ATROVENT UDV'S

Main information

  • Trade name:
  • ATROVENT UDV'S
  • Dosage:
  • 500/2 Microgram/ML
  • Pharmaceutical form:
  • Nebuliser Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATROVENT UDV'S
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/173/002
  • Authorization date:
  • 09-01-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA0465/173/002

CaseNo:2054664

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PCOManufacturingLimited

Unit10,AshbourneBusinessPark,Rath,Ashbourne,Co.Meath,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AtroventUDVs500microgram/2mlNebuliserSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom20/10/2008until08/01/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Atrovent ®

UDVs ®

500micrograms/2mlNebulisersolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsingledoseunitcontains0.025%w/vipratropiumbromide(monohydrate)i.e.500microgramsin2ml.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

NebuliserSolution.

ProductimportedfromtheUK:

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ATROVENT250UDVs,1mlandATROVENTUDVs,2mlareindicatedformaintenancetreatmentofbronchospasm

associatedwithchronicobstructivepulmonarydiseaseand,whenusedconcomitantlywithinhaledbeta

-agonists,for

treatmentofacuteandchronicasthmaandacutebronchospasmassociatedwithchronicobstructivepulmonarydisease.

4.2Posologyandmethodofadministration

Thedosageshouldbeadaptedtotheindividualneedsofthepatient.Unlessotherwiseprescribedthefollowingdoses

arerecommended:

Adults(includingtheelderly)andchildrenover12yearsofage:

500micrograms3to4timesdaily.

Fortreatmentofacutebronchospasm,500micrograms.

Repeateddosescanbeadministereduntilthepatientisstable.Thetimeintervalbetweenthedosesmaybedetermined

bythephysician.

Itisadvisablenottoexceedtherecommendeddailydoseduringeitheracuteormaintenancetreatment.Dailydoses

exceeding2mginadultsandchildrenover12yearsofageshouldonlybegivenundermedicalsupervision.

Childrenunder12yearsofage:

250microgramsuptoatotaldailydoseof1mg.

Thetimeintervalbetweendosesmaybedeterminedbythephysician.

Foracutebronchospasm,repeateddosesmaybeadministereduntilthepatientisstable.Thetimeintervalbetween

dosesmaybedeterminedbythephysician.

Itisadvisablenottoexceedtherecommendeddailydose.Dailydosesexceeding1mginthisagegroupshouldbegiven

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Thereislimitedinformationforchildrenunder6yearsofage,thereforetherecommendeddoseshouldonlybegiven

undermedicalsupervision.

ATROVENTUDVscanbeadministeredcombinedwithaninhaledbeta

-agonist.

Thedoseofnebulisersolutionmayneedtobedilutedinordertoobtainafinalvolumesuitablefortheparticular

nebuliserbeingused;ifdilutionisnecessaryuseonlysterilesodiumchloride0.9%solution.

Iftherapydoesnotproduceasignificantimprovementorifthepatient'sconditiongetsworse,medicaladvicemustbe

sought.Inthecaseofacuteorrapidlyworseningdyspnoea(difficultyinbreathing)adoctorshouldbeconsulted

immediately.

ATROVENTUDVscanbeadministeredusingarangeofcommerciallyavailablenebulisingdevices.

ATROVENTUDVsanddisodiumcromoglycateinhalationsolutionsthatcontainthepreservativebenzalkonium

chlorideshouldnotbeadministeredsimultaneouslyinthesamenebuliserasprecipitationmayoccur.

Administration

Theunitdosevialsareintendedonlyforinhalationwithsuitablenebulisingdevicesandshouldnotbetakenorallyor

administeredparenterally.

1.Getyournebuliserreadybyfollowingthemanufacturer'sinstructionsandtheadviceofyourdoctor.

2.Carefullyseparateanewdoseunitfromthestrip.NEVERuseonewhichhasbeenopenedalready.

3.Openbysimplytwistingoffthetop,alwaystakingcaretoholditinanuprightposition.

4.Unlessotherwiseinstructedbyyourdoctor,squeezeallthecontentsintothenebuliserchamber.Ifdilutionis

necessarythisshouldbecarriedoutusingONLYsterilesodiumchloride0.9%solutionandasinstructedbyyour

doctor.

5.Useyournebuliserasdirectedbyyourdoctor.

6.Afteryouhavefinished,throwawayanyleftoversolution.Followthemanufacturer'sinstructionsforcleaningyour

nebuliser.Itisimportantthatyournebuliseriskeptclean.

4.3Contraindications

Knownhypersensitivitytoatropineoritsderivatives,ortoanyothercomponentoftheproduct.

