ADVIL LIQUIGELS, 200MG CAPSULES

Main information

  • Trade name:
  • ADVIL LIQUIGELS, 200MG CAPSULES
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL LIQUIGELS, 200MG CAPSULES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/029/002
  • Authorization date:
  • 08-03-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AdvilLiqui-gel,200mgcapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains200mgIbuprofen.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Softcapsule

Greentranslucent,ovalsoftgelatincapsuleprinted‘Advil’ononesideinwhiteink.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofmildtomoderatepainincludingrheumaticandmuscularpain,backache,headache,dentalpain,

dysmenorrhoea,feverishnessandforthereliefofsymptomsofcoldandinfluenza.

4.2Posologyandmethodofadministration

Fororaladministrationandshort-termuseonly.

Forallindications:

Adults,theelderlyandchildrenover12yearsofage:

Thelowesteffectivedoseshouldbeusedfortheshortestdurationnecessarytorelievesymptoms.Thepatientshould

consultadoctorifsymptomspersistorworsen,oriftheproductisrequiredformorethan10days.

1or2capsulesuptothreetimesperdayasrequired.Therespectivedosingintervalshouldbechoseninlinewiththe

observedsymptomsandthemaximumrecommendeddailydose.Dosesshouldbegivenapproximatelyevery6-8

hours,withaminimumintervalof4hoursbetweeneachdose.Atotaldoseof1200mgofibuprofen(6capsules)

shouldnotbeexceededinany24hourperiod.Thecapsulesshouldbetakenwithwater.

Nottobeusedforchildrenunder12yearsofage.

4.3Contraindications

Hypersensitivitytoibuprofenoranyoftheotheringredients.

Useinpatientshypersensitivetoaspirinorwithbronchospasm,asthma,rhinitis,angioedemaorurticariaassociated

withnon-steroidalanti-inflammatorydrugs(NSAIDs).

Ibuprofenshouldnotbegiventopatientswithactiveorhistoryofrecurrentpepticulcer/haemorrhage(twoormore

distinctepisodesofprovenulcerationorbleeding).

HistoryofgastrointestinalbleedingorperforationrelatedtopreviousNSAIDtherapy.

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Severehepaticfailure,severerenalfailureorsevereheartfailure.

Lasttrimesterofpregnancy(seesection4.6).

4.4Specialwarningsandprecautionsforuse

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seegastrointestinalandcardiovascularrisksbelow).

Elderly:

TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDs,especiallygastrointestinalbleedingand

perforationwhichmaybefatal.

Respiratory:

Bronchospasmmaybeprecipitatedinpatientssufferingfromorwithaprevioushistoryofbronchialasthmaorallergic

diseaseandAdvilLiquigel200mgCapsulesshouldnotbeusedwhereotherNSAIDshaveproducedreactions.

OtherNSAIDs:

TheuseofAdvilLiquigel200mgCapsuleswithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitors

shouldbeavoided(seesection4.5).

SystemicLupusErythematosus(SLE)andmixedconnectivetissuedisease:

CautionshouldbetakenwhenibuprofenisgiventopatientswithSLEandautoimmunediseases–increasedriskof

asepticmeningitishasbeenreported.(seesection4.8).

Renal,CardiacandHepatic:

Cautionisrequiredinpatientswithrenal,cardiacorhepaticimpairmentsincerenalfunctionmaydeteriorate(see

sections4.3and4.8).Thedoseshouldbeaslowaspossibleandrenalfunctionshouldbemonitored.

Cardiovascularandcerebrovasculareffects:

Caution(discussionwithdoctororpharmacist)isrequiredpriortostartingtreatmentinpatientswithahistoryof

hypertensionand/orheartfailureasfluidretention,hypertensionandoedemahavebeenreportedinassociationwith

NSAIDtherapy.

Clinicaltrialandepidemiologicaldatasuggestthatuseofibuprofen,particularlyathighdoses(2400mgdaily)andin

long-termtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen(e.g. 1200

mgdaily)isassociatedwithanincreasedriskofmyocardialinfarction.

