Floxabactin

Main information

  • Trade name:
  • Floxabactin
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Floxabactin
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NL/V/0135/003
  • Authorization date:
  • 08-01-2011
  • EU code:
  • NL/V/0135/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin150 mgtabletsfordogs

FloxabactinVet.(DK)

FloxabactinVet.150 mgtabletsfordogs(SE,NO, FI)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Enrofloxacin 150.0 mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Awhitetoslightlyyellow,round,convexsnap-tabtabletfororaladministrationto dogs.

Thetabletcanbedividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse, specifyingthetargetspecies

Treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiacoliorProteusmirabilis.

Treatmentofsuperficialanddeep pyoderma.

4.3 Contraindications

Donotuseinyoungorgrowingdogs(agedlessthan12months(smallbreed)orlessthan18

months(largebreed))astheproductmaycauseepiphysealcartilagealterationsingrowing

puppies.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycauseCNSstimulation.

Donotuseindogswithknownhypersensitivitytofluoroquinolonesortoanyofthe

excipientsoftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecrossresistance

to otherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.Pregnantandlactatinganimals,pleaseseesection4.7.

4.4 Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisprudenttoreservethefluoroquinolonesforthetreatmentofclinicalconditionsthathave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantibiotics.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Officialand

localantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.Useofthe

productdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialcrossresistance.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandto treattheanimalaccordingly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletto

thephysician.

Washhandsafterhandlingtheproduct.

Incaseofcontactwiththeeyes,rinseimmediatelywithplentyofwater.

Donothandletheproductincaseofknownhypersensitivitytotheproduct

4.6Adversereactions(frequencyandseriousness)

-Hypersensitivityreactions

-AlterationsinCentralNervousSystem

Possiblejointcartilagealterationsingrowingpuppies(see4.3 contraindications).

Inrarecasesvomitingandanorexiaareobserved.

4.7Useduringpregnancy,lactationorlay

Useduringpregnancy:

Studiesinlaboratoryanimals(rat,chinchilla)havenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffect.Useonlyaccordingtothebenefit/riskassessment

bytheresponsibleveterinarian.

Useduringlactation:

Asenrofloxacinpassesintothematernalmilk,theuseisnotrecommendedduringlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadto adverseeventsrelatedto delayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminiumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

Donotadministersimultaneouslywithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticaffects.

Donotadministersimultaneouslywithnon-steroidalantiinflamatorydrugs,convulsionscan

occur

4.9 Amountstobeadministeredandadministrationroute

Oraluse

5 mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor30kgdailyfor:

-10 daysinlowerurinarytractinfections

-15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

-Upto 21 daysinsuperficialpyodermadependingonclinicalresponse

Upto 49 daysindeep pyodermadependingonclinicalresponse

Thetreatmentshouldbeconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

Thetabletsmaybeadministereddirectlyinthemouthofthedogorsimultaneouslywithfood

ifnecessary.

Donotexceedtherecommendedtreatmentdose.

Afterbreakingatablet,usetheremainingtablethalveforthenextdose.Storethetablethalve

intheoriginalblisterpocket

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convlusions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5 timestherecommendeddoseforamonths.

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Fluoroquinoloneantibiotics

ATCvetcode:QJ01MA90

5.1 Pharmacodynamicproperties

Enrofloxacinisasyntheticfluoroquinoloneantibioticthatexertsitsactivitybyinhibiting

topoisomeraseII,anenzymeinvolvedinthemechanismofbacterialreplication.

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilarvaluesof

minimalinhibitconcentrationandminimalbactericideconcentrations.Italsopossesses

activityagainstbacteriainthestationaryphasebyanalterationofthepermeabilityofthe

outermembranephospholipidcellwall.

Ingeneral,enrofloxacinexhibitsgoodactivityagainstmostgram-negativebacteria,especially

thoseoftheENterobacteriacea.Escherichiacoli,Klebsiellaspp.,Proteusspp.,and

Enterobacterspp.Aregenerallysusceptible.

Pseudomonasaeruginosaisvariablysusceptibleand,whenitissusceptible,usuallyhasa

higherMICthanothersusceptibleorganisms.

