BETAGAN 0.5 %w/v Eye Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
LEVOBUNOLOL HYDROCHLORIDE
Available from:
B & S Healthcare
INN (International Name):
LEVOBUNOLOL HYDROCHLORIDE
Dosage:
0.5 %w/v
Pharmaceutical form:
Eye Drops Solution
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PPA1328/137/001
Authorization date:
0000-00-00

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betagan0.5%w/vEyeDrops,Solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlsolutioncontains5mglevobunololhydrochloride.

Excipient(s):Containsbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution.

ProductimportedfromUK

Aclear,colourlesstolightyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthecontrolofintraocularpressureinchronicopenangleglaucomaandocularhypertension.

4.2Posologyandmethodofadministration

Adults(includingtheelderly):TherecommendeddosageisonedropofBetaganintheaffectedeye(s)onceortwice

daily.

Betaganisnotrecommendedforuseinchildrenduetolackofsafetyandefficacydata(seesection5.1).

Methodofadministration:topicalintotheconjunctivalsac.

Ifrequired,Betaganmaybeusedwithotheragentstolowerintra-ocularpressure.Theuseoftwotopicalbeta-

adrenergicblockingagentsisnotrecommended(seesection4.4).

IntraocularpressureshouldbemeasuredapproximatelyfourweeksafterstartingtreatmentwithBetaganasareturnto

normalocularpressurecantakeafewweeks.

Aswithanyeyedrops,toreducepossiblesystemicabsorption,itisrecommendedthatthelachrymalsaciscompressed

atthemedialcanthus(punctualocclusion)foroneminute.Thisshouldbeperformedimmediatelyfollowingthe

instillationofeachdrop.

Transferfromotherbeta-blockingtreatment

Whenanotherbetablockingagentisbeingusedtreatmentmustbediscontinuedafterafulldayoftherapy.Start

treatmentwithBetaganthenextdaywithonedropofBetagantopicallyappliedintotheconjunctivalsacintheaffected

eye(s)onceortwiceaday.

IfBetaganistoreplaceacombinationofanti-glaucomaproducts,onlyasingleproductshouldberemovedatatime.

Useinrenalandhepaticimpairment

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 1

beusedintreatingsuchpatients(seesection4.4).

Whenusingnasolacrimalocclusionorclosingtheeyelidsfor2minutes,thesystemicabsorptionisreduced.Thismay

resultinadecreaseinsystemicsideeffectsandanincreaseinlocalactivity.

4.3Contraindications

Hypersensitivitytotheactivesubstance(substances)ortoanyoftheexcipients.

Reactiveairwaydiseaseincludingbronchialasthmaorahistoryofbronchialasthma,severechronicobstructive

pulmonarydisease.

Sinusbradycardia,sicksinussyndromesino-atrialblock,secondorthirddegreeatrioventricularblocknotcontrolled

withpace-maker.Overtcardiacfailure,cardiogenicshock.

4.4Specialwarningsandprecautionsforuse

Likeothertopically-appliedophthalmicagents,levobunololisabsorbedsystemically.Duetobeta-adrenergic

component,levobunolol,thesametypesofcardiovascular,pulmonaryandotheradversereactionsseenwithsystemic

beta-adrenergicblockingagentsmayoccur.IncidenceofsystemicADRsaftertopicalophthalmicadministrationis

lowerthanforsystemicadministration.Toreducethesystemicabsorption,see4.2.

Cardiacdisorders:

Inpatientswithcardiovasculardiseases(e.g.coronaryheartdisease,Prinzmetal’sanginaandcardiacfailure)and

hypotensiontherapywithbeta-blockersshouldbecriticallyassessedandthetherapywithotheractivesubstances

shouldbeconsidered.Patientswithcardiovasculardiseasesshouldbewatchedforsignsofdeteriorationofthese

diseasesandofadversereactions.

Duetoitsnegativeeffectonconductiontime,beta-blockersshouldonlybegivenwithcautiontopatientswithfirst

degreeheartblock.