Impairedfemalefertility:

Thereislimitedevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

femalefertilitybyaneffectonovulation.Thisisreversibleuponwithdrawaloftreatment.

Gastrointestinal:

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(e.g.ulcerativecolitis,Crohn’s

disease)astheseconditionsmaybeexacerbated(seesection4.8).

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdosesinpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.Thesepatients

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PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding),particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitors(SSRIs)

oranti-plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingibuprofen,thetreatmentshouldbewithdrawn.

Dermatological:

Severeskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8).Patients

appeartobeathighestriskforthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.AdvilLiquigel200mgCapsulesshouldbediscontinuedatthe

firstappearanceofskinrash,mucosallesionsoranyothersignofhypersensitivity.

Thepharmacologicalactivityofibuprofenmayreducefeverandinflammation,thusdiminishingtheirutilityas

diagnosticsignsindetectingunderlyingconditions.

Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

Thelabelwillinclude:

Readtheenclosedleafletbeforetakingthisproduct.

Donottakeifyou:

have(orhavehadtwoormoreepisodesof)astomachulcer,perforationorbleeding.

areallergictoibuprofenoranyotheringredientoftheproduct,aspirinorotherrelatedpainkillers.

aretakingotherNSAIDpainkillers,oraspirinwithadailydoseabove75mg.

Speaktoapharmacistoryourdoctorbeforetakingifyou:

haveorhavehadasthma,diabetes,highcholesterol,highbloodpressure,astroke,heart,liver,kidneyorbowel

problems.

areasmoker.

arepregnant.

Ifsymptomspersistorworsen,consultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ibuprofenshouldbeavoidedincombinationwith:

Aspirin:

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofexvivo

datatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andnoclinically

relevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

OtherNSAIDs:

IbuprofenshouldnotbeusedwithotherpainrelieverssuchasNSAIDs.

Ibuprofenshouldbeusedwithcautionincombinationwith:

Anticoagulants:NSAIDsmayenhancetheeffectsofanticoagulantssuchaswarfarin(seesection4.4).Whentaking

anticoagulantsitshouldbetakenintoaccountthatlong-termuseofibuprofenmayincreasetheriskofbleeding.

Antihypertensivesanddiuretics:NSAIDsmaydiminishtheeffectsofantihypertensivesorthiazidediuretics.Diuretics

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Corticosteroids:Whentakingcorticosteroidsandibuprofenconcomitantlythereisanincreasedriskofgastrointestinal

ulcerationorbleeding.(seesection4.4).

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):Increasedriskofgastrointestinalbleeding(see

section4.4)

Cardiacglycosides:Ibuprofenmayincreaseserumdigitalisconcentrations.Serumdigitalisconcentrationsshould

thereforebemonitoredinpatientswithdecreasedrenalfunctionorcongestiveheartfailure.

Lithium:Increasesinserumlithiumconcentrationsfollowingadministrationofibuprofenmaybeclinicallysignificant.

Methotrexate:Concomitantadministrationofibuprofenwithmoderateandhighdosesofmethotrexatemayleadto

seriousandfatalmethotrexatetoxicity.Patientswithreducedrenalfunctionmaybeatadditionalriskoftoxicityfrom

thecombinationevenwhenlowdosesofmethotrexate(20mg/week)areused.

Ciclosporin:Increasedriskofnephrotoxicity.

Tacrolimus:PossibleincreasedriskofnephrotoxicitywhenNSAIDsaregivenwithtacrolimus.

Zidovudine:IncreasedriskofhaematologicaltoxicitywhenNSAIDsaregivenwithzidovudine.Thereisevidenceof

anincreasedriskofhaemarthrosesandhaematomainHIV(+)haemophiliacsreceivingconcurrenttreatmentwith

zidovudineandibuprofen.

