AMINOPLASMAL 10% E WITHOUT CARBOHYDRATES SOLUTION

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  • AMINOPLASMAL 10% E WITHOUT CARBOHYDRATES SOLUTION
    Ireland
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  • English

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  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/020/001
  • Authorization date:
  • 08-04-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aminoplasmal10%EwithoutCarbohydratesSolutionforInfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1000mlofsolutioncontains

Isoleucine 5.10 g

Leucine 8.90 g

LysineHydrochloride 7.00 g

(equivalenttolysine5.60g)

Methionine 3.80 g

Phenylalanine 5.10 g

Threonine 4.10g

Tryptophan 1.80g

Valine 4.80g

Arginine 9.20 g

Histidine 5.20 g

Glycine 7.90 g

Alanine 13.70g

Proline 8.90 g

AsparticAcid 1.30 g

AsparagineMonohydrate 3.72 g

(equivalenttoasparagine3.27g)

Acetylcysteine 0.68 g

(equivalenttocysteine0.50g)

GlutamicAcid 4.60 g

OrnithineHydrochloride 3.20 g

(equivalenttoornithine2.51g)

Serine 2.40 g

Tyrosine 0.30 g

Acetyltyrosine 1.23 g

(equivalenttotyrosine1.0g)

SodiumAcetateTrihydrate 3.95 g

PotassiumAcetate 2.45 g

MagnesiumAcetateTetrahydrate 0.56 g

SodiumDihydrogenPhosphateDihydrate1.40 g

Sodiumhydroxide 0.20 g

MalicAcid 1.01 g

Electrolyteconcentrations:

Sodium 43.0 mmol/l

Potassium 25.0 mmol/l

Magnesium 2.6 mmol/l

Acetate 59.0 mmol/l

Chloride 57.0 mmol/l

Dihydrogenphosphate 9.0 mmol/l

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Date Printed 11/11/2008 CRN 2058214 page number: 1

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionforinfusion

Aclear,colourlessorfaintlystraw-colouredaqueoussolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Supplyofaminoacidsasasubstrateforproteinsynthesisinparenteralnutrition,whenoralorenteralnutritionis

impossible,insufficientorcontraindicated.

Inparenteralnutrition,aminoacidinfusionsshouldalwaysbecombinedwithadequatecaloriesupply,e.g.intheform

ofcarbohydratesolutions.

4.2Posologyandmethodofadministration

Thedosageisadjustedaccordingtotheindividualneedofaminoacids,electrolytesandfluid,dependingonthe

patient’sclinicalcondition(nutritionalstatusand/ordegreeofnitrogencatabolismduetounderlyingdisease).

Adultsandadolescentsfrom15to17years:

Averagedailydose:

10–20ml/kgbodyweight(BW) 1.0–2.0gofaminoacids/kgBW,

700-1400mlforapatientof70kgBW

Maximumdailydose:

20ml/kgBW 2.0gofaminoacids/kgBW,

140gofaminoacidsforapatientof70kgBW

1400mlforapatientof70kgBW

Maximuminfusionanddroprates,respectively:

1.0ml/kgBW/h, 0.1gofaminoacids/kgBW/h,

25drops/minforapatientof70kgBW

140ml/h2.34ml/minfora70kgpatient

Childrenandadolescentsupto14years:

Thedosagesforthisagegroupasstatedbelowareaveragevaluesforguidance.Theexactdosageshouldbeadjusted

Totalaminoacidscontent 100 g/l

Totalnitrogencontent 16.0 g/l

Caloricvalue: 1675 kJ/l 400kcal/l

Theoreticalosmolarity 1030 mOsm/l

Acidity(titrationtopH7.4)approx. 22 mmol/l

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Dailydosesfor:

to5 th

yearoflife: 15ml/kgBW,correspondingto1.5gaminoacids/kgBW

to14 th

yearoflife: 10ml/kgBW,correspondingto1.0gaminoacids/kgBW

Maximuminfusionrate:

1ml/kgBW/h,correspondingto0.1gaminoacids/kgBW/h

Methodofadministrationanddurationofuse

Intravenoususe(centralvenousinfusion)

Thesolutioncanbeadministeredaslongasthereisanindicationforparenteralnutrition.

