iMedi.co.uk

Aurimic Ear Drops And Cutaneous Suspension For Dogs And Cats

Revised: July 2015

AN: 00317/2015



SUMMARYOFPRODUCTCHARACTERISTICS



NAME OF THE VETERINARY MEDICINAL PRODUCT


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)



QUALITATIVE AND QUANTITATIVE COMPOSITION


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


PHARMACEUTICAL FORM


Eardropsand cutaneoussuspension.

White suspension.



CLINICAL PARTICULARS


Target species


Dogs and cats.


Indications for use, specifying the target species


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


  • Gram-positive bacteria

    • Staphylococcus spp.

    • Streptococcus spp.

  • Gram-negative bacteria

    • Pseudomonas spp.

    • Escherichia coli

  • Yeasts and fungi

    • Malassezia pachydermatis

    • Candida spp.

    • Microsporum spp.

    • Trichophyton spp.


TreatmentofOtodectes cynotis infestations wherethere isconcurrentinfectionwith miconazoleand polymyxin Bsensitive pathogens.


Contraindications


Do notuse:


Special warnings for each target species


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


Special precautions for use


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.


Adverse reactions (frequency and seriousness)


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.


Use during pregnancy and lactation


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.


Interaction with other medicinal products and other forms of interaction


No dataavailable.


Amounts to be administered and administration route


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.


Overdose (symptoms, emergency procedures, antidotes), if necessary


No othersymptoms thanthose mentionedin section 4.6 areexpected.


Withdrawal period(s)


Notapplicable.



PHARMACOLOGICAL PROPERTIES


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


Pharmacodynamic properties

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 fromreduct