BUDESITAN 1.0MG/2ML NEBULISER SUSPENSION

Main information

  • Trade name:
  • BUDESITAN 1.0MG/2ML NEBULISER SUSPENSION
  • Dosage:
  • 1.0mg/2ml
  • Pharmaceutical form:
  • Nebuliser Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUDESITAN 1.0MG/2ML NEBULISER SUSPENSION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1518/001/002
  • Authorization date:
  • 05-09-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Budesitan1.0mg/2mlNebuliserSuspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlofsuspensioncontains0.5mgbudesonide.

Oneampouleof2mlsuspensioncontains1.0mgbudesonide.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Nebulisersuspension

Whitetooff-whitesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofpersistentbronchialasthmainpatientswhereuseofapressurisedinhalerordrypowderformulationis

unsatisfactoryorinappropriate.

4.2Posologyandmethodofadministration

Routeofadministration:Forinhalationuseonly.

Thedoseshouldbegiventwicedaily.

Administrationoncedailymaybeconsideredincasesofmildtomoderatestableasthma.

Initialdosage:

Theinitialdoseshouldbetailoredtotheseverityofthediseaseandthereaftershouldbeadjustedonanindividualbasis.

Thefollowingdosesarerecommendedbuttheminimumeffectivedoseshouldalwaysbesought:

Childrenaged6monthsandabove:

0.25–1.0mgdaily.Forpatientsinmaintenancetherapywithoralsteroidsahigherinitialdosageupto2.0mgdaily

shouldbeconsidered.

Adults(includingtheelderly)andchildren/adolescentsover12yearsofage:

0.5-2mgdaily.Inveryseverecasesthedosagemaybeincreasedfurther.

Maintenancedose:

Themaintenancedoseshouldbeadjustedtomeettherequirementsoftheindividualpatienttakingaccountofthe

severityofthediseaseandtheclinicalresponseofthepatient.Whenthedesiredclinicaleffecthasbeenobtained,the

maintenancedoseshouldbereducedtotheminimumrequiredforcontrolofthesymptoms.

Childrenaged6monthsandabove:

0.25-1.0mgdaily.

Adults(includingtheelderly)andchildren/adolescentsover12yearsofage:

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Administrationoncedaily:

Administrationoncedailyshouldbeconsideredforchildrenandadultswithmildtomoderatestableasthmaandwitha

maintenancedosebetween0.25mgand1mgbudesonidedaily.Once-dailyadministrationmaybeinitiatedbothin

patientswhoarenotreceivingcorticosteroidtreatmentandinwell-controlledpatientswhoarealreadytakinginhaled

steroids.Thedosemaybegiveninthemorningorevening.Ifaworseningoftheasthmaoccurs,thedailydoseshould

beincreasedbyadministeringthedosetwicedaily.

Onsetofeffect:

Animprovementoftheasthmafollowingadministrationofbudesonidemayoccurwithin3daysafterinitiationof

therapy.Themaximumeffectwillonlybeobtainedafter2-4weeksoftreatment.

Patientsinmaintenancetherapywithoralglucocorticosteroids:

WithBudesitan1.0mg/2mlNebuliserSuspensionitispossibletoreplaceorconsiderablyreducethedoseoforal

glucocorticosteroidsandstillmaintainorimprovethecontrolofasthma.

Initially,ahighdoseofinhaledbudesonideshouldbeadministered.Itmaybeco-administeredwiththepreviouslyused

oralglucocorticosteroidforapproximately10days.Theoraldoseisthenreduced(byforexample2.5mgprednisolone

orequivalentdosepermonth)tothelowestpossiblelevel.Inmanypatientsitispossibletoreplacetheoral

glucocorticosteroidentirelywithinhaledbudesonide.

Whentaperingoffsystemiccorticosteroidssomepatientswillexperiencesteroidwithdrawalsymptoms,e.g.joint

and/ormusclepain,lackofenergyanddepressionorevenadecreasedlungfunction.Suchpatientsmustbeadvisedto

continuetheinhaledbudesonidetherapy,buttheyshouldalsobeexaminedforanyobjectivesignsofadrenocortical

insufficiency.Ifsuchsignsarepresent,thedoseofthesystemiccorticosteroidshouldbetemporarilyincreasedandthen

taperedoffevenmoreslowly.Inperiodsofstressorsevereasthmaattacks,patientsinthetransitionphasemayrequire

treatmentwithsystemiccorticosteroids.

