CLINIMIX N12G20E

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Localization

  • Available in:
  • CLINIMIX N12G20E
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/098/003
  • Authorization date:
  • 30-04-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0167/098/003

CaseNo:2063572

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CLINIMIXN12G20E,solutionforinfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/05/2009until11/12/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CLINIMIX ®

N12G20E,solutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CLINIMIX ®

N12G20Eispackagedinadualcompartmentplasticbagcontainingrespectivelyanaminoacidsolution

withelectrolytesandaglucosesolutionwithcalcium.

Theinjectableaminoacidsolutioncontains15L-aminoacids(8essentialaminoacids)neededfortheprotein

synthesis.

Theaminoacidprofileisthefollowing:

Essentialaminoacids/Totalaminoacids=41.3%

Essentialaminoacids/Totalnitrogen=2.83

Branchedchainaminoacids/Totalaminoacids=19%

ThequantitativecompositionofCLINIMIX ®

N12G20Eisthefollowing:

7%Aminoacidsolutionwith

electrolytes 20%Glucosesolution

withcalcium

Activeingredients

L-Leucine

L-Phenylalanine

L-Methionine

L-Lysine

(asL-Lysinechlorhydrate)

L-Isoleucine

L-Valine

L-Histidine

L-Threonine

L-Tryptophan

L-Alanine

L-Arginine

Glycine

L-Proline

L-Serine

L-Tyrosine

Sodiumacetate,3H

Dibasicpotassiumphosphate

Sodiumchloride

Magnesiumchloride6H

Glucose

(asmonohydrateglucose)

Calciumchloride,2H

5.11g/l

3.92g/l

2.80g/l

4.06g/l

(5.07g/l)

4.20g/l

4.06g/l

3.36g/l

2.94g/l

1.26g/l

14.49g/l

8.05g/l

7.21g/l

4.76g/l

3.50g/l

0.28g/l

5.15g/l

5.22g/l

1.88g/l

1.02g/l

200g/l

(220g/l)

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Aftermixingofthecontentsofbothcompartments,thecompositionofthebinarymixture,foralltheavailablebag

sizes,isthefollowing:

3PHARMACEUTICALFORM

Solutionforinfusion.

Appearancepriortoreconstitution:Theaminoacidandglucosesolutionsareclearandcolourlessorslightlyyellow

Appearanceafterreconstitution:Clearandcolourlessorslightlyyellowsolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Parenteralnutritionwhenoralorenteralalimentationisimpossible,insufficientorcontra-indicated.

Forpatientundergoinglong-termparenteralnutrition,theadditionofalipidemulsiontoCLINIMIX ®

inorderto

supplybothcaloriesandessentialfattyacidsispossible.

4.2Posologyandmethodofadministration

4.2.1Dosageandrateofinfusion

Thedosageischosenaccordingtothemetabolicneeds,theenergyexpenditureandtheclinicalstatusofthepatient.

Inadults,therequirementsrangefrom0.16gofnitrogen/kg/d(approximately1gofaminoacid/kg/d)to0.35gof

nitrogen/kg/d(approximately2gofaminoacid/kg/d).

Ininfants,therequirementsrangefrom0.35gofnitrogen/kg/d(approximately2gofaminoacid/kg/d)to0.45gof

nitrogen/kg/d(approximately3gofaminoacid/kg/d).

Thecalorierequirementsrangefrom25kcal/kg/dto40kcal/kg/d,dependingonthenutritionalstatusofthepatientand

thedegreeofcatabolism.Insomecases,theadditionofalipidemulsiontoCLINIMIX ®

N12G20E

1l N12G20E

1.5l N12G20E

2l

Nitrogen(g)

Aminoacids(g)

Glucose(g) 5.8

11.6

Totalcalories(kcal)

Glucosecalories(kcal) 540

1080

Sodium(mmol)

Potassium(mmol)

Magnesium(mmol)

Calcium(mmol)

Acetate(mmol)

Chloride(mmol)

PhosphateasHPO

Osmolarity(mOsm/l) 6

1060 6

1060 6

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Therateofadministrationshouldbeadjustedaccordingtothedosage,thecharacteristicsoftheinfusedsolution,the

totalvolumeintakeper24hoursandthedurationoftheinfusion.Theinfusiontimeshouldbehigherthan8hours.

