BUDESONIDE TEVA

Main information

  • Trade name:
  • BUDESONIDE TEVA
  • Dosage:
  • 0.5 mg/ 2ml
  • Pharmaceutical form:
  • Nebuliser Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUDESONIDE TEVA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0749/141/001
  • Authorization date:
  • 11-03-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BudesonideTeva0.5mg/2mlNebuliserSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each2mlampoulecontains0.5mgbudesonide(0.25mg/ml).

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

NebuliserSuspension.

Awhitetooffwhitesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BudesonideNebuliserSuspensionisindicatedinadults,adolescentsandininfantsandchildrenagedsixmonthsto12

years.

BronchialAsthma

BudesonideNebuliserSuspensionisindicatedforuseinbronchialasthma,inpatientswhereuseofapressurised

metereddoseinhalerordrypowderdeviceisunsatisfactoryorinappropriate.

4.2Posologyandmethodofadministration

Posology

Paediatricpopulation

ThesafetyandefficacyofBudesonideNebuliserSuspensionininfantsagedlessthansixmonthshasnotyetbeen

established.

ThereisnorelevantuseofBudesonideNebuliserSuspensioninchildrenagedlessthansixmonthsintheindication.

Methodofadministration

Forinhalationuseonly.

Precautionstobetakenbeforehandlingoradministratingthemedicinalproduct.

BudesonideNebuliserSuspensionisforinhalationuse.Donotuseapartiallyused,openedordamagedampoule.

BudesonideNebuliserSuspensionshouldbeadministeredviaasuitablenebuliser,whichshouldbedesignedtoprovide

nebulisedparticlesofanappropriatesizetopermitpassageofdropletsintothelungs.TypicallythesewillhaveaDV

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Initiationoftherapy

Whentreatmentisstarted,duringperiodsofsevereasthmaandwhilereducingordiscontinuingoral

glucocorticosteroids,therecommendeddoseofBudesonideNebuliserSuspensionis:

Adults(includingelderly)andadolescentsover12yearsofage:Usually0.5–2.0mgdaily.Inveryseverecasesthe

dosagemaybefurtherincreased.

Children(6monthsto12years):0.25–1mgdaily.Forpatientsinmaintenancetherapywithoralsteroids,ahigher

initialdoseofupto2.0mgdailycouldbeconsidered.

ChildrenshoulduseBudesonideNebuliserSuspensionundersupervisionofanadult.Theinhalationshouldbe

performedinanuprightposition.

Maintenance

Themaintenancedoseshouldbeadjustedtotheneedsoftheindividualpatienttakingintoaccounttheseverityof

diseaseandtheclinicalresponseofthepatient.Whentherapeuticeffectsareobtained,themaintenancedoseshouldbe

reducedtothelowestdose,whichmaintainsgoodasthmacontrol.

Adults(includingelderlyandadolescents):0.5–2.0mgtwicedaily.Inveryseverecases,thedosemaybefurther

increased.

Children(6monthsto12years):0.25–1.0mgdaily.

Once-dailyadministration:

Once-dailyadministrationshouldbeconsideredforchildrenandadultswithmildtomoderatestableasthma.The

maintenancedoseshouldbebetween0.25mgand1.0mgBudesonideNebuliserSuspensiondaily.Once-daily

administrationmaybeinitiatedinpatientswhoarenotreceivingcorticosteroidtreatmentandinwell-controlledpatients

whoarealreadytakinginhaledsteroids.Thedosemaybegiveninthemorningortheevening.Iftheasthma

symptomsworsen,thedailydoseshouldbeincreasedbyadministeringthedosetwicedaily.

Onsetofeffect

AnimprovementoftheasthmamayoccurwithinthreedaysafterinitiationofBudesonidetherapy.Themaximum

effectwillonlybeobtainedafter2–4weeksoftreatment.

Patientsmaintainedonoralglucocorticosteroids

BudesonideNebuliserSuspensionmayallowsubstitutionorareductioninthedoseoforalglucocorticosteroidswhilst

maintainingasthmacontrol.Forfurtherinformationonthewithdrawaloforalcorticosteroids,seesection4.4.

