AEROLIN AUTOHALER CFC-FREE 100 MICROGRAMS PER METE

Main information

  • Trade name:
  • AEROLIN AUTOHALER CFC-FREE 100 MICROGRAMS PER METE
  • Dosage:
  • 100 Mcg/Acutuation
  • Pharmaceutical form:
  • Pressurised Inhalation Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AEROLIN AUTOHALER CFC-FREE 100 MICROGRAMS PER METE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0436/034/001
  • Authorization date:
  • 08-03-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AerolinAutohalerCFC-Free100microgramspermetereddosePressurisedInhalationSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachactuationofAerolinAutohalerCFC-FreedeliversSalbutamolSulphatePh.Eur.equivalenttoSalbutamol100

microgramsintothemouthpieceoftheadapter.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension.

Pressurisedaluminiumcontainerfittedwitha25µlmeteringvalveandsuppliedwithaplasticbreath-activatedactuator.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AerolinAutohalerCFC-Freeisindicatedforthetreatmentofacuteattacksorexacerbationsofbronchialasthmaandfor

thetreatmentofreversibleairwaysobstruction.AerolinAutohalerCFC-Freemayalsobetakenprophylacticallybefore

exertiontopreventexercise-inducedasthma.

4.2Posologyandmethodofadministration

Fororalinhalationuse.

ADULTSANDCHILDREN:Forthereliefofacutebronchospasmandformanagingintermittentepisodesofasthma,

oneinhalation,increasingtotwoinhalationsifnecessary.

Forpreventionofexercise-inducedbronchospasm,oneinhalationbeforeexertion,increasingtotwoinhalationsif

necessary.

Adults(includingtheElderly)

OndemanduseofSalbutamolinhalationaerosolorpowdershouldnotexceedeightinhalationsin24hours.

Children

Ondemanduseshouldnotexceed4inhalationsin24hours.

Forallpatients,inhalationsshouldnotusuallyberepeatedmoreoftenthanevery4hours.

4.3Contraindications

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4.4Specialwarningsandprecautionsforuse

Salbutamolcausesperipheralvasodilationwhichmayresultinreflextachycardiaandincreasedcardiacoutput.Caution

shouldbeusedinpatientssufferingfromangina,severetachycardiaorthyrotoxicosis.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingsalbutamol.

Thereissomeevidencefrompost-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemia

associatedwithsalbutamol.Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaor

severeheartfailure)whoarereceivingsalbutamolshouldbewarnedtoseekmedicaladviceiftheyexperiencechest

painorothersymptomsofworseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchas

dyspnoeaandchestpain,astheymaybeofeitherrespiratoryorcardiacorigin.

Thepatientshouldbeadvisedtoseekmedicaladviceifthetreatmentceasestobeeffectiveand/ortheirasthmaseems

tobeworsening,andnottoincreasethedosewithoutmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandnon-selectivebeta-blockersshouldnotusuallybeprescribedtogether.Cautionshouldbeexercisedin

itsusewithanaestheticagentssuchaschloroform,cyclopropane,halothaneandotherhalogenatedagents.Theeffects

ofthisproductmaybealteredbyguanethidine,reserpine,methyldopa,tricyclicantidepressantsandmonoamine

oxidaseinhibitors.

BecauseAerolinAutohalerCFC-Freecontainsethanolthereisatheoreticalpotentialforinteractioninpatientstaking

disulfiramormetronidazole.TheamountofethanolinAerolinAutohalerCFC-Freeissmallbutitmaybeenoughto

precipitateareactioninsomesensitivepatients.

4.6Pregnancyandlactation

AerolinAutohalerCFC-Free

Thereisnoexperienceofthisproductinpregnancyandlactationinhumans.Aninhalationreproductivestudywiththe

productinratsdidnotexhibitanyteratogeniceffects.

Propellant134a

Studiesofpropellant134aadministeredtopregnantandlactatingratsandrabbitshavenotrevealedanyspecialhazard.

Salbutamol

Salbutamolshouldonlybeusedduringpregnancyandlactationifconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

AerolinAutohalerCFC-Freehasnoinfluenceontheabilitytodriveandusemachines.

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)

Metabolismandnutritiondisorders:Potentiallyserioushypokalaemia,raisedserumlactate/Lacticacidosis(rarely).

Psychiatricdisorders:Hyperactivityinchildren(rarely)

Nervoussystemdisorders:Headaches(rarely)

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Respiratory,thoracicandmediastinaldisorders:Paradoxicalbronchospasm.

Musculoskeletalandconnectivetissuedisorders:Mildtremor(rarely)

Unknown:myocardialischaemia*(seesection4.4).

*reportedspontaneouslyinpost-marketingdatathereforefrequencyregardedasunknown.

4.9Overdose

Acardioselectivebeta-blockingagentshouldbeadministered,buttheseshouldbeusedwithcautioninpatientswitha

historyofbronchospasm.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCodeR03AC02

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.

AerolinAutohalerCFC-Free

Safetystudieswiththeproductinratanddogshowedfewadverseeffects.Theseoccurredathighdosesandwere

consistentwiththeknowneffectsofsalbutamolinhalation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

OleicAcid

Ethanol

Norflurane(Propellant134a)

6.2Incompatibilities

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6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Donotrefrigerateorfreeze.Thiscanistercontainsapressurizedliquid.Donotexposeto

temperatureshigherthan50°C.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

AerolinAutohalerCFC-Free:Suppliedasacompleteunitdelivering200inhalationsthroughabreath-actuated

actuator.10mlAluminiumbasedpressurisedcontainerfittedwitha25µlmetereddosevalveandsuppliedwitha

plasticAutohaleractuator.

6.6Specialprecautionsfordisposalandotherhandling

Asthecanisterispressurised,noattemptshouldbemadetopunctureordisposeofitbyburning.

7MARKETINGAUTHORISATIONHOLDER

NortonWaterfordLimited

T/AIVAXPharmaceuticalsIreland

Unit301

IDAIndustrialPark

Waterford

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA436/34/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:8 th

March2002

Dateoflastrenewal:8 th

March2007

10DATEOFREVISIONOFTHETEXT

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