COMPOUND SODIUM LACTATE & GLUCOSE 5%

Main information

  • Trade name:
  • COMPOUND SODIUM LACTATE & GLUCOSE 5%
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMPOUND SODIUM LACTATE & GLUCOSE 5%
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/063/005
  • Authorization date:
  • 17-04-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0167/063/005

CaseNo:2069237

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CompoundSodiumLactate&Glucose5%w/vSolutionforInfusion.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 15/03/2010 CRN 2069237 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CompoundSodiumLactate&Glucose5%w/vSolutionforInfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Glucose(asmonohydrate) 50.0g/l

SodiumChloride: 6.00g/l

PotassiumChloride: 0.40g/l

CalciumChloridedihydrate: 0.27g/l

SodiumLactate: 3.20g/l

(lactate)

mmol/l 131 5 2 111 29

mEq/l 131 5 4 111 29

200kcal/L(840kJ/L)

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Solutionforinfusion.

Clearsolution,freefromvisibleparticles.

555mOsm/l(approx).pH:4.0–6.5

4CLINICALPARTICULARS

4.1TherapeuticIndications

CompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&Glucose5%w/vsolution)isusedinthe

followingindicationswhenasourceofcarbohydrateisrequired

Restorationofextracellularfluidandelectrolytesbalancesorreplacementofextracellularfluidlosswhere

isotonicconcentrationsofelectrolytesaresufficient

Shorttermvolumereplacement(aloneorinassociationwithcolloid)incaseofhypovolemiaorhypotension.

Regulationormaintenanceofmetabolicacidosisbalanceand/ortreatmentofmildtomoderatemetabolic

acidosis(exceptlacticacidosis)

4.2Posologyandmethodofadministration

Adults,theElderlyandChildren:

Thedosagedependsontheage,weight,clinicalandbiological(acid-basebalance)conditionsofthepatient,and

concomitanttherapy.

Recommendeddosage:

TheamountofCompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&Glucose5%w/vsolution)

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Therecommendeddosageis:

foradults:500mlto3Litres/24h

forbabiesandchildren:

0-10kgbodyweight: 100ml/kg/24h

10-20kgbodyweight: 1000ml+(50ml/kgover10kg)/24h

>20kgbodyweight: 1500ml+(20ml/kgover20kg)/24h.”.

Administrationrate:

Theinfusionrateisusually40mL/kg/24hinadults.

Inpediatricpatientstheinfusionrateis5ml/kg/hinaveragebutthevaluevarieswithage:6-8mL/kg/hforinfants,4-6

mL/kg/hfortoddlers,and2-4mL/kg/hforschoolchildren.Inchildrenwithburns,thedoseisonaverage3.4mL/kg/per

centburnat24hpost-burnand6.3mL/kg/percentburnat48h.Inseverelyhead-injuredchildrenthedoseison

average2850mL/m².

Infusionrateandtotalvolumecanbehigherinsurgeryorincaseofneed

Theinfusionrateshouldnotexceedthepatient’sglucoseoxidationcapacitiesinordertoavoidhyperglycaemia.

Thereforethemaximumacuteadministrationraterangesfrom5mg/kg/minforadultsto10-18mg/kg/minforbabies

andchildren,dependingontheageandthetotalbodymass.

Note:

infantsandtoddlers:agerangesfromabout28daysto23months(atoddlerisaninfantwhocanwalk)

ChildrenandSchoolchildren:agerangesfromabout2yearsto11years

Administration:

Theadministrationisperformedbyintravenousrouteusingsterileandnon-pyrogenicequipment.

4.3Contraindications

Thesolutioniscontra-indicatedinpatientspresenting:

Extracellularhyperhydrationorhypervolemia

Severerenalinsufficiency(witholiguria/anuria)

Uncompensatedcardiacfailure

Hyperkalemia

Hypernatremia

Hypercalcaemia

Hyperchloremia

Metabolicalkalosis

Severemetabolicacidosis.

