AUGMENTIN ES

Main information

  • Trade name:
  • AUGMENTIN ES
  • Dosage:
  • 600/42.9 Milligram
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AUGMENTIN ES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/093/009
  • Authorization date:
  • 10-11-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/093/009

CaseNo:2043772

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AugmentinES600/42.9mgPowderfororalsuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/05/2008until09/11/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AugmentinES600/42.9mgPowderfororalsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofreconstitutedsuspensioncontains600mgamoxicillin(asthetrihydrate)and42.9mgclavulanicacid(asthe

potassiumsalt)

AlsocontainsAspartame(E951)13.60mg

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Powderfororalsuspension

Afreeflowing,off-whitepowderwithcharacteristicstrawberryodour

4CLINICALPARTICULARS

4.1TherapeuticIndications

Indications:

AugmentinESisindicatedforshort-termtreatmentofbacterialinfectionsatthefollowingsiteswhencausedby

Augmentin-susceptibleorganisms:

Upperrespiratorytractinfectionse.gacuteotitismediaduetoStreptococcuspneumoniae(includingPRSP),

HaemophilusinfluenzaeandMoraxellacatarrhalis;tonsillopharyngitis,andsinusitistypicallycausedbyStreptococcus

pneumoniae(includingPRSP),Haemophilusinfluenzae,MoraxellacatarrhalisandStreptococcuspyogenes.

Lowerrespiratorytractinfectionse.g.lobarandbroncho-pneumonia,typicallycausedbyStreptococcuspneumoniae

(includingPRSP),HaemophilusinfluenzaeandMoraxellacatarrhalis.

Skinandsofttissueinfections,typicallycausedbyStaphylococcusaureusandStreptococcuspyogenes.

4.2Posologyandmethodofadministration

AugmentinESisrecommendedfordosingat90/6.4mg/kg/dayintwodivideddosesat12-hourlyintervalsfor10days,

inchildrenaged3monthsandolder.

Thereisnoexperienceinpaediatricpatientsweighing>40kgorinadults.

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AugmentinESdoesnotcontainthesameamountofclavulanicacid(asthepotassiumsalt)asanyoftheother

Augmentinsuspensions.AugmentinEScontains42.9mgofclavulanicacidper5mlwhereasAugmentin200mg/5ml

suspensioncontains28.5mgofclavulanicacidper5mlandthe400mg/5mlsuspensioncontains57mgofclavulanic

acidper5ml.Therefore,theAugmentin200mg/5mland400mg/5mlsuspensionsshouldnotbesubstitutedfor

AugmentinES,astheyarenotinterchangeable.

Renalimpairment:

Therearenodosagerecommendationsforpatientswithacreatinineclearanceof<30ml/minute.

Hepaticimpairment:

Dosewithcaution,monitorhepaticfunctionatregularintervals.Thereareinsufficientdataonwhichtobaseadosage

recommendation.

Methodofadministration

AugmentinESisadministeredbytheoralroute.

Tominimisepotentialgastrointestinalintolerance,administeratthestartofameal.

TheabsorptionofclavulanicacidisenhancedwhenAugmentinESistakenatthestartofameal.

Treatmentshouldnotbeextendedbeyond14dayswithoutreview.

4.3Contraindications

AugmentinESiscontra-indicatedinpatientswithahistoryofhypersensitivitytobeta-lactams,e.g.penicillinsand

cephalosporins.

AugmentinESiscontra-indicatedinpatientswithaprevioushistoryofAugmentin-associatedjaundice/hepatic

dysfunction.

4.4Specialwarningsandprecautionsforuse

BeforeinitiatingtherapywithAugmentinEScarefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillins,cephalosporins,orotherallergens.

Seriousandoccasionallyfatalhypersensitivity(anaphylactoid)reactionshavebeenreportedinpatientsonpenicillin

therapy.Thesereactionsaremorelikelytooccurinindividualswithahistoryofpenicillinhypersensitivity.Ifan

allergicreactionoccurs,AugmentinEStherapyshouldbediscontinuedandappropriatealternativetherapyinstituted.

Seriousanaphylactoidreactionsrequireimmediateemergencytreatmentwithadrenaline.Oxygen,intravenoussteroids

andairwaymanagement,includingintubationmayalsoberequired.

