AMINOPLASMAL 10% E WITHOUT CARBOHYDRATES SOLUTION 10 %w/v Solution for Infusion

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE DL-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE AMINOACETIC ACID ALANINE PROLINE ASPARTIC ACID ASPARGINE MONOHYDRATE ACETYLCYSTEINE GLUTAMIC ACID ORNITHINE HYDROCHLORIDE SERINE TYROSINE SODIUM ACETATE TRIHYDRATE POTASSIUM ACETATE MAGNESIUM ACETATE TETRAHYDRATE SODIUM PHOSPHATE MONOBASIC MALIC ACID N-ACETYLTYROSINE PH. EUR.
Available from:
B. Braun Medical Limited
INN (International Name):
LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE DL-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE
Dosage:
10 %w/v
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization number:
PA0179/020/001
Authorization date:
0000-00-00

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

Irish Medicines Board

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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

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

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