AIROMIR AUTOHALER 100 MICROGRAMS PER METERED DOSE,

Main information

  • Trade name:
  • AIROMIR AUTOHALER 100 MICROGRAMS PER METERED DOSE,
  • Dosage:
  • 100 Mcg/Acutuation
  • Pharmaceutical form:
  • Pressurised Inhalation Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AIROMIR AUTOHALER 100 MICROGRAMS PER METERED DOSE,
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0436/033/002
  • Authorization date:
  • 08-03-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AiromirAutohaler100microgramspermetereddose,pressurisedinhalationsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachactuationofAiromirAutohalerdeliversSalbutamolSulphatePh.Eur.equivalenttoSalbutamol100micrograms

intothemouthpieceoftheadapter.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension

Pressurisedaluminiumcontainerfittedwitha25microlitrevalveandsuppliedwithaplasticbreath-actuatedactuator.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AiromirAutohalerisindicatedforthetreatmentofacuteattacksorexacerbationsofbronchialasthmaandforthe

treatmentofreversibleairwaysobstruction.AiromirAutohalermayalsobetakenprophylacticallybeforeexertionto

preventexercise-inducedasthma.

4.2Posologyandmethodofadministration

Fororalinhalationuse.

ADULTSANDCHILDREN:Forthereliefofacutebronchospasmandformanagingintermittentepisodesofasthma,

oneinhalation,increasingtotwoinhalationsifnecessary.

Forpreventionofexercise-inducedbronchospasm,oneinhalationbeforeexertion,increasingtotwoinhalationsif

necessary.

ELDERLY:Nospecialdosagerecommendationsaremadeforelderlypatients.

Forallpatients,themaximumrecommendeddoseshouldnotexceedeightinhalationsin24hours.Withrepetitive

dosing,inhalationsshouldnotusuallyberepeatedmoreoftenthanevery4hours.

4.3Contraindications

HypersensitivitytosalbutamoloranyoftheinactiveingredientsinAiromirAutohaler.

4.4Specialwarningsandprecautionsforuse

Salbutamolcausesperipheralvasodilationwhichmayresultinreflextachycardiaandincreasedcardiacoutput.Caution

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Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingsalbutamol.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemiaassociatedwithsalbutamol.

Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingsalbutamolshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

maybeofeitherrespiratoryorcardiacorigin.

Thepatientshouldbeadvisedtoseekmedicaladviceifthetreatmentceasestobeeffectiveand/ortheirasthmaseems

tobeworsening,andnottoincreasethedosewithoutmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandnon-selectivebeta-blockersshouldnotusuallybeprescribedtogether.Cautionshouldbeexercisedin

itsusewithanaestheticagentssuchaschloroform,cyclopropane,halothaneandotherhalogenatedagents.Theeffects

ofthisproductmaybealteredbyguanethidine,reserpine,methyldopa,tricyclicantidepressantsandmonoamine

oxidaseinhibitors.

BecauseAiromirAutohalercontainsethanolthereisatheoreticalpotentialforinteractioninpatientstakingdisulfiram

ormetronidazole.TheamountofethanolinAiromirAutohalerissmallbutitmaybeenoughtoprecipitateareactionin

somesensitivepatients.

4.6Pregnancyandlactation

AiromirAutohaler

Thereisnoexperienceofthisproductinpregnancyandlactationinhumans.Aninhalationreproductivestudywith

Airomirinratsdidnotexhibitanyteratogeniceffects.

Propellant134a

Studiesofpropellant134aadministeredtopregnantandlactatingratsandrabbitshavenotrevealedanyspecialhazard.

Salbutamol

Salbutamolshouldonlybeusedduringpregnancyandlactationifconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

AiromirAutohalerhasnoinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Mildtremor,headacheandtransientmusclecrampsmayrarelyoccur.Potentiallyserioushypokalaemiahasbeen

reportedinpatientstakingbeta-2-agonisttherapy.Hypersensitivityreactionsandhyperactivityinchildrenhavebeen

reportedrarely.

Veryrare:Cardiacarrythmias(includingatrialfibrillation,supraventriculartachycardiaandextrasystoles).

Unknown:Myocardialischaemia*(seesection4.4)

Aswithotherinhalationtherapy,paradoxicalbronchospasmmayoccurimmediatelyafterdosing.Inthisinstance,

AiromirAutohalershouldbediscontinuedimmediatelyandalternativetherapyinstitutedifnecessary.

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*reportedspontaneouslyinpostmarketingdatathereforefrequencyregardedasunknown.

4.9Overdose

Acardioselectivebeta-blockingagentshouldbeadministered,buttheseshouldbeusedwithcautioninpatientswitha

historyofbronchospasm.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:RO3AC02

Salbutamolisasympathomimeticagentwhichhasaselectiveactiononbeta-2-adrenergicreceptorsinbronchial

smoothmuscle.

5.2Pharmacokineticproperties

Onsetofactionisusuallywithin10minutesofinhalationandlasts4-6hoursinmostpatients.

5.3Preclinicalsafetydata

Propellant134a

Inanimalstudiespropellant134ahasbeenshowntohavenosignificantpharmacologicaleffectsotherthanatveryhigh

exposureconcentrations,whennarcosisandarelativelyweakcardiacsensitisingeffectwerefound.Thepotencyofthe

cardiacsensitisationwaslessthanthatofCFC-11(trichlorofluoromethane).

Instudiestodetecttoxicity,repeatedhighdoselevelsofpropellant134aindicatedthatsafetymarginsbasedon

systemicexposurewouldbeoftheorder2200,1314and381formouse,ratanddogwithrespecttohumans.

Therearenoreasonstoconsiderpropellant134aasapotentialmutagen,clastogenorcarcinogenjudgedfrominvitro

andinvivostudiesincludinglong-termadministrationbyinhalationinrodents.

AiromirAutohaler

Safetystudieswiththeproductinratanddogshowedfewadverseeffects.Theseoccurredathighdosesandwere

consistentwiththeknowneffectsofsalbutamolinhalation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

OleicAcid

Ethanol

Norflurane(Propellant134a)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

Donotrefrigerateorfreeze.Thiscanistercontainsapressurisedliquid.

Donotexposetotemperatureshigherthen50ºC.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

AiromirAutohaler:Suppliedasacompleteunitdelivering200inhalationsthroughabreath-actuatedactuator.10ml

Aluminiumbasedpressurisedcontainerfittedwitha25microlitremetereddosevalveandsuppliedwithaplastic

Autohaleractuator.

6.6Specialprecautionsfordisposalandotherhandling

Asthecanisterispressurised,noattemptshouldbemadetopunctureordisposeofitbyburning.

7MARKETINGAUTHORISATIONHOLDER

NortonWaterfordLimited

T/AIVAXPharmaceuticalsIreland

Unit301

IDAIndustrialPark

Waterford

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA436/33/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8 th

March2002

Dateoflastauthorisation:8 th

March2007

10DATEOFREVISIONOFTHETEXT

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