Zobuxa 15mg tablet for cats and small dogs

Main information

  • Trade name:
  • Zobuxa 15mg tablet for cats and small dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zobuxa 15mg tablet for cats and small dogs
    Slovenia
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0376/001
  • Authorization date:
  • 03-01-2012
  • EU code:
  • UK/V/0376/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

Page2of7

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.

Page4of7

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.

Page5of7

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

Page7of7

Vm12501/4178

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

28/10/2011

10 DATEOFREVISIONOFTHETEXT

October2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety

29-5-2018

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Roche Registration GmbH)

EU/3/15/1453 (Active substance: Chimeric 2'-O-(2-methoxyethyl) modified oligonucleotide targeted to huntingtin RNA) - Transfer of orphan designation - Commission Decision (2018)3401 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/256/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (Active substance: Live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O) - Transfer of orphan designation - Commission Decision (2018)1819 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/162/15/5T/01

Europe -DG Health and Food Safety

5-3-2018

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (La Jolla Pharmaceutical II BV)

EU/3/15/1555 (Active substance: Synthetic hepcidin) - Transfer of orphan designation - Commission Decision (2018)1426 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/15/T/02

Europe -DG Health and Food Safety