StaphylococcusaureusandStaphylococcusintermediususuallyaresusceptible.

Streptococci,enterococci,anaerobicbacteriacangenerallybeconsideredresistant.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthegyrasegeneof

bacteriaandbychangesincellpermeabilitytowardsquinolones.

5.2 Pharmacokineticparticulars

Enrofloxacinisapproximately100%bioavailableafteroraladministration.Itisunaffectedby

food.Enrofloxacinisrapidlymetabolizedtoformanactivecompound,ciprofloxacin.

Afteradoseof5mg/kgbodyweight,maximumplasmalevelsofapproximately1.5µg/mLin

dogsarereachedafter0.5 to 2.0 hours.

Enrofloxacinisprimarilyexcretedviathekidneys.Amajorportionoftheparentdrugandits

metabolitesisrecoveredinurine.

Enrofloxaciniswidelydistributedinthebody.Thetissueconcentrationsareoftenhigherthan

theserumconcentrations.Enrofloxacincrossestheblood-brainbarrier.Thedegreeofprotein

bindinginserumis14%indogs.Thehalf-lifeisapproximately3.0 hoursfordogs.

Approximately25%ofthedoseofenrofloxacinisexcretedintheurineand75%viathe

faeces.Approximately60%ofthedoseisexcretedasunchangedenrofloxacinintheurineand

theremainderasmetabolites,amongstothersciprofloxacin.Thetotalclearanceis

approximately9 mL/minute/kgbodyweight.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

PovidoneK25

Cellulose,powdered

Croscarmellosesodium

Crospovidone

Colloidalanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 3 years

Shelflifeofdividedtablets:24 hours

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded.

6.4.Specialprecautionsforstorage

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25°C.

Dividedtabletsshouldbestoredintheblisterpack.

6.5Natureandcompositionofimmediatepackaging

Alu-PVC/PE/PVDCblisterorAlu-PVC/PVDCblisterwith10 tablets;

Boxwith1 blister(10tablets);

Boxwith2 blisters(20tablets);

Boxwith3 blisters(30tablets);

Boxwith5 blisters(50tablets);

Boxwith6 blisters(60tablets);

Boxwith10 blisters(100tablets);

Boxwith15 blisters(150tablets)

Notallpack sizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

7. MARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

Carton

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin150 mgtabletsfordogs

Enrofloxacin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Eachtabletcontains:

Enrofloxacin 150.0 mg

3. PHARMACEUTICALFORM

Tablets

4. PACKAGESIZE

10/20/30/50/60/100/150tablets

5. TARGETSPECIES

Dogs

6. INDICATIONS

7. METHODANDROUTE(S)OFADMINISTRATION

Fororaladministration.

Readthepackageleafletbeforeuse.

8. WITHDRAWALPERIOD

Notapplicable

9. SPECIALWARNING(S),IFNECESSARY

10.EXPIRYDATE

EXP:(month/year)

11.SPECIALSTORAGECONDITIONS

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25 0 C.

Dividedtabletsshouldbestoredintheblisterpack.

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly–to besuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keep outofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

16.MARKETINGAUTHORISATIONNUMBER(S)

{xxxxx}

17.MANUFACTURER’SBATCHNUMBER

Lot:

MINIMUMPARTICULARSTOAPPEARONBLISTERSORSTRIPS

BLISTERS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin150 mgtabletsfordogs

enrofloxacin

2. NAMEOFTHEMARKETINGAUTHORISATIONHOLDER

LeVet

3. EXPIRYDATE

EXP{month/year}

4. BATCHNUMBER

Lot{number}

5. THEWORDS“FORANIMALTREATMENTONLY”

Foranimaltreatmentonly–to besuppliedonlyonveterinaryprescription.

PACKAGELEAFLET

Floxabactin150 mgtabletsfordogs

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder:

LeVetB.V.

Willeskop212

3421 GWOudewater

TheNetherlands

Manufacturerforthebatchrelease:

ArtesanPharmaGmbH&Co KG

Wendlandstrasse1

29439 Lüchow

Germany

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floxabactin150 mgtabletsfordogs

Enrofloxacin

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER

INGREDIENT(S)

Floxabactin150mgisaslightlyyellow,round,convexsnap-tabtabletfororaladministration

to dogs.

