GERIVENT CFC FREE

Main information

  • Trade name:
  • GERIVENT CFC FREE
  • Dosage:
  • 100 Microgram
  • Pharmaceutical form:
  • Pressurised Inhalation Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERIVENT CFC FREE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/056/001
  • Authorization date:
  • 13-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GeriventCFCFree100microgramspermetereddosepressurisedinhalationsuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachmetereddosecontainsSalbutamolsulphateequivalenttosalbutamol100micrograms.

Forafulllistofexcipients,see6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension.

Pressurisedaluminiumcontainerclosedwithameteringvalvecontainingawhiteoralmostwhitesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

GeriventCFCFreeInhalerisindicatedinthemanagementofbronchialasthma,forthereliefofwheezingandshortness

ofbreathusedonanasrequiredbasis.GeriventCFCFreeInhalermaybeusedasnecessarytorelieveattacksofacute

dyspnoeaandmaybeusedtopreventrecognisedallergenorexerciseinducedbronchospasm.

GeriventCFCFreeInhalermayalsobeusedinthetreatmentofreversibleairwaysobstructionassociatedwithchronic

bronchitisandemphysema.

4.2Posologyandmethodofadministration

ADULTS:Forthereliefofwheezing,shortnessofbreathandattacksofacutedyspnoeainpatientswithasthma,or

reversibleairwaysobstructionassociatedwithchronicbronchitisandemphysema,oneortwoinhalationsmaybe

administeredasasingedose.

Forprophylaxisofrecognizedallergenorexercise-inducedasthma,twoinhalations.

CHILDREN:Forthereliefofwheezing,shortnessofbreathandattacksofacutedyspnoeainchildrenwithasthma,

oneinhalationincreasingtotwoifnecessarymaybeadministeredasasingledose.

Forprophylaxisofrecognizedallergenorexercise-inducedasthma,oneinhalationincreasingtotwoifnecessary.

ELDERLY:Nospecialdosagerecommendationsaremadeforelderlypatients.

Forallpatients,themaximumrecommendeddoseshouldnotexceedeightinhalationsin24hours.Withrepetitive

dosing,inhalationsshouldnotusuallyberepeatedmoreoftenthanevery4hours.

InstructionsforUse(seealsoPILforpictograms)

Removethedustcapfromthemouthpieceoftheactuator(plasticcase)byholdingitbetweenthethumband

forefingerandsqueezinggentlywhilstpullingthemapart.Checkthattherearenoobjectsinthemouthpiece

andthatitisclean.

Holdtheinhaleruprightwithyourthumbonthebaseandyourfirstfingeronthetopofthecan,andshake

well.

Breatheoutslowlythoroughyourmouthasfarasiscomfortableandthenimmediatelyplacethemouthpieceof

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Breatheinslowlyanddeeplyandasyoustarttodosopressthemetalcanisterdownfirmlywithyourfirst

fingertospraytheaerosolandreleasethemedicine.ThisactiondeliversameasuredamountofGerivent

CFC-freeInhaler.

Relaxthepressureonthemetalcanister.Continuetobreatheinsteadilyanddeeply.

Removethemouthpieceoftheactuatorfromyourmouthwhileholdingyourbreathforabout10seconds,or

aslongascomfortable,thenbreatheoutslowly.

Ifyourdoctorinstructsyoutotakeafurtherpuff,waitforaboutoneminuteandthenrepeatsteps2to6.

Replacethedustcaponthemouthpiecebysnappingitintoplacetoprotectthemouthpiecefromdirtanddust.

TestFiring

Testtheinhalerifitisneworhasnotbeenusedformorethanoneweekbyshakingitwellandfiringtwopuffsintothe

airtocheckthatitworks.

IfyourGeriventCFC-freeInhalergetsverycold,removethemetalcanisterfromtheactuatorandwarmitbyrolling

betweenyourhands.DONOTUSEANYOTHERSOURCEOFHEATTOWARMITUP.

Cleaning

Cleantheinhaleronceaweek.Tocleanit:

Removethemetalcanisterbygrippingitfirmlyandpullingitoutoftheactuator.Thenremovethedustcap

fromtheactuator.

Cleanthemouthpieceanddustcapinwarmwater.Youcanalsoaddamilddetergentorbabybottlecleaning

solutiontothewater,yourpharmacistcanadviseyouaboutthis.Ifyouuseacleaningsolutionrinsethe

actuatoranddustcapinrunningwater.DONOTputthemetalcanisterintowater.

Drytheactuatoranddustcapinawarmplace,butavoidexcessivedirectheat.

Replacethedustcapandmetalcanisterbyreversingstep1.

Caution

Thecanisterispressurized–donotpunctureorexposethecanistertoexcessiveheatevenwhenempty.

4.3Contraindications

HypersensitivitytosalbutamoloranyoftheinactiveingredientsinGeriventCFCFreeInhaler.

GeriventCFCFreeInhaleriscontraindicatedforuseinthemanagementofprematurelabourandthreatenedabortion.

4.4Specialwarningsandprecautionsforuse

4.4.1 Specialwarnings

Potentiallyserioushypokalaemiahasbeenreportedinpatientstakingbeta-2-agonisttherapy.Particularcautionis

advisedinpatientswithsevereasthma.Hypokalaemiamayalsooccurinhypoxicpatientsandthosetreatedwith

xanthinederivatives,steroids,diureticsandlong-termlaxatives.Extracareshouldthereforebetakenifbeta-2-agonists

areusedinthesegroupsofpatientsandserumpotassiumlevelsshouldbemonitored.