Quinoloneantibiotics:AnimaldataindicatethatNSAIDscanincreasetheriskofconvulsionsassociatedwith

quinoloneantibiotics.PatientstakingNSAIDsandquinolonesmayhaveanincreasedriskofdevelopingconvulsions.

Phenytoin:Ibuprofenmayincreasepharmacologicallyactivefreephenytoin.Patientstakingibuprofenforlong-term

useshouldbemonitored.

Antacids:Certainantacidsmayincreasethegastrointestinalabsorptionofibuprofen.Thisisconsideredtobeofclinical

relevanceparticularlyduringlong-termuseofibuprofen.

4.6Fertility,pregnancyandlactation

Pregnancy

Inhibitionofprostaglandinsynthesismayadverselyaffectthepregnancyand/ortheembryo/foetaldevelopment.Data

fromepidemiologicalstudiessuggestanincreasedriskofmiscarriageandofcardiacmalformationandgastroschisis

afteruseofaprostaglandinsynthesisinhibitorinearlypregnancy.Theabsoluteriskforcardiovascularmalformation

wasincreasedfromlessthan1%,uptoapproximately1.5%.Theriskisbelievedtoincreasewithdoseanddurationof

therapy.Inanimals,administrationofaprostaglandinsynthesisinhibitorhasbeenshowntoresultinincreasedpre-and

post-implantationlossandembryo-foetallethality.Inaddition,increasedincidencesofvariousmalformations,

includingcardiovascular,havebeenreportedinanimalsgivenaprostaglandinsynthesisinhibitorduringthe

organogeneticperiod.Duringthefirstandsecondtrimesterofpregnancy,ibuprofenshouldnotbegivenunlessclearly

necessary.Ifibuprofenisusedbyawomanattemptingtoconceive,orduringthefirstandsecondtrimesterof

pregnancy,thedoseshouldbekeptaslowanddurationoftreatmentasshortaspossible.

Duringthethirdtrimesterofpregnancy,allprostaglandinsynthesisinhibitorsmayexposethefoetusto:

-cardiopulmonarytoxicity(withprematureclosureoftheductusarteriosusandpulmonaryhypertension);

-renaldysfunction,whichmayprogresstorenalfailurewitholigo-hydroamniosis;

themotherandtheneonate,attheendofpregnancy,to:

-possibleprolongationofbleedingtime,ananti-aggregatingeffectwhichmayoccurevenatverylowdoses.

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Consequently,ibuprofeniscontraindicatedduringthethirdtrimesterofpregnancy.

Lactation

Inlimitedstudies,ibuprofenappearsinbreastmilkinverylowconcentrations.Baseduponthelowleveldetected

(0.0008%ofmaternaldose),itisunlikelytoaffectthebreast-fedinfantadversely.

Seesection4.4regardingfemalefertility.

4.7Effectsonabilitytodriveandusemachines

Noneexpectedatrecommendeddosesanddurationoftherapy.

4.8Undesirableeffects

ThefollowinglistofadverseeffectsrelatestothoseexperiencedwithibuprofenatOTCdoses,forshort-termuse.In

thetreatmentofchronicconditions,underlong-termtreatment,additionaladverseeffectsmayoccur.

Theadverseeffectshavebeenlistedinorderofdecreasingfrequency,usingthefollowingconvention:verycommon(

1/10);common( 1/100to<1/10);uncommon( 1/1,000to<1/100);rare( 1/10,000to<1/1,000);veryrare

(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Investigations: Veryrare: Decreasedhaematocritandhaemoglobin

levels.

CardiacDisorders: Notknown: Oedema,hypertension,anginapectorisand

cardiacfailure,havebeenreportedin

associationwithNSAIDtreatment.

Clinicaltrialandepidemiologicaldata

suggestthatuseofibuprofen(particularly

athighdoses2400mgdaily)andinlong-

termtreatmentmaybeassociatedwitha

smallincreasedriskofarterialthrombotic

events(forexamplemyocardialinfarction

orstroke)(seesection4.4).

