XEDEN 50mg

Main information

  • Trade name:
  • XEDEN 50mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XEDEN 50mg
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0186/002
  • Authorization date:
  • 30-09-2010
  • EU code:
  • FR/V/0186/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VETERINARYMEDICINALPRODUCT

XEDEN50mgtabletfordogs

PARTIB

SUMMARYOFPRODUCTCHARACTERISTICS

PharmaceuticalForm

Tablet

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

XEDEN50mgtabletfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Onetabletcontains:

Enrofloxacin............................................................50.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Clover-shapedscoredbeigetablet

Thetabletcanbedividedintofourequalparts.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:

-Treatmentoflowerurinarytractinfections(associatedornotwithprostatitis)andupper

urinarytractinfectionscausedbyEscherichiaColiorProteusmirabilis.

-Treatmentofsuperficialanddeeppyoderma.

4.3 Contraindications

Donotuseinyoungorgrowingdogs(dogsagedlessthan12months(smallbreed)orless

than18months(largebreed))astheproductmaycauseepiphysealcartilagealterationsin

growingpuppies.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycauseCNSstimulation.

Donotuseindogswithknownhypersensitivitytofluoroquinolonesortoanyoftheexcipients

oftheproduct.

Donotuseincaseofresistancetoquinolones,asthereexistsalmostcompletecross

resistancetootherquinolonesandcompletecrossresistancetootherfluoroquinolones.

Seealsosection4.7and4.8.

4.4Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Whereverpossible,fluoroquinolonesshouldbeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincreasetheprevalence

ofbacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatment

withotherquinolonesduetothepotentialforcrossresistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductis

used.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

Pyodermaismostlysecondarytoanunderlyingdisease.Itisadvisabletodeterminethe

underlyingcauseandtotreattheanimalaccordingly.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

leaflettothephysician.

Washhandsafterhandlingtheproduct

Incaseofcontactwitheyes,rinseimmediatelywithplentyofwater.

4.6Adversereactions(frequencyandseriousness)

Possiblejointcartilagealterationsingrowingpuppies(see4.3contra-indications).

Inrarecasesvomitingandanorexiaareobserved.

Inrarecase,hypersensitivereactionsmayoccur.Inthiscase,theadministrationoftheproduct

shouldbestopped.

Neurologicalsigns(seizures,tremors,ataxia,excitation)canoccur.

4.7Useduringpregnancy,lactationorlay

Useduringpregnancy:Laboratorystudiesinlaboratoryanimals(rat,chinchilla)havenot

producedanyevidenceofateratogenic,foetotoxic,maternototoxiceffect.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Useduringlactation:Asenrofloxacinpassesintothematernalmilk,theuseisnot

recommendedduringlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentuseofflunixinshouldbeundercarefulveterinarymonitoring,astheinteractions

betweenthesedrugsmayleadtoadverseeventsrelatedtodelayedelimination.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevelsof

theophyllinemayincrease.

Concurrentuseofmagnesiumoraluminumcontainingsubstances(suchasantacidsor

sucralfate)mayreduceabsorptionofenrofloxacin.Thesedrugsshouldbeadministeredtwo

hoursapart.

Donotusewithtetracyclines,phenicolsormacrolidesbecauseofpotentialantagonistic

effects.

4.9 Amountstobeadministeredandadministrationroute

Oraluse

5mgofenrofloxacin/kg/dayasasingledailydosing,i.e.onetabletfor10kgdailyfor:

- 10daysinlowerurinarytractinfections

- 15daysinupperurinarytractinfectionsandlowerurinarytractinfectionsassociated

withprostatitis

- Upto21daysinsuperficialpyodermadependingonclinicalresponse

- Upto49daysindeeppyodermadependingonclinicalresponse

Thetreatmentshouldbereconsideredincaseoflackofclinicalimprovementathalfofthe

treatmentduration.

XEDEN50mg

Numberoftabletsperday XEDEN150mg

Numberoftabletsperday Dogweight(kg)

¼ ≥2 - <4

½ ≥4 - <6.5

¾ ¼ ≥6.5 - <8.5

1 ¼ ≥8.5 - <11

1¼ ½ ≥11 - <13.5

1½ ½ ≥13.5 - <17

¾ ≥17 - <25

1 ≥25 - <35

1¼ ≥35 - <40

1½ ≥40 - <50

1¾ ≥50 - <55

2 ≥55

- <65

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

Thetabletsareflavoured,andarewellacceptedbydogs.Thetabletsmaybeadministered

directlyinthemouthofthedogorsimultaneouslywithfoodifnecessary.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingcancausevomitingandnervoussigns(muscletremor,incoordinationand

convulsions)whichmayrequiretreatmentdiscontinuation.