4.4Specialwarningsandprecautionsforuse

Cautionisadvocatedintheuseofanticholinergicagentsinpatientswithnarrow-angleglaucoma,orwithprostatic

hyperplasiaorbladder-outflowobstruction.

Aspatientswithcysticfibrosismaybepronetogastro-intestinalmotilitydisturbances,ATROVENT,aswithother

anticholinergics,shouldbeusedwithcautioninthesepatients.

ImmediatehypersensitivityreactionsfollowingtheuseofATROVENThavebeendemonstratedbyrarecasesof

urticaria,angioedema,rash,bronchospasm,oropharyngealoedemaandanaphylaxis.

Therehavebeenisolatedreportsofocularcomplications(i.e.mydriasis,increasedintra-ocularpressure,narrow-angle

glaucoma,eyepain)whenaerosolisedipratropiumbromide,eitheraloneorincombinationwithanadrenergicbeta

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Eyepainordiscomfort,blurredvision,visualhalosorcolouredimagesinassociationwithredeyesfromconjunctival

andcornealcongestionmaybesignsofacutenarrow-angleglaucoma.Shouldanycombinationofthesesymptoms

develop,treatmentwithmioticdropsshouldbeinitiatedandspecialistadvicesoughtimmediately.

PatientsmustbeinstructedinthecorrectadministrationofATROVENTUDVs.Caremustbetakennottoallowthe

solutionormisttoentertheeyes.Itisrecommendedthatthenebulisedsolutionisadministeredviaamouthpiece.If

thisisnotavailableandanebulisermaskisused,itmustfitproperly.Patientswhomaybepredisposedtoglaucoma

shouldbewarnedspecificallytoprotecttheireyes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThereisevidencethattheadministrationofATROVENTwithbeta-adrenergicdrugsandxanthinepreparationsmay

intensifythebronchodilatoreffectofATROVENT.

Theriskofacuteglaucomainpatientswithahistoryofnarrow-angleglaucoma(seeSpecialWarningsandSpecial

PrecautionsforUse)maybeincreasedwhennebulisedipratropiumbromideandbeta

-agonistsareadministered

simultaneously.

4.6Pregnancyandlactation

ThesafetyofATROVENTduringhumanpregnancyhasnotbeenestablished.ThebenefitsofusingATROVENT

duringaconfirmedorsuspectedpregnancymustbeweighedagainstthepossiblehazardstotheunbornchild.

Preclinicalstudieshaveshownnoembryotoxicorteratogeniceffectsfollowinginhalationorintranasalapplicationat

dosesconsiderablyhigherthanthoserecommendedinman.

ItisnotknownwhetherATROVENTisexcretedintobreastmilk.ItisunlikelythatATROVENTwouldreachthe

infanttoanimportantextent,howevercautionshouldbeexercisedwhenATROVENTisadministeredtonursing

mothers.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Themostfrequentnon-respiratoryadversereactionsreportedinclinicaltrialswithATROVENTwereheadache,

nausea(withorwithoutvomiting)anddrynessofthemouth.

ThefollowingsideeffectshavebeenobservedwithATROVENT:tachycardia,palpitations,supraventricular

tachycardiaandatrialfibrillationinpatientsknowntobesusceptible,visualaccommodationdisturbances,gastro-

intestinalmotilitydisturbancesandurinaryretention.Thesesideeffectshavebeenrareandreversible.Theriskof

urinaryretentionmaybeincreasedinpatientswithpre-existingurinaryoutflowtractobstruction.

Ocularsideeffectshavebeenreported(see:SpecialWarningsandSpecialPrecautionsforUse).

Aswithotherinhaledbronchodilatortherapy,cough,localirritationandinhalationinducedbronchoconstrictionmay

occur.

Allergic-typereactionssuchasskinrash,angioedemaofthetongue,lipsandface,urticaria,laryngospasmand

anaphylacticreactionshavebeenreported.

4.9Overdose

Nosymptomsspecifictooverdosagehavebeenencountered.Inviewofthewidetherapeuticwindowandtopical

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anticholinergics,drymouth,visualaccommodationdisturbancesandtachycardiawouldbetheexpectedsymptomsand

signsofoverdose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATROVENTisaquaternaryammoniumcompoundwithanticholinergic(parasympatholytic)

properties.Inpreclinicalstudies,itappearstoinhibitvagallymediatedreflexesbyantagonisingtheactionof

acetylcholine,thetransmitteragentreleasedfromthevagusnerve.Anticholinergicspreventtheincreaseinintracellular

concentrationofcyclicguanosinemonophosphate(cyclicGMP)causedbyinteractionofacetylcholinewiththe

muscarinicreceptoronbronchialsmoothmuscle.