Lacticacidosis.

Severehepatocellularinsufficiencyorimpairedlactatemetabolism

Generaloedemaandasciticcirrhosis

Concomitantdigitalistherapy(seesection4.5"Interactionswithothermedicinalproductsandotherforms

ofinteraction")

Thesolutionisalsocontraindicatedincaseofuncompensateddiabetes,otherknownglucoseintolerances(suchas

metabolicstresssituations),hyperosmolarcoma,hyperglycaemia,hyperlactatemia.

4.4Specialwarningsandprecautionsforuse

CompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)solutionisanhypertonicsolution,

withanapproximateosmolarityof555mOsm/l

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Thepatient'sclinicalstatusandlaboratoryparameters(electrolytesandglucoselevelsinbloodandurineaswellas

acid-basebalance)mustbemonitoredduringuseofthissolution.Theplasmapotassiumlevelofthepatientmustbe

particularlycloselymonitoredinpatientsatriskofhyperkalaemia.

Solutionscontainingsodiumchlorideshouldbecarefullyadministeredtopatientswithhypertension,heartfailure,

peripheralorpulmonaryedema,impairedrenalfunction,pre-eclampsia,aldosteronism,orotherconditionsassociated

withsodiumretention(seealsoSection4.5-Interactionswithothermedicinalproductsandotherformsofinteraction)

Solutionscontainingpotassiumsaltsshouldbeadministeredwithcautiontopatientswithcardiacdiseaseorconditions

predisposingtohyperkalemiasuchasrenaloradrenocorticalinsufficiency,acutedehydration,orextensivetissue

destructionasoccurswithsevereburns.

AlthoughCompoundSodiumLactate&Glucose5%solution(RingerLactate&Glucose5%solution)hasapotassium

concentrationsimilartotheconcentrationinplasma,itisinsufficienttoproduceausefuleffectincaseofsevere

potassiuminsufficiencyandthereforeitshouldnotbeusedforthispurpose.

Calciumchlorideisirritant,thereforecareshouldbetaketopreventextravasationduringintravenousinjectionand

intramuscularinjectionmustbeavoided.Solutionscontainingcalciumsaltsshouldbegivencautiouslytopatientswith

impairedrenalfunction,ordiseaseassociatedwithelevatedvitaminDconcentrationssuchassarcoidosis.Theyshould

beavoidedinpatientswithcalciumrenalcalculi,orahistoryofrenalcalculi.Incaseofconcomitantbloodtransfusion

andbecauseofthepresenceofcalcium,CompoundSodiumLactate&Glucose5%w/vsolution(Ringerlactate&

Glucose5%w/vsolution)mustnotbeadministeredviathesameinfusionsystembecauseoftheriskofcoagulation.

InfusionofCompoundSodiumLactate&Glucose5%w/v(Ringerlactate&Glucose5%w/v)solutionmaycause

metabolicalkalosisbecauseofthepresenceoflactateions.

CompoundSodiumLactate&Glucose5%w/vmaynotproduceitsalkalinizingactioninpatientswithliver

insufficiencysincelactatemetabolismmaybeimpaired.

Thesolutioncontaininglactateshouldbeadministeredwithparticularcaretoneonateslessthan3monthsold.

Duetoglucosepresence,CompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)should

notbeinfusedconcomitantlytomassivebloodtransfusion(riskofpseudo-agglutination)throughthesameinfusionset.

Administrationofglucosecontainingsolutionsmayleadtohyperglycaemia.Inthiscase,itisrecommendednottouse

thissolutionafteracuteischemicstrokesashyperglycemiahasbeenimplicatedinincreasingcerebralischemicbrain

damageandimpairingrecovery.Infusionofglucosesolutioncouldbecontraindicatedinthefirst24hoursfollowing

headtraumaandbloodglucoseconcentrationshouldbecloselymonitoredduringintracranialhypertensionepisodes.If

hyperglycaemiaoccurs,rateofinfusionshouldbeadjustedorinsulinadministered.

