COMBIVENT METERED AERSOL

Main information

  • Trade name:
  • COMBIVENT METERED AERSOL
  • Dosage:
  • 20/ 100 Mcg/ Acutuation
  • Pharmaceutical form:
  • Unknown
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMBIVENT METERED AERSOL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1151/032/001
  • Authorization date:
  • 22-06-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1151/032/001

CaseNo:2069197

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ImbatLimited

UnitL2,NorthRingBusinessPark,Santry,Dublin9

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CombiventMeteredAersol,20/100Mcg/Acutuation

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/08/2009until21/06/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CombiventMeteredAerosol20micrograms/100microgramspermetereddosePressurisedInhalation,Suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosedelivers20microgramsofipratropiumbromide(asmonohydrate)and100microgramsof

salbutamol(assulphate).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension.

ProductimportedfromGreece.

Pressurisedmetereddoseinhalerwithametalcanistercoveredwithatransparentplasticcoverandagreymouthpiece

andcapcontainingacreamy-whitesuspension.

Boehringerlogoisembossedonthebaseofthegreymouthpiece.

4CLINICALPARTICULARS

4.1TherapeuticIndications

COMBIVENTisindicatedforthetreatmentofbronchospasmassociatedwithchronicobstructivepulmonarydiseasein

patientswhorequireregulartreatmentwithbothipratropiumandsalbutamol.

4.2Posologyandmethodofadministration

Adults:Twoinhalationsfourtimesaday.

(includingelderlypatients)

Children:ThereisnoexperienceoftheuseofCOMBIVENTinchildrenbelowtheageof12years.

Administration

Thecorrectoperationofthemeteredaerosolapparatusisessentialforsuccessfultherapy.

Theaerosolshouldbeshakenandthevalvedepressedonceortwicebeforetheapparatusisinitiallyused.

Beforeeachusethefollowingrulesshouldbeobserved:

1)Removeprotectivecap.

2)Shakethemeteredaerosolwellbeforeeachuse

3)Breatheoutdeeply.

4)Holdthemeteredaerosolandcloselipsoverthemouthpiece.Thearrowandthebaseofthecontainershouldbe

pointingupwards.

5)Breatheinasdeeplyaspossible,pressingthebaseofthecontainerfirmlyatthesametime,thisreleasesonemetered

dose.Holdthebreathforafewseconds,thenremovethemouthpiecefromthemouthandbreatheout.

6)Replacetheprotectivecapafteruse.

Asthecontainerisnottransparentitisnotpossibletoseewhenthecontentsareusedup,butshakingthecontainerwill

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Themouthpieceshouldalwaysbekeptcleanandcanbewashedwithwarmwater.Ifsoapordetergentisused,the

mouthpieceshouldbethoroughlyrinsedinclearwater.

4.3Contraindications

COMBIVENTMeteredAerosoliscontraindicatedinpatientswithhypertrophicobstructivecardiomyopathyor

tachyarrhythmia,andinpatientswithahistoryofhypersensitivitytoanyofitscomponents,ortoatropineorits

derivatives.

COMBIVENTMeteredAerosolisalsocontraindicatedinpatientswithahistoryofhypersensitivitytosoyalecithinor

relatedfoodproductssuchassoyabeanandpeanut.ForsuchpatientsCOMBIVENTUnitDoseVialswithoutsoya

lecithincanbeused.

4.4Specialwarningsandprecautionsforuse

ImmediatehypersensitivityreactionsmayoccurafteradministrationofCOMBIVENTMeteredAerosol,as

demonstratedbyrarecasesofurticaria,angioedema,rash,bronchospasmandoropharyngealoedema.

Ocularcomplications:Therehavebeenrarereportsofocularcomplications(i.e.mydriasis,blurringofvision,narrow-

angleglaucoma,eyepain)whenthecontentsofmeteredaerosolscontainingipratropiumbromidehavebeensprayed

inadvertentlyintotheeye.CaremustbetakentopreventCOMBIVENTfromenteringtheeye,particularlyinpatients

whomaybepre-disposedtoglaucoma.Suchpatientsshouldbespecificallywarnedtoprotecttheireyes.

Eyepainordiscomfort,blurredvision,visualhalosorcolouredimages,inassociationwithredeyesfromconjunctival

congestionandcornealoedemamaybesignsofacutenarrow-angleglaucoma.Shouldanycombinationofthese

symptomsdevelop,treatmentwithmioticdropsshouldbeinitiatedandspecialistadvicesoughtimmediately.

PatientsmustbeinstructedinthecorrectadministrationofCOMBIVENTMeteredAerosol.

InthefollowingconditionsCOMBIVENTshouldonlybeusedaftercarefulrisk/benefitassessment:

Insufficientlycontrolleddiabetesmellitus,recentmyocardialinfarctionand/orsevereorganicheartorvascular

disorders,hyperthyroidism,pheochromocytoma,prostatichypertrophyandriskofnarrow-angleglaucoma.

Inthecaseofacute,rapidlyworseningdyspnoea(difficultyinbreathing)adoctorshouldbeconsultedimmediately.

Ifbronchialobstructiondeterioratesitisinappropriateandpossiblyhazardoustosimplyincreasetheuseof

COMBIVENTbeyondtherecommendeddoseoverextendedperiodsoftime.Ifhigherthanrecommendeddosesof

COMBIVENTarerequiredtocontrolsymptoms,thepatient'stherapyplanshouldbereviewed.

Potentiallyserioushypokalemiamayresultfrombeta2-agonisttherapy.Particularcautionisadvisedinsevereairway

obstruction,asthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroidsanddiuretics.