ThebronchodilationfollowinginhalationofATROVENTisinducedbylocaldrugconcentrationssufficientfor

anticholinergicefficacyatthebronchialsmoothmuscleandnotbysystemicdrugconcentrations.

PreclinicalandclinicalevidencesuggestnodeleteriouseffectofATROVENTonairwaymucoussecretion,

mucociliaryclearanceorgasexchange.

Incontrolled90daystudiesinpatientswithbronchospasmassociatedwithchronicobstructivepulmonarydisease(e.g.

chronicbronchitisandemphysema)significantimprovementsinpulmonaryfunction(FEV

andFEF

25-75% increases

of15%ormore)occurredwithin15minutes,reachedapeakin1-2hours,andpersistedinthemajorityofpatientsup

to6hours.

ThebronchodilatoreffectofATROVENTinthetreatmentofacutebronchospasmassociatedwithasthmahasbeen

showninstudiesinadultsandchildrenover6yearsofage.InmostofthesestudiesATROVENTwasadministeredin

combinationwithaninhaledbeta

-agonist.

Althoughthedataarelimited,ATROVENThasbeenshowntohaveatherapeuticeffectinthetreatmentof

bronchospasmassociatedwithviralbronchiolitisandbronchopulmonarydysplasiaininfantsandverysmallchildren.

5.2Pharmacokineticproperties

ThetherapeuticeffectofATROVENTisproducedbyalocalactionintheairways.Thereforetimecoursesof

bronchodilationandsystemicpharmacokineticsdonotruninparallel.

Followinginhalation,doseportionsfrom10to30%,dependingontheformulationandinhalationtechnique,are

generallydepositedinthelungs.Themajorpartofthedoseisswallowedandpassesthroughthegastro-intestinaltract.

Duetothenegligiblegastro-intestinalabsorptionofipratropiumbromidethebioavailabilityoftheswalloweddose

portionaccountsforonlyapproximately2%ofthedose.Thisfractionofthedosedoesnotmakearelevantcontribution

totheplasmaconcentrationsoftheactiveingredient.Theportionofthedosedepositedinthelungsreachesthe

circulationrapidly(withinminutes)andhasanearlycompletesystemicavailability.

Fromdataofrenalexcretion(0-24hours)thetotalsystemicbioavailability(pulmonaryandgastro-intestinalportions)

ofinhaleddosesofipratropiumbromidewasestimatedtobeintherangeof7to28%.Itisassumedthatthisisalsoa

validrangefortheinhalationfromthesolutionforinhalationpreparation.

Kineticparametersdescribingthedistributionofipratropiumbromidewerecalculatedfromplasmaconcentrationsafter

i.v.administration.

Arapidbiphasicdeclineinplasmaconcentrationsisobserved.Thevolumeofdistribution(Vz)is338L(4.6L/kg).

Thedrugisminimally(lessthen20%)boundtoplasmaproteins.Theipratropiumiondoesnotcrosstheblood-brain

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Thehalf-lifeoftheterminaleliminationphaseisabout1.6hours.

Themeantotalclearanceofthedrugisdeterminedtobe2.3L/min.Themajorportionofapproximately60%ofthe

systemicavailabledoseiseliminatedbymetabolicdegradation,probablyintheliver.Themainurinarymetabolites

bindpoorlytothemuscarinicreceptorandhavetoberegardedasineffective.

Aportionofapproximately40%ofthesystemicavailabledoseisclearedviaurinaryexcretioncorrespondingtoan

experimentalrenalclearanceof0.9L/min.(Afteroraldosinglessthan1%ofthedoseisrenallyexcreted,indicatingan

insignificantabsorptionofipratropiumbromidefromthegastro-intestinaltract.)

Inexcretionbalancestudiesafterintravenousadministrationofaradioactivedose,lessthan10%ofthedrug-related

radioactivity(includingparentcompoundandallmetabolites)isexcretedviathebiliary-faecalroute.Thedominant

excretionofdrug-relatedradioactivityoccursviathekidneys.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SodiumChloride

1NHydrochloricAcid

PurifiedWater

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Astheproductcontainsapreservative,afreshvialshouldbeusedforeachdoseandthevialshouldbeopened

immediatelybeforeadministration.

Anysolutionleftinthevialshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Low-densitypolyethylene(LDPE)singledoseunitsformedinstripsof10.Eachsingledoseunitcontains2mlof

solution.Packsizesof60.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

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PCOManufacturingLimited

Unit222,

WesternIndustrialEstate,

NaasRoad,

Dublin12.

8MARKETINGAUTHORISATIONNUMBER

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