Vasculardisorders

Patientswithsevereperipheralcirculatorydisturbance/disorders(i.e.severeformsofRaynaud’sdiseaseorRaynaud’s

syndrome)shouldbetreatedwithcaution.

Respiratorydisorders

Respiratoryreactionsincludingdeathduetobronchospasminpatientswithasthmahavebeenreportedfollowing

administrationofsomeophthalmicbeta-blockers.

BETAGANshouldbeusedwithcaution,inpatientswithmild/moderatechronicobstructivepulmonarydisease

(COPD)andonlyifthepotentialbenefitoutweighsthepotentialrisk.

Hypoglycaemia/diabetes

Beta-blockersshouldbeadministeredwithcautioninpatientssubjecttospontaneoushypoglycaemiaortopatientswith

labilediabetes,asbeta-blockersmaymaskthesignsandsymptomsofacutehypoglycaemia.

Beta-blockersmayalsomaskthesignsofhyperthyroidism.

Cornealdiseases:

Ophthalmic-blockersmayinducedrynessofeyes.Patientswithcornealdiseasesshouldbetreatedwithcaution.

Otherbeta-blockingagents

Theeffectonintra-ocularpressureortheknowneffectsofsystemicbeta-blockademaybepotentiatedwhen

levobunololisgiventothepatientsalreadyreceivingasystemicbeta-blockingagent.Theresponseofthesepatients

shouldbecloselyobserved.Theuseoftwotopicalbeta-adrenergicblockingagentsisnotrecommended(seesection

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 2

Anaphylacticreactions

Whiletakingbeta-blockers,patientswithahistoryofatopyorahistoryofsevereanaphylacticreactiontoavarietyof

allergensmaybemorereactivetorepeatedchallengewithsuchallergensandunresponsivetotheusualdoseof

adrenalineusedtotreatanaphylacticreactions.

Choroidaldetachment

Choroidaldetachmenthasbeenreportedwithadministrationofaqueoussuppressanttherapy(e.g.timolol,

acetazolamide)afterfiltrationprocedures.

Surgicalanaesthesia

-blockingophthalmologicalpreparationsmayblocksystemic-agonisteffectse.g.ofadrenaline.The

anaesthesiologistshouldbeinformedwhenthepatientisreceivinglevobunolol.

Cautionshouldbeexercisedintreatingpatientswithsevereorunstableanduncontrolledcardiovasculardisease

includingfirstdegreeatrioventricularblock.Cardiacfailureshouldbeadequatelycontrolledbeforebeginningtherapy.

Patientswithahistoryofseverecardiacdiseaseshouldbewatchedforsignsofcardiacfailureandhavetheirpulserates

checked.

Cardiacandrespiratoryreactions,includingdeathduetobronchospasminpatientswithasthmas,and,rarelydeathin

associationwithcardiacfailureshavebeenreportedfollowingadministrationoflevobunolol.

Theeffectonintra-ocularpressureortheknowneffectsofsystemicbeta-blockademaybeexaggeratedwhenBetagan

isgiventopatientsalreadyreceivingasystemicbetablockingagent.Theresponseofthesepatientsshouldbeclosely

observed.Theuseoftwotopicalbeta-adrenergicblockingagentsisnotrecommended.

Inpatientswithangleclosureglaucoma,theimmediateobjectiveoftreatmentistoreopentheangle.Thisrequires

constrictingthepupilwithamiotic.Betaganhaslittleornoeffectonthepupil.WhenBetaganisusedtoreduce

elevatedintra-ocularpressureinangle-closureglaucomaitshouldbeusedwithamioticandnotalone.

Inpatientswithsevererenalimpairmentondialysis,treatmentwithlevobunololhasbeenassociatedwithpronounced

hypotension.

Levobunololmayimpaircompensatorytachycardiaandincreaseriskofhypotensionwhenusedinconjunctionwith

anaesthetics.TheanaesthetistmustbeinformedifthepatientisusingBetagan.