Additionally,hypoxiamayaggravatetheeffectsofhypokalemiaoncardiacrhythm,especiallyinpatientsreceiving

digoxin.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

Patientswithcysticfibrosismaybemorepronetogastro-intestinalmotilitydisturbances.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Beta-adrenergics,xanthinederivativesandcorticosteroidsmayenhancetheeffectofCOMBIVENT.Theconcurrent

administrationofotherbeta-mimetics,systemicallyabsorbedanticholinergicsandxanthinederivativesmayincrease

thesideeffects.Apotentiallyseriousreductionineffectmayoccurduringconcurrentadministrationofbeta-blockers.

Beta-adrenergicagonistsshouldbeadministeredwithcautioninpatientsbeingtreatedwithmonoamineoxidase

inhibitorsortricyclicantidepressants,sincetheactionofbeta-adrenergicagonistsmaybeenhanced.

Inhalationofhalogenatedhydrocarbonanaestheticssuchashalothane,trichloroethyleneandenfluranemayincreasethe

susceptibilitytothecardiovasculareffectsofbeta-agonists.

Anticholinergiceffectsofotherdrugscanbeenhanced.

4.6Pregnancyandlactation

COMBIVENTshouldonlybeusedinpregnancyandduringthelactationperiodifthepotentialbenefitjustifiesthe

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4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Incommonwithotherbeta-agonistsmorefrequentundesirableeffectsofCOMBIVENTarefinetremorofskeletal

musclesandnervousness,lessfrequentaretachycardia,dizziness,palpitationsorheadache,especiallyinhypersensitive

patients.

Potentiallyserioushypokalemiamayresultfrombeta2-agonisttherapy.

Inisolatedcasestheremaybelocalreactionssuchasdrynessofthemouth,throatirritation,dysphoniaorallergic

reactions.

Aswithotherbronchodilators,insomecasescough,inveryrareinstancesparadoxicalbronchoconstrictionshavebeen

observed.

Aswithotherbeta-mimetics,nausea,vomiting,sweating,weaknessandmyalgia/musclecrampsmayoccur.Inrare

casesdecreaseindiastolicbloodpressure,increaseinsystolicbloodpressure,arrhythmias,particularlyafterhigher

dosesmayoccur.

Inindividualcasespsychologicalalterationshavebeenreportedunderinhalationaltherapywithbeta-mimetics.

Isolatedreportsofocularcomplications(i.e.mydriasis,increasedintraocularpressure,angle-closureglaucoma,eye

pain)whenaerosolisedipratropiumbromideeitheraloneorincombinationwithanadrenergicbeta2-agonisthas

escapedintotheeyes.

Ocularsideeffects,gastro-intestinalmotilitydisturbancesandurinaryretentionmayoccurinrarecasesandare

reversible(seeSpecialPrecautions).

Allergic-typereactionssuchasskinrash,angioedemaofthetongue,lipsandface,urticaria(includinggianturticaria),

laryngospasmandanaphylacticreactionshavebeenreported.Manyofthepatientshavehadahistoryofallergyto

otherdrugsand/orfoods,includingsoyabean(seeContraindications).Thepossibilityofanaphylacticreactionsto

activeorinactiveconstituentsofCOMBIVENTisacknowledged.

4.9Overdose

Theeffectsofoverdosageareexpectedtobeprimarilyrelatedtosalbutamolbecauseacuteoverdosagewith

ipratropiumbromideisunlikelyasitisnotwellabsorbedsystemicallyafterinhalationororaladministration.

Manifestationsofoverdosagewithsalbutamolmayincludeanginalpain,hypertension,hypokalemiaandtachycardia.

Thepreferredantidoteforoverdosagewithsalbutamolisacardioselectivebeta-blockingagentbutduecareand

attentionshouldbeusedinadministeringthesedrugsinpatientswithahistoryofbronchospasm.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ipratropiumbromideisananticholinergicagentwhichinhibitsvagallymediatedreflexesbyantagonisingtheactionof

acetylcholine,thetransmitteragentreleasedfromthevagusnerve.Thebronchodilationfollowinginhalationof

ipratropiumbromideisprimarilylocalandsitespecifictothelungandnotsystemicinnature.

Salbutamolsulphateisabeta2-adrenergicagentwhichactsonairwaysmoothmuscleresultinginrelaxation.

Salbutamolrelaxesallsmoothmusclefromthetracheatotheterminalbronchiolesandprotectsagainstall

bronchoconstrictorchallenges.

5.2Pharmacokineticproperties

Ipratropiumbromideisnotreadilyabsorbedintothesystemiccirculationeitherfromthesurfaceofthelungorfromthe

gastrointestinaltractascomparedbybloodlevelandrenalexcretionstudies.Thehalf-lifeeliminationisabout3-4

hoursafterinhalationorintravenousadministration.Ipratropiumbromidedoesnotpenetratethebloodbrainbarrier.

Salbutamolsulphateisrapidlyandcompletelyabsorbedfollowingoraladministrationeitherbytheinhaledorgastric

route.Peakplasmasalbutamolconcentrationsareseenwithinthreehoursofadministrationandthedrugisexcreted

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Intravenoussalbutamolwillcrossthebloodbrainbarrierreachingconcentrationsamountingtoaboutfivepercentof

theplasmaconcentrations.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dichlorodifluoromethane

Cryofluorane

Trichloromonofluoromethane

Soyalecithin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotfreeze.

Thecanistercontainsapressurisedliquid.Donotexposetotemperatureshigherthan50°C.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

A17mlpressurisedaluminiumcontainercontaining10mlofsuspensionclosedwitha50microlitremeteringvalve

containing200metereddoses,suppliedwithaplasticactuator.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

ImbatLimited

UnitL2

NorthRingBusinessPark

Santry

Dublin9

Irish Medicines Board

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PPA1151/32/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:22ndJune2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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