AugmentinESshouldbeavoidedifinfectiousmononucleosisissuspectedsincetheoccurrenceofamorbilliformrash

hasbeenassociatedwiththisconditionfollowingtheuseofamoxicillin.

Prolongedusemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Periodicassessmentoforgansystemfunctions,includingrenal,hepaticandhaematopoieticfunctionisadvisable

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ProlongationofprothrombintimehasbeenreportedrarelyinpatientsreceivingAugmentinES.Appropriate

monitoringshouldbeundertakenwhenanticoagulantsareprescribedconcomitantly.

AugmentinESshouldbeusedwithcautioninpatientswithevidenceofhepaticdysfunction.

Inpatientswithrenalimpairment,dosageofAugmentinshouldbeadjustedaccordingtothedegreeofimpairment.No

dosingrecommendationscanbemadeforAugmentinESinrenallyimpairedpatients(seeSection4.2Posologyand

methodofadministration).

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.Duringtheadministrationofhighdosesofamoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofamoxicillincrystalluria.

AugmentinESsuspensioncontainsaspartame,whichisasourceofphenylalanineandsoshouldbeusedwithcaution

inpatientswithphenylketonuria.Each5mLoftheAugmentinESsuspensioncontains7mgofphenylalanine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuseofprobenecidisnotrecommended.Probeneciddecreasestherenaltubularsecretionofamoxicillin.

ConcomitantusewithAugmentinESmayresultinincreasedandprolongedbloodlevelsofamoxicillinbutnotof

clavulanicacid.

Concomitantuseofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskinreactions.

TherearenodataontheconcomitantuseofAugmentinESandallopurinol.

Incommonwithotherbroad-spectrumantibiotics,AugmentinESmayreducetheefficacyoforalcontraceptivesand

patientsshouldbewarnedaccordingly.

4.6Pregnancyandlactation

UseinPregnancy

Reproductionstudiesinanimals(miceandratsatdosesupto10timesthehumandose)withorallyandparenterally

administeredAugmentinhaveshownnoteratogeniceffects.Inasinglestudyinwomenwithpreterm,prematurerupture

foetalmembrane(pPROM),itwasreportedthatprophylactictreatmentwithAugmentinESmaybeassociatedwithan

increasedriskofnecrotisingenterocolitisinneonates.Aswithallmedicines,useshouldbeavoidedinpregnancy,unless

consideredessentialbythephysician.

UseinLactation

AugmentinESmaybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitization,

associatedwiththeexcretionoftracequantitiesinbreastmilk,therearenoknowndetrimentaleffectsforthebreast-

fedinfant.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Approximately14%ofthosepatientswhotookAugmentinESintheGSKclinicaltrialprogrammereportedatleast

oneadverseeventthattheinvestigatorconsideredtobeofsuspected,orprobable,relationshiptothestudymedication.

DatafromlargeclinicaltrialswithAugmentinESwereusedtodeterminethefrequencyofverycommontorare

undesirableeffects.Thefrequenciesassignedtoallotherundesirableeffects(i.e.,thoseoccurringat<1/10,000)were

mainlydeterminedusingpost-marketingdatafromallformulationsofAugmentinandrefertoareportingraterather

thanatruefrequency.

Thefollowingconventionhasbeenusedfortheclassificationoffrequency:Verycommon>1/10,common>1/100and

<1/10,uncommon>1/1000and<1/100,rare>1/10,000and<1/1000,veryrare<1/10,000.

Infectionsandinfestations

Common Mucocutaneouscandidiasis

Bloodandlymphaticsystemdisorders

Rare Reversibleleucopenia(includingneutropenia)andthrombocytopenia

Veryrare Reversibleagranulocytosisandhaemolyticanaemia.Prolongationofbleedingtimeandprothrombin

time(seeSection4.4SpecialWarningsandSpecialPrecautionsforUse)

Immunesystemdisorders

VeryRare Angioneuroticoedema,anaphylaxis,serumsickness-likesyndrome,hypersensitivityvasculitis

Nervoussystemdisorders

Uncommon Dizziness,headache

VeryRare Reversiblehyperactivityandconvulsions.Convulsionsmayoccurinpatientswithimpairedrenal

functionorinthosereceivinghighdoses.

Gastrointestinaldisorders

Common Diarrhoea,nausea,vomiting

Nauseaismoreoftenassociatedwithhigheroraldosages.Ifgastrointestinalreactionsareevident,theymaybereduced

bytakingAugmentinatthestartofameal.

