COMBIVENT METERED AEROSOL 20 MICROGRAMS/100 MICROG

Main information

  • Trade name:
  • COMBIVENT METERED AEROSOL 20 MICROGRAMS/100 MICROG
  • Dosage:
  • 20/100mcg/ Mcg/Dose
  • Pharmaceutical form:
  • Pressurised Inhalation Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COMBIVENT METERED AEROSOL 20 MICROGRAMS/100 MICROG
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0007/052/001
  • Authorization date:
  • 14-04-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0007/052/001

CaseNo:2062024

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BoehringerIngelheimLimited

EllesfieldAvenue,Bracknell,BerkshireRG128YS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CombiventMeteredAerosol20micrograms/100microgramspermetereddose,PressurisedInhalationSuspension.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom27/02/2009until12/11/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

COMBIVENTMeteredAerosol20micrograms/100microgramspermetereddose,PressurisedInhalationSuspension.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosedelivers20microgramsofipratropiumbromide(asmonohydrate)and100microgramsof

salbutamol(assulphate).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Pressurisedinhalation,suspension.

Pressurisedaluminiumcontainerclosedwithameteringvalvecontainingacreamy-whitesuspensioninsertedintoa

greyplasticactuator(mouthpiece).

4CLINICALPARTICULARS

4.1TherapeuticIndications

COMBIVENTisindicatedforthetreatmentofbronchospasmassociatedwithchronicobstructivepulmonarydiseasein

patientswhorequireregulartreatmentwithbothipratropiumandsalbutamol.

4.2Posologyandmethodofadministration

Adults(includingelderlypatients)

Twoinhalationsfourtimesaday.

Children

ThereisnoexperienceoftheuseofCOMBIVENTinchildrenbelowtheageof12years.

Administration

Thecorrectoperationofthemeteredaerosolapparatusisessentialforsuccessfultherapy.

Theaerosolshouldbeshakenandthevalvedepressedonceortwicebeforetheapparatusisinitiallyused.

Beforeeachusethefollowingrulesshouldbeobserved:

Removeprotectivecap.

Shakethemeteredaerosolwellbeforeeachuse

Breatheoutdeeply

Holdthemeteredaerosolandcloselipsoverthemouthpiece.Thearrowandthebaseofthecontainershouldbe

pointingupwards.

Breatheinasdeeplyaspossible,pressingthebaseofthecontainerfirmlyatthesametime,thisreleasesone

metereddose.Holdthebreathforafewseconds,thenremovethemouthpiecefromthemouthandbreatheout.

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Asthecontainerisnottransparentitisnotpossibletoseewhenthecontentsareusedup,butshakingthecontainerwill

showifthereisanyremainingfluid.

Themouthpieceshouldalwaysbekeptcleanandcanbewashedwithwarmwater.Ifsoapordetergentisused,the

mouthpieceshouldbethoroughlyrinsedinclearwater.

4.3Contraindications

COMBIVENTMeteredAerosoliscontraindicatedinpatientswithhypertrophicobstructivecardiomyopathyor

tachyarrhythmia,andinpatientswithahistoryofhypersensitivitytoanyofitscomponents,ortoatropineorits

derivatives.

COMBIVENTMeteredAerosolisalsocontraindicatedinpatientswithahistoryofhypersensitivitytosoyalecithinor

relatedfoodproductssuchassoyabeanandpeanut.ForsuchpatientsCOMBIVENTUnitDoseVialswithoutsoya

lecithincanbeused.

4.4Specialwarningsandprecautionsforuse

ImmediatehypersensitivityreactionsmayoccurafteradministrationofCOMBIVENTMeteredAerosol,as

demonstratedbyrarecasesofurticaria,angioedema,rash,bronchospasmandoropharyngealoedema.

Therehavebeenrarereportsofocularcomplications(i.e.mydriasis,blurringofvision,narrow-angleglaucoma,eye

pain)whenthecontentsofmeteredaerosolscontainingipratropiumbromidehavebeensprayedinadvertentlyintothe

eye.CaremustbetakentopreventCOMBIVENTfromenteringtheeye,particularlyinpatientswhomaybepre-

disposedtoglaucoma.Suchpatientsshouldbespecificallywarnedtoprotecttheireyes.

Eyepainordiscomfort,blurredvision,visualhalosorcolouredimages,inassociationwithredeyesfromconjunctival

congestionandcornealoedemamaybesignsofacutenarrow-angleglaucoma.Shouldanycombinationofthese

symptomsdevelop,treatmentwithmioticdropsshouldbeinitiatedandspecialistadvicesoughtimmediately.

PatientsmustbeinstructedinthecorrectadministrationofCOMBIVENTMeteredAerosol.

InthefollowingconditionsCOMBIVENTshouldonlybeusedaftercarefulrisk/benefitassessment:

Insufficientlycontrolleddiabetesmellitus,recentmyocardialinfarctionand/orsevereorganicheartorvascular

disorders,hyperthyroidism,pheochromocytoma,riskofnarrow-angleglaucoma,prostatichypertrophyor

bladder-neckobstruction.

Inthecaseofacute,rapidlyworseningdyspnoea(difficultyinbreathing)adoctorshouldbeconsulted

immediately.

Ifbronchialobstructiondeterioratesitisinappropriateandpossiblyhazardoustosimplyincreasetheuseof

COMBIVENTbeyondtherecommendeddoseoverextendedperiodsoftime.Ifhigherthanrecommendeddosesof

COMBIVENTarerequiredtocontrolsymptoms,thepatient'stherapyplanshouldbereviewed.