BloodandLymphatic

SystemDisorders: Veryrare: Haematopoieticdisorders(anaemia,

haemolyticanaemia,aplasticanaemia,

leucopenia,thrombocytopenia,

pancytopenia,agranulocytosis).Firstsigns

are:fever,sorethroat,superficialmouth

ulcers,influenza-likesymptoms,severe

exhaustion,unexplainedbleedingand

bruising.

NervousSystem

Disorders: Uncommon: Headache,dizziness,cerebrovascular

accident

Veryrare: Asepticmeningitis–singlecaseshavebeen

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EyeDisorders: Veryrare: Visualdisturbance.

EarandLabyrinth

Disorders: Veryrare: Tinnitusandvertigo.

Respiratory,Thoracic

andMediastinal

Disorders: Veryrare: Asthma,bronchospasm,dyspnoeaand

wheezing.

Gastrointestinal

Disorders: Themostcommonly-observedadverse

eventsaregastrointestinalinnature.

Uncommon: Abdominalpain,abdominaldistension,

nauseaanddyspepsia.

Rare: Diarrhoea,flatulence,constipationand

vomiting.

Veryrare: Pepticulcer,perforationorgastrointestinal

haemorrhage,melaena,haematemesis,

sometimesfatal,particularlyintheelderly,

ulcerativestomatitis,gastritis,mouthulcer.

Notknown: ExacerbationofcolitisandCrohn’sdisease

(seesection4.4).

RenalandUrinary

Disorders: Veryrare: Acuterenalfailure,interstitialnephritis,

nephriticsyndrome,papillarynecrosis,

especiallyinlong-termuse,associatedwith

increasedserumureaandoedema;

haematuriaandproteinuria.

Skinand

SubcutaneousTissue

Disorders: Uncommon: Variousskinrashes

Veryrare: Severeformsofskinreactionssuchas

bullousreactions,includingStevens-

JohnsonSyndrome,erythemamultiforme

andtoxicepidermalnecrolysiscanoccur.

Infectionsand

Infestations: Notknown: Meningitis,asepticmeningitis.

VascularDisorders: Veryrare: Hypertension.

GeneralDisordersand

AdministrationSite

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4.9Overdose

Inchildreningestionofmorethan400mg/kgmaycausesymptoms.Inadultsthedoseresponseeffectislessclearcut.

Thehalf-lifeinoverdoseis1.5–3hours.

Symptoms

MostpatientswhohaveingestedclinicallyimportantamountsofNSAIDswilldevelopnomorethannausea,vomiting,

epigastricpain,ormorerarelydiarrhoea.Tinnitus,headacheandgastrointestinalbleedingarealsopossible.Inmore

seriouspoisoning,toxicityisseeninthecentralnervoussystem,manifestingasdrowsiness,occasionallyexcitationand

disorientationorcoma.Occasionallypatientsdevelopconvulsions.Inseriouspoisoningmetabolicacidosismayoccur

andtheprothrombintime/INRmaybeprolonged,probablyduetointerferencewiththeactionsofcirculatingclotting

factors.Acuterenalfailureandliverdamagemayoccur.Exacerbationofasthmaispossibleinasthmatics.

Management

Managementshouldbesymptomaticandsupportiveandincludethemaintenanceofaclearairwayandmonitoringof

cardiacandvitalsignsuntilstable.Consideroraladministrationofactivatedcharcoalifthepatientpresentswithin1

hourofingestionofapotentiallytoxicamount.Iffrequentorprolonged,convulsionsshouldbetreatedwith

ImmuneSystem

Disorders: Uncommon: Hypersensitivityreactionswithurticaria

andpruritis.

Veryrare: Severehypersensitivityreactions.

Symptomscouldbe:facial,tongueand

laryngealswelling,dyspnoea,tachycardia,

hypotension(anaphylaxis,angioedemaor

severeshock).

