CLINIMIX N17G35E

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  • Available in:
  • CLINIMIX N17G35E
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/098/005
  • 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)

PA0167/098/005

CaseNo:2063572

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BaxterHealthcareLimited

CaxtonWay,Thetford,NorfolkIP243SE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CLINIMIXN17G35E,solutionforinfusion

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

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

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CLINIMIX ®

N17G35E,solutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CLINIMIX ®

N17G35Eispackagedinadualcompartmentplasticbagcontainingrespectivelyanaminoacidsolution

withelectrolytesandaglucosesolutionwithcalcium.

Theinjectableaminoacidsolutioncontains15L-aminoacids(8essentialaminoacids)neededfortheprotein

synthesis.

Theaminoacidprofileisthefollowing:

Essentialaminoacids/Totalaminoacids=41.3%

Essentialaminoacids/Totalnitrogen=2.83

Branchedchainaminoacids/Totalaminoacids=19%

ThequantitativecompositionofCLINIMIX ®

N17G35Eisthefollowing:

10%Aminoacidsolution

withelectrolytes 35%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

7.30g/l

5.60g/l

4.00g/l

5.80g/l

(7.25g/l)

6.00g/l

5.80g/l

4.80g/l

4.20g/l

1.80g/l

20.70g/l

11.50g/l

10.30g/l

6.80g/l

5.00g/l

0.40g/l

6.80g/l

5.22g/l

1.17g/l

1.02g/l

350g/l

(385g/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 ®

isrecommended.

Therateofadministrationshouldbeadjustedaccordingtothedosage,thecharacteristicsoftheinfusedsolution,the

N17G35E

1l N17G35E

1.5l N17G35E

2l

Nitrogen(g)

Aminoacids(g)

Glucose(g) 8.3

12.4

16.5

Totalcalories(kcal)

Glucosecalories(kcal) 900

1350

1050 1800

1400

Sodium(mmol)

Potassium(mmol)

Magnesium(mmol)

Calcium(mmol)

Acetate(mmol)

Chloride(mmol)

PhosphateasHPO

(mmol) 35

Osmolarity(mOsm/l) 6

1625 6

1625 6

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Themaximuminfusionrateis1.4ml/kg/houror85ml/hourto100ml/hour(forapatientweighing60kgto70kg).

Themaximumdailydoseis30ml/kgor1800mlto2100ml(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 ®

topregnantorbreastfeeding

women.

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/mixturesATCcode: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 ®

N9G15Eispackagedinadualcompartmentplasticbagcontainingrespectivelyanaminoacidsolution

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(thesmallerportofthepairofportsofthe

container,seefigure2or4).

Firmlyinserttheadministrationsetspikeintotheadministrationport.

AdditiontoCLINIMIX ®

(seesection6.2.also)

Warning:Thesupplementationcanbemade,eitherbeforeactivationofthecontainerinthedextrosesolutionfor

vitaminsonly,orafteropeningthepeelseals(oncethetwosolutionshavebeenmixed)foralladditives.CLINIMIX ®

maybesupplementedwith:

Lipidemulsions(forexampleClinOleic®)atarateof50to250mlperlitreofCLINIMIX®.

CLINIMIX ®

N17G35E

1l

250mllipids20%* CLINIMIX ®

N17G35E1.5l

500mllipids20%* CLINIMIX ®

N17G35E2l

500mllipids20%

Nitrogen(g)

Aminoacids(g)

Glucose(g)

Lipid(g) 8.3

12.4

16.5

Totalcalories(kcal)

Glucosecalories

(kcal)

Lipidcalories(kcal)

Glucose/lipidsRatio 1400

58/42 2350

1050

1000

51/49 2800

1400

1000

58/42

Sodium(mmol)

Potassium(mmol)

Magnesium(mmol)

Calcium(mmol)

Acetate(mmol)

Chloride(mmol)

PhosphateasHPO

(mmol) 35

Osmolarity(mOsm/l) 6

1360 6

1290 6

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Electrolytes:perlitreofClinimix®

Traceelements:perlitreofClinimix®

Vitamins:perlitreofClinimix®

StabilitydataforsupplementationofCLINIMIX ®

withothermarketedlipidemulsionsandotheradditivesornutrientsa

availableuponrequest.

Ifsomelightcreamingisobserved,mixthoroughlytheadmixturebygentleagitationtogetauniformemulsionbeforeth

infusion.

Additionsshouldbeperformedunderasepticconditions.

Additionscanbemadewithasyringeoratransferset.

Additionwithasyringeoratransfersetfittedwithaneedle

Preparetheinjectionsite(thesingleport,seefigure2or4).

Puncturetheportandinject.

Mixthesolutionsandtheadditives.

Additionwithatransfersetfittedwithaspike

Pleaserefertothe“Directionsforuse”ofthelipidtransfersetused.

Sodium Potassium Magnesium Calcium

Uptoafinal

concentrationof 80mmol 60mmol 5.6mmol 3.0mmol

Uptoafinal

concentrationof Copper 10µmol Zinc 77µmol

Chromium 0.14

µmol Manganese 2.5µmol

Fluorine 38µmol Cobalt 0.0125

µmol

Selenium 0.44

µmol Molybdenum 0.13

µmol

Iodine 0.5

µmol 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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7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE

8MARKETINGAUTHORISATIONNUMBER

PA0167/098/005

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 30April1996

Dateoflastrenewal: 12December2004

10DATEOFREVISIONOFTHETEXT

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