Intheabsenceofanyknownantidote,applydrugeliminationmethodsandsymptomatic

treatment.

Ifnecessary,administrationofaluminium-ormagnesium-containingantacidsoractivated

carboncanbeusedtoreduceabsorptionofenrofloxacin.

Accordingtoliterature,signsofoverdosagewithenrofloxacinindogssuchasinappetence

andgastrointestinaldisturbancewereobservedatapproximately10timestherecommended

dosewhenadministeredfortwoweeks.Nosignsofintolerancewereobservedindogs

administered5timestherecommendeddoseforamonth.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QJ01MA90

Pharmacotherapeuticgroup:Fluoroquinolones

5.1 Pharmacodynamicproperties

Enrofloxacinisasyntheticfluoroquinoloneantibioticthatexertsitsactivitybyinhibiting

topoisomeraseII,anenzymeinvolvedinthemechanismofbacterialreplication.

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilarvaluesof

minimalinhibitconcentrationandminimalbactericideconcentrations.Italsopossesses

activityagainstbacteriainthestationaryphasebyanalterationofthepermeabilityofthe

outermembranephospholipidcellwall.

Ingeneral,enrofloxacinexhibitsgoodactivityagainstmostgram-negativebacteria,

especiallythoseoftheEnterobacteriacea.Escherichiacoli,Klebsiellaspp.,Proteusspp.,

andEnterobacterspp.aregenerallysusceptible.

Pseudomonasaeruginosaisvariablysusceptibleand,whenitissusceptible,usuallyhasa

higherMICthanothersusceptibleorganisms.

StaphylococcusaureusandStaphylococcusintermediususuallyaresusceptible.

Streptococci,enterococci,anaerobicbacteriacangenerallybeconsideredresistant.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthegyrasegeneof

bacteriaandbychangesincellpermeabilitytowardsquinolones.

5.2Pharmacokineticparticulars

Enrofloxacinisrapidlymetabolisedtoformanactivecompound,ciprofloxacin.

AfteroraladministrationofXEDEN50(5mg/kg)indogs:

- Themaximalplasmaconcentrationofenrofloxacinof1.72µg/mLwasobservedone

hourfollowingadministration.

- Themaximalplasmaconcentrationofciprofloxacin(0.32µg/mL)wasobservedtwo

hoursfollowingadministration.

Enrofloxacinisprimarilyexcretedviathekidneys.Amajorportionoftheparentdrugandits

metabolitesisrecoveredinurine.

Enrofloxaciniswidelydistributedinthebody.Thetissueconcentrationsareoftenhigherthan

theserumconcentrations.Enrofloxacincrossestheblood-brainbarrier.Thedegreeof

proteinbindinginserumis14%indogs.Thehalf-lifeinserumis3-5hoursindogs(5mg/kg).

Approximately60%ofthedoseisexcretedasunchangedenrofloxacinandtheremainderas

metabolites,amongstothersciprofloxacin.Thetotalclearanceisapproximately9

ml/minute/kgbodyweightindogs.

Environmentalproperties

Notapplicable

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pigliverpowder

Yeast

Cellulosemicrocrystalline

Croscarmellosesodium

Copovidone

Silicacolloidalanhydrous

Hydrogenatedcastoroil

Lactosemonohydrate

6.2Incompatibilities

Notknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

3years

Shelf-lifeofdividedtablets:

72hours

6.4.Specialprecautionsforstorage

Storeintheoriginalcontainer

Protectfromlight

Thismedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

Anydividedtabletsshouldbereturnedtotheoriginalblisterforstorage.

Anydividedtabletsremainingafter72hoursshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

Blistercomplex:PVDC-TE-PVC/Aluminiumheatsealedblisterswith10tablets/blister

Cardboardboxwith1blisterof10tablets

Cardboardboxwith10blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

France

Tel:33.2.43.49.51.51

Fax:33.2.43.53.97.00

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletedinaccordancewithnationalrequirements.

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