Uncommon Indigestion

VeryRare Antibiotic-associatedcolitis(includingpseudomembranouscolitisandhaemorrhagiccolitis).

Superficialtoothdiscolourationhasbeenreportedveryrarelyinchildren.Goodoralhygienemayhelp

topreventtoothdiscolourationasitcanusuallyberemovedbybrushing.

Hepatobiliarydisorders

Uncommon AmoderateriseinASTand/orALThasbeennotedinpatientstreatedwithbeta-lactamclass

antibiotics,butthesignificanceofthesefindingsisunknown

VeryRare Hepatitisandcholestaticjaundice.Theseeventshavebeennotedwithotherpenicillinsand

cephalosporins.

Hepaticeventshavebeenreportedpredominantlyinmalesandelderlypatientsandmaybeassociatedwithprolonged

treatment.Theseeventshavebeenveryrarelyreportedinchildren.

Signsandsymptomsusuallyoccurduringorshortlyaftertreatmentbutinsomecasesmaynotbecomeapparentuntil

severalweeksaftertreatmenthasceased.Theseareusuallyreversible.Hepaticeventsmaybesevereandinextremely

rarecircumstances,deathshavebeenreported.Thesehavealmostalwaysoccurredinpatientswithseriousunderlying

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Skinandsubcutaneoustissuedisorders

Uncommon Skinrash,pruritus,urticaria

Rare Erythemamultiforme

VeryRare Stevens-Johnsonsyndrome,toxicepidermalnecrolysis,bullousexfoliative-dermatitis,acutegeneralised

exanthemouspustulosis(AGEP)

Ifanyhypersensitivitydermatitisreactionoccurs,treatmentshouldbediscontinued.

Renalandurinarydisorders

Veryrare Interstitialnephritis,crystalluria

4.9Overdose

Gastrointestinalsymptomsanddisturbanceofthefluidandelectrolytebalancesmaybeevident.Theymaybetreated

symptomatically,withattentiontothewater/electrolytebalance.Augmentincanberemovedfromthecirculationby

haemodialysis.

Amoxicillincrystalluriahasbeenobserved.(seeSection4.4Specialwarningsandspecialprecautionsforuse).

Aprospectivestudyof51paediatricpatientsatapoisoncontrolcentresuggestedthatoverdosagesoflessthan

250mg/kgofamoxicillinarenotassociatedwithsignificantclinicalsymptomsanddonotrequiregastricemptying.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antibacterial,ATCcode:J01CR02

AmoxicillinisasemisyntheticantibioticwithabroadspectrumofbactericidalactivityagainstmanyGram-positiveand

Gram-negativemicroorganisms.Amoxicillinis,however,susceptibletodegradationbybeta-lactamasesandtherefore

thespectrumofactivityofamoxicillinalonedoesnotincludeorganismswhichproducetheseenzymes.

Clavulanicacidisabeta-lactam,structurallyrelatedtothepenicillins,whichpossessestheabilitytoinactivateawide

rangeofbeta-lactamaseenzymescommonlyfoundinmicro-organismsresistanttopenicillinsandcephalosporins.In

particular,ithasgoodactivityagainsttheclinicallyimportantplasmidmediatedbeta-lactamasesfrequentlyresponsible

fortransferreddrugresistance.Itisgenerallylesseffectiveagainstchromosomally-mediatedtype1beta-lactamases.

ThepresenceofclavulanicacidinAugmentinformulationsprotectsamoxicillinfromdegradationbybeta-lactamase

enzymesandeffectivelyextendstheantibacterialspectrumofamoxicillintoincludemanybacterianormallyresistant

toamoxicillinandotherpenicillinsandcephalosporins.ThusAugmentinpossessesthedistinctivepropertiesofabroad

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Breakpoints

TheMICbreakpoints(µg/ml)forAugmentinESareshowninthefollowingtable:

Antibacterialspectrum

Theprevalenceofresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformationon

resistanceisdesirable,particularlywhentreatingsevereinfections.Thisinformationgivesonlyanapproximate

guidanceonprobabilitieswhethermicroorganismswillbesusceptibletoAugmentinESornot.Whereresistance