Aminoplasmal–10%EwithoutCarbohydratesisonlyonecomponentofparenteralnutrition.Inparenteralnutrition,

aminoacidsupplymustbecombinedwithsupplyofcaloriesources,essentialfattyacids,vitamins,andtraceelements.

4.3Contraindications

Contraindicationsrelatedtotheproductortoparenteralnutrition

Hypersensitivitytoanyoftheingredientspresentinthesolution

Congenitalabnormalitiesofaminoacidmetabolism

Severecirculatorydisorderswithvitalrisk,(e.g.shock)

Hypoxia

Metabolicacidosis

Advancedliverdisease

Severerenalinsufficiencywithoutaccesstohaemofiltrationorhaemodialysis

Highandpathologicalplasmaconcentrationofoneoftheelectrolytescontainedintheproduct

Thissolutionmustnotbeadministeredtoneonates,infantsorchildrenuptothecompleted2 nd

yearasthenutrient

relationsdonotproperlymeetthespecialpaediatricrequirements.

Contraindicationsrelatedtoinfusiontherapyingeneral

Uncompensatedcardiacinsufficiency

Acutepulmonaryoedema

Hyperhydration

4.4Specialwarningsandprecautionsforuse

Thissolutionshouldonlybeadministeredaftercarefulbenefit-riskassessmentinthepresenceofdisordersofamino

acidmetabolismofotheroriginthanstatedundersection4.3.Contraindications.

Inpatientswithhepaticorrenalinsufficiency,thedosemustbeadjustedaccordingtoindividualrequirements.

Cautionistobeexercisedinpatientswithincreasedserumosmolarity

Electrolyteandfluidimbalancessuchashypotonicdehydrationandhyponatraemia,shouldbecorrectedbyadequate

supplyoffluidandelectrolytespriortoparenteralnutrition.

Serumelectrolytes,bloodglucose,fluidbalance,acid-basebalanceandrenalfunction(BUN,creatinine)shouldbe

monitoredregularly.

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Aminoplasmal–10%EwithoutCarbohydratesisapplicableaspartofatotalparenteralnutritionregimenin

combinationwithadequateamountsofenergysupplements(carbohydratesolutions,fatemulsions),vitaminsandtrace

elements.

Thesiteofinfusionshouldbecheckeddailyforsignsofinflammationorinfection.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pharmacologicalinteractionsarenotknown.

4.6Pregnancyandlactation

Studiesinpregnantorbreast-feedingwomenhavenotbeenconductedwiththismedicinalproduct.Therearenopre-

clinicaldataregardingtheadministrationofAminoplasmal–10%EwithoutCarbohydratesduringpregnancy.

Aminoplasmal–10%EwithoutCarbohydratesshouldthereforebeadministeredwithcautionduringpregnancyand

lactationandonlyifdeemedclearlyindicatedafterassessmentofitsbenefitsandpossiblerisks.

4.7Effectsonabilitytodriveandusemachines

Thismedicinalproducthasnoeffectontheabilitytodriveandtousemachines.

4.8Undesirableeffects

Undesirableeffectsthat,however,arenotspecificallyrelatedtotheproductbuttoparenteralnutritioningeneralmay

occur,especiallyatthebeginningofparenteralnutrition.

Uncommon(<1:100, ≥1:1000oftreatedpatients):

Gastrointestinaldisorders: nausea,vomiting

Generaldisorders: headache,shivering,fever

4.9Overdose

Symptoms

Overdoseortoohighinfusionratesmayleadtointolerancereactionsmanifestingintheformofshivering,nausea,

vomiting,andrenalaminoacidlosses.

Treatment

Ifintolerancereactionsoccur,theaminoacidinfusionshouldbeinterruptedandresumedlateratalowerinfusionrate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmaco-therapeuticgroup:Solutionsforparenteralnutrition

ATCcode:B05BA10

Theaimofparenteralnutritionisthesupplyofallnutrientsnecessaryforthegrowth,maintenanceandregenerationof

bodytissuesetc.