Beta-blockersmayalsomaskthesignsofhyperthyroidismandcausesworseningogPrinzmetalangina,severe

peripheralandcentralcirculatorydisordersandhypotension.Betaganmustbeusedincautioninpatientswith

metabolicacidosisanduntreatedphaeochromocytoma.

Beta-adrenergicblockingagentsshouldbeadministeredwithcautioninpatientssubjecttospontaneoushypoglycaemia

ortouncontrolleddiabeticpatients(especiallythosewithlabilediabetes)asbeta-blockersmaymaskthesignsand

symptomsofacutehypoglycaemia.Theindicatorysignsofacutehypoglycaemiamaybemasked,inparticular

tachycardia,palpitationsandsweating.

Betaganshouldbeusedwithcautioninpatientswithdepression,cerebralorcoronaryinsufficiency.Raynaud's

phenomenon,orthostatichypotensionorthromboangiitisobliterans.

Whiletakingbeta-blockers,patientswithahistoryofatopyorahistoryofsevereanaphylacticreactiontoavarietyof

allergensmaybeunresponsivetotheusualdoseofadrenalineusedtotreatanaphylacticreactions.

Aswithsystemicbeta-blockers,ifdiscontinuationoftreatmentisneededinpatientswithcoronaryheartdisease,

therapyshouldbewithdrawngraduallytoavoidrhythmdisorders,myocardialinfarctionorsuddendeath.

Choroidaldetachmentafterfiltrationprocedureshasbeenreportedwithadministrationofaqueoussuppressanttherapy

(e.g.timolol,acetazolamide).

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 3

diagnosis&undercontinuousmonitoringatshortintervals.

Skinrashesand/ordryeyesassociatedwiththeuseofbeta-blockershavebeenreported.Theincidenceissmalland

symptomshavestoppedonwithdrawalofthebeta-blockers.Discontinuationoftheuseofbeta-blockersshouldbe

consideredifthesesymptomsarereportedbutcessationoftreatmentshouldbegradual.

ThepreservativeinBetagan,benzalkoniumchloride,maycauseeyeirritation.Removecontactlensespriorto

applicationandwaitatleast15minutesbeforereinsertion.Benzalkoniumchlorideisknowntodiscoloursoftcontact

lenses.Avoidcontactwithsoftcontactlenses.

Betagancontainssodiummetabisulphitewhichmayrarelycauseseverehypersensitivityreactionsandbronchospasm.

AthletesshouldbeawarethatBetagancontainslevonbunololthatmayinduceapositiveresultinanti-dopingcontrols.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificdruginteractionstudieshavebeenperformedwithlevobunololhydrochloride.

AlthoughspecificdruginteractionsstudieshavenotbeenconductedwithBetagan,thetheoreticalpossibilityofan

additiveorpotentiatingeffectwithCNSdepressants(alcohol,barbiturates,opiates,sedatives,oranaesthetics)should

beconsidered.

Thereispotentialforadditiveeffectsresultinginhypotension,and/ormarkedbradycardiawhenophthalmicbeta-

blockerssolutionisadministeredconcomitantlywithoralcalciumchannelblockers,beta-adrenergicblockingagents,

antiarrhythmics(includingamiodarone),digitalisglycosides,parasympathomimetics,guanethidine.

CautionshouldbeexercisedandpatientsmustbemonitoredwhenBetaganisusedconcomitantlywithoralbeta-

adrenergicblockingagents,becauseofthepotentialforadditiveeffectsonsystemicblockade.

Enhancedhypotensiveeffectisseenwhenbaclofenisgivenwithbetablockers.Sincesomesystemicabsorptionmay

followtopicalapplicationofbeta-blockers,regularbloodpressuremonitoringisadvised.

Mydriasisresultingfromconcomitantuseofophthalmicbeta-blockersandadrenaline(epinephrine)hasbeenreported

occasionally.