Themaximuminfusionrateis2.5ml/kg/houror150ml/hourto175ml/hour(forapatientweighing60kgto70kg).

Themaximumdailydoseis40ml/kgor2400mlto2800ml(forapatientweighing60kgto70kg).

4.2.2Routesofadministration

Theaminoacidandglucosesolutionsshouldbeinfusedviaacentralvein.

Theaminoacidandglucosesolutionsareusuallyadministeredtogetherwithalipidemulsion.Solutionsormixtures

withanosmolarityabove800mOsm/lshouldbeinfusedviaacentralvein.

4.3Contraindications

Knownhypersensitivitytoanyoftheingredients.

Renalfailureintheabsenceofhaemodialysis,haemofiltrationorhaemo-dia-filtration.

Severeliverdisease.

Aminoacidmetabolismdisorders

Metabolicacidosis,hyperlactataemia

Adrenalinsufficiency

Hyperosmolarcoma

Generalcontra-indicationsofaninfusiontherapysuchaspulmonaryoedema,hyperhydratationand

decompensatedcardiacinsufficiency.

CLINIMIX ®

withoutelectrolytesshouldnotbeusedincasesofhypokalaemiaandhyponatraemia.

CLINIMIX ®

containingelectrolytesshouldnotbeusedinpatientswithhyperkalaemiaandhypernatraemia.

4.4Specialwarningsandprecautionsforuse

Specialclinicalmonitoringisrequiredatthebeginningofanyintravenousinfusion.Shouldanyabnormalsign

occur,theinfusionmustbestopped.

Hypertonicsolutionsmaycausevenousirritationifinfusedintoaperipheralvein.Thechoiceofaperipheralor

centralveindependsonthefinalosmolarityofthemixture.

Thegeneralacceptedlimitforperipheralinfusionisabout800mOsm/lbutitvariesconsiderablywiththeage

andthegeneralconditionofthepatientandthecharacteristicsoftheperipheralveins.

Frequentclinicalevaluationandlaboratorydeterminationsarenecessaryforcorrectmonitoringduring

administration.Theseshouldincludebloodglucose,ionogramandkidneyandliverfunctiontests.

Theelectrolyterequirementsofpatientsreceivingthesolutionsshouldbecarefullydeterminedandmonitored

especiallyfortheelectrolyte-freesolutions.

Glucoseintoleranceisacommonmetaboliccomplicationinseverelystressedpatients.Withtheinfusionofthe

products,hyperglycaemia,glycosuria,andhyperosmolarsyndromemayoccur.Bloodandurineglucoseshould

bemonitoredonaroutinebasisandfordiabeticsinsulindosageshouldbeadapted,ifnecessary.

Fluidbalanceshouldbemonitoredduringtherapy.

Careshouldbetakentoavoidcirculatoryoverloadparticularlyinpatientswithcardiacinsufficiencyand/or

failure.

Inpatientswithhepaticinsufficiency,apartfromroutineliverfunctiontests,possiblesymptomsof

hyperammonaemiashouldbecontrolled.

Solutionscontainingelectrolytesmustbeinfusedwithcautioninpatientswithabnormallyhighserumlevelsof

theseelements,especiallyinpatientswithimpairedrenalfunction.

Iftheinfusionisnotcontinuousover24hours,keeptoanappropriateinfusionrate;possiblywithagradual

increaseinthefirsthourandagradualdecreaseinthelasthourtoavoidabnormalglycaemicpeaks.

Incaseofseverekidneyfailure,speciallyformulatedaminoacidsolutionsshouldbepreferred.

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

ThesafetyofCLINIMIX ®

inpregnancyandlactationhasnotbeenprovenduetothelackofclinicalstudies.The

prescribershouldconsiderthebenefit/riskrelationshipinordertoadministerCLINIMIX ®

topregnantorbreast-

feedingwomen.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Theeffectswhichmayoccurandwhichrequirethetreatmenttobediscontinuedareasfollows:nausea,vomitingand

shivering.

Thesepotentialundesirableeffectsmayoccurasaresultofinappropriateuse:forexample,overdose,excessivelyfast

infusionrate(seesections4.4Specialwarningsandspecialprecautionsforuse,and4.9Overdosage)

Glucoseintoleranceisacommonmetaboliccomplicationinseverelystressedpatients.Withtheinfusionofthe

products,hyperglycaemia,glycosuria,andhyperosmolarsyndromemayoccur.