Pathogen

MICbreakpoint(µg/ml)for

AugmentinES

S I R

S.pneumoniae 4/2 8/4 16/8

Haemophilusspp 4/2 8/4

Moraxellacatarrhalis 4/2 8/4

Staphylococcusspp 4/2 8/4

Microbialspecies Europeanrangeofacquiredresistancefor

AugmentinESwhenthisisknowntovary

Susceptible

Gram-positiveaerobes:

Staphylococcusaureus(methicillin-susceptible,

including-lactamase-producingstrains)*

Streptococcuspneumoniae(including

penicillin-resistantstrains(PRSP)with

penicillinMIC4µg/ml)*

Streptococcuspyogenes*

Gram-negativeaerobes:

Haemophilusinfluenzae(including-

lactamase-producingstrains)*

Moraxellacatarrhalis(including-lactamase-

0.00–9.84

1.47–1.82

0.00–0.29

0.00

Resistant

Gram-positiveaerobes

Methicillin-resistantstaphylococci

(MRSA/MRSE)

Gram-negativeaerobes

Pseudomonasaeruginosa N/A

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N/A=notapplicable

*Clinicalefficacyhasbeendemonstratedforsusceptibleisolatesinapprovedclinicalindications

Cross-resistance:Amoxicillinonitsownmayshowcross-resistancetootherbeta-lactams,beta-lactam/beta-lactamase

inhibitorcombinations,andcephalosporinsdependingonthefrequencyofthediversemechanismofresistanceinthe

differentpathogens.Inthecaseofalterationofthetarget(thepenicillin-bindingproteins[PBPs])asinS.pneumoniae,

onlytheisolateswithhighresistancetopenicillinarelikelytoshowcross-resistancetoamoxicillin.Theseisolateswith

resistancetoamoxicillinshowahighproportionofcross-resistancetomacrolidesandvirtuallytoallsecond-generation

cephalosporins.

Amoxicillin/clavulanicacidcanhaveactivityagainsttheplasmid-encodedbeta-lactamasesknownastheextended

spectrumbeta-lactamases(ESBL)thatareproducedprimarilybyK.pneumoniaeandE.coli.EnzymesTEM-3toTEM-

26andSHV-2toSHV-6areincludedinthisgroup,andconferresistancetothesecond-andthird-generation

cephalosporinsandmonobactams.Themetalloenzymesareanothergroupofplasmid-mediatedbeta-lactamasesfound

inS.maltophilia,Aeromonassp.,B.cepacea,B.fragilis,S.marcescens,andP.aeruginosa.Thecurrentbeta-

lactamaseinhibitorsarenotactiveagainsttheseenzymes.Thechromosomally-encodedorinduciblebeta-lactamasesof

theAmpCclasscanbefoundinEnterobacter,Citrobacter,Morganella,Serratia,Providencia,andPseudomonas

aeruginosa.Resistanceisseeninthefirst-,second-,andthird-generationcephalosporinsandbeta-lactam/beta-

lactamaseinhibitorcombinationsincludingamoxicillin/clavulanicacid.Thepenicillinasesofthegram-positive

organism,S.aureus,arenotactiveagainstclavulanicacid.

ResistanceMechanisms:Clavulanicacidprotectsagainstresistancemediatedbycertainplasmid-encodedbeta-

lactamaseenzymes(TEM-1,TEM-2,SHV-1)commoninsomestrainsofEscherichia,Shigella,Salmonella,Proteus

andKlebsiella.Similarly,clavulanicacidmaintainsitsactivityagainstESBL.Nevertheless,clavulanicacidwouldnot

adequatelyprotectamoxicillinagainstisolateswithmetallo-enzymes,orinducibleorchromosomally-encodedbeta-

lactamaseenzymes.ThehighamoxicillincontentofAugmentinESimprovesefficacyagainstorganismswith

resistancemediatedbymodifiedpencillin-bindingproteins(PBPs).

5.2Pharmacokineticproperties

a.Absorption:

Thetwocomponents,ofAugmentin,amoxicillinandclavulanicacid,arefullydissociatedinaqueoussolutionat

physiologicalpH.Bothcomponentsarerapidlyandwellabsorbedbytheoralrouteofadministration.Absorptionof

Stenotrophomonasmultophilia

Acinetobacterspp

Serratiaspp

Citrobacterspp

Anaerobes

Clostridiumdifficile

Atypicalorganisms

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b.Pharmacokinetics

Pharmacokineticparameters(mean+SD)*aregivenbelowforAugmentinESadministeredat45mg/kgevery12

hourstopaediatricpatients

*medianandrangeprovidedfort

AmoxicillinserumconcentrationsachievedwithAugmentinaresimilartothoseproducedbytheoraladministrationof

equivalentdosesofamoxicillinalone.

