Zobuxa 100 mg tablet for cats and dogs

Main information

  • Trade name:
  • Zobuxa 100 mg tablet for cats and dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zobuxa 100 mg tablet for cats and dogs
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0376/003
  • Authorization date:
  • 03-01-2012
  • EU code:
  • UK/V/0376/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Zobuxa100mgtabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activesubstance(s):

Enrofloxacin 100mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beige-coloured,round,slightlydottedtabletwithscorelineonbothsides.Thetablets

canbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofbacterialinfectionsofthealimentary,respiratoryandurogenitaltracts,skin,

woundinfectionsandotitisexterna.

4.3Contraindications

Donotuseinyoungorgrowingdogs(dogsagedlessthan12months(smallbreed))or

lessthan18months(largebreed)astheproductmaycauseepiphysealcartilage

alterationsingrowingpuppies.

Donotuseindogsthathaveseizuredisorders,sinceenrofloxacinmaycauseCNS

stimulation.

Donotuseindogswithknownhypersensitivitytofluoroquinolonesortoanyofthe

excipientsoftheproduct.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

Pregnantandlactatinganimals,pleaseseesection4.7.

Donotuseforprophylaxis.

4.4Specialwarningsforeachtargetspecies

Page3of7

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisprudenttoreservethefluoroquinolonesforthetreatmentofclinicalconditionsthat

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antibiotics.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttofluoroquinolonesandmaydecreasetheeffectiveness

oftreatmentwithotherquinolonesduetothepotentialforcrossresistance.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecross

resistancetootherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandtotreattheanimalaccordingly.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivitytofluoroquinolonesshouldavoidcontactwiththe

product.

Washhandsafterhandlingtheproduct.

Incaseofcontactwiththeeyes,washimmediatelywithplentyofcleanwater.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleaflettothephysician.

Donotsmoke,eatordrinkwhilehandlingtheproduct.

4.6Adversereactions(frequencyandseriousness)

Duringtheperiodofrapidgrowth,Enrofloxacinmayaffectarticularcartilage

development.

Typicalsideeffectsofantimicrobialsincludegastrointestinaldisorderssuchastransient

andmildtomoderatediarrhoea,andarealsoreportedforfluoroquinolonesfordogs.In

severecasesthetreatmentshouldbediscontinued.

-Hypersensitivityreactions

-AlterationsinCentralNervousSystem

Possiblejointcartilagealterationsingrowingpuppies(see4.3contraindications).

Inrarecasesvomitingandanorexiaareobserved.

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4.7Useduringpregnancy,lactationorlay

Useduringpregnancy:

Studiesinlaboratoryanimals(rat,chinchilla)havenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffect.Useonlyaccordingtothebenefit/risk

assessmentbytheresponsibleveterinarian.

Useduringlactation:

Asenrofloxacinpassesintothematernalmilk,theuseisnotrecommendedduring

lactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,asthe

interactionsbetweenthesedrugsmayleadtoadverseeventsrelatedtodelayed

elimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevels

oftheophyllinemayincrease.

Concurrentuseofmagnesiumoraluminiumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministered

twohoursapart.

Donotadministersimultaneouslywithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticaffects.

Donotadministersimultaneouslywithnon-steroidalanti-inflammatorydrugs,

convulsionscanoccur.

4.9Amountstobeadministeredandadministrationroute

Fororaluse.

Thedosageis5mgenrofloxacinperkgbodyweightoncedaily.

Thisisequivalentto1tabletper20kgbodyweight.

Thetabletscanbeadministereddirectlyorwiththefeed.

Treatmentisgenerallyadministeredover5 –10consecutivedays.

Therecommendeddosageshouldnotbeexceeded.

Treatmentshouldbere-evaluatedifnoimprovementisseen.Itiscommonlyadvisedto

re-evaluatethetreatmentifnoclinicalimprovementisobservedwithin3days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convulsions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsor

activatedcarboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchas

inappetenceandgastrointestinaldisturbancewereobservedatapproximately10times

therecommendeddosewhenadministeredfortwoweeks.Nosignsofintolerancewere

observedindogsadministered5timestherecommendeddoseforamonth.

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Donotexceedtherecommendeddose.Incaseofoverdose,vomiting,diarrhoeaand

CNS/behaviouralchangesmayoccur,thiswillstopwhencorrectdosingisresumed.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,quinoloneandquinoxaline

antibacterials,fluoroquinolones,enrofloxacin.

ATCVetCode:QJ01MA90

5.1Pharmacodynamicproperties

Enrofloxacinisasyntheticfluoroquinoloneantibioticthatexertsitsactivitybyinhibiting

topoisomeraseII,anenzymeinvolvedinthemechanismofbacterialreplication.

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilarvaluesof

minimalinhibitconcentrationandminimalbactericideconcentrations.Italsopossesses

activityagainstbacteriainthestationaryphasebyanalterationofthepermeabilityofthe

outermembranephospholipidcellwall.

Ingeneral,enrofloxacinexhibitsgoodactivityagainstmostgram-negativebacteria,

especiallythoseoftheEnterobacteriacea.Escherichiacoli,Klebsiellaspp.,Proteus

spp.,andEnterobacterspp.aregenerallysusceptible.

Pseudomonasaeruginosaisvariablysusceptibleand,whenitissusceptible,usually

hasahigherMICthanothersusceptibleorganisms.

StaphylococcusaureusandStaphylococcusintermediususuallyaresusceptible.

Streptococci,enterococci,anaerobicbacteriacangenerallybeconsideredresistant.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthegyrasegene

ofbacteriaandbychangesincellpermeabilitytowardsquinolones.

5.2Pharmacokineticparticulars

Enrofloxacinisapproximately100%bioavailableafteroraladministration.Itis

unaffectedbyfood.Enrofloxacinisrapidlymetabolizedtoformanactivecompound,

ciprofloxacin.

Afteradoseof5mg/kgbodyweight,maximumplasmalevelsofapproximately0.9

µg/mLarereachedindogs.

Enrofloxacinisprimarilyexcretedviathekidneys.Amajorportionoftheparentdrugand

itsmetabolitesisrecoveredinurine.

Enrofloxaciniswidelydistributedinthebody.Thetissueconcentrationsareoftenhigher

thantheserumconcentrations.Enrofloxacincrossestheblood-brainbarrier.Thedegree

ofproteinbindinginserumis14%indogs.Thehalf-lifeliesbetween2to7hoursfor

dogs.

Approximately25%ofthedoseofenrofloxacinisexcretedintheurineand75%viathe

faeces.Approximately60%(dogs)ofthedoseisexcretedasunchangedenrofloxacinin

theurineandtheremainderasmetabolites,amongstothersciprofloxacin.Thetotal

clearanceisapproximately9mL/minute/kgbodyweight.

Page6of7

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Cellulose,microcrystalline

Povidone(K-30)

Croscarmellosesodium

Silica,colloidalanhydrous

Magnesiumstearate

Artificialflavour(beef)

6.2Incompatibilities

Notapplicable.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeofdividedtabletsafterfirstopeningtheblister: 2days

6.4Specialprecautionsforstorage

Returnanydividedtablettotheopenedblisterandusewithin2days.

6.5Natureandcompositionofimmediatepackaging

Containermaterial:Aluminiumfoilblister

Containervolume:Boxwith10and100tablets.10tabletsperblistereach.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthUKLimited

FrimleyBusinessPark

Frimley

Camberley

Surrey

GU16/SR

8. MARKETINGAUTHORISATIONNUMBER

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Vm12501/4178

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

28/10/2011

10 DATEOFREVISIONOFTHETEXT

October2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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