AMINOPLASMAL 5% E WITHOUT CARBOHYDRATES SOLUTION F

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  • AMINOPLASMAL 5% E WITHOUT CARBOHYDRATES SOLUTION F
    Ireland
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  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0179/019/001
  • Authorization date:
  • 08-04-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aminoplasmal5%EwithoutCarbohydratesSolutionforInfusion.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1000mlofsolutioncontains:

Isoleucine 2.55 g

Leucine 4.45 g

LysineHydrochloride 3.50 g

(equivalenttolysine2.80g)

Methionine 1.90 g

Phenylalanine 2.55 g

Threonine 2.05 g

Tryptophan 0.90 g

Valine 2.40 g

Arginine 4.60 g

Histidine 2.60 g

Glycine 3.95 g

Alanine 6.85 g

Proline 4.45 g

AsparticAcid 0.65 g

Asparaginemonohydrate 1.86 g

(equivalenttoasparagine1.64g)

Acetylcysteine 0.34 g

(equivalenttocysteine0.25g)

Glutamicacid 2.30 g

Ornithinehydrochloride 1.60 g

(equivalenttoornithine1.25g)

Serine 1.20 g

Tyrosine 0.30 g

Acetyltyrosine 0.43 g

(equivalenttotyrosine0.35g)

Sodiumacetatetrihydrate 3.95 g

Potassiumacetate 2.45 g

Magnesiumacetatetetrahydrate 0.56 g

Sodiumdihydrogenphosphatedihydrate1.40 g

Sodiumhydroxide 0.20 g

Irish Medicines Board

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Date Printed 11/11/2008 CRN 2058197 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

20–40ml/kgbodyweight(BW) 1.0–2.0gofaminoacids/kgBW,

1400–2800mlforapatientof70kgBW

Maximumdailydose:

40ml/kgBW 2.0gofaminoacids/kgBW,

140gofaminoacidsforapatientof70kgBW

Electrolyteconcentrations

Sodium 43 mmol/l

Potassium 25 mmol/l

Magnesium 2.6 mmol/l

Acetate 59 mmol/l

Chloride 29 mmol/l

Dihydrogenphosphate 9.0 mmol/l

L-Malate 7.5 mmol/l

Totalaminoacidscontent 50 g/l

Totalnitrogencontent 8.0 g/l

Caloricvalue 835 kJ/l 200kcal/l

Osmolarity 590 mOsm/l

Acidity(titrationtopH7.4),approx. 18 mmol/l

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Maximuminfusionanddroprates,respectively:

2.0ml/kgBW/h 0.1gofaminoacids/kgBW/h,

45drops/minforapatientof70kgBW

2.34ml/minfora70kgpatient

Childrenandadolescentsupto14years:

Thedosagesforthisagegroupasstatedbelowareaveragevaluesforguidance.Theexactdosageshouldbeadjusted

individuallyaccordingtoage,developmentalstageandprevailingdisease.

Dailydosesfor:

to5 th

yearoflife: 30ml/kgBW,correspondingto1.5gaminoacids/kgBW

to14 th

yearoflife: 20ml/kgBW,correspondingto1.0gaminoacids/kgBW

Maximuminfusionrate:

2ml/kgBW/h,correspondingto0.1gaminoacids/kgBW/h

Inthecaseofaminoacidrequirementsof1g/kgBW/dayormore,particularattentionshouldbepaidtothelimitations

offluidinput.Toavoidfluidoverload,aminoacidsolutionswithhigheraminoacidcontentmayhavetobeusedin

suchsituations.

Methodofadministrationanddurationofuse

Intravenoususe

Thesolutioncanbeadministeredaslongasthereisanindicationforparenteralnutrition.

Aminoplasmal–5%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

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4.4Specialwarningsandprecautionsforuse

Thissolutionshouldonlybeadministeredaftercarefulbenefit-riskassessmentinthepresenceofdisordersofamino

acidmetabolismofotheroriginthanstatedundersection4.3,Contraindications.

Careshouldbeexercisedintheadministrationoflargevolumeinfusionfluidstopatientswithcardiacinsufficiency.

Inpatientswithhepaticorrenalinsufficiency,thedosemustbeadjustedaccordingtoindividualrequirements.

Cautionistobeexercisedinpatientswithincreasedserumosmolarity

Electrolyteandfluidimbalancessuchashypotonicdehydrationandhyponatraemia,shouldbecorrectedbyadequate

supplyoffluidandelectrolytespriortoparenteralnutrition.

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

monitoredregularly.

Monitoringshouldalsoincludeserumproteinandliverfunctiontests.

Aminoplasmal–5%EwithoutCarbohydratesisapplicableaspartofatotalparenteralnutritionregimenin

combinationwithadequateamountsofenergysupplements(carbohydratesolutions,fatemulsions),vitaminsandtrace

elements.

Ifthesolutionsareadministeredincombinationwithothernutrientsolutions,thepossibilityofperipheralvenous

infusiondependsontheosmolarityoftheresultingmixture.