Concomitantuseofprobeneciddelaysamoxicillinexcretionbutdoesnotdelayrenalexcretionofclavulanicacid(see

Section4.5,Interactionwithothermedicamentsandotherformsofinteraction).

c.Distribution:

Followingintravenousadministrationtherapeuticconcentrationsofbothamoxicillinandclavulanicacidmaybe

detectedinthetissuesandinterstitialfluid.Therapeuticconcentrationsofbothdrugshavebeenfoundingallbladder,

abdominaltissue,skin,fat,andmuscletissues;fluidsfoundtohavetherapeuticlevelsincludesynovialandperitoneal

fluids,bileandpus.

Neitheramoxicillinnorclavulanicacidishighlyproteinbound,studiesshowthatabout25%forclavulanicacidand

18%foramoxicillinoftotalplasmadrugcontentisboundtoprotein.Fromanimalstudiesthereisnoevidenceto

suggestthateithercomponentaccumulatesinanyorgan.

Amoxicillin,likemostpenicillins,canbedetectedinbreastmilk.Tracequantitiesofclavulanatecanalsobedetectedin

breastmilk.Withtheexceptionoftheriskofsensitisationassociatedwiththisexcretion,therearenoknown

detrimentaleffectsforthebreast-fedinfant.

Reproductionstudiesinanimalshaveshownthatbothamoxicillinandclavulanicacidpenetratetheplacentalbarrier.

However,noevidenceofimpairedfertilityorharmtothefoetuswasdetected.

d.Elimination:

Aswithotherpenicillins,themajorrouteofeliminationforamoxicillinisviathekidney,whereasforclavulanateitis

bybothrenalandnon-renalmechanisms.Approximately60-70%oftheamoxicillinandapproximately40-65%ofthe

clavulanicacidareexcretedunchangedinurineduringthefirst6hoursafteradministrationofasingle250/125mgora

single500/125mgtablet.

Amoxicillinisalsopartlyexcretedintheurineastheinactivepenicilloicacidinquantitiesequivalentto10-25%ofthe

initialdose.Clavulanicacidisextensivelymetabolizedinmanto2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-

carboxylicacidand1-amino-4-hydroxy-butan-2-oneandeliminatedinurineandfaecesascarbondioxideinexpired

Formulation C

max

(mg/l) t

max*

(hours) AUC

(0-t)

(mg.h/l) t

½

(hours)

AugmentinES

600/42.9mg/5ml

(14:1)

Dosedat

45mg/kg

amoxicillin12-

hourly Amoxicillin

15.7+

(1.0–4.0) 59.8+20.0 1.4+0.3

Clavulanicacid

1.7+0.9 1.1

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5.3Preclinicalsafetydata

Nofurtherinformationofrelevance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Silica,colloidalanhydrous

CarboxymethylcelluloseSodium12

Aspartame(E951)

Xanthangum

Silicondioxide

Artificialstrawberrycreamflavour

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Drypowder:

18months

Suspension:

Afterreconstitutionuseformaximum10days

6.4Specialprecautionsforstorage

Drypowder:

Donotstoreabove25oC.Keepthecontainertightlyclosed.

Suspension:

Oncereconstituted,storeat2 °

Cto8 °

C.Donotfreeze.

6.5Natureandcontentsofcontainer

Clearglassbottles(TypeIII)closedwithanaluminiumclosurewithPVCliner.Ameasuringcupisprovidedineach

pack.

Bottlesizesof20ml,50ml,75ml,100mland150ml.Thebottlepackisplacedinacardboardcarton.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Tapbottleuntilallthepowderflowsfreely.Addapproximately2/3ofthetotalamountofwaterforreconstitution(see

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Each5mlofreconstitutedsuspensioncontains600mgamoxicillinasthetrihydrateand42.9mgofclavulanicacidas

thepotassiumsalt.

Note:SHAKEORALSUSPENSIONWELLBEFOREUSING.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA1077/93/9

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:10 th

November2006

AugmentinES

BottleSize(ml) AmountofWaterRequiredfor

Suspension(ml)

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