4.9Overdose

Incasesofincorrectadministration(dosageandrate),signsofhypervolemiaandacidosismaybeobserved.

Hyperglycemia,glycosuria,andahyperosmolarsyndromemayoccurwithexcessiveglucoseinfusion.Atoorapid

infusionofaminoacidmayresultinnausea,vomitingandshivering.Insuchcases,discontinuetheinfusion

immediately.

Insomeseriouscases,haemodialysis,haemofiltrationorhaemo-dia-filtrationmaybenecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Solutionsforparentalnutrition/mixtures

ATCcode:B05BA10

Asaparenteralnutritionintravenousfluid,CLINIMIX ®

injectionsprovidenutritionalsupporttomaintainthecomplex

nitrogen-energybalancewhichmaybealteredbynutritionaldepletionandtrauma.CLINIMIX ®

solutionsprovidea

biologicallyavailablesourceofnitrogen(L-aminoacids),carbohydrates(asglucose)andelectrolytes.

5.2Pharmacokineticproperties

Theaminoacids,electrolytesandglucoseofCLINIMIX ®

aredistributed,metabolisedandexcretedinanidentical

mannertypicaltotheseparateaminoacids,glucoseandelectrolytesintravenoussolutions.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Aminoacidssolution:

Aceticacid

Waterforinjections

Glucosesolution:

Hydrochloricacid

Waterforinjections

6.2Incompatibilities

Additivesmaybeincompatible,refertothemanufacturerforfurtherdetails.

Ifadditivesarenecessary,compatibilitiesshouldbecheckedandthestabilityofmixturesshouldbecontrolled.

Thesolutionshouldnotbeadministeredwith,before,orafteranadministrationofbloodthroughthesameequipment

becauseofthepossibilityofpseudoagglutination.

6.3ShelfLife

Forthedualbagsintheiroverpouch,theshelflifeis2years.

Afterthepeelsealactivation,chemicalandphysicalin-usestabilityhasbeendemonstratedfor7daysat2to8°

Cfollowedby48hoursbelow25°C.

Whenadditionshavebeenmade,fromamicrobiologicalpointofview,theadmixtureshouldbeused

immediately.Ifnotusedimmediately,in-usestoragetimesandconditionspriortousearetheresponsibilityof

theuserandwouldnormallynotbelongerthan24hoursat2to8°C,unlessadditionshavebeenmadeunder

controlledandvalidatedasepticconditions.Iflongerstorageperiodsarerequiredinexceptionalcircumstances,

thecompanycanbecontactedaschemicalandphysicalin-usestabilitydatafor7daysat2-8°Cfollowedby48

hoursbelow25°Careavailablefortheproductslistedinsection6.6.d.

6.4Specialprecautionsforstorage

Donotfreeze.

Fortheproductsuppliedintheclearoverpouch,keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

CLINIMIX ®

N12G20Eispackagedinadualcompartmentplasticbagcontainingrespectivelyanaminoacidsolution

withelectrolytesandaglucosesolutionwithcalcium.

Thedualcontainerisamultilayerplasticbagpackagedinanoxygenbarrieroverpouch.Theoverpouchmayeitherbe

analuminisedplasticlaminateoraclearplasticlaminateonewithanoxygen-absorbingsachet.Thesachetmustbe

discardedafterremovaloftheoverpouch.Thebagmaterialisamultilayerplasticfilm,ofwhichtheinsidelayeris

EVA(ethylvinylacetate).Thebagwillbepresentedinoneoftwodesigns,horizontalpeelsealandverticalpeelseal

(seeFigures2and4respectively).Theplacementofbagportsisdependantuponthedesign.SeeFigures2and4.The

multilayerplasticiscompatiblewithlipids.

Bothcompartmentsareseparatedbyapeelseal.Justbeforeadministration,thecontentsofbothchambersaremixedby

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3differentformatsareavailable:

1litre Packagesize:8

1.5litres Packagesize:6

2litres Packagesize:4

Thecompartmentsvolumesarethefollowing:

Notallpacksizesmaybemarketed

Figure1

Bagsize

Compartments 1l 1.5l 2l

Aminoacidssolution 500ml 750ml 1000ml

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Donotuseunlesssolutionisclearandcontainerundamaged.

CLINIMIX ®

activationcanbeperformedintheoverpouchorafteritsremoval.Administertheproductonly

afterbreakingthesealandmixingthecontentsofbothcompartments.