Althoughlevobunololhaslittleeffectonthesizeofthepupil,mydriasishasoccasionallybeenreportedwhen

levobunololhasbeenusedwithmydriaticagentssuchasadrenaline.

Beta-blockersmayincreasethehypoglycaemiceffectofantidiabeticagents.Beta-blockerscanmaskthesignsand

symptomsofhypoglycaemia(seesection4.4)

Thehypertensivereactiontosuddenwithdrawalofclonidinecanbepotentiatedwhentakingbeta-blockers.

Potentiatedsystemicbeta-blockade(e.g.decreasedheartrate)hasbeenreportedduringcombinedtreatmentwith

quinidineandlevobunolol,possibilybecausequinidineinhibitsthemetabolismoflevonbunololviatheP450enzyme,

CYP2D6.

Concomitantuseofabeta-blockerwithanaestheticdrugsmayattenuatecompensatorytachycardiaandincreasetherisk

ofhypotension(seesection4.4),andthereforetheanaesthetistmustbeinformedifthepatientisusingBetagan.

CautionmustbeexercisedifBetaganisusedconcomitantlywithiodinecontrastproductsorintravenously

administeredlidocaine.

Cimetidinemayincreasetheplasmaconcentrationsoflevobunolol.

NodataonthelevelofcirculatingcatecholaminesafterBetaganadministeredareavailable.Caution,however,is

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 4

chlorpromazine,methylphenidate,reserpinebecauseofpossibleadditiveeffectsandtheproductionofhypertension

and/ormarkedbradycardia,whichmayproductvertigo,syncopeorposturalhypotension.

AlthoughspecificdruginteractionsstudieshavenotbeenconductedwithBetagan,knownadditiveIOPloweringeffect

withprostamides,prostaglandins,alpha-agonists,carbonicanhydraseinhibitorsandpilocarpineshouldbeconsidered.

4.6Fertility,pregnancyandlactation

Pregnancy

Therearenoadequatedatafortheuseoflevobunololhydrochlorideinpregnantwomen.Levobunololhydrochloride

shouldnotbeusedduringpregnancyunlessclearlynecessary.

Toreducesystemicabsorption,see4.2.

Epidemiologicalstudieshavenotrevealedmalformativeeffectsbutshowariskforintrauterinegrowthretardation

whenbeta-blockersareadministeredbytheoralroute.Inaddition,signsandsymptomsofbeta-blockade(e.g.

bradycardia,hypotension,respiratorydistressandhypoglycaemia)havebeenobservedintheneonatewhenbeta-

blockershavebeenadministereduntildelivery.IfBetaganisadministereduntildelivery,theneonateshouldbe

carefullymonitoredduringthefirstdaysoflife.

Animalstudieswithlevobunololhaveshownreproductivetoxicityatdosessignificantlyhigherthanwouldbeusedin

clinicalpractice.

Lactation

Beta-blockersareexcretedinbreastmilk.However,attherapeuticdosesoflevobunololineyedropsitisnotlikelythat

sufficientamountswouldbepresentinbreastmilktoproduceclinicalsymptomsofbeta-blockadeintheinfant.To

reducethesystemicabsorptionsee4.2.

Levobunololisexcretedinbreastmilk.Betaganshouldnotbeusedbybreast-feedingwomen.

4.7Effectsonabilitytodriveandusemachines

Betaganhasminorinfluenceontheabilitytodriveandusemachines.Betaganmaycausetransientblurringofvision,

fatigueand/ordrowsinesswhichmayimpairtheabilitytodriveoroperatemachines.Thepatientshouldwaituntil

thesesymptomshaveclearedbeforedrivingorusingmachinery.

4.8Undesirableeffects

Likeothertopicallyappliedophthalmicdrugs,levobunololisabsorbedintothesystemiccirculation.Thismaycause

similarundesirableeffectsasseenwithsystemicbeta-blockingagents.IncidenceofsystemicADRsaftertopical

ophthalmicadministrationislowerthanforsystemicadministration.Listedadversereactionsincludereactionsseen

withintheclassofophthalmicbeta-blockers.