Thetabletcanbedividedintoequalhalves.

Eachtabletcontains:

Activesubstance: Enrofloxacin150.0 mg

4. INDICATION(S)

Treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiacoliorProteusmirabilis.

Treatmentofsuperficialanddeep pyoderma.

5. CONTRAINDICATIONS

Donotuseinyoungorgrowingdogs(agedlessthan12months(smallbreed)orlessthan18

months(largebreed))astheproductmaycauseepiphysealcartilagealterationsingrowing

puppies.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycauseCNSstimulation.

Donotuseindogswithknownhypersensitivitytofluoroquinolonesortoanyofthe

excipientsoftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecrossresistance

to otherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

6. ADVERSEREACTIONS

-Hypersensitivityreactions

-AlterationsinCentralNervousSystem

Possiblejointcartilagealterationsingrowingpuppies(see4.3 contraindications).

Inrarecasesvomitingandanorexiaareobserved.

Ifyounoticeanyseriouseffectsorothereffectsnotmentionedinthispackageleaflet,please

informyourveterinarysurgeon

7. TARGETSPECIES

Dogs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF

ADMINISTRATION

Oraluse

5 mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor10 kgdailyfor:

-10 daysinlowerurinarytractinfections

-15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

-Upto 21 daysinsuperficialpyodermadependingonclinicalresponse

Upto 49 daysindeep pyodermadependingonclinicalresponse

Thetreatmentshouldbeconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

Thetabletsmaybeadministereddirectlyinthemouthofthedogorsimultaneouslywithfood

ifnecessary.

Donotexceedtherecommendedtreatmentdose.

9. ADVICEONCORRECTADMINISTRATION

Afterbreakingatablet,usetheremainingtablethalveforthenextdose.Storethetablethalve

intheoriginalblisterpocket.

10. WITHDRAWALPERIOD

Notapplicable.

11. SPECIALSTORAGEPRECAUTIONS

Keep outofthereachandsightofchildren.

DonotuseaftertheexpirydatestatedontheblisterandcartonafterEXP.

Veterinarymedicinalproductaspackagedforsale:No specialprecautionsforstorage.

Dividedtablets:Storebelow25°C.

Dividedtabletsshouldbestoredintheblisterpack

Anydividedtabletportionsremainingafter24 hoursshouldbediscarded

12. SPECIALWARNING(S)

Specialprecautionsforuseinanimals

Itisprudenttoreservethefluoroquinolonesforthetreatmentofclinicalconditionsthathave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantibiotics.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Officialand

localantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.Useofthe

productdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialcrossresistance.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandto treattheanimalaccordingly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletto

thephysician.

Washhandsafterhandlingtheproduct.

Incaseofcontactwiththeeyes,rinseimmediatelywithplentyofwater.

Donothandletheproductincaseofknownhypersensitivitytotheproduct

Useduringpregnancy,lactationorlay

Useduringpregnancy:

Studiesinlaboratoryanimals(rat,chinchilla)havenotproducedanyevidenceofa

teratogenic,foetotoxic,maternotoxiceffect.Useonlyaccordingtothebenefit/riskassessment

bytheresponsibleveterinarian.

Useduringlactation:

Asenrofloxacinpassesintothematernalmilk,theuseisnotrecommendedduringlactation.

Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadto adverseeventsrelatedto delayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminiumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

Donotadministersimultaneouslywithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticaffects.

Donotadministersimultaneouslywithnon-steroidalantiinflamatorydrugs,convulsionscan

occur

Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convlusions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5 timestherecommendeddoseforamonths.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

<MM/JJJJ>

15. OTHERINFORMATION

Alu-PVC/PE/PVDCblisterorAlu-PVC/PVDCblisterwith10 tablets;

Boxwith1 blister(10tablets);

Boxwith2 blisters(20tablets);

Boxwith3 blisters(30tablets);

Boxwith5 blisters(50tablets);

Boxwith6 blisters(60tablets);

Boxwith10 blisters(100tablets);

Boxwith15 blisters(150tablets);

Notallpack sizesmaybemarketed.

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