Forsingleuseonly.Donotstorepartlyusedcontainersanddiscardallequipmentafteruse.Donotreconnect

partiallyusedbag.Donotconnectinseriesinordertoavoidairembolismduetopossibleresidualaircontained

intheprimarybag.

Aswithallparenteralsolutions,compatibilityshouldbecheckedwhenadditivesareused.Thoroughandcareful

asepticmixingofanyadditivesismandatory.

CLINIMIX ®

solutionsarepresentedintwodifferentbagsdesigns,seeSection6.5fordetails.Thedirectionforuse

hereafterappliesforbothdesigns.

Toopentheoverpouch

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Tomixsolutions

Ensurethattheproductisatroomtemperature.

Graspthecontainerfirmlyoneachsideofthetopofthebag.

Squeezetoactivate.(seefigure1or3).Productsuppliedwiththeverticalpeel-sealdesignmayalsobeactivated

byrolling(seeFigure3).

Mixbyinvertingthebag2or3times.

Preparationforadministration

Suspendthecontainer.

Removetheprotectivecoverfromtheadministrationportsite(thesmallerportofthepairoftheportsofthe

container,seefigure2or4).

Firmlyinserttheadministrationsetspikeintotheadministrationport.

AdditiontoCLINIMIX ®

(seesection6.2.also)

Warning:Thesupplementationcanbemade,eitherbeforeactivationofthecontainerinthedextrosesolutionfor

vitaminsonly,orafteropeningthepeelseals(oncethetwosolutionshavebeenmixed)foralladditives.CLINIMIX ®

maybesupplementedwith:

Lipidemulsions(forexampleClinOleic®)atarateof50to250mlperlitreofCLINIMIX®

CLINIMIX ®

N12G20E1l

100mllipids20%* CLINIMIX ®

N12G20E1.5l

250mllipids20%* CLINIMIX ®

N12G20E2l

250mllipids20%

Nitrogen(g)

Aminoacids(g)

Glucose(g)

Lipid(g) 5.8

11.6

Totalcalories(kcal)

Glucosecalories(kcal)

Lipidcalories(kcal)

Glucose/lipidsRatio 740

67/33 1310

55/45 1580

62/38

Sodium(mmol)

Potassium(mmol)

Magnesium(mmol)

Calcium(mmol)

Acetate(mmol)

Chloride(mmol)

PhosphateasHPO

(mmol) 35

Osmolarity(mOsm/l) 6

Sodium Potassium Magnesium Calcium

Uptoafinal

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Traceelements:perlitreofClinimix ®

Vitamins:perlitreofClinimix®

StabilitydataforsupplementationofCLINIMIX ®

withothermarketedlipidemulsionsandotheradditivesornutrientsa

availableuponrequest.

Ifsomelightcreamingisobserved,mixthoroughlytheadmixturebygentleagitationtogetauniformemulsionbeforeth

infusion.

Additionsshouldbeperformedunderasepticconditions.

Additionscanbemadewithasyringeoratransferset.

Additionwithasyringeoratransfersetfittedwithaneedle

Preparetheinjectionsite(thesingleport,seefigure2or4).

Puncturetheportandinject.

Mixthesolutionsandtheadditives.

Additionwithatransfersetfittedwithaspike

Pleaserefertothe“Directionsforuse”ofthelipidtransfersetused.

Connectthespiketothetransfusionsite(thelongestport).

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE

8MARKETINGAUTHORISATIONNUMBER

Uptoafinal

concentrationof Copper 10µmol Zinc 77µmol

Chromium 0.14

µmol Manganese 2.5µmol

Fluorine 38µmol Cobalt 0.0125

µmol

Selenium 0.44

µmol Molybdenum 0.13µmol

Iodine 0.5µmol Iron 10µmol

Uptoafinal

concentrationof vitaminA 1750IU Biotin 35µg

vitaminB6 2.27mg vitaminB1 1.76mg

vitaminD 110IU Folicacid 207µg

vitaminB12 3.0µg vitaminB2 2.07mg

vitaminE 5.1mg vitaminC 63mg

vitaminPP 23mg vitaminB5 8.63mg

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateoffirstAuthorisation:30April1996

Dateoflastrenewal: 12December2004

10DATEOFREVISIONOFTHETEXT

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