Dosageschedule:

Divisionofthedoseandmiscibility:

Thecontentsofthesingle-dosecontainermaybedividedforadjustmentofthedose.

Halftheampoulecontentsshouldbeplacedinthenebulisercupandmixedwithanequalvolumeof0.9%sodium

chloridesolution.Toensureaccuratedosingtheuseofameasuringsyringeisrecommended.

Budesitan1.0mg/2mlNebuliserSuspensionmaybemixedwith0.9%sodiumchloridesolutionandwithsolutionsfor

inhalationcontainingterbutaline,salbutamol,sodiumcromoglycateoripratropium.

Nebuliser:

Budesitan1.0mg/2mlNebuliserSuspensionmustbeadministeredwithajetnebulisersuppliedwithamouthpieceor

mask.Thenebulisershouldbeconnectedtoanaircompressorwithadequateairflow(5-8l/min),andthefilling

Dosageinmg VolumeofBudesonide

NebuliserSuspension

0.25

0.75

2ml

3ml

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Therecanbevariationintheperformance(dosedelivered)betweennebulizers,eventhoseofthesamemakeandmodel

Note!UltrasoundnebulisersarenotsuitablefornebulisationofBudesitan1.0mg/2mlNebuliserSuspensionand

thereforecannotberecommended.

Instructionforuse:

Thespraycontainershouldbeshakenbeforeuse.

Topreventirritationofthefacialskinthefaceshouldbewashedafterusingthenebuliserwithamask.

Thenebulisershouldbecleanedaftereachuse.

Washthenebulisercontainerandmouthpieceorface-maskinwarmwaterusingamilddetergentinaccordancewith

themanufacturer’sinstructions.Rinsewellanddryitbyconnectingthenebulisercontainertothecompressorortheair

inlet.

4.3Contraindications

Hypersensitivitytobudesonideoranyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Budesitan1.0mg/2mlNebuliserSuspensionisnotindicatedforthetreatmentofacutedyspnoeaorstatusasthmaticus.

Theseconditionsshouldbetreatedwithshortacting-sympathomimeticsandotherbronchodilators.

Thetransferofpatientstreatedwithoralcorticosteroidstotheinhaledcorticosteroidandtheirsubsequentmanagement

requiresspecialcare.Thepatientsshouldbeinareasonablystablestatebeforeinitiatingahighdoseofinhaled

corticosteroidinadditiontotheirusualmaintenancedoseofsystemiccorticosteroid.Afterabout10days,withdrawal

ofthesystemiccorticosteroidisstartedbyreducingthedailydosegradually(byforexample2.5milligrams

prednisoloneortheequivalenteachmonth)tothelowestpossiblelevel.Itmaybepossibletocompletelyreplacethe

oralcorticosteroidwithinhaledcorticosteroid.Transferredpatientswhoseadrenocorticalfunctionisimpairedmay

needsupplementarysystemiccorticosteroidduringperiodsofstresse.g.surgery,infectionorworseningasthma

attacks.Thisappliesalsotopatientswhohavereceivedprolongedtreatmentwithhighdosesofinhaled

corticosteroids.Theymayalsohaveimpairedadrenocorticalfunctionwhichmayresultinclinicallysignificantadrenal

suppressionandmayneedsystemiccorticosteroidcoverduringperiodsofstress.

Duringtransferfromoraltherapytoinhaledbudesonide,symptomsmayappearthathadpreviouslybeensuppressedby

systemictreatmentwithglucocorticosteroids,forexamplesymptomsofallergicrhinitis,eczema,muscleandjoint

pain.Specifictreatmentshouldbeco-administeredtotreattheseconditions.

Somepatientsmayfeelunwellinanon-specificwayduringthewithdrawalofsystemiccorticosteroidsdespite

maintenanceorevenimprovementinrespiratoryfunction.Suchpatientsshouldbeencouragedtocontinuetreatment

withinhaledbudesonideandwithdrawaloforalcorticosteroidunlessthereareclinicalsignstoindicatethecontrary,for

examplesignswhichmightindicateadrenalinsufficiency.