Notknown: Non-specificallergicreactions

Respiratorytractreactivity(e.g.asthma,

aggravatedasthmaandbronchospasm).

Variousskinreactionsincludingexfoliative

andbullousdermatoses(including

epidermalnecrolysisanderythema

multiforme).

Inpatientswithexistingauto-immune

disorders(suchassystemiclupus

erythematosus,mixedconnectivetissue

disease)duringtreatmentwithibuprofen,

singlecasesofsymptomsofaseptic

meningitis,suchasstiffneck,headache,

nausea,vomiting,feverordisorientation

havebeenobserved(seesection4.4).

Hepatobiliary

Disorders: Veryrare: Liverdisorders,hepatitisandjaundice.

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Propionicacidderivatives

ATCcode:M01AE01

IbuprofenisapropionicacidderivativeNSAIDthathasdemonstrateditsefficacybyinhibitionofprostaglandin

synthesis.Inhumansibuprofenreducesinflammatorypain,swellingsandfever.Furthermore,ibuprofenreversibly

inhibitsplateletaggregation.

Clinicalevidencedemonstratesthatwhen400mgofibuprofenaretaken,painrelievingeffectscanlastforupto8

hours.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hoursbeforeor

within30minutesafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofaspirinontheformationof

thromboxaneorplateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregarding

extrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofen

use,andnoclinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Afteroraladministration,solubilizedibuprofen(aspresentinLiquigelCapsules)isquicklyabsorbedwhen

administeredunderfastingconditions.C

isachievedwithin0.6hourscomparedtoconventionaltablets(¾–1½

hours).Whentakenwithfood,peaklevelsareobservedafter1-2hours.

Ibuprofenproteinbindingisapproximately99%.Afteranoraldose,ibuprofenis75–85%excretedintheurineduring

thefirst24hours(mainlyintheformoftwometabolites),theremainderbeingeliminatedinthefaecesfollowing

excretioninbile.Excretioniscompletewithin24hours.

Thehalf-lifeofibuprofeninplasmaisapproximately2hours.

Inlimitedstudies,ibuprofenappearsinthebreastmilkinverylowconcentrations.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesonsafetypharmacology,repeated

dosetoxicity,genotoxicityandcarcinogenicpotential.Noteratogeniceffecthasbeendemonstratedinanimal

experiments,however,useofibuprofenduringpregnancyshould,ifpossible,beavoided.

Preclinicaleffectswereobservedonlyatexposuresconsideredsufficientlyinexcessofthemaximumhumanexposure,

indicatinglittlerelevancetoclinicaluse.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol600,potassiumhydroxide,sorbitolliquid,partiallydehydrated,gelatin,quinolineyellow(E104),patentblue(E131),

purifiedwater,soyalecithin,triglycerides(mediumchain),glycerylstearate,oleicacid,ascorbylpalmitate,OpacodeWhiteink:

titaniumdioxide(E171),propyleneglycol,polyvinylacetatephthalate,Macrogol400.

6.2Incompatibilities

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6.3Shelflife

3years

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

TheLiquigelCapsulesarepackedintoblisterstripsinacardboardbox.

PackA:

Blister:WhiteopaquethermoformedunplasticisedPVC(250µm)/Polyethyleneextrusioncoating(30

µm)/PVdC(90gsm)heatsealedtothefoil.

Foil: Hardtemperaluminiumfoil(20µm)/Heatseallacquer(7gsm)

PackB:

Blister:WhiteopaquethermoformedunplasticisedPVC(250µm)/PVdCcoating(60gsm)heatsealedtothe

foil.

Foil: Glassine(35gsm)/Laminationadhesive/Aluminiumfoil(9µm)/Heatseallacquer(7gsm).

Apackrangewillconsistofpacksof6,10,12,20,24,30,36,40,48,50,60,70,72,80,90,96and100Liquigel

capsules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0172/029/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08March2002

Dateoflastrenewal: 09November2009

10DATEOFREVISIONOFTHETEXT

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