Whereanincreasedtherapeuticeffectisdesired,especiallyinthosepatientswithoutmajormucussecretioninthe

airways,anincreaseddoseofBudesonideNebuliserSuspensionisrecommended,ratherthancombinedtreatmentwith

oralcorticosteroids,becauseofthelowerriskofsystemiceffects.

RecommendedDosageTable:

Dose(mg) BudesonideNebuliserSuspension

0.5mg/2ml

(0.25mg/ml)

Volume(ml)

0.25 1*

0.75 3

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DosedivisionandMiscibility

BudesonideNebuliserSuspensioncanbemixedwith0.9%salinesolutionandwithnebulisersolutionssuchas

terbutaline,salbutamol,sodiumcromoglycateoripratropiumbromide.

Thecontentsofthesingle-doseampoulemaybedividedforadjustmentofthedose.Halftheampoulecontentsshould

beplacedintheNebulisercupandmixedwithanequalvolumeof0.9%saline.Toensureaccuratedosinga1ml

graduationismarkedontheampouleandameasuringsyringeisrecommended.

InstructionforUseofBudesonideNebuliserSuspension

BudesonideNebuliserSuspensionshouldbeadministeredfromsuitablenebulisers.Ultrasonicnebulisersarenot

suitablefortheadministrationofBudesonideNebuliserSuspension.

Thedosedeliveredtothepatientvariesdependingonthenebulisingequipmentused.Thenebulisationtimeandthe

dosedeliveredaredependentonflowrate,volumeofnebuliserchamberandfillvolume.BudesonideNebuliser

Suspensionshouldbeadministeredviaajetnebuliserequippedwithamouthpieceorsuitablefacemask.Thenebuliser

shouldbeconnectedtoanaircompressorwithanadequateairflow(5-8L/min),andthefillvolumeshouldbe2-

4ml.PatientsshouldbeinstructedontheproperuseofBudesonideNebuliserSuspension.Childrenandtheir

caregiversshouldbeencouragedandtrainedtousethemouthpieceratherthanthefacemask.

Instructionforuse:

Preparethenebuliserforuseaccordingtothemanufacturer’sinstructions;

Removeanampoulefromthelabelledstripbytwistingandpulling;

Shaketheampoulegently;

Holdtheampouleuprightandtwistoffthecap;

Squeezethecontentsintothereservoirofthenebuliser;

BudesonideNebuliserSuspensionisasingle-useampoule.Thereforeaftereachadministrationanyunused

medicationshouldbediscardedandthenebuliserchambershouldbewashedandcleaned.Washthenebuliser

chamberandmouthpieceorfacemaskinwarmwaterormilddetergent.Rinsewellanddrybyconnectingthe

nebuliserchambertothecompressedairinletorcompressor.

Patientsshouldbeinstructedtorinsetheirmouthoutwithwaterafterinhalingtheprescribeddosetominimise

theriskoforopharyngealthrush.

Patientsshouldbeinstructedtowashthefacialskinwithwaterafterusingthefacemasktopreventirritation.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

BudesonideNebuliserSuspensionisnotindicatedforthetreatmentofacutedyspnoeaorstatusasthmaticus.These

conditionsshouldbetreatedwithshort-acting-adrenoceptoragonistsandotherbronchodilators.

Specialcareisneededinpatientswithpulmonarytuberculosisandviralinfectionsoftheairways.Budesonide

NebuliserSuspensionshouldonlybeusedwhentheseconditionsareappropriatelytreated.

Nonsteroid-dependentpatients:

Usuallyatherapeuticeffectcanbereachedwithin10days.Ashort(about2weeks)additionaloralcorticosteroid

treatmentcanbegiveninitially,inpatientswithexcessivemucussecretioninthebronchi.Afterthecourseoftheoral

drug,BudesonideNebuliserSuspensionaloneshouldbesufficienttherapy.

Steroid-dependentpatients:

Thetransferofpatientstreatedwithoralcorticosteroidstotheinhaledcorticosteroidandtheirsubsequentmanagement

requiresspecialcare.Thepatientshouldbeinarelativelystablephasebeforetransferfromoralcorticosteroidto

treatmentwithBudesonideNebuliserSuspensionisinitiated.BudesonideNebuliserSuspensionisthengiven,in

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Afterthat,theoralsteroiddoseshouldbegraduallyreduced(by,forexample,2.5mgprednisoloneortheequivalent

eachmonth),tothelowestpossiblelevel.Inmanycases,itispossibletocompletelysubstituteBudesonideNebuliser

Suspensionfortheoralcorticosteroid.