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Thefollowingterminologieshavebeenusedinordertoclassifytheoccurrenceofundesirableeffects:VeryCommon

(1/10);Common(1/100to<1/10);Uncommon(1/1,000to<1/100);Rare(1/10,000to<1/1,000);Veryrare

(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

PsychiatricDisorders

Notknown:Depression

NervousSystemDisorders

Notknown:Ataxia,Confusion,Dizziness,Somnolence,Lethargy,Headache

EyeDisorders

VeryCommon:Eyeirritation,Conjunctivalirritation

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 5

Notknown:Cornealreflexdecreased,Iridocyclitis,Keratitis,Visualdisturbance,Eye/Eyelidspruritus,Eye/Eyelid

oedema,Eyedischarge,Lacrimationincreased,dryeye.

CardiacDisorders

Notknown:Syncope,Bradycardia,Atrioventricularblock,Palpitations

VascularDisorders

Notknown:Hypotension

Respiratory,Thoracic,andMediastinalDisorders

Notknown:Asthma,Dyspnoea,Throatirritation,Nasaldiscomfort

GastrointestinalDisorders

Notknown:Nausea

SkinandSubcutaneousTissueDisorders

Notknown:Urticaria,Dermatitis,Rash,Erythema,Skinexfoliation,Lichenoidkeratosis,Pruritus

GeneralDisordersandAdministrationSiteConditions

Notknown:Faceoedema,Fatigue.

Thefollowingeventshavebeenreportedwithsystemicbeta-blockerformulationsandmayoccurwiththetopical

formulation:

NervousSystemDisorders:Sleepdisturbance

Psychiatricdisorders:Impotence,hallucinations,nightmares

CardiacDisorders:Cardiacfailure

VascularDisorders:Coldextremities,Raynaud'sphenomenon,worseningintermittentclaudication

GastrointestinalDisorders:Abdominalpainupper,vomiting,diarrhea

Respiratory,ThoracicandMediastinalDisorders:Bronchospasm

EndocrineDisorders:Hypoglycaemia

SkinandsubcutaneousTissueDisorders:Angioedema(Quincke'soedema),cutaneous(seesection4.4)andpsoriasis-

likesymptoms.

Datafromclinicalstudiesincludingfrequencies(ifavailable).

Additionaladversereactionshavebeenseenwithophthalmicbeta-blockersandmaypotentiallyoccurwith

BETAGAN:

Immunesystemdisorders:

Systemicallergicreactionsincludingangioedema,urticaria,localizedandgeneralizedrash,pruritus,anaphylactic

reaction.

Metabolismandnutritiondisorders:

Hypoglycaemia.

Psychiatricdisorders:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 6

Nervoussystemdisorders:

Syncope,cerebrovascularaccidents,cerebralischemia,increasesinsignsandsymptomsofmyastheniagravis,

dizziness,paraesthesia,andheadache.

Eyedisorders:

Signsandsymptomsofocularirritation(e.g.burning,stinging.itching,tearing,redness),blepharitis,keratitis,blurred

visionandchoroidaldetachmentfollowingfiltrationsurgery(see4.4Specialwarningsandspecialprecautionsforuse).

Decreasedcornealsensitivity,dryeyes,cornealerosion,ptosis,diplopia.

Cardiacdisorders:

Bradycardia,chestpain,palpitations,oedema,arrhythmia,congestiveheartfailure,atrioventricularblock,cardiac

arrest,cardiacfailure.

Vasculardisorders:

Hypotension,Raynaud’sphenomenon,coldhandsandfeet.

Respiratory,thoracic,andmediastinaldisorders:

Bronchospasm,(predominantlyinpatientswithpre-existingbronchospasticdisease),dyspnoea,cough.

Gastrointestinaldisorders:

Dysgeusia,nausea,dyspepsia,diarrhoea,drymouth,abdominalpain,vomiting.