Thesiteofinfusionshouldbecheckeddailyforsignsofinflammationorinfection.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pharmacologicalinteractionsarenotknown.

4.6Pregnancyandlactation

Studiesinpregnantorbreast-feedingwomenhavenotbeenconductedwiththismedicinalproduct.Therearenopre-

clinicaldataregardingtheadministrationofAminoplasmal–5%EwithoutCarbohydratesduringpregnancy.

Aminoplasmal–5%EwithoutCarbohydratesshouldthereforebeadministeredwithcautionduringpregnancyand

lactationandonlyifdeemedclearlyindicatedafterassessmentofitsbenefitsandpossiblerisks.

4.7Effectsonabilitytodriveandusemachines

Thismedicinalproducthasnoeffectontheabilitytodriveandtousemachines.

4.8Undesirableeffects

Undesirableeffectsthat,however,arenotspecificallyrelatedtotheproductbuttoparenteralnutritioningeneralmay

occur,especiallyatthebeginningofparenteralnutrition.

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

Gastrointestinaldisorders: nausea,vomiting

Irish Medicines Board

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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

exogenousaminoacidsserveassubstrateforthesynthesisoffunctionalandstructuralproteins.

Topreventthemetabolisationofaminoacidsforenergyproduction,andalsotofueltheotherenergyconsuming

processesintheorganism,simultaneousenergysupply(intheformofcarbohydrateorfat)isnecessary.

5.2Pharmacokineticproperties

BecauseAminoplasmal–5%EwithoutCarbohydratesisinfusedintravenously,thebio-availabilityoftheaminoacids

andelectrolytescontainedinthesolutionis100percent.

ThecompositionofAminoplasmal–5%EwithoutCarbohydratesisbasedontheresultsofclinicalinvestigationsof

themetabolismifintravenouslyadministeredaminoacids.

ThequantitiesoftheaminoacidscontainedinAminoplasmal–5%EwithoutCarbohydrateshavebeenchosensothat

ahomogenousincreaseoftheconcentrationsofallplasmaaminoacidsisachieved.Thephysiologicalrelationsof

plasmaaminoacids,i.e.theaminoacidhomeostasisisthusmaintainedduringinfusionofAminoplasmal–5%E

withoutCarbohydrates.

Aminoacidsthatdonotenterproteinsynthesis,aremetabolizedasfollows.Theaminogroupisseparatedfromthe

carbonskeletonbytransamination.ThecarbonchainiseitheroxidizeddirectlytoCO

orutilizedassubstratefor

gluconeogenesisintheliver.Theaminogroupisalsometabolizedinthelivertourea.

5.3Preclinicalsafetydata

Preclinicalstudieshavenotbeenperformedwiththismedicinalproduct.

Aminoplasmal–5%EwithoutCarbohydratesonlycontainsaminoacidsandelectrolytesthataresubstratesofhuman

metabolism.Therefore,notoxicreactionsareexpectedtooccuraslongastheindicationscontraindicationsanddosage

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DisodiumEdetate

WaterforInjections

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6,Special

precautionsfordisposalofausedmedicinalproductorwastematerialsderivedfromsuchmedicinalproductandother

handlingoftheproduct.

6.3ShelfLife

Unopened:3years

Shelflifeafterfirstopeningthecontainer

Themedicinalproductmustbeusedimmediately.

Shelflifeaftermixingwithothercomponents

Chemicalandphysicalcompatibilityofanyadmixturesmustbecheckedbeforeadministration.

Fromthemicrobiologicalpointofview,mixturesshouldbeadministeredimmediatelyafterpreparation.Ifnot

administeredimmediately,storagetimesandconditionsofmixturespriortousearetheresponsibilityoftheuserand

wouldnormallynotbelongerthan24hoursat2°C–8°C,unlessmixinghastakenplaceundercontrolledand

validatedasepticconditions.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Keepbottlesintheoutercartoninordertoprotectfromlight.

Donotfreeze

6.5Natureandcontentsofcontainer

Aminoplasmal–5%EwithoutCarbohydratesissuppliedincolourlessglassbottles(glasstypeIIPh.Eur.)sealedwith

rubberstoppers.

Contents: 500ml,availableinpacksof10bottles.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Containersareforsingleuseonly.Discardanyunusedcontentsremainingaftertheendoftheinfusion.

Thesolutionshouldonlybeusediftheclosureofthecontainerisnotdamagedandifthesolutionisclear.

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Ifinthesettingofcompleteparenteralnutritionitisnecessarytoaddothernutrientssuchascarbohydrates,lipids,

vitaminsandtraceelementstothismedicinalproduct,admixingmustbeperformedunderstrictasepticconditions.Mix

wellafteradmixtureofanyadditive.Payspecialattentiontocompatibility.

7MARKETINGAUTHORISATIONHOLDER

B.BraunMedicalLimited

3NaasRoadIndustrialPark

Dublin12

Ireland.

8MARKETINGAUTHORISATIONNUMBER

PA0179/019/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 08April1987

Dateoflastrenewal: 08April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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