Transferredpatientswhoseadrenalfunctionisimpairedmayrequiresupplementarysystemiccorticosteroidsduring

periodsofstresse.g.,surgery,infectionorworseningasthmaattacks.Thisalsoappliestopatientswhohavereceived

prolongedtreatmentwithhighdosesofinhaledcorticosteroids.Theymayalsohaveimpairedadrenocorticalfunction

thatmayresultinclinicallysignificantadrenalsuppressionandmayneedsystemiccorticosteroidtherapyduring

periodsofstress.

AgenerallylowersystemiccorticosteroidactionwillbeexperiencedduringtransferfromoraltherapytoBudesonide

NebuliserSuspension,whichmayresultintheappearanceofallergicorarthriticsymptomssuchasrhinitis,eczemaand

muscleandjointpain.Specifictreatmentshouldbeinstigatedfortheseconditions.Ageneraldeficiencyof

glucocorticosteroideffectshouldbesuspectedif,inrarecases,symptomssuchastiredness,headache,nauseaand

vomitingshouldoccur.Inthesecasesatemporaryincreaseinthedoseoforalglucocorticosteroidsissometimes

necessary.

Aswithotherinhalationtherapy,paradoxicalbronchospasmmayoccur,withanimmediateincreaseinwheezingafter

dosing.Ifaseverereactionoccurs,treatmentshouldbereassessedandanalternativetherapyestablishedifnecessary.

Whenanacuteepisodeofdyspnoeaoccurs,despiteawell-monitoredtreatment,afast-actinginhaledbronchodilator

shouldbeusedandmedicalreassessmentshouldbeconsidered.Ifasthmasymptomsarenotadequatelycontrolled,

despitemaximumdosesofinhaledcorticosteroids,patientsmayrequiretreatmentwithsystemiccorticosteroidsfora

shortperiodoftime.Insuchcases,itisnecessarytomaintaintheinhaledcorticosteroidtherapyinconjunctionwith

systemictreatment.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Theseeffectsaremuchlesslikelytooccurthanwithoralcorticosteroids.PossiblesystemiceffectsincludeCushing's

syndrome,Cushingoidfeatures,adrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbone

mineraldensity,cataract,glaucoma,andmorerarely,arangeofpsychologicalorbehaviouraleffectsincluding

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

therefore,thatthedoseofinhaledcorticosteroidistitratedtothelowestdoseatwhicheffectivecontrolofasthmais

maintained.Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithinhaledcorticosteroidsis

regularlymonitored.Ifgrowthisslowed,therapyshouldbereviewed,withtheaimofreducingthedoseofinhaled

corticosteroid,ifpossible,tothelowestdoseatwhicheffectivecontrolofasthmaismaintained.Inaddition,

considerationshouldbegiventoreferringthepatienttoapaediatricrespiratoryspecialist.

BudesonideNebuliserSuspensionisnotintendedforrapidreliefofacuteepisodesofasthmawhereaninhaledshort-

actingbronchodilatorisrequired.Ifpatientsfindshort-actingbronchodilatortreatmentineffective,ortheyneedmore

inhalationsthanusual,medicalattentionmustbesought.Inthissituationconsiderationshouldbegiventotheneedfor

anincreaseintheirregulartherapy,e.g.,higherdosesofinhaledbudesonideortheadditionofalong-actingbeta

agonist,orforacourseoforalglucocorticosteroid.

Reducedliverfunctionmayaffecttheeliminationofglucocorticosteroids.Theplasmaclearancefollowingan

intravenousdoseofbudesonidehoweverwassimilarincirrhoticpatientsandinhealthysubjects.Afteroralingestion

systemicavailabilityofbudesonidewasincreasedbycompromisedliverfunctionduetodecreasedfirstpass

metabolism.TheclinicalrelevanceofthistotreatmentwithBudesonideNebuliserSuspensionisunknownasnodata

existforinhaledbudesonide,butincreasesinplasmalevelsandhenceanincreasedriskofsystemicadverseeffects

couldbeexpected.