Indiabeticpatients,theamountofinfusedglucosehastobetakenintoaccountandinsulinrequirementsmaybe

modified

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Interactionrelatedtothepresenceofsodium:

Corticoids/Steroidsandcarbenoxolonewhichareassociatedwiththeretentionofsodiumandwater(with

oedemaandhypertension).

Interactionrelatedtothepresenceofpotassium:

Potassium-sparingdiuretics(amiloride,spironolactone,triamterene,aloneorinassociation).

Angiotensinconvertingenzymeinhibitors(ACEi)and,byextrapolation,angiotensinIIreceptorantagonists

Tacrolimus,cyclosporinewhichincreaseconcentrationofpotassiumintheplasmaandmayleadtopotentially

fatalhyperkalemianotablyincaseofarenalfailureincreasingthehyperkalemiceffect

Interactionrelatedtothepresenceofcalcium:

Digitalisglycosides(digitaliscardiotonic)whoseeffectsareenhancedbythepresenceofcalciumandmaylead

toseriousorfatalcardiacarrhythmia.

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Bisphosphonates,fluoride,somefluoroquinolonesandtetracyclineswhicharelessabsorbed(lower

availability)whenadministeredwithcalcium.

Interactionrelatedtothepresenceoflactate(whichismetabolizedintobicarbonate):

Acidicdrugssuchassalicylates,barbituratesandlithiumwhoserenalclearanceisincreasedbecauseofthe

alkalinisationofurinebythebicarbonateresultingfromlactatemetabolism.

Alkalinedrugs,notablysympathomimetics(e.g.ephedrine,pseudoephedrine)andstimulants(e.g.

dexamphetaminesulphate,phenfluraminehydrochloride)whosehalflifeisprolonged(slowestelimination).

4.6Pregnancyandlactation

CompoundSodiumLactate&Glucose5%w/vSolutionforInfusion(RingerLactate&Glucose5%w/vsolutionfor

infusion)canbeusedsafelyduringpregnancyandlactationaslongastheelectrolyte-andfluidbalanceiscontrolled.

Itisremindedthatcalciumcrossestheplacentaandisdistributedintobreastmilk.

Whenamedicationisadded,thenatureofthedruganditsuseduringpregnancyandlactationhavetobeconsidered

separately.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

DuringadministrationofLactatedringer’s&Glucose5%injection,USP,thefollowingundesirableeffectshavebeen

reportedas:

verycommon:

Allergicreactionsoranaphylactic/anaphylactoidsymptomssuchaslocalizedorgeneralizedurticaria,skinrash&

erythemaanditching/pruritis;skinswelling,periobialfacialand/orlaryngealedema(Quincke'sedema).

Nasalcongestion,coughing,sneezing,bronchospasmand/ordifficultybreathing”

common:

Chesttightness,chestpain,withtachycardiaorbradycardia”

Pruritushasbeenreportedtooccurinabout10%ofpatientsreceivingCompoundSodiumLactate(RingerLactate).

Hyperhydrationandheartfailureareverycommoninpatientwithcardiacdisorderorpulmonaryoedema

Electrolytesdisturbanceshavebeenverycommonlyreportedtoo.

Lactateinfusionscommonlyinducefeelingofanxiety,andfewcasesofpanicattackhavebeenreported

Seizuremaybeprecipitatedbythealkalosisinducedbylactatebutthisisuncommon.

Adversereactionsmaybeassociatedtothetechniqueofadministrationincludingfebrileresponse,infectionatthesite

ofinjection,localpainorreaction,veinirritation,venousthrombosisorphlebitisextendingfromthesiteofinjection,

extravasation,andhypervolemia.

Adversereactionsmaybeassociatedtothemedicationsaddedtothesolution;thenatureoftheadditivewilldetermine

thelikelihoodofanyotherundesirableeffects.