Aswithotherinhalationtherapiesparadoxicalbronchospasmmayoccur,manifestedbyanimmediateincreasein

wheezingandshortnessofbreathafterdosing.Paradoxicalbronchospasmrespondstoarapid-actinginhaled

bronchodilatorandshouldbetreatedstraightaway.Budesonideshouldbediscontinuedimmediately,thepatient

shouldbeassessedand,ifnecessary,alternativetreatmentinstituted.

Whenanacuteepisodeofdyspnoeaoccursdespiteawellmonitoredtreatment,arapid-actinginhaledbronchodilator

shouldbeusedandmedicalreassessmentshouldbeconsidered.Ifdespitemaximumdosesofinhaledcorticosteroids,

asthmasymptomsarenotadequatelycontrolled,patientsmayrequireshort-termtreatmentwithsystemic

corticosteroids.Insuchcases,itisnecessarytomaintaintheinhaledcorticosteroidtherapyinassociationwith

treatmentbythesystemicroute.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

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syndrome,Cushingoidfeatures, adrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbone

mineraldensity,cataract,glaucomaandmorerarely,arangeofpsychologicalorbehaviouraleffectsincluding

psychomotorhyperactivity,sleepdisorders,anxiety,depressionoraggression(particularlyinchildren).Itisimportant,

therefore,thatthedoseofinhaledcorticosteroidistitratedtothelowestdoseatwhicheffectivecontrolofasthmais

maintained

Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithinhaledcorticosteroidsisregularly

monitored.Ifgrowthisslowed,therapyshouldbereviewedwiththeaimofreducingthedoseofinhaled

corticosteroid,ifpossible,tothelowestdoseatwhicheffectivecontrolofasthmaismaintained.Inaddition,

considerationshouldbegiventoreferringthepatienttoapaediatricrespiratoryspecialist.

Patientswhohavepreviouslybeendependentonoralcorticosteroidsmay,asaresultofprolongedsystemic

corticosteroidtherapy,experienceeffectsofimpairedadrenalfunction.Recoverymaytakeaconsiderableamountof

timeaftercessationoforalcorticosteroidtherapyandhenceoralsteroid-dependentpatientstransferredtobudesonide

mayremainatriskfromimpairedadrenocorticalfunctionforsomeconsiderabletime.Insuchcircumstances

hypothalamicpituitaryadrenocortical(HPA)axisfunctionshouldbemonitoredregularly.

Toreducetheriskoforalcandidiasisandhoarsenesspatientsshouldbeadvisedtorinseoutthemouthproperlyor

brushtheteethaftereachadministrationofinhaledcorticosteroid.Oralcandidiasiscanberapidlycontrolledbylocal

antimycotictreatmentwithouttheneedtodiscontinuethetreatmentwithinhaledbudesonide.

Exacerbationofclinicalsymptomsofasthmamaybeduetoacuterespiratorytractbacterialinfectionsandtreatment

withappropriateantibioticsmayberequired.Suchpatientsmayneedtoincreasethedoseofinhaledbudesonideanda

shortcourseoforalcorticosteroidsmayberequired.Arapid-actinginhaledbronchodilatorshouldbeusedas“rescue”

medicationtorelieveacuteasthmasymptoms.

Specialcareandadequatespecifictherapeuticcontrolofpatientswithactiveandquiescentpulmonarytuberculosisis

necessarybeforecommencingtreatmentwithinhaledbudesonide.Similarlypatientswithfungal,viralorother

infectionsoftheairwaysrequirecloseobservationandspecialcareandshouldusebudesonideonlyiftheyarealso

receivingadequatetreatmentforsuchinfections.

Inpatientswithexcessivemucoussecretionintherespiratorytract,short-termtherapywithoralcorticosteroidsmaybe

necessary.

Inpatientswithseverehepaticdysfunction,treatmentwithinhaledbudesonidecanresultinareducedeliminationrate

andhenceenhancedsystemicavailability.PossiblesystemiceffectsmaythenresultandthereforeHPAaxisfunctionin

thesepatientsshouldbemonitoredatregularintervals.

ConcomitanttreatmentwithketoconazoleorotherpotentCYP3A4inhibitorsshouldbeavoided(seesection4.5).If

thisisnotpossiblethetimeintervalbetweenadministrationofthetwodrugsshouldbeaslongaspossible.