Invivostudieshaveshownthatoraladministrationofketoconazoleanditraconazole(knowninhibitorsofCYP3A4

activityintheliverandintheintestinalmucosa)causesanincreaseinthesystemicexposuretobudesonide.

ConcomitanttreatmentwithketoconazoleanditraconazoleorotherpotentCYP3A4inhibitorsshouldbeavoided(see

section4.5Interactions).Ifthisisnotpossible,thetimeintervalbetweenadministrationsoftheinteractingdrugsshould

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Toreducetheriskoforalcandidiasisandhoarseness,patientsshouldbeadvisedto:

rinsetheirmouthwithwateraftereachinhalationtominimisetheriskoforopharyngealthrush;

washtheirfaceaftertheuseofthefacemasktopreventskinirritation;

Oralcandidiasiscanberapidlycontrolledbylocalantimycotictreatmentwithouttheneedtodiscontinuetreatmentwith

BudesonideNebulisersuspension.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThemetabolismofbudesonideisprimarilymediatedbyCYP3A4.Inhibitorsofthisenzyme,e.g.ketoconazoleand

itraconazole,canthereforeincreasesystemicexposuretobudesonide,(seeSection4.4SpecialWarningsand

PrecautionsforUseandSection5.2PharmacokineticProperties).OtherpotentinhibitorsofCYP3A4suchas

erythromycin,clarithromycin,ritanovirandsaquinavirarealsolikelytomarkedlyincreaseplasmalevelsof

budesonide.Simultaneousadministrationwithcimetidinecancauseaslightincreaseinplasmabudesonide

concentration,whichisgenerallynotofclinicalsignificance.

Thesuppressiveeffectonadrenalfunctionisadditiveifusedconcomitantlywithsystemicorintranasalsteroids.

4.6Fertility,pregnancyandlactation

Pregnancy

Theadministrationofbudesonideduringpregnancyrequiresthatthebenefitsforthemotherbeweighedagainsttherisk

forthefoetus.Inhaledglucocorticosteroidsshouldbeconsideredinpreferencetooralglucocorticosteroidsbecauseof

thelowersystemiceffectsatthedosesrequiredtoachievesimilarpulmonaryresponses.

Neonates,borntomotherswhohadreceivedbudesonideduringpregnancy,needtobemonitoredforadrenocortical

hypoactivity.

Inanimalstudies,glucocorticosteroidshavebeenshowntoinducemalformations(seeSection5.3).Thisisnotlikelyto

berelevantforhumansgivenrecommendeddoses,buttherapywithinhaledbudesonideshouldberegularlyreviewed

andmaintainedatthelowesteffectivedose.Dataonapproximately2000exposedpregnanciesindicatenoincreased

teratogenicriskassociatedwiththeuseofinhaledbudesonide.

Lactation

Budesonideisexcretedintobreastmilk.However,attherapeuticdoses,noeffectsonthesucklingchildareexpected.

BudesonideNebuliserSuspensioncanbeusedduringbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

BudesonideNebuliserSuspensionhasnoinfluenceontheabilitytodriveorusemachines.

4.8Undesirableeffects

Adverseeventsarelistedbelowbysystemorganclass,symptomsandfrequency.Frequenciesaredefinedas:very

common(1/10),common(1/100and<1/10),uncommon(1/1,000and<1/100),rare(1/10,000and<1/1,000)andvery

rare(<1/10,000),notknow(cannotbeestimatedfromtheavailabledata).

SystemOrganClass Symptoms Frequency

Infectionsandinfestations Candidainfectioninthe

oropharynx Common

Immunesystemdisorders Immediateanddelayed

hypersensitivityreactions Rare

Endocrinedisorders Adrenalsuppression Veryrare

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Thecandidainfectionintheoropharynxisduetodrugdeposition.AdvisingthepatienttousetheirBudesonide

NebuliserSuspensionbeforemealsandtorinsethemouthoutwithwateraftereachdosingwillminimisetherisk.

CandidiasisrespondstotopicalantifungaltherapywithouttheneedtodiscontinueinhaledBudesonide.