Potentiallyserioushypokalemiamayresultfrombeta-agonisttherapy.Particularcautionisadvisedinsevereairway

obstruction,asthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroidsand

diuretics.Additionally,hypoxiamayaggravatetheeffectsofhypokalemiaoncardiacrhythm,especiallyinpatients

receivingdigoxin.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

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Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingsalbutamol.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofmyocardialischaemiaassociatedwithsalbutamol.Patientswith

underlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoarereceiving

salbutamolshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsofworsening

heartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpainastheymaybeof

eitherrespiratoryorcardiacorigin.

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

potentialrisks.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Thefollowingsideeffectshavebeenreportedbasedonclinicaltrialsinvolving821patients.

Frequencies

Verycommon ≥1/10

Common ≥1/100<1/10

Uncommon ≥1/1,000<1/100

Rare ≥1/10,000<1/1,000

Veryrare ≥1/10,000

Notknown cannotbeestimatedfromtheavailabledata

Immunesystemdisorders:

Notknown:Anaphylacticreaction

Notknown:Hypersensitivity

Metabolismandnutritiondisorders:

Notknown:Hypokalaemia

Psychiatricdisorders:

Notknown:Mentaldisorder

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Nervoussystemdisorders:

Uncommon:Dizziness

Uncommon:Headache

Uncommon:Tremor

Eyedisorders:

Notknown:Angleclosureglaucoma

Notknown:Eyepain

Notknown:Intraocularpressureincreased

Notknow:Mydriasis

Notknown:Visionblurred

Therehavebeenisolatedreportsofocularcomplicationswithsymptomsmentionedabovewhenaerosolised

ipratropiumbromideeitheraloneorincombinationwithanadrenergicbeta2-agonist,hasescapedintotheeyes.

Cardiacdisorders:

Veryrare:Arrhythmia

Veryrare:Atrialfibrillation

Veryrare:Myocardialischaemia

Uncommon:Palpitations

Uncommon:Tachycardia

Notknown:Bloodpressurediastolicdecreased

Notknown:Bloodpressuresystolicincreased

Respiratory,thoracicandmediastinaldisorders:

Notknown:Bronchospasm

Notknown:Laryngospasm

Notknown:Pharyngealoedema

Uncommon:Cough

Uncommon:Dysphonia

Notknown:Throatirritation

Gastrointestinaldisorders:

Notknow:Oedemamouth

Common:Drymouth

Notknown:Gastrointestinalmotilitydisorder

Uncommon:Nausea

Notknown:Vomiting

Skinandsubcutaneoustissuedisorders:

Notknown:Angioedema

Notknown:Hyperhidrosis

Notknown:Rash

Notknown:Skinreaction

Notknown:Urticaria

Musculoskeletalandconnectivetissuedisorders:

Notknown:Musclespasms

Notknown:Muscularweakness

Notknown:Myalgia

Renalandurinarydisorders:

Uncommon:Urinaryretention

Generaldisordersandadministrationsiteconditions:

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4.9Overdose

Theeffectsofoverdosageareexpectedtobeprimarilyrelatedtosalbutamolbecauseacuteoverdosagewith

ipratropiumbromideisunlikelyasitisnotwellabsorbedsystemicallyafterinhalationororaladministration.

Manifestationsofoverdosagewithsalbutamolmayincludeanginalpain,hypertension,hypokalemiaandtachycardia.

Thepreferredantidoteforoverdosagewithsalbutamolisacardioselectivebeta-blockingagentbutduecareand

attentionshouldbeusedinadministeringthesedrugsinpatientswithahistoryofbronchospasm.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ipratropiumbromideisananticholinergicagentwhichinhibitsvagallymediatedreflexesbyantagonisingtheactionof

acetylcholine,thetransmitteragentreleasedfromthevagusnerve.Thebronchodilationfollowinginhalationof

ipratropiumbromideisprimarilylocalandsitespecifictothelungandnotsystemicinnature.

Salbutamolsulphateisabeta-adrenergicagentwhichactsonairwaysmoothmuscleresultinginrelaxation.

Salbutamolrelaxesallsmoothmusclefromthetracheatotheterminalbronchiolesandprotectsagainstall

bronchoconstrictorchallenges.

5.2Pharmacokineticproperties

Ipratropiumbromideisnotreadilyabsorbedintothesystemiccirculationeitherfromthesurfaceofthelungorfromthe

gastrointestinaltractascomparedbybloodlevelandrenalexcretionstudies.Thehalf-lifeeliminationisabout3-4

hoursafterinhalationorintravenousadministration.

Ipratropiumbromidedoesnotpenetratethebloodbrainbarrier.

Salbutamolsulphateisrapidlyandcompletelyabsorbedfollowingoraladministrationeitherbytheinhaledorgastric

route.Peakplasmasalbutamolconcentrationsareseenwithinthreehoursofadministrationandthedrugisexcreted

unchangedintheurineafter24hours.Intravenoussalbutamolwillcrossthebloodbrainbarrierreachingconcentrations

amountingtoaboutfivepercentoftheplasmaconcentrations.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dichlorodifluoromethane

Dichlorotetrafluoroethane

Trichloromonofluoromethane

SoyaLecithin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Storebelow25°C.

Protectfromdirectsunlight.Donotfreeze.

Thecanistercontainsapressurisedliquid.Donotexposetotemperatureshigherthan50ºC.Donotpiercethecanister.

6.5Natureandcontentsofcontainer

A17mlpressurisedaluminiumcontainercontaining10mlofsuspensionclosedwitha50microlitremeteringvalve

containing200metereddoses,suppliedwithaplasticactuator.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimLimited

EllesfieldAvenue

Bracknell

Berkshire

RG128YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0007/052/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14 th

April1994

Dateoflastrenewal:13 th

November2005

10DATEOFREVISIONOFTHETEXT

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