Skinandsubcutaneoustissuedisorders:

Alopecia,psoriasiformrashorexacerbationofpsoriasis,skinrash.

Musculoskeletalandconnectivetissuedisorders:

Myalgia.

Reproductivesystemandbreastdisorders:

Sexualdysfunction,decreasedlibido.

Generaldisordersandadministrationsiteconditions:

Asthenia/fatigue

4.9Overdose

TherearenodataavailableonhumanoverdosagewithBetagan,whichisunlikelytooccurviatheocularroute.Should

accidentalocularoverdosageoccur,flushtheeye(s)withwaterornormalsaline.Ifaccidentallyingested,systemic

symptomsmayresultandeffortstodecreasefurtherabsorptionmaybeappropriate.Thesymptomsassociatedwith

systemicoverdosagearemostlikelytobebradycardia,hypotension,bronchospasmandcardiacfailure.Therapyfor

overdosageofabeta-adrenergicagentshouldbeinstituted,suchasintravenousadministrationofatropinesulphate0.25

to2mgtoinducevagalblockade.Conventionaltherapyforhypotension,bronchospasm,heartblockandcardiacfailure

maybenecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

SafetyandeffectivenessofBetaganinpaediatricpatientshavenotbeenestablished.

Levobunololisanon-cardioselectivebeta-adrenoceptorblockingagent,equipotentatbothbetaandbetareceptors.

Levobunololisgreaterthan60timesmorepotentthanitsdextroisomerinitsbeta-blockingactivity.

Inordertoobtainthehighestdegreeofbeta-blockingpotentialwithoutincreasingthepotentialfordirectmyocardial

depression,thelevoisomer,levobunolol,isused.Levobunololdoesnothavesignificantlocalanaesthetic(membrane-

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 7

intraocularpressure.

Betaganwheninstilledintheeyewilllowerelevatedintraocularpressureaswellasnormalintraocularpressure,

whetherornotaccompaniedbyglaucoma.Elevatedintraocularpressurepresentsamajorriskfactorinthepathogenesis

ofglaucomatousfieldloss.Thehigherthelevelofintraocularpressure,thelikelihoodofopticnervedamageandvisual

fieldloss.

Theprimarymechanismofactionoflevobunololinreducingintraocularpressureismostlikelyadecreaseinaqueous

humourproduction.Betaganreducesintraocularpressurewithlittleornoeffectonpupilsizeincontrasttothemiosis

whichcholinergicagentsareknowntoproduce.

TheblurredvisionandnightblindnessoftenassociatedwithmioticswouldnotbeexpectedwiththeuseofBetagan.

Patientswithcataractsavoidtheinabilitytoseearoundlenticularopacitiescausedbypupilconstriction.

5.2Pharmacokineticproperties

TheonsetofactionwithonedropofBetagancanbedetectedwithinonehourafterinstillation,withmaximumeffect

seenbetweentwoandsixhours.Asignificantdecreasecanbemaintainedforupto24hoursfollowingasingledose.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Poly(vinylalcohol)

Benzalkoniumchloride

Sodiummetabisulphite(E223)

Sodiumchloride

Disodiumedetate

Sodiumphosphate,dibasic,heptahydrate

Potassiumdihydrogenphosphate

Sodiumhydroxide(toadjustpH)or

Hydrochloricacid(toadjustpH)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthebottleandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 8

6.5Natureandcontentsofcontainer

Whitebottleanddroppertipmadeoflowdensitypolyethylene.Thecapiseitheragreenorwhitepolystyrenecapora

white,polystyrenecompliancecap(C-Cap®)withanexternalrotatingsleeveindicatingdailydosagestatus.Eachhave

asafetysealtoensureintegrity.

Thebottlecontains5mlofsolution.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4,BradfieldRoad

MiddlesexHA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/137/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3 rd

September2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/05/2012 CRN 2109823 page number: 9

Similar products

Search alerts related to this product

View documents history

Share this information