Coughingcanbepreventedbyinhalinga

-adrenoceptoragonist5–10minutesbeforeadministeringBudesonide

NebuliserSuspension.

Theabilitytoadapttostressmaybeimpaired(seesection4.4).

4.9Overdose

Acuteoverdosewithbudesonideshouldnotpresentaclinicalproblem.Afterchronicuseofveryhighdoses,

adrenocorticalsuppressionmayoccur.

Treatment

Acuteoverdosage:Thereisnoneedtotakeacutemeasures;treatmentwithBudesonideshouldcontinuewiththelowest

possibleeffectivemaintenancedose.Theimpairedadrenocorticalfunctionwillrepairautomaticallywithinafewdays.

Chronicoverdosage:Thepatientshouldbetreatedasasteroiddependentandbetransferredtoasuitablemaintenance

dosewithasystemicsteroide.g.,prednisolone.Whentheconditionisstabilised,thepatientshouldcontinuetreatment

withinhaledBudesonideattherecommendeddose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:otherdrugsforobstructiveairwaydiseases,inhalants,glucocorticoids

ATCCode:RO3BA02

Budesonideisaglucocorticosteroid,whichpossessesahighlocalanti-inflammatoryaction,withalowerincidenceand

severityofadverseeffectsthanthoseseenwithoralcorticosteroids.

Topicalanti-inflammatoryeffect

Theexactmechanismofactionofglucocorticosteroidsinthetreatmentofasthmaisnotfullyunderstood.Anti-

inflammatoryactions,suchasinhibitionofinflammatorymediatorreleaseandinhibitionofcytokine-mediatedimmune

sleepdisorders,anxiety,

depression,aggression,

behaviouralchanges

(predominantlyinchildren)

Eyedisorders Cataract,glaucoma Veryrare

Respiratory,thoracicand

mediastinaldisorders Hoarseness,coughing,

Paradoxicalbronchospasm Common

Rare

Gastrointestinaldisorders Oralmucosalirritation,

difficultyinswallowing Common

Skinandsubcutaneoustissue

disorders Facialskinirritation,rash,

dermatitis,urticaria,pruritus,

erythema,bruising,

angioedema Rare

Musculoskeletal,connective

tissueandbonedisorders Growthretardation,decrease

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Aclinicalstudyinpatientswithasthmacomparinginhaledandoralbudesonideatdosescalculatedtoachievesimilar

systemicbioavailabilitydemonstratedstatisticallysignificantevidenceofefficacywithinhaledbutnotoralbudesonide.

Thus,thetherapeuticeffectofconventionaldosesofinhaledbudesonidemaybelargelyexplainedbyitsdirectaction

ontherespiratorytract.

Inaprovocationstudy,pre-treatmentwithbudesonideforfourweeksshoweddecreasedbronchialconstrictionin

immediateaswellaslateasthmaticreactions.

Onsetofeffect

Afterasingledoseoforallyinhaledbudesonide,deliveredviadrypowderinhaler,improvementofthelungfunctionis

achievedwithinafewhours.Aftertherapeuticuseoforallyinhaledbudesonidedeliveredviadrypowderinhaler,

improvementinlungfunctionhasbeenshowntooccurwithin2daysofinitiationoftreatmentalthoughmaximum

benefitmaynotbeachieveduntil4weeks.

Airwayreactivity

Budesonidehasbeenshowntodecreaseairwayreactivitytohistamineandmethacholineinhyperreactivepatients.

Exercise-inducedasthma

Therapywithinhaledbudesonidehaseffectivelybeenusedforpreventionofexercise-inducedasthma.

Growth

Limiteddatafromlong-termstudiessuggestthatmostchildrenandadolescentstreatedwithinhaledbudesonide

ultimatelyachievetheiradulttargetheight.However,aninitialsmallbuttransientreductioningrowth(approximately

1cm)hasbeenobserved.Thisgenerallyoccurswithinthefirstyearoftreatment(seesection4.4).

5.2Pharmacokineticproperties

Budesonideundergoesanextensivebiotransformationintheliver,tometabolitesoflowglucocorticosteroidactivity.

