OTOMAX

Main information

  • Trade name:
  • OTOMAX
  • Pharmaceutical form:
  • Ear ointment
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OTOMAX
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • betamethasone and antiinfectives
  • Therapeutic area:

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0110/001
  • Authorization date:
  • 23-11-2011
  • EU code:
  • FR/V/0110/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OTOMAXEARDROPSSUSPENSION

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmloftheveterinarymedicinalproductcontains:

Activesubstance:

Gentamicinbase(assulfate) 2640 IU

Betamethasone(asvalerate) 0.88 mg

Clotrimazole 8.80 mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Eardropssuspension.

Asmooth,uniform,whiteto off-whiteviscoussuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse, specifyingthetargetspecies

Indog:

Treatmentofacuteexternalotitis.Alsofortreatmentofshorttermexacerbationofthe

acutesignsofchronicexternalotitisofbacterialandfungaloriginduetobacteria

susceptibletogentamicin,suchasStaphylococcusintermedius,andfungisusceptibleto

clotrimazole,inparticularMalasseziapachydermatis.

4.3 Contraindications

Donotadministerto dogswithaperforatedeardrum.

Donotadministerinthecaseofknownhypersensitivitytoanyoftheingredients

Seealsosection4.7.

Seealsosection4.8

4.4 Specialwarningsforeachtargetspecies

Contactwitheyesshouldbeavoided.Incaseofaccidentalcontact,flushwithplentywater.

Bacterialandfungalotitisisoftensecondaryinnature.Theunderlyingcauseshouldbe

identifiedandtreated.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Beforetheproductisapplied,theexternalauditorycanalmustbeexaminedthoroughlyto

ensurethattheeardrumisnotperforatedinordertoavoidtheriskoftransmissionofthe

infectionto themiddleearandto preventdamagetothecochlearandvestibularapparatus.

Theouterearshouldbecleanedmeticulouslyanddriedbeforetreatment.Excesshair

aroundthetreatmentareashouldbecut.

Useoftheproductshouldbebasedonsusceptibilityofisolatedbacteriaand/orother

appropriatediagnostictests.Ifthisisnotpossible,therapyshouldbebasedonlocal

(regional,farmlevel)epidemiologicalinformationaboutsusceptibilityofthetarget

bacteria.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttogentamicinandmaydecreasetheeffectivenessof

treatmentwithotheraminoglycosides,dueto thepotentialforcrossresistance.

Prolongedandintensiveuseoftopicalcorticosteroidspreparationisknowntotriggerlocal

andsystemiceffects,includingsuppressionofadrenalfunction,thinningoftheepidermis

anddelayedhealing.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidcontactwiththeproduct.

Washhandscarefullyafterapplyingtheproduct.Incaseofaccidentalcontactwiththe

eyes,rinsewithcopiousamountsofwater.

Donothandletheproductifyouhaveknownhypersensitivityagainstcompoundsinthe

product.

4..6 Adversereactions(frequencyandseriousness)

Erythematouspapulesmayappearlocally;theselesionsregresswhentreatmentis

discontinued.

Temporaryimpairmentofhearingandextremelyrarecasesofirreversiblelossofhearing

havebeenobserved,especiallyinelderlyanimals.

Intheeventofauditoryorvestibulardysfunction,treatmentmustbediscontinued

immediatelyandtheauditorycanalcleanedcarefullyusinganon-ototoxicsolution.

Prolongedandextensiveuseoftopicalcorticosteroidpreparationshavebeenknownto

inducelocalandsystemicside-effects.Theseincludesuppressionofadrenalfunction,

epidermalthinning,anddelayedwoundhealing.

4.7 Useduringpregnancy,lactationorlay

Donotadministerto pregnantorlactatingbitches.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Donotadministertheproductconcurrentlywithothersubstancesknowntocause

ototoxicity

4.9 Amountstobeadministeredandadministrationroute

Foroticuseonly.

Shaketheproductwellbeforeadministration

Dogsweighinglessthan15 kg:apply4 dropsto theeartwiceaday.

Dogsweighingmorethan15kg:apply8dropstotheeartwiceaday.Thedurationof

treatmentis7 days.

Afterapplicationthebaseoftheearmaybemassagedbrieflyandgentlytoallowthe

preparationto penetrateto thelowerpartoftheearcanal.

1dropoftheproductcorrespondsto66.9IUgentamicin,22.3µgbetamethasoneand223

µgclotrimazole.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Localandtransienteruptionofpapuleshavebeenobservedat5timestherecommended

dosage

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Otologicalscorticosteroidsandantiinfectivesincombination

ATCvetcode:QS02CA90

5.1 Pharmacodynamicproperties

Gentamicinsulphateisanaminoglycosidebactericidalantibioticwhichactsbyinhibiting

proteinsynthesis.ItsspectrumofactivityincludesGram-positiveandGram-negative

bacteria,suchasthefollowingpathogenicorganismsisolatedfromtheearsofdogs:

Staphylococcus intermedius, coagulase-positive Staphylococcus spp. and Proteus

mirabilis.

Betamethasonevalerateisasyntheticdexamethasone-analoguecorticosteroidwithananti-

inflammatory,anti-pruriticactivitywhenappliedtopically.Ithasmildmineralocorticoid

properties.Betamethasonevalerateisabsorbedaftertopicalapplication.Absorptionmay

beincreasedifthereisinflammationoftheskin.

Clotrimazoleisanantifungalagentwhichactsbycausingchangesinthecellmembrane,

whichleadtoalossofintracellularcomponentsandconsequentlytoacessationof

molecularsynthesis.Clotrimazolehasabroadspectrumofactivityandisusedinthe

treatmentofskinconditionscausedbyvariousspeciesofpathogenicdermatophytesandby

moulds,inparticularMalasseziapachydermatis

5.2 Pharmacokineticparticulars

Notdocumented.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ParaffinLightLiquid

PlasticizedHydrocarbonGelOintmentBase

6.2Incompatibilities

Notknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelf-lifeafterfirstopeningtheimmediatepackaging: 14days

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

6.5Natureandcompositionofimmediatepackaging

Containersandclosures:

Bottles

14mland34mlhighdensitypolyethylene(HDPE)bottlewithalowdensitypolyethylene

(LDPE)cap andLDPEapplicator/cap.

Tubes

8.5 mland17 mllinedaluminiumtubeswithHDPEwhitescrewcap andLDPEapplicator/cap.

Packagesizes:

Boxcontaining1 tubeof8.5 ml

Boxcontaining1 tubeof17 ml

Boxcontaining1 plasticbottleof14 ml

Boxcontaining1 plasticbottleof34 ml

Boxcontaining6 tubesof8.5 ml

Boxcontaining6 tubesof17 ml

Boxcontaining12 tubesof8.5 ml

Boxcontaining12 tubesof17 ml

Notallpack sizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

Schering-PloughLtd

ShirePark

WelwynGardenCity

UnitedKingdom

AL71TW

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm00201/4154

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

05 October1998

10 DATEOFREVISIONOFTHETEXT

QRDformat:July2009

Legalcategory: POM-V

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety