AIROMIR INHALER 100 MICROGRAMS PER METERED DOSE PR

Main information

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

Documents

Localization

  • Available in:
  • AIROMIR INHALER 100 MICROGRAMS PER METERED DOSE PR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0436/033/001
  • Authorization date:
  • 19-09-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0436/033/001

CaseNo:2055550

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NortonWaterfordLimited

T/AIVAXPharmaceuticalsIreland,Unit301,IDAIndustrialPark,Waterford,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AiromirInhaler100microgramspermetereddosepressurisedinhalationsuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom01/10/2008until18/09/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 01/10/2008 CRN 2055550 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AiromirInhaler100microgramspermetereddosepressurisedinhalationsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains100microgramsSalbutamol(assulphate).

Forexcipientsseesection6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension

Ahomogenous,creamy–whitetogreysuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AiromirInhalerisindicatedforthetreatmentofacuteattacksorexacerbationsofbronchialasthmaandforthe

treatmentofreversibleairwaysobstruction.AiromirInhalermayalsobetakenprophylacticallybeforeexertionto

preventexercise-inducedasthma.

4.2Posologyandmethodofadministration

Fororalinhalationuse.

ADULTSANDCHILDREN:Forthereliefofacutebronchospasmandformanagingintermittentepisodesofasthma,

oneinhalation,increasingtotwoinhalationsifnecessary.

Forpreventionofexercise-inducedbronchospasm,oneinhalationbeforeexertion,increasingtotwoinhalationsif

necessary.

ELDERLY:Nospecialdosagerecommendationsaremadeforelderlypatients.

Forallpatients,themaximumrecommendeddoseshouldnotexceedeightinhalationsin24hours.Withrepetitive

dosing,inhalationsshouldnotusuallyberepeatedmoreoftenthanevery4hours.

MethodofAdministration:

Inhalationuse.

4.3Contraindications

HypersensitivitytosalbutamoloranyoftheinactiveingredientsinAiromirInhaler.

4.4Specialwarningsandprecautionsforuse

Salbutamolcausesperipheralvasodilationwhichmayresultinreflextachycardiaandincreasedcardiacoutput.Caution

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Cardiovasculareffectsmaybeseenwithsympathomimeticdrugsincludingsalbutamol.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurencesofmyocardialischaemiaassicuatedwithsalbutamol.

Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,tachyarrythmiaorsevereheartfailure)who

arereceivingsalbutamolforrespiratorydisease,shouldbewarnedtoseekmedicaladviceiftheyexperiencechest

paingorothersumptimsofworseningheartdisease.Attentionshouldpaidtoassessmentofsymptomssuchas

dyspnoeaandchestpain,astheymaybebeofeitherrespiratoryorcardiacorigin.

Thepatientshouldbeadvisedtoseekmedicaladviceifthetreatmentceasestobeeffectiveand/ortheirasthmaseems

tobeworsening,andnottoincreasethedosewithoutmedicaladvice.

Incommonwithotherbeta-adrenoceptoragonists,salbutamolcaninducereversiblemetabolicchangessuchas

increasedbloodglucoselevels.Diabeticpatientsmaybeunabletocompensatefortheincreaseinbloodglucoseandthe

developmentofketoacidosishasbeenreported.Concurrentadministrationofglucorticoidscanexaggeratethiseffect.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandnon-selectivebeta-blockersshouldnotusuallybeprescribedtogether.Cautionshouldbeexercisedin

itsusewithanaestheticagentssuchaschloroform,cyclopropane,halothaneandotherhalogenatedagents.Theeffects

ofthisproductmaybealteredbyguanethidine,reserpine,methyldopa,tricyclicantidepressantsandmonoamine

oxidaseinhibitors.

BecauseAiromircontainsethanolthereisatheoreticalpotentialforinteractioninpatientstakingdisulfiramor

metronidazole.TheamountofethanolinAiromirissmallbutitmaybeenoughtoprecipitateareactioninsome

sensitivepatients.

4.6Pregnancyandlactation

AiromirInhaler

Thereisnoexperienceofthisproductinpregnancyandlactationinhumans.Aninhalationreproductivestudywith

AiromirInhalerinratsdidnotexhibitanyteratogeniceffects.

Propellant134a

Studiesofpropellant134aadministeredtopregnantandlactatingratsandrabbitshavenotrevealedanyspecialhazard.

Salbutamol

Salbutamolshouldonlybeusedduringpregnancyandlactationifconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Frequencyestimate:verycommon=10%,common=1%to<10%;uncommon=0.1%to<1%;rare=0.01%to<

0.1%;veryrare<0.01%.

Immunesystemdisorders:Hypersensitivityreactions(veryrarely).

Metabolismandnutritionaldisorder:Potentiallyserioushypokalaemia,raisedserumlactate/Lacticacidosis(rarely).

Psychiatricdisorders:Hyperactivityinchildren(rarely).

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Veryrare:Cardiacarrythmias(includingatrialfibrillation,supraventriculartachycardiaandextrasystoles)

Respiratory,thoracicandmediastinaldisorders:Paradoxicalbronchospasm.

Musculoskeletalandconnectivetissuedisorders:Mildtremor(rarely).

Unknown*:Myocardialischaemia

*Reportedspontaneouslyinpost-marketingdatathereforefrequencyregardedasunknown.

4.9Overdose

Acardioselectivebeta-blockingagentshouldbeadministered,buttheseshouldbeusedwithcautioninpatientswitha

historyofbronchospasm.HyperglycaemiaandagitationhavealsobeenreportedfollowingoverdosewithSalbutamol.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

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.

AiromirInhaler

SafetystudieswithAiromirinratanddogshowedfewadverseeffects.Theseoccurredathighdosesandwere

consistentwiththeknowneffectsofsalbutamolinhalation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

OleicAcid

Ethanol

Norflurane

6.2Incompatibilities

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6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Donotrefrigerateorfreeze.

Thecanistercontainsapressurisedliquid.Donotexposetotemperatureshigherthan50 °

C.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

AiromirInhaler:Suppliedasacompleteunitdelivering200inhalations.

10mlAluminiumbasedPressurisedcontainerfittedwitha25microlitremetereddosevalueandsuppliedwithaplastic

inhalationadaptor.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

ForpatientsrequiringaspacerdevicetheAerochamberhasbeenshowntobecompatiblewithAiromirInhaler.

Asthecanisterispressurised,noattemptshouldbemadetopunctureordisposeofitbyburning.

7MARKETINGAUTHORISATIONHOLDER

NortonWaterfordLimited

Unit301

IndustrialPark

Waterford

Ireland

Tradingas:

IVAXPharmaceuticalsIreland

8MARKETINGAUTHORISATIONNUMBER

PA436/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19September1995

Dateoflastrenewal:19September2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 01/10/2008 CRN 2055550 page number: 5