RecentepidemiologicalstudiesshowthatthereisanincreasedincidenceofpneumoniainpatientswithChronic

ObstructivePulmonaryDisease(COPD)treatedwithinhaledcorticosteroids,withanadjustedoddsratioof1.7

(Reference).Careshouldbeexercisedinprescribingbudesonideforthosepatientswhoserespiratorydiseasemight

haveacomponentofCOPD.

Budesitan1.0mg/2mlNebuliserSuspensionshouldbeusedwithajetnebuliserdevice.Anultrasonicnebulisershould

notbeusedasthisisnotappropriatefornebulisersuspensions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Budesitan1.0mg/2mlNebuliserSuspensioncanincreasetheefficacyofinhaledbeta-2-sympathomimetics.

Ketoconazole200mgoncedailyincreasedtheplasmaconcentrationsofconcomitantlyadministeredoralbudesonide

(3mgsingle-dose)onaveragesixfold.Whenketoconazolewasadministered12hoursafterbudesonide,theaverage

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plasmalevelscouldbeexpected.Astherearenodatatosupportdosagerecommendations,thecombinationshouldbe

avoided.Ifthisisnotpossible,thetimeintervalbetweenadministrationofketoconazoleandbudesonideshouldbeas

longaspossible.Areductionofthebudesonidedoseshouldalsobeconsidered.OtherpotentCYP3A4inhibitorssuch

aserythromycin,clarithromycin,itraconazole,ketoconazole,ritonavirandsaquinavirarealsolikelytomarkedly

increaseplasmaconcentrationsofbudesonide.

Cimetidinehadaweakbutclinicallyinsignificantinhibitingeffectonhepaticmetabolismofbudesonide.

Thesuppressiveeffectonadrenalfunctionisadditiveifusedconcomitantlywithsystemicorintranasalsteroids.

4.6Fertility,pregnancyandlactation

Pregnancy:

Inhaledbudesonideshouldonlybeusedduringpregnancywhentheexpectedbenefitstothemotheroutweighthe

possibleriskstothefoetus.Inhaledglucocorticosteroidsshouldbeconsideredinpreferencetooralglucocorticosteroids

becauseofthelowersystemiceffectsatthedosesrequiredtoachievesimiliarpulmonaryresponses.

Dataonapproximately2000exposedpregnanciesindicatenoincreasedteratogenicriskassociatedwiththeuseof

inhaledbudesonide.Inanimalstudies,glucocorticosteroidshavebeenshowntoinducemalformations(seesection

5.3).Thisisnotlikelytoberelevantforhumansgivenrecommendeddosesbuttherapywithinhaledbudesonide

shouldberegularlyreviewedandmaintainedatthelowesteffectivedose.Theriskforintrauterinegrowthinhibition

andcortexsuppressioninthenewbornshouldbetakenintoconsideration.

Lactation:

Budesonideisexcretedinbreastmilk.However,attherapeuticdosesofBudesitan1.0mg/2mlNebuliserSuspensionno

effectsonthesucklingchildareanticipatedduetolowsystemicabsorption.Budesitan1.0mg/2mlNebuliser

Suspensioncanbeusedduringbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Inhaledbudesonidehasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Adversereactions,whichhavebeenassociatedwithbudesonide,aregivenbelow,listedbysystemorganclassand

frequency.Frequencyaredefinedas:Verycommon(>1/10);common(>1/100,<1/10);uncommon(>1/1,000,<1/100);

rare(>1/10,000,<1/1,000);veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Infectionsandinfestations Common oropharyngealcandidiasis

Immunesystemdisorders Rare hypersensitivity

Endocrinedisorders Veryrare adrenalsuppression

Psychiatricdisorders Veryrare restlessness,nervousness,depression,,

sleepdisorders,anxiety,aggression,

behaviouralchanges(predominantlyin

children)

Nervoussystemdisorders Veryrare psychomotorhyperactivity

Eyedisorders Veryrare cataracts,glaucoma

Respiratory,thoracicand

mediastinaldisorders Common hoarseness,cough

Rare paradoxicalbronchospasm

Gastrointestinaldisorders Common oralmucosalirritation,difficultyin

swallowing

Skinandsubcutaneoustissue

disorders Rare skinreactions,urticaria,rash,dermatitis,

pruritus,erythema,bruising,

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Treatmentwithinhaledbudesonidemayresultincandidainfectionintheoropharynx.Experiencehasshownthat

candidainfectionoccurslessoftenwheninhalationisperformedbeforemealsand/orwhenthemouthisrinsedafter

inhalation.Inmostcasesthisconditionrespondstotopicalanti-fungaltherapywithoutdiscontinuingtreatmentwith

inhaledbudesonide.

