SUMMARYOFPRODUCTCHARACTERISTICS

Mitexeardrops andcutaneous suspensionfordogs and cats

(AT, DE, EE,EL, ES, FR,HR,IT, LT, LV,PT

Saniotic vet. eardropsandcutaneoussuspensionfordogs and cats

(DK, FI,IS, NO, SE

Aurimic eardrops and cutaneoussuspension fordogsand cats

(BE, BG, IE, NL, RO, UK

Orilan eardropsand cutaneous suspensionfordogs and cats

(CZ, HU, PL, SK)

Eachmlcontains:

Active substances:

Miconazolenitrate 23.0 mg

(equivalentto19.98 mg miconazole)

Prednisoloneacetate 5.0 mg

(equivalentto4.48 mgprednisolone)

Polymyxin Bsulfate 0.5293mg

(equivalentto5500 IUpolymyxin Bsulfate)

Excipients:

Forthe fulllistofexcipients, seesection6.1

Eardropsand cutaneoussuspension.

White suspension.

Dogs and cats.

Forthe treatmentofotitis externa andsmalllocalisedsuperficialskininfectionsindogs and cats caused byinfections with the followingmiconazole and polymyxin Bsensitive bacteriaandfungi:

TreatmentofOtodectes cynotis infestations wherethere isconcurrentinfectionwith miconazoleand polymyxin Bsensitive pathogens.

Do notuse:

• in case of hypersensitivity to the active substances of the veterinary medicinal product, as well as to other corticosteroids, to other azole antifungal agents, or to the excipients

• in animals with perforated ear drums

• in animals, where resistance of causative agents to polymyxin B and/or miconazole is known

• on the mammary glands of lactating bitches and queens

Bacterialand fungalotitisis often secondaryinnature.The underlyingcause should beidentified and treated.

Special precautions for usein animals

Use ofthe productshould be based on microbiologicalsamplingandsusceptibilitytestingofthe bacteria and/orfungi isolated fromthe animal. Ifthis is notpossible,therapyshould be based upon

local(regional)epidemiologicalinformationaboutsusceptibilityofthetargetpathogens.

Systemic corticosteroid effectsare possible,especiallywhen the productis used underan occlusive dressing, on extensive skinlesions,with increased skinbloodflow, oriftheproductis ingestedby licking.

Oralingestion ofthe productbytreated animals oranimals havingcontactwithtreated animals should be avoided.

Special precautions tobetakenbythe person administeringthe veterinarymedicinal producttoanimals

Peoplewith known hypersensitivityto prednisolone, polymyxin Bormiconazoleshould avoid contact withthe veterinarymedicinalproduct.

Avoid contactwithskinoreyes. In case ofaccidentalspillage, skin oreyes shouldbe rinsed immediatelywith plentyofwater. Always wearsingleuse disposable gloves whenapplyingthe veterinarymedicinalproductto animals. Wash handsafteruse.

In case ofaccidentalingestion, seekmedicaladviceimmediatelyandshowthe leafletorthe labelto the physician.

Use ofthis veterinarymedicinalproduct may veryrarelybe associatedwiththe occurrence ofdeafness (especiallyin olderdogs),in this casetreatmentshouldbe discontinued.

Prolonged and extensive use oftopicalcorticosteroid preparations is known totriggerlocaland systemic effects,includingsuppression ofadrenalfunction,thinningofthe epidermis and delayed healing.

Thesafetyoftheproducthas notbeen assessed duringpregnancyandlactation.

Absorptionofmiconazole,polymyxin Band prednisolone through the skin beinglow, noteratogenic/ embryotoxic/foetotoxic andmaternotoxiceffectsareexpected in dogs andcats. Oralingestion ofthe active substances bytreatedanimals whengroomingcan possiblyoccurand appearance ofthe active ingredients inblood and milkcan beexpected.

Use onlyaccordinglyto thebenefit/riskassessmentbythe veterinarian.

No dataavailable.

Forauricularand cutaneoususe.

Shake wellbefore use.

Atthebeginningoftreatment, hairsurroundingorcoveringthelesions mustbeclipped;this should be repeated duringtreatmentifnecessary.