Aminoacidsareofspecialimportanceastheypartlyareessentialforproteinsynthesis.Intravenouslyadministered

aminoacidsareincorporatedintherespectiveintravascularandintracellularaminoacidpools.Bothendogenousand

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Topreventthemetabolisationofaminoacidsforenergyproduction,andalsotofueltheotherenergyconsuming

processesintheorganism,simultaneousenergysupply(intheformofcarbohydrateorfat)isnecessary.

5.2Pharmacokineticproperties

BecauseAminoplasmal–10%EwithoutCarbohydratesisinfusedintravenously,thebio-availabilityoftheamino

acidsandelectrolytescontainedinthesolutionis100percent.

ThecompositionofAminoplasmal–10%EwithoutCarbohydratesisbasedontheresultsofclinicalinvestigationsof

themetabolismifintravenouslyadministeredaminoacids.

ThequantitiesoftheaminoacidscontainedinAminoplasmal–10%EwithoutCarbohydrateshavebeenchosenso

thatahomogenousincreaseoftheconcentrationsofallplasmaaminoacidsisachieved.Thephysiologicalrelationsof

plasmaaminoacids,i.e.theaminoacidhomeostasisisthusmaintainedduringinfusionofAminoplasmal–10%E

withoutCarbohydrates.

Aminoacidsthatdonotenterproteinsynthesis,aremetabolizedasfollows:Theaminogroupisseparatedfromthe

carbonskeletonbytransamination.ThecarbonchainiseitheroxidizeddirectlytoCO

orutilizedassubstratefor

gluconeogenesisintheliver.Theaminogroupisalsometabolizedinthelivertourea.

5.3Preclinicalsafetydata

Preclinicalstudieshavenotbeenperformedwiththismedicinalproduct.

Aminoplasmal–10%EwithoutCarbohydratesonlycontainsaminoacidsandelectrolytesthataresubstratesofhuman

metabolism.Therefore,notoxicreactionsareexpectedtooccuraslongastheindicationscontraindicationsanddosage

recommendationsaredulyobserved.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DisodiumEdetate

WaterforInjections

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6,Special

precautionsfordisposalofausedmedicinalproductorwastematerialsderivedfromsuchmedicinalproductandother

handlingoftheproduct.

6.3ShelfLife

Shelflifeofthemedicinalproductaspackagedforsale:

Unopened:3years

Shelflifeafterfirstopeningthecontainer:

Themedicinalproductmustbeusedimmediately.

Shelflifeaftermixingwithothercomponents

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Fromthemicrobiologicalpointofview,mixturesshouldbeadministeredimmediatelyafterpreparation.Ifnot

administeredimmediately,storagetimesandconditionsofmixturespriortousearetheresponsibilityoftheuserand

wouldnormallynotbelongerthan24hoursat2°C–8°C,unlessmixinghastakenplaceundercontrolledand

validatedasepticconditions.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Keepbottlesintheoutercartoninordertoprotectfromlight.

Donotfreeze.

Coolstorageofthesolution,below15C,mayleadtoformationofcrystals,thatcan,however,beeasilydissolvedby

gentlewarmingat25°Cuntildissolutioniscomplete.Shakecontainergentlytoensurehomogeneity.

6.5Natureandcontentsofcontainer

Aminoplasmal–10%EwithoutCarbohydratesissuppliedincolourlessglassbottles(glasstypeIIPh.Eur.)sealed

withrubberstoppers.

Contents: 500ml,availableinpacksof10bottles

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Containersareforsingleuseonly.Discardanyunusedcontentsremainingaftertheendoftheinfusion.

Thesolutionshouldonlybeusediftheclosureofthecontainerisnotdamagedandifthesolutionisclear.

Useasterilegivingsetforadministration.

Ifinthesettingofcompleteparenteralnutritionitisnecessarytoaddothernutrientssuchascarbohydrates,lipids,

vitaminsandtraceelementstothismedicinalproduct,admixingmustbeperformedunderstrictasepticconditions.Mix

wellafteradmixtureofanyadditive.Payspecialattentiontocompatibility.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

Dublin12

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0179/020/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08April1987

Dateoflastrenewal: 08April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 11/11/2008 CRN 2058214 page number: 6