Ubiflox 20 mg Tablets for Dogs

Main information

  • Trade name:
  • Ubiflox 20 mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ubiflox 20 mg Tablets for Dogs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0434/002
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0434/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:May2013

AN:01887/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ubiflox20mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin .20mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Lightbrownishyellow,round,biconvex,marbletabletswithbevellededgesandwithpossible

darkandwhitespots,scoredononeside.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibletomarbofloxacinin

dogs:

skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,furunculosis,

cellulitis);

urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis;

respiratorytractinfections.

4.3 Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsforexceptionallylarge

breedsofdogs,suchasGreatDanes,Briard,Bernese,BouvierandMastiffs,withalonger

growthperiod.

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipientsoftheproduct.

4.4 Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.Pyoderma

occursmostlysecondarytoanunderlyingdisease,thus,itisadvisabletodeterminethe

underlyingcauseandtotreattheanimalaccordingly.

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AN:01887/2011

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Highdosesofsomefluoroquinolonesmayhaveepileptogenicpotential.Cautioususeis

recommendedindogsdiagnosedassufferingfromepilepsy.However,atthetherapeutic

recommendeddosage,nosevereside-effectsaretobeexpectedindogs.Inparticular,no

lesionsofthearticularjointswereencounteredinclinicalstudiesattherecommendeddose

rate.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheveterinary

medicinalproductisused.Fluoroquinolonesshouldbereservedforthetreatmentofclinical

conditionswhichhaverespondedpoorly,orareexpectedtorespondpoorlytootherclasses

ofantimicrobials.Wheneverpossible,useoffluoroquinolonesshouldbebasedon

susceptibilitytesting.UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothe(fluoro)quinolonesandmaydecrease

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthisproduct.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstortransient

increaseinactivitymayoccasionallyoccur.Thesesignsceasespontaneouslyaftertreatment

anddonotnecessitatecessationoftreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,rabbit)showednoembryotoxicity,teratogenicityand

maternotoxicitywithmarbofloxacinattherapeuticdoses.Howevernospecificstudieshave

beencarriedoutinpregnantorlactatingcatsanddogs.Therefore,intheseclassesof

animals,useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,Calcium,

Magnesium,Iron).Insuchcases,thebioavailabilityofmarbofloxacinmaybereduced.

Concurrentadministrationoftheophyllineproductsmaybefollowedbyinhibitedtheophylline

clearance.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateis2mg/kg/day(1tabletfor10kgperday)insingledaily

administration.

Whereappropriate,theuseofcombinationsofwholeorhalftabletsofdifferentstrengths(5

mg,20mgor80mg)willallowaccuratedosing.

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AN:01887/2011

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Animalbodyweight

(kg) Numberoftablets

(20mg+5mg

strengths) Approx.dosagerange

(mg/kg)

4 –6 0.5+0.5 2.1 –3.1

>6 –9 1 2.0 –3.3

>9 –11 1+1 2.3 –2.8

>11 –15 1.5 2.0 –2.7

>15 –20

2 2.0 –2.7

>20 –25 2.5 2.0 –2.5

>25 –30 3 2.0 –2.4

>30 –35 3.5 2.0 –2.3

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

Durationoftreatment:

inskinandsofttissueinfections,treatmentdurationisatleast5daysanddepending

onthecourseofthedisease,itmaybeextendedupto40days.

inurinarytractinfections,treatmentdurationisatleast10daysanddependingonthe

courseofthedisease,itmaybeextendedupto28days.

inrespiratoryinfections,treatmentdurationisatleast7daysanddependingonthe

courseofthedisease,itmaybeextendedupto21days.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,whichshouldbe

treatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

groupwhichactsbyinhibitionofDNAgyraseandoftopoisomeraseIV.Itiseffectiveagainst

awiderangeofGrampositivebacteria(includingStreptococciandinparticular

Staphylococci)andGramnegativebacteria(Escherichiacoli,Citrobacterfreundii,Proteus

spp.,Klebsiellaspp,Shigellaspp.,Pasteurellaspp.,Pseudomonasspp.)aswellas

Mycoplasmaspp.

Asecondaryliteraturereportofmicrobiologicalsusceptibilitydatawhosesourceincludedtwo

Europeanfieldsurveys,eachinvolvinghundredsofcanineandfelinepathogenssusceptible

tomarbofloxacin,waspublishedin2009.

Microorganism MIC(µg/ml)

Staphylococcus

intermedius 0.23-0.25

Escherichiacoli 0.125-0.25

Pasteurellamultocida 0.04

Pseudomonasaeruginosa 0.94

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AN:01887/2011

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usceptibilitybreakpointshavebeendeterminedas≤1µg/mlforsensitive,2µg/mlfor

intermediateand≥4µg/mlforresistantbacterialstrains.

Marbofloxacinisnotactiveagainstanaerobes,yeastorfungi.Casesofresistancehavebeen

observedinStreptococcus.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:

decreaseofthebacterialwallpermeability,expressionofeffluxpumpormutationof

enzymesresponsibleformoleculebinding.

5.2 Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacinis

readilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2hours

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandinmost

tissues(liver,kidney,skin,lung,bladder,digestivetract)itachieveshigherconcentrations

thaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hindogs)predominantlyinthe

activeforminurine(2/3)andfaeces(1/3).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone(K90)

Yeastpowder

Meatflavour

Crospovidone

Castoroil,hydrogenated

Silica,ColloidalAnhydrous

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeofhalf-tablets:5days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchloride-aluminium-orientedpolyamide/Aluminiumcoldformedblistercontaining10

tablets.

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Boxeswiththeinstructionleafletwith10tabletsand100tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4051

9. DATEOFFIRSTAUTHORISATION

10May2013

10. DATEOFREVISIONOFTHETEXT

May2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 10/05/2013