemiamaybemanagedbyfluidreplacementeitherorallyorintravenously,dependingonthedegreeof

dehydration.

Undesirableeffects Frequency Procedure-

related Solution-

related

Metabolism and

nutritiondisorders Hyperglycaemia

Hypercalcaemia

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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Themostprobabledisturbance,hypokalaemia,maybemanagedbytheoralingestionofpotassiumorbyadditionof

potassiumchlorideintheperitonealdialysissolutionprescribedbythetreatingphysician.

Hyperglycaemia(indiabeticpatients)shallbemanagedbyadjustingtheinsulindoseaccordingtotheinsulin

schemeprescribedbythetreatingphysician.

Managementwhenthepatienthasnotusedthecorrectsolution:

TheelectrolytecompartmentCwithnoglucoseconcentrationhasbeendrainedintothepatient:thefluidshouldbe

drainedoutandanewbagpreparedandinfused.Theglucosesolutionaloneshouldneverbeeninfusedtothe

patient.

Alowerglucoseconcentrationthanintendedhasbeendrainedintothepatient:atthenextexchangethepatient

shoulduseahigherglucoseconcentration.

Ahigherglucoseconcentrationthanintendedhasbeendrainedintothepatient:atthenextexchangethepatient

shouldusealowerglucoseconcentration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:

L:Peritonealdialytics,Isotonicsolutions,ATCcodeB05DA00

M:Peritonealdialytics,Hypertonicsolutions,ATCcodeB05DB00

H:Peritonealdialytics,Hypertonicsolutions,ATCcodeB05DB00

Sterilesolution,freefrombacterialendotoxinsforintraperitonealadministrationbyperitonealdialysis.

Thelevelofelectrolyteinthereconstitutedsolutionsissimilartothephysiologicallevelinplasmaexceptfor

potassiumandlactateandmagnesium.

Theosmolarityofthereconstitutedsolutionsisdependentontheglucoseconcentration.

Lactateisusedasanalkalisingbuffertocorrectand/ormaintaintheacid/basebalance.Theisomericformoflactatein

Gambrosoltrio10istheS(+)whichisthenaturallypresentforminhumans.

5.2Pharmacokineticproperties

Intraperitoneallyadministeredglucose,buffer,electrolytesandwaterareabsorbedintothebloodandmetabolisedby

theusualpathways.

Glucoseismetabolised(1gglucose=4calories)intoCO

andH

Formalinteractionstudieshavenotbeenperformed.

5.3Preclinicalsafetydata

ThereisnodataofrelevancetotheprescriberthathavenotbeenincludedelsewhereintheSummaryofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlucosecompartmentsAandB:

Hydrochloricacidconcentrated(37%)(forpHadjustment),waterforinjections.

ElectrolytecompartmentC:

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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)isathree-compartmentbag.Theelectrolytesolutioncompartment

(C)isfittedwithaninjectionportfordrugadmixtureafterreconstitutionatthetopsideandatthebottomanotherport

fortheconnectiontothepatientwithasuitableset(tubingorconnectors).Thebagisoverwrappedwithatransparent

overpouchmadeofmultilayercopolymers.

Typeofpackaging

Singlebagwithconnector:System10

Singlebagwithtubing:System100

Doublebagwithconnector:Gemini10

Doublebagsystem:Gemini100

Sizeofpackaging

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalandotherhandling

Gambrosoltrioperitonealdialysissolutionsareintendedforintraperitonealadministrationonly.

Priortopreparingforadministration,inspectvisuallythebagforparticulatematters,colorationordamageofcontainer

andensurethatallthesolutionsareclearandallthesealsintact.Discardanysolutionpresentingdefects.Washthe

hands,cleantheworkingareawithaspecificdisinfectantprescribedbythephysicianandplacethesolutionbagonthe

System10 System100 Gemini10 Gemini100

4x2000ml 4x2000ml 4x2000ml 4x2000ml

4x2500ml 4x2500ml 4x2500ml 4x2500ml

3x3000ml 3x3000ml 3x3000ml 3x3000ml

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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.

TheadditionofanyothermedicinetoGambrosoltrio10mustonlybemadetothefinalsolutionaftermixingwhen

readyforuseinperitonealdialysis.

Aseptictechniquemustbeappliedduringconnection/disconnectionofthelines.

Whenusingthebagwiththeconnector,itisrecommendedthat,priortodisconnection,theexternalsurfacesofthe

line/bagconnectorshouldbedisinfected.Afterremovingtheprotectivecaponthenewbag,disinfectantshouldalsobe

appliedtotheinterioroftheconnector.

Anyunusedsolutionorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

DetailedinstructionontheCAPDexchangeprocedureisgiventopatientsbymeansoftraining,inaspecialised

trainingcentre,priortohomeuse.

7MARKETINGAUTHORISATIONHOLDER

FreseniusMedicalCareDeutschlandGmbH

61346BadHomburgv.d.H.

Germany

8MARKETINGAUTHORISATIONNUMBER

PA953/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07July2000

Dateoflastrenewal:30April2009

10DATEOFREVISIONOFTHETEXT

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