Unwantedstimulationofcardiacadrenergicreceptorscanoccurinpatientstakingbeta-2-agonisttherapy.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingsalbutamol.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofmyocardialischaemiaassociatedwithsalbutamol.Patientswith

underlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoarereceiving

salbutamolshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsofworsening

heartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpainastheymaybeof

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4.4.2 Specialprecautionsforuse

Thepatientshouldbeadvisedtoseekmedicaladviceifthetreatmentceasestobeeffectiveand/ortheirasthmaseems

tobeworsening,andnottoincreasethedosewithoutmedicaladvice.

Administercautiouslytopatientswithangina,severetachycardiaorthyrotoxicosis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandbeta-blockersshouldnotusuallybeprescribedtogether.

Hypokalaemiaoccurringwithbeta-2-agonisttherapymaybeexacerbatedbytreatmentwithxanthines,steroids,

diureticsandlong-termlaxatives.

Cautionshouldbeexercisedintheuseofsalbutamolwithanaestheticagentssuchaschloroform,cyclopropane,

halothaneandotherhalogenatedagents.

Theeffectsofsalbutamolmaybealteredbyguanethidine,reserpine,methyldopa,tricyclicantidepressantsand

monoamineoxidaseinhibitors.

4.6Fertility,pregnancyandlactation

GeriventCFCFreeInhalershouldnotbeusedinpregnancyandlactationunlesstheunexpectedbenefittothemotheris

thoughttooutweighanyrisktothefoetusorneonate.

Thesafeuseofinhaledsalbutamolduringpregnancyhasnotbeenestablishedbutithasbeeninwidespreadusefor

manyyearsinhumanbeingswithoutapparentillconsequence.Inmiceandrabbitslargedosesofsalbutamolhave

beenshowntobeteratogenic.

Itisnotknownwhethersalbutamolisdistributedintobreastmilk.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Mildtremor,headache,palpitations,tachycardiaandtransientmusclecrampsmayrarelyoccur.Potentiallyserious

hypokalaemiahasbeenreportedinpatientstakingbeta-2-agonisttherapy.Myocardialischaemiahasbeenreported

spontaneouslyinpost-marketingdatatherforeitsfrequencyisregardedasunknown.

Hypersensitivityreactionsandhyperactivityinchildrenhavebeenreportedrarely.

Aswithotherinhalationtherapy,paradoxicalbronchospasmmayoccurimmediatelyafterdosing.Inthisinstance,

GeriventCFCFreeInhalershouldbediscontinuedimmediatelyandalternativetherapyinstitutedifnecessary.

4.9Overdose

Treatment:

Asthmaticpatients:Monitorbiochemicalabnormalities,particularlyhypokalaemiawhichshouldbetreatedwith

potassiumreplacementwherenecessary.Beta-adrenoceptorantagonists,evenbeta-1-selectiveantagonists,are

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Non-asthmaticpatients:Monitorandcorrectbiochemicalabnormalities,particularlyhypokalaemia.Anon-selective

beta-adrenoceptorantagonist(e.g.nadolol,propranolol)willcompetitivelyreversebothhypokalaemiaandtachycardia

(beta-1-selectivedrugswillbelargelyineffective).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Salbutamolisasympathomimeticagentwhichhasaselectiveactiononbeta-2-adrenergicreceptorsinbronchial

smoothmuscle.

5.2Pharmacokineticproperties

Salbutamolisreadilyabsorbedfromthegastro-intestinaltract,butthesystemicabsorptionoftheinhaleddrug

substanceislow.Theactionofinhaledsalbutamoldependsondirectstimulationofreceptorsinthelung.Onsetof

actionisusuallywithin10minutesofinhalationandlasts4-6hoursinmostpatients.

Salbutamolissubjecttofirst-passmetabolismintheliver;abouthalfisexcretedintheurineasaninactivesulphate

conjugate.Itdoesnotappeartobemetabolisedinthelungandthereforeitsfatefollowinginhalationtherapydepends

onthedeliverymethodused,whichdeterminestheproportionofsalbutamolinhaledrelativetotheproportion

inadvertentlyswallowed.Ithasbeensuggestedthattheslightlyextendedhalf-lifefollowinginhalationmayreflectslow

removalofactivedrugfromthelungs.

5.3Preclinicalsafetydata

Salbutamolhasbeeninwidespreaduseformanyyears;therehavebeennoadverseclinicalfindingswithGeriventCFC

FreeInhalerwhichmightreflectpre-clinicalsafetyissues(seePregnancyandLactation).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

OleicAcid

Norfurane(HFA134a)

Ethanol,Anhydrous

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Thecanistercontainsapressurisedliquid.

Donotexposetotemperaureshigherthan50°C.

Donotstoreabove25°C.

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6.5Natureandcontentsofcontainer

Apressurisedmetereddoseinhalerconsistingof:

Abluewelly-bootshapedplasticactuatorwitharemovabledustcapatoneend.

Analuminiumcontainer,withasilverferrulevalve.

Eachcompleteunitcontains200metereddoses.

6.6Specialprecautionsfordisposalandotherhandling

Patientsshouldbeadvisedfullyonthetechniqueforusingtheirinhalerbyreferencingthefulllistofinstructions

providedinthePatientInformationLeaflet.InstructionsforuseandcleaningarepresentedinSection4.2:Posology

andmethodofadministration.

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLtd.

T/aGerardLaboratories

35/36BaldoyleIndustrialEstate

GrangeRoad

Dublin13

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA577/56/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:13April2006

DateofLastRenewal:13April2011

10DATEOFREVISIONOFTHETEXT

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