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4.9Overdose

Overuseortoofastadministrationmayleadtowaterandsodiumoverloadwithariskofoedema,particularlywhen

thereisadefectiverenalsodiumexcretion.Inthiscaseextrarenaldialysismaybenecessary.

Excessiveadministrationofpotassiummayleadtothedevelopmentofhyperkalemia,especiallyinpatientswithrenal

impairment.Symptomsincludeparesthesiaoftheextremities,muscleweakness,paralysis,cardiacarrhythmias,heart

block,cardiacarrest,andmentalconfusion.

Excessiveadministrationofcalciumsaltsmayleadtohypercalcemia.Symptomsofhypercalcemiamayinclude

anorexia,nausea,vomiting,constipation,abdominalpain,muscleweakness,mentaldisturbances,polydipsia,polyuria,

nephrocalcinosis,renalcalculi,and,inseverecases,cardiacarrhythmiasandcoma.Toorapidintravenousinjectionof

calciumsaltsmayalsoleadtomanyofthesymptomsofhypercalcemiaaswellastochalkytaste,hotflushes,and

peripheralvasodilatation.Mildasymptomatichypercalcemiawillusuallyresolveonstoppingadministrationofcalcium

andothercontributorydrugssuchasvitaminD.Ifhypercalcemiaissevere,urgenttreatment(suchasloopdiuretics,

hemodialysis,calcitonin,bisphosphonates,trisodiumedetate)isrequired.

Excessiveadministrationofsodiumlactatemayleadtohypokalemiaandmetabolicalkalosis,especiallyinpatients

withimpairedrenalfunction.Symptomsmayincludemoodchanges,tiredness,shortnessofbreath,muscleweakness,

andirregularheartbeat.Musclehypertonicity,twitching,andtetanymaydevelopespeciallyinhypocalcemicpatients.

Treatmentofmetabolicalkalosisassociatedwithbicarbonateoverdoseconsistsmainlyofappropriatecorrectionof

fluidandelectrolytebalance.Replacementofcalcium,chloride,andpotassiummaybeofparticularimportance.

Prolongedadministrationorrapidinfusionoflargevolumesofglucosecontainingsolutionmayleadto

hyperosmolarity,dehydration,hyperglycaemia,hyperglucosuriaandosmoticdieresis(duetohyperglycaemia).

Whenoverdoseisrelatedtomedicationsaddedtothesolutioninfused,thesignsandsymptomsofoverinfusionwill

berelatedtothenatureoftheadditivebeingused.Intheeventofaccidentaloverinfusion,treatmentshouldbe

discontinuedandthepatientshouldbeobservedfortheappropriatesignsandsymptomsrelatedtothedrug

administered.Therelevantsymptomaticandsupportivemeasuresshouldbeprovidedasnecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup(ATCcode):B05BB02“ElectrolyteswithCarbohydrates”.

CompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&Glucose5%w/vsolution)isanhypertonic

solutionofelectrolytesandglucose.

ThepharmacologicalpropertiesoftheCompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&

Glucose5%w/vsolution)arethoseofitscomponents(glucose,sodium,potassium,calcium,chlorideandlactate).

Glucoseisthemainsourceofenergy,andthissolutionprovides200kcal/L.

ThemaineffectofCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)istheexpansion

oftheextracellularcompartmentincludingboththeinterstitialfluidandtheintravascularfluid.

Thelactateismetabolisedintobicarbonate,mainlyintheliver,andproducesanalkalinisingeffectontheplasma.

InhealthyvolunteersreceivingCompoundSodiumLactate(RingerLactate),centralvenouspressurechangeswere

associatedwithasecretionofatrialnatriureticpeptide.

Thereisnosignificantchangesinglucagon,norepinephrine,epinephrine,bloodglucoseandinsulinlevelsinaortic

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WhenmedicationisaddedtoCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v),the

overallpharmacodynamicsofthesolutionwilldependonthenatureofthedrugused.

