ATROVENT 500 UDVS

Main information

  • Trade name:
  • ATROVENT 500 UDVS
  • Dosage:
  • 0.25 anhyd mg/ ml
  • Pharmaceutical form:
  • Nebuliser Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATROVENT 500 UDVS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/070/002
  • Authorization date:
  • 29-06-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PPA1328/070/002

CaseNo:2029758

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Atrovent500UDVs500micrograms/2mlNebuliserSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom29/06/2007until28/06/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Atrovent500UDVs500micrograms/2mlNebuliserSolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsingle-doseunitcontains500microgramsipratropiumbromide(asipratropiumbromidemonohydrate)in2mlof

nebulisersolution.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Nebulisersolution.

ProductimportedfromSpain:

Clear,colourless,aqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ATROVENTUDVs,2mlareindicatedformaintenancetreatmentofbronchospasmassociatedwithchronic

obstructivepulmonarydiseaseand,whenusedconcomitantlywithinhaledbeta

-agonists,fortreatmentofacuteand

chronicasthmaandacutebronchospasmassociatedwithchronicobstructivepulmonarydisease.

4.2Posologyandmethodofadministration

Thedosageshouldbeadaptedtotheindividualneedsofthepatient.Unlessotherwiseprescribedthefollowingdoses

arerecommended:

Adults(includingtheelderly)andchildrenover12yearsofage:

500micrograms3to4timesdaily.

Fortreatmentofacutebronchospasm,500micrograms.

Repeateddosescanbeadministereduntilthepatientisstable.Thetimeintervalbetweenthedosesmaybedetermined

bythephysician.

Itisadvisablenottoexceedtherecommendeddailydoseduringeitheracuteormaintenancetreatment.Dailydoses

exceeding2mginadultsandchildrenover12yearsofageshouldonlybegivenundermedicalsupervision.

Childrenunder12yearsofage:

250microgramsuptoatotaldailydoseof1mg.

Thetimeintervalbetweendosesmaybedeterminedbythephysician.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 2

Thetimeintervalbetweendosesmaybedeterminedbythephysician.

Itisadvisablenottoexceedtherecommendeddailydose.Dailydosesexceeding1mginthisagegroupshouldbegiven

undermedicalsupervision.

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

Cautionisadvocatedintheuseofanticholinergicagentsinpatientspredisposedtoorwithnarrow-angleglaucoma,or

withprostatichyperplasiaorbladder-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

agonist,hascomeintocontactwiththeeyes.

Eyepainordiscomfort,blurredvision,visualhalosorcolouredimagesinassociationwithredeyesfromconjunctival

congestionandcornealoedemamaybesignsofacutenarrow-angleglaucoma.Shouldanycombinationofthese

symptomsdevelop,treatmentwithmioticdropsshouldbeinitiatedandspecialistadvicesoughtimmediately.

PatientsmustbeinstructedinthecorrectadministrationofATROVENTUDVs.Caremustbetakennottoallowthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 3

Ifthisisnotavailableandanebulisermaskisused,itmustfitproperly.

Patientswhomaybepredisposedtoglaucomashouldbewarnedspecificallytoprotecttheireyes.

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

Thefollowingsideeffectshavebeenreported.Thefrequenciesgivenbelowarebasedonclinicaltrialsinvolving3250

patientswhohavebeentreatedwithATROVENT(ipratropiumbromide).

Frequencies

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

Immunesystemdisorders

AnaphylacticreactionRare

Angio-oedemaoftongue,lips,faceRare

Urticaria (1)

Uncommon

Nervoussystemdisorders

HeadacheCommon

DizzinessCommon

Eyedisorders

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 4

Intraocularpressureincreased (2)

Rare

Narrowangleglaucoma (2)

Uncommon

Eyepain (2)

Rare

Mydriasis (2)

Rare

CardiacDisorders

PalpitationsRare

IncreasedheartrateUncommon

SupraventriculartachycardiaRare

AtrialfibrillationRare

Respiratory,ThoracicandMediastinalDisorders

CoughCommon

LocalirritationCommon

InhalationinducedbronchospasmCommon

LaryngospasmRare

Gastro-intestinalDisorders

DrynessofmouthCommon

NauseaRare

Gastro-intestinalmotilitydisorder (3)

Common

SkinandSubcutaneousDisorders

SkinrashUncommon

PruritusUncommon

RenalandUrinaryDisorders

Urinaryretention (4)

Rare

includinggianturticaria

ocularcomplicationshavebeenreportedwhenaerolisedipratropiumbromide,eitheraloneorincombinationwith

anadrenergicbeta

-agonist,hascomeintocontactwiththeeyes–seesection4.4.

e.g.constipation,diarrhoea,vomiting

theriskofurinaryretentionmaybeincreasedinpatientswithpre-existingurinaryoutflowtractobstruction

4.9Overdose

Nosymptomsspecifictooverdosagehavebeenencountered.Inviewofthewidetherapeuticwindowandtopical

administrationofATROVENT,noseriousanticholinergicsymptomsaretobeexpected.Aswithother

anticholinergics,drymouth,visualaccommodationdisturbancesandtachycardiawouldbetheexpectedsymptomsand

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 5

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATROVENTisaquaternaryammoniumcompoundwithanticholinergic(parasympatholytic)

properties.Inpreclinicalstudies,itappearstoinhibitvagallymediatedreflexesbyantagonisingtheactionof

acetylcholine,thetransmitteragentreleasedfromthevagusnerve.

Anticholinergicspreventtheincreaseinintracellularconcentrationofcyclicguanosinemonophosphate(cyclicGMP)

causedbyinteractionofacetylcholinewiththemuscarinicreceptoronbronchialsmoothmuscle.

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).The

drugisminimally(lessthen20%)boundtoplasmaproteins.Theipratropiumiondoesnotcrosstheblood-brainbarrier,

consistentwiththeammoniumstructureofthemolecule.

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 6

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

Hydrochloricacid(forpH-adjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

Forsingleuseonly.Discardanyunusedsolution.

Astheproductcontainsnopreservative,afreshvialshouldbeusedforeachdoseandthevialshouldbeopened

immediatelybeforeadministration.Anysolutionleftinthevialshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepvialsintheoutercarton.

6.5Natureandcontentsofcontainer

Low-densitypolyethylene(LDPE)single-doseunitsformedinstripsof10.Eachsingle-doseunitcontains2mlof

solution.

2mlofnebulisersolutioncomesinpacksizesof20single-dosecontainers.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 7

8ParallelProductAuthorisationNumber

PPA1328/70/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:29thJune2007

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/07/2007 CRN 2029758 page number: 8