Infectionsoftheexternalauditorycanal (otitis externa):

Cleantheexternalearcanalandauricleand place 5 drops ofthe veterinarymedicinalproductinto the externalauditorycanaltwice a day. Massage the earand theauditorycanal thoroughlyto ensure

properdistribution ofthe active substances, butgentlyenough to avoidcausingpain tothe animal.

Treatmentshould becontinued withoutinterruption untilafewdays aftercomplete disappearance of the clinicalsymptoms, atleastfor7-10 days up to 14days.

Where concurrentearmite(Otodectes cynotis)infestation is present,consideration should be given to treatingbothears even ifinfestationisonlyapparentinone ear. Instill5drops twice dailyfor14 days.

Skin infections(smalllocalisedsuperficial):

Applya fewdrops ofthe veterinarymedicinalproduct to theskinlesionsto betreated twice adayand rub well.

Treatmentshould becontinued withoutinterruption untilafewdays aftercomplete disappearance of the clinicalsymptoms, up to 14 days.

In some persistentcases (earorskin infections), treatmentmayneed to becontinuedfor2to 3 weeks. In cases whereprolonged treatmentis necessaryrepeated clinicalexaminationsincludinga re- assessmentofthediagnosisarerequired.

No othersymptoms thanthose mentionedin section 4.6 areexpected.

Notapplicable.

Pharmacotherapeutic group:Otologicals, corticosteroids and anti-infectives in combination ATCvetcode:QS02CA01

Miconazolebelongs tothegroup of N-substitutedimidazole derivatives andinhibits ergosterol de novosynthesis. Ergosterolis anessentialmembranelipid and mustbe synthesised byfungi. Ergosteroldeficiencyimpedes numerous membrane functions,eventuallyleadingto the cell’sdeath. Thespectrumofactivitiescovers nearlyallfungiand yeasts ofrelevanceto veterinarymedicine as wellasGram-positive bacteria. Practicallyno developmentofresistance has beenreported. Miconazolehasa fungistatic mode ofaction, buthighconcentrationsare also observed to produce fungicidaleffects.

Polymyxin Bbelongs tothe polypeptide antibiotics whichareisolatedfrombacteria.Itisonlyactive againstGram-negative bacteria.Thedevelopmentofresistance is chromosomalinnatureand the developmentofresistantGram-negative pathogensisarelativelyrareevent. However, allProteus speciesshare anaturalresistance topolymyxinB.

Polymyxin Bbindsto phospholipids in the cytoplasmic membranetodisturb membrane permeability. Thisresults inautolysis ofthe bacteria, thus achievingbactericidalactivity.

Prednisoloneisa syntheticcorticosteroidand is used forits anti-inflammatory, anti-pruritic, anti- exudative andanti-proliferative effects.The anti-inflammatoryactivityofprednisolone acetateresults fromreduction ofthepermeabilityofcapillaries,improved bloodflowand inhibition offibroblast action.

Theexactmechanismofthe acaricidaleffectis unclear. Itis assumed thatthe mites are suffocated or immobilised bythe oilyexcipients.

Followingtopicalapplication ofpolymyxinB, there isvirtuallyno absorption ofthe compound through intactskin and mucous membranes, butsignificantabsorption viawounds.

Aftertopicalapplication ofmiconazole, thereis virtuallyno absorption ofthecompound through intactskinormucous membranes.

Whenappliedtopicallyto intactskin, prednisolone is subjectto limitedand delayed absorption. Greaterabsorptionofprednisoloneshould beexpectedin casesofcompromisedskin barrier function

(e.g. skin lesions).

Silica,colloidalanhydrous Paraffin liquid

None known.

Shelf-life ofthe veterinarymedicinalproductaspackaged forsale:2 years

Shelf-life afterfirstopeningthe immediatepackaging:3 months

Do notstore above 30°C.

Afterfirstopeningdo notstore above 25°C.

Droppercontainerofwhite,opaque LDPEwith white,opaque HDPEscrewcap. Packsize:1 x20 ml

Anyunused veterinarymedicinalproductorwastematerialsderived fromsuch veterinarymedicinal productshould be disposedofinaccordance withlocalrequirements.

RichterPharma AG

Feldgasse19

4600 Wels

Austria

Vm 22080/4006

05 March 2015

July 2015

APPROVED 23/07/15