5.2Pharmacokineticproperties

ThepharmacokineticpropertiesoftheCompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&

Glucose5%w/vsolution)arethoseofitscomponents(glucose,sodium,potassium,calcium,chlorideandlactate).

InfusionofCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)innormal

hemodynamicallystableadultsdoesnotincreasecirculatinglactateconcentrations.

ThepharmacokineticsofD-lactateandL-lactatearesimilar.

ThelactateinCompoundSodiumLactate&Glucose5%w/vsolution(RingerLactate&Glucose5%w/vsolution)is

metabolizedbybothoxidationandgluconeogenesis,predominantlyintheliver,andbicarbonateisgeneratedbyboth

processesover1-2h.

WhenmedicationisaddedtoCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v),the

overallpharmacokineticsofthesolutionwilldependonthenatureofthedrugused.

5.3Preclinicalsafetydata

PreclinicalsafetydataofCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)solution

inanimalsarenotrelevantsinceitsconstituentsarephysiologicalcomponentsinanimalandhumanplasma.

Toxiceffectsarenottobeexpectedundertheconditionofclinicalapplication.

Thesafetyofpotentialadditivesshouldbeconsideredseparately.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections.

6.2Incompatibilities

Aswithallparenteralsolutions,beforeaddingmedications,compatibilityoftheseadditiveswiththesolutioninViaflo

containermustbeassessed.

ItistheresponsibilityofthephysiciantojudgetheincompatibilityofanadditivemedicationwiththeCompound

SodiumLactate&Glucose5%w/vsolution(RingerLactate&Glucose5%w/vsolution)bycheckingforeventual

colorchangeand/oreventualprecipitate,insolublecomplexesorcrystalsapparition.TheInstructionsforUseofthe

medicationtobeaddedmustbeconsulted.

Beforeaddingadrug,verifyitissolubleandstableinwateratthepHofCompoundSodiumLactate&Glucose5%

w/v(RingerLactate&Glucose5%w/v)(pH4.0to6.5).

WhenacompatiblemedicationisaddedtotheCompoundSodiumLactate&Glucose5%w/v(RingerLactate&

Glucose5%w/v),thesolutionmustbeadministeredimmediately.

AsaguidancethefollowingmedicationsareincompatiblewiththeCompoundSodiumLactate&Glucose5%w/v

solution(RingerLactate&Glucose5%w/vsolution)(non-exhaustivelisting):

MedicationsincompatiblewithCompoundSodiumLactate&Glucose5%w/v(RingerLactate&Glucose5%w/v)

Aminocaproicacid(Amicar®)

AmphotericinB

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Diethylstilbestrol

Etamivan(Emivan®)

Ethylalcohol

Phosphateandcarbonatesolutions

Oxytetracycline(Terramycyn®)

Thiopentalsodium

Versenatedisodium

MedicationswithpartialincompatibilitywithCompoundSodiumLactate&Glucose5%w/v(RingerLactate&

Glucose5%w/v):

Tetracycline(Achromycin®)stablefor12hours

Ampicillinsodium

concentrationof2%-3%stablefor4hours

concentration>3%mustbegivenwithin1hour

Minocycline(Minocin®)stablefor12hours

Doxycycline(Vibramycin®)stablefor6hours

Thoseadditivesknowntobeincompatibleshouldnotbeused.

6.3ShelfLife

Shelf-life(Unopened):30monthsfor1000mlcontainer.

2yearsfor250mland500mlcontainer.

In-useshelf-life:Additives

ChemicalandPhysicalstabilityofanyadditiveatthepHofCompoundSodiumLactate&Glucose5%w/vsolution

(RingerLactateandGlucose5%w/vsolution)intheViaflocontainershouldbeestablishedpriortouse.