Coughingcanusuallybepreventedbyinhalingabeta-2agonist(e.g.terbutaline)5-10minutesbeforeadministrationof

Budesitan1.0mg/2mlNebuliserSuspension.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Thesemayincludeadrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbonemineral

density,cataractandglaucoma,andsusceptibilitytoinfections.Theabilitytoadapttostressmaybeimpaired.The

systemiceffectsdescribed,however,aremuchlesslikelytooccurwithinhaledbudesonidethanwithoral

corticosteroids.

4.9Overdose

Symptoms:

Acuteoverdosewithbudesonideusuallydoesnotconstituteaclinicalproblem.Theonlyharmfuleffectafteralarge

amountofspraysduringashortperiodisasuppressionofthecortexfunction.

Ifitisamatterofchronicuseofveryhighdoses,effectssuchasadegreeofcortexatrophyinadditionto

adrenocorticalsuppressionmayoccur.

Treatment:

Acuteoverdosage:Thereisnoneedforacutemeasures.Thetreatmentwithbudesonideshouldbecontinuedwiththe

lowestpossibleeffectivemaintenancedose,andtheadrenocorticalfunctionwillrepairitselfautomaticallywithin1-2

days.

Chronicoverdosage:Thepatientshouldbetreatedasasteroiddependentandbetransferredtoasuitablemaintenance

dosewithasystemicsteroid,forexampleprednisolone.Whentheconditionisstabilized,thepatientshouldcontinue

thetreatmentwiththeinhalationofbudesonideattherecommendeddose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherdrugsforobstructiveairwaysdiseases,inhalant,Glucocorticoids

ATCcode:R03BA02

Budesonideisaglucocorticosteroidwithapowerfullocalanti-inflammatoryaction.

Theprecisemechanismofactionofglucocorticosteroidsinthetreatmentofasthmaisnotfullyunderstood.Anti-

inflammatoryeffects(includingT-cells,eosinophiliccellsandmastcells)suchasinhibitionofthereleaseof

inflammatorymediatorsandinhibitionofcytokine-mediatedimmuneresponse,areprobablyimportant.Thestrengthof

budesonide,measuredasaffinityforglucocorticoidreceptors,isapproximately15timesstrongerthanthatof

prednisolone.

Aclinicaltrialwithasthmapatientsinwhichinhaledandoralbudesonidewascomparedwithplacebo,showed

statisticallysignificanteffectsofinhaledbudesonide,butnotoforalbudesonide.Thetherapeuticeffectofnormally

useddosesofinhaledbudesonidemaythereforechieflybeexplainedbyadirecteffectontheairways.

Budesonidehasdemonstratedananti-anaphylacticandanti-inflammatoryeffectinchallengetestsinexperimental

Musculoskeletaland

connectivetissuedisorders Rare growthretardation

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laterallergicreaction.

Itwasalsodemonstratedthatbudesonidereducestheairways’reactivitytohistamineandmetacholineinhyperreactive

patients.Treatmentwithinhaledbudesonidehasbeenusedtoeffectivelypreventexercise-inducedasthma.

InrecommendeddosesBudesonideNebuliserSuspensionhasasignificantlysmallerinfluenceontheadrenalfunction

than10mgprednisone,shownbytheACTHtest.Noclinicallyrelevantchangesintheplasmacortisolvaluesor

responsetoACTHstimulationwereobservedwhenbudesonidewasgivenindosesupto1600µgdailyfor3monthsto

adultsandupto800µgdailytochildren.Long-termmonitoringforupto52weeksconfirmedthattheHPAaxiswas

notsuppressed.