Theglucocorticosteroidactivityofthemajormetabolites,6-hydroxybudesonideand16-hydroxyprednisolone,isless

than1%ofthatofbudesonide.ThemetabolismofbudesonideisprimarilymediatedbyCYP3A4,amemberofthe

cytochromep450enzymefamily.

Inastudy,100mgketoconazoletakentwicedaily,increasedplasmalevelsofconcomitantlyadministeredoral

budesonide(singledoseof10mg)onaverage,by7.8-fold.Informationaboutthisinteractionislackingforinhaled

budesonide,butmarkedincreasesinplasmalevelscouldbeexpected.

Ofthefractionofbudesonidewhichisswallowed,approximately90%isinactivatedatfirstpassagethroughtheliver.

Themaximalplasmaconcentrationafterinhalationof1mgbudesonide,deliveredviadrypowderinhaler,is

approximately3.5nmol/Landisreachedafterapproximately20minutes.

5.3Preclinicalsafetydata

Theacutetoxicityofbudesonideislowandofthesameorderofmagnitudeandtypeasthatofother

glucocorticosteroidsincludingbeclomethasonedipropionateandfluocinoloneacetonide.

Resultsfromsubacuteandchronictoxicitystudiesshowthatthesystemiceffectsofbudesonidearelessseverethan,or

similarto,thoseobservedafteradministrationofotherglucocorticosteroids,e.g.decreasedbody-weightgainand

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Anincreasedincidenceofbraingliomasinmalerats,inacarcinogenicitystudy,couldnotbeverifiedinarepeatstudy

inwhichtheincidenceofgliomasdidnotdifferbetweenanyofthegroupsonactivetreatment(budesonide,

prednisolone,triamcinoloneacetonide)andthecontrolgroups.

Liverchanges(primaryhepatocellularneoplasms)foundinmaleratsintheoriginalcarcinogenicitystudywerenoted

withbudesonide,aswellaswiththereferenceglucocorticosteroids.Theseeffectsaremostprobablyrelatedtoa

receptoreffectandthusrepresentaclasseffect.

Availableclinicalexperienceindicatesthattherearenosuggestionsthatbudesonide,orotherglucocorticosteroids,

inducebraingliomasorprimaryhepatocellularneoplasmsinman.

Inanimalreproductionstudies,corticosteroidssuchasbudesonidehavebeenshowntoinducemalformations(cleft

palate,skeletalmalformations).However,theseanimalexperimentalresultsdonotappeartoberelevantinhumansat

therecommendeddoses.

Resultsfromanimalstudieshavealsoidentifiedaninvolvementofexcessprenatalglucocorticosteroids,inincreased

riskforintrauterinegrowthretardation,adultcardiovasculardiseaseandpermanentchangesinglucocorticoidreceptor

density,neurotransmitterturnoverandbehaviouratexposuresbelowtheteratogenicdoserange.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DisodiumEdetate

SodiumChloride

Polysorbate80E433

CitricAcidMonohydrateE330

SodiumCitrateE331

WaterforInjections

6.2Incompatibilities

Thismedicinalproductmustnotbemixedwithothermedicinalproductsexceptthosementionedinsection6.6.

6.3Shelflife

2years

Afterfirstopeningthefoilsachet:3months.

Forsingleuseonly.Anyunusedsolutionshouldbediscarded.

6.4Specialprecautionsforstorage

Storeintheuprightposition.

Donotstoreabove25°C.Storetheampouleintheoriginalpackageinordertoprotectfromlight.

Forstorageconditionsoftheopenedproductseesection6.3.

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6.5Natureandcontentsofcontainer

Singledoseampoulemadeoflowdensitypolyethylene.Eachampoulecontains2mlofsuspension.Stripsof5units

arepackedintoafoilsachet.

Sachetsarepackedintoacarton.

Packsizes:

5,10,15,20,25,30,40,50or60ampoulesforsingleuseonly.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

BudesonideNebuliserSuspensioncanbemixedwith0.9%salineandwithsolutionsofterbutaline,salbutamol,sodium

cromoglycateoripratropiumbromide.Theadmixtureshouldbeusedwithin30minutes.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

TevaPharmaB.V.

Computerweg10

3542DRUtrecht

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER

PA749/141/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11thMarch2011

10DATEOFREVISIONOFTHETEXT

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