Fromamicrobiologicalpointofview,thedilutedproductmustbeusedimmediatelyunlessdilutionhastakenplacein

controlledandvalidatedasepticconditions.Ifnotusedimmediately,in-usestoragetimesandconditionsarethe

responsibilityoftheuser.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

ThebagsknownasViafloarecomposedofpolyolefin/polyamideco-extrudedplastic(PL2442).

Bagsizes:250ml,500mland1000ml.

Thebagsareoverwrappedwithaprotectiveplasticpouchcomposedofpolyamide/polypropylene.

Outercartoncontents: 30 bagsof 250ml

20 bagsof 500ml

10 bagsof 1000ml

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Useonlyifthesolutionisclear,withoutvisibleparticlesandifthecontainerisundamaged.Administerimmediately

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Donotremoveunitfromoverwrapuntilreadyforuse.

Theinnerbagmaintainsthesterilityoftheproduct.

Donotuseplasticcontainersinseriesconnections.Suchusecouldresultinairembolismduetoresidualairbeing

drawnfromtheprimarycontainerbeforetheadministrationofthefluidfromthesecondarycontaineriscompleted.

Thesolutionshouldbeadministeredwithsterileequipmentusinganaseptictechnique.Theequipmentshouldbe

primedwiththesolutioninordertopreventairenteringthesystem.

Additivesmaybeintroducedbeforeinfusionorduringinfusionthroughtheinjectionsite.

Whenadditiveisused,verifyisotonicitypriortoparenteraladministration.Thoroughandcarefulasepticmixingofany

additiveismandatory.Solutionscontainingadditivesshouldbeusedimmediatelyandnotstored.

Addingothermedicationorusinganincorrectadministrationtechniquemightcausetheappearanceoffeverreactions

duetothepossibleintroductionofpyrogens.Incaseofadversereaction,infusionmustbestoppedimmediately.

Discardaftersingleuse.

Discardanyunusedportion.

Donotreconnectpartiallyusedbags.

Opening

RemovetheViaflocontainerfromtheoverpouchjustbeforeuse.

Checkforminuteleaksbysqueezinginnerbagfirmly.Ifleaksarefound,discardsolution,assterilitymaybe

impaired.

Checkthesolutionforlimpidityandabsenceofforeignmatters.Ifsolutionisnotclearorcontainsforeign

matters,discardthesolution.

Preparationforadministration

Usesterilematerialforpreparationandadministration.

Suspendcontainerfromeyeletsupport.

Removeplasticprotectorfromoutletportatbottomofcontainer:

gripthesmallwingontheneckoftheportwithonehand,

gripthelargewingonthecapwiththeotherhandandtwist,

thecapwillpopoff.

Useanasepticmethodtosetuptheinfusion.

Attachadministrationset.Refertocompletedirectionsaccompanyingsetforconnection,primingofthesetand

administrationofthesolution.

Techniquesforinjectionofadditivemedications

Warning:Additivesmaybeincompatible.

Toaddmedicationbeforeadministration

Disinfectmedicationsite.

Usingsyringewith19to22gaugeneedle,punctureresealablemedicationportandinject.

Mixsolutionandmedicationthoroughly.Forhigh-densitymedicationsuchaspotassiumchloride,taptheports

gentlywhileportsareuprightandmix.

Caution:Donotstorebagscontainingaddedmedications.

Toaddmedicationduringadministration

Closeclampontheset.

Disinfectmedicationsite.

Usingsyringewith19to22gaugeneedle,punctureresealablemedicationportandinject.

RemovecontainerfromIVpoleand/orturntoanuprightposition.

Evacuatebothportsbytappinggentlywhilethecontainerisinanuprightposition.

Mixsolutionandmedicationthoroughly.

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7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.

CaxtonWay,Thetford

NorfolkIP243SE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0167/063/005

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17April2003

Dateoflastrenewal:19March2006

10DATEOFREVISIONOFTHETEXT

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