CLINIMIX N17G35

Main information

  • Trade name:
  • CLINIMIX N17G35
  • Dosage:
  • 10/35 %v/v
  • Pharmaceutical form:
  • Solution for Infusion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINIMIX N17G35
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0167/098/008
  • Authorization date:
  • 30-04-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CLINIMIX ®

N17G35,solutionforinfusion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CLINIMIX ®

N17G35ispackagedinadualcompartmentplasticbagcontainingrespectivelyanaminoacidsolution

withoutelectrolytesandaglucosesolutionwithoutcalcium.

Theinjectableaminoacidsolutioncontains15L-aminoacids(8essentialaminoacids)neededfortheprotein

synthesis.

Theaminoacidprofileisthefollowing:

Essentialaminoacids/Totalaminoacids=41.3%

Essentialaminoacids/Totalnitrogen=2.83

Branchedchainaminoacids/Totalaminoacids=19%

ThequantitativecompositionofCLINIMIX ®

N17G35isthefollowing:

10%Aminoacid

solutionwithout

electrolytes 35%Glucosesolution

withoutcalcium

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

Glucose

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

350g/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

totalvolumeintakeper24hoursandthedurationoftheinfusion.Theinfusiontimeshouldbehigherthan8hours.

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

N17G35

1l N17G35

1.5l N17G35

2l

Nitrogen(g)

Aminoacids(g)

Glucose(g) 8.3

12.4

16.5

Totalcalories(kcal)

Glucosecalories(kcal) 900

1350

1050 1800

1400

Acetate(mmol)

Chloride(mmol) 43

Osmolarity(mOsm/l) 6

1490 6

1490 6

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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/lbutitvaries

considerablywiththeageandthegeneralconditionofthepatientandthecharacteristicsoftheperipheralveins.

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.

Vitaminsandtraceelementsshouldbeprovidedtopatientsreceivingparenteralnutritionforalongperiod.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

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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,beforeorafteranadministrationofbloodthroughthesameequipment

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 ®

N17G35

1l

250mllipids20%* CLINIMIX ®

N17G35

1.5l

500mllipids20%* CLINIMIX ®

N17G35

2l

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

Acetate(mmol)

Chloride(mmol) 43

Osmolarity

(mOsm/l) 6

1255 6

1195 6

1255

Sodium Potassium Magnesium Calcium

Uptoafinal

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Traceelements:perlitreofClinimix ®

Vitamins:perlitreofClinimix®

StabilitydataforsupplementationofCLINIMIX ®

withothermarketedlipidemulsionsandotheradditivesornutrients

areavailableuponrequest.

Ifsomelightcreamingisobserved,mixthoroughlytheadmixturebygentleagitationtogetauniformemulsionbefore

theinfusion.

Additionsshouldbeperformedunderasepticconditions.

Additionscanbemadewithasyringeoratransferset.

Additionwithasyringeoratransfersetfittedwithaneedle

Preparetheinjectionsite(thesingleport,seefigure2or4).

Puncturetheportandinject.

Mixthesolutionsandtheadditives.

Additionwithatransfersetfittedwithaspike

Pleaserefertothe“Directionsforuse”ofthelipidtransfersetused.

Connectthespiketothetransfusionsite(thelongestport).

7MARKETINGAUTHORISATIONHOLDER

BaxterHealthcareLtd.,

CaxtonWay,

Thetford,

Norfolk,

IP243SE

8MARKETINGAUTHORISATIONNUMBER

PA0167/098/008

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30April1996

Uptoafinal

concentrationof Copper 10µmol Zinc 77µmol

Chromium 0.14µmol Manganese 2.5µmol

Fluorine 38µmol Cobalt 0.0125

µmol

Selenium 0.44µmol 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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10DATEOFREVISIONOFTHETEXT

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