Bothasthmaandinhaledglucocorticosteroidsmayaffectthegrowthinlength.TheeffectofBudesonideNebuliser

Suspensiononthegrowthinlengthwasstudiedin519children(from8monthsto9years)inthreeprospective,

randomised,open,non-blindedstudies.Thestudiesdidnotshowanysignificantdifferenceinthegrowthinlengthof

childrentreatedeitherwithBudesonideNebuliserSuspensionorwithconventionalasthmatherapy.Twostudies(N=

239and72patients,respectively)showed7mmand8mmgreatergrowthafteroneyearoftreatmentwithBudesonide

NebuliserSuspensioncomparedwithtraditionalasthmatherapy(notstatisticallysignificant),whileonestudy(N=

208)showedagrowthinlengththatafteroneyearwas8mmsmallerintheBudesonideNebuliserSuspensiongroup

thaninthegroupofconventionalasthmatreatment(statisticallysignificantdifference).

5.2Pharmacokineticproperties

Absorption:

InadultsthesystemicbioavailabilityofbudesonidefollowingadministrationofBudesonideNebuliserSuspensionviaa

jetnebuliserisapproximately15%ofthedeclareddoseand40-70%ofthedosedeliveredtothepatient.Asmallpart

ofthesystemicallyavailabledosecomesfrominhalationsuspensionthatisswallowed.Thepeakplasmaconcentration

followingadministrationofasingledoseof2mgisachieved10-30minutesafterthebeginningofinhalationandis

approximately4nmol/l.Inchildren(4-6years),thesystemicbioavailabilityofbudesonideafteradministrationof

BudesonideNebuliserSuspensionviaajetnebuliserisapproximately6%ofthedeclareddoseand26%ofthedose

administeredtothepatient.Thepeakplasmaconcentrationfollowingadministrationofasingledoseof1mgis

reachedapproximately20minutesafterthebeginningofinhalationandisapproximately2.4nmol/l.

Distribution:

Thevolumeofdistributioninadultsisapproximately3l/kg.Plasmaproteinbindingisapproximately85-90%.

Metabolism:

Budesonideundergoesextensive(~90%)firstpassbiotransformationintheliverviaCYP3A4tometaboliteswitha

lowglucocorticosteroidactivity.Thein-vitroactivityofthemainmetabolites,6--hydroxybudesonideand16--

hydroxyprednisolone,islessthan1%ofthatofbudesonide.

Excretion:

Themetabolitesareexcretedinunchangedorconjugatedformpredominantlyviathekidneys.Nounchanged

budesonideisfoundintheurine.Budesonidehasahighsystemicclearance(approximately1.2litres/min)inhealthy

adults,andtheeliminationhalf-lifefollowingintravenousadministrationisapproximately2-3hours.Budesonidehasa

systemicclearanceofapproximately0.5l/minin4to6-year-oldasthmaticchildren.Childrenhaveanapproximately50

%higherclearanceperkgbodyweightthanadults.Thehalf-lifeofbudesonidefollowinginhalationisabout2.3hours

inasthmaticchildren,whichisroughlythesameasinhealthyadults.

5.3Preclinicalsafetydata

Preclinicaldatarevealednospecialhazardforhumansinthetherapeuticdoserangebasedonstudiesofchronic

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Glucocorticoids,includingbudesonide,haveproducedteratogeniceffectsinanimals,includingcleftpalateandskeletal

abnormalities.Similareffectsareconsideredunlikelytooccurinhumansattherecommendeddoselevels.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Disodiumedetate

Sodiumchloride

Polysorbate80

Citricacid

Sodiumcitrate

Waterforinjection

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6

6.3Shelflife

3years.

Afterfirstopeningofthefoilsachet,theampoulemaybestoredunopenedforthreemonths.

Useampoulewithin12hoursofopening.

6.4Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlightandmoisture.

6.5Natureandcontentsofcontainer

Lowdensitypolyethyleneampoulecontaining2mlnebulisersuspension.

Packsizes:Tri-laminatefoilsachetscontaining5,20,24,40(2x20)and60ampoules(instripsof4,5,8,10or12

ampoules).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Budesonidenebulisersuspensioncanbemixedwith0.9%salineandwithsolutionsofterbutaline,salbutamol,sodium

chromoglycate,oripratropiumbromide.

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7MARKETINGAUTHORISATIONHOLDER

BreathePharmaceuticalsLimited

Unit20ABeckettWay

ParkWestBusinessPark

Dublin12

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1518/001/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21October2005

Dateoflastrenewal:24February2009

10DATEOFREVISIONOFTHETEXT

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