Zobuxa 50 mg tablet for cats and dogs

Main information

  • Trade name:
  • Zobuxa 50 mg tablet for cats and dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zobuxa 50 mg tablet for cats and dogs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0376/002
  • Authorization date:
  • 03-01-2012
  • EU code:
  • UK/V/0376/002
  • 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.

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

5-12-2018

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods Inc. Recalls Cow Pie Fresh Frozen Meats for Dogs and Cats Because of Possible <em>Listeria monocytogenes</em> Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily recalling 933 packages of Cow Pie fresh frozen meats for dogs and cats, produced in August 2017, because it has the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration