Enroxil Flavour Tablets 50 mg

Main information

  • Trade name:
  • Enroxil Flavour Tablets 50 mg
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enroxil Flavour Tablets 50 mg
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0255/002
  • Authorization date:
  • 12-10-2009
  • EU code:
  • UK/V/0255/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:December2009

AN:01103/2009

SUMMARYOFPTODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EnroxilFlavour50mgTabletsfordogs

EnroxFlavour50mgTabletsfordogs(UnitedKingdom,Austria,Belgium,

Germany,Denmark,Greece,Ireland,Italy,Luxembourg,Netherlands)

EnroxSabor50mgTabletsfordogs(Spain,Portugal)

EnroxilFlavour50mgTabletsfordogs(Bulgaria,CzechRepublic,Hungary,

Lithuania,Latvia,Poland,Romania,Slovenia,Slovakia)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains:

Enrofloxacin50mg

Excipients:Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Roundslightlybiconvex,creamtolightbrownishtabletswithpossiblevisible

whiteordarkerspots,onesidescoredandbevel-edged.Thetabletscanbe

dividedintoequalhalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Theproductisforuseindogsforthetreatmentofbacterialinfectionsofthe

alimentary,respiratoryandurogenitaltracts,skin,secondarywoundinfections

andotitisexternawhereclinicalexperience,supportedwherepossibleby

sensitivitytestingofthecausalorganism,indicatesenrofloxacinasthedrugof

choice.

4.3 Contraindications

Donotuseindogslessthan1yearofageorinexceptionallylargebreedsof

dogwithalongergrowthperiodlessthan18monthsofage,asarticular

cartilagemaybeaffectedduringtheperiodofrapidgrowth.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseindogshavingseizuredisorders,sinceenrofloxacinmaycause

CNSstimulation.

Revised:December2009

AN:01103/2009

4.4 Specialwarningsforeachtargetspecies

Pleaseseepoint4.3.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditions

whichhaverespondedpoorly,orareexpectedtorespondpoorlytoother

classesofantimicrobials.Wheneverpossible,useoffluoroquinolonesshould

bebasedonsusceptibilitytesting.Useoftheproductdeviatingfromthe

instructionsgivenintheSPCmayincreasetheprevalenceofbacteria

resistanttothefluoroquinolonesandmaydecreasetheeffectivenessof

treatmentwithotherquinolonesduetothepotentialforcross-resistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Donotexceedtherecommendeddosage.

Theproductshouldnotbeusedforprophylaxis.

Usetheproductwithcautionindogswithsevererenalorhepaticimpairment.

ii) Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Incaseofcontactwiththeeyes,washwithplentyofcleanwater.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshow

thepackageleaflettothephysician..

Peoplewithknownhypersensitivitytofluoroquinolonesshouldavoidcontact

withtheproduct.

4.6Adversereactions(frequencyandseriousness)

Duringtheperiodofrapidgrowth,enrofloxacinmayaffectarticularcartilage

development.

Inrarecasesvomitingandanorexiaareobserved

4.7Useduringpregnancy,lactationorlay

Useonlyaccordingtothebenefit:riskassessmentbytheveterinarysurgeon.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotcombinewithtetracyclines,phenicolsormacrolidesbecauseof

potentialantagonisticeffects.

Concurrentadministrationoffluoroquinolonesmayincreasetheactionoforal

anticoagulants.

Donotcombinewiththeophyllineasthiscouldleadtoaprolongedelimination

ofthissubstance.

Revised:December2009

AN:01103/2009

Concurrentadministrationofmagnesiumoraluminumcontainingsubstances

maybefollowedbyretardedabsorptionofenrofloxacin.

4.9 Amountstobeadministeredandadministrationroute

Donotexceedtherecommendeddose.Thedosagerateofenrofloxacinis5

mg/kggivenorallyoncedailyorasadivideddosetwicedailyfor5to10days

withorwithoutfood.

Thedurationoftreatmentindogsmaybeextendeddependingontheclinical

responseandthejudgementoftheresponsibleveterinarysurgeon.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

Thedailydoseisachievedasfollows:

Mediumdogs:onetabletper10kgbodyweight.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inaccidentaloverdosevomiting,diarrhoeaandCNS/behaviouralchanges

mayoccur.Thereisnoantidoteandtreatmentshouldbesymptomatic.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Enrofloxacinisasynthetic,broadspectrum

antimicrobialsubstance,belongingtothefluoroquinolonegroupofantibiotics.

ATCvetcode:QJ01MA90

5.1 Pharmacodynamicproperties

EnrofloxacinisbactericidalinactionwithactivityagainstGrampositiveand

Gramnegativebacteriaandmycoplasmas.Themechanismofactionofthe

quinolonesisuniqueamongantimicrobials –theyactprimarilytoinhibit

bacterialDNAgyrase,anenzymeresponsibleforcontrollingthesupercoiling

ofbacterialDNAduringreplication.Resealingofthedoublestandardhelixis

inhibitedresultinginirreversibledegradationofthechromosomalDNA.The

fluoroquinolonesalsopossessactivityagainstbacteriainthestationaryphase

byanalterationofthepermeabilityoftheouthermembranephospholipidcell

wall.

Bacterialresistancetofluoroquinolonesmostcommonlyoccursbyalterationof

thetarget,DNA-gyrase,viamutation.Lesscommonlymutationoccursatthe

topoisomerase-IVtarget.Othermechanismsofresistanceoccurwhen

bacteriadecreasetheabilityofthedrugtoenterthecellorincreaseactive

transportoutofthecell.Resistanceisusuallychromosomallydevelopedand,

therefore,remainsafterantimicrobialtherapyends.Cross-resistanceof

enrofloxacinwithotherfluoroquinolonescanoccur.Changesinlevelsof

resistancetofluoroquinolonesovertimebyCampylobacterandSalmonella

Revised:December2009

AN:01103/2009

speciesarebeingmonitoredbecauseoftheirpossibleimpactonhuman

health.

5.2 Pharmacokineticparticulars

Thepharmacokineticsofenrofloxacinindogsissuchthatoralandparenteral

administrationleadstosimilarserumlevels.

Enrofloxacinisrapidlyabsorbedafteroral,intramuscularandsubcutaneous

administration.

Inthestudyconductedindogsthedoseofenrofloxacinadministeredwas4.91

mg/kg.Themaximalplasmaconcentrationwas1179.94±260,83ng/mL,Tmax

was1.57±0.62h,halflife3,78h(harmonicmean)andAUC

tot value

4037±1155.82ngh/mL.

Approximately40%oftheoralorintravenousenrofloxacindoseadministered

indogsismetabolisedtociprofloxacin.

Themeanmaximalconcentrationforciprofloxacinreached491.99±57.95

ng/mL,tmax1.79±2.6handtheapparentterminalhalflifewas5.10h

(harmonicmean).ThemeanAUC

tot forciprofloxacinwas3737.21±562.65

ngh/mL.

Enrofloxacinpossessesahighdistributionvolume.Tissuelevels2-3times

higherthanthatfoundintheserum,havebeendemonstratedinlaboratory

animalsandtargetspecies.Organsinwhichhighlevelscanbeexpectedare

thelungs,liver,kidney,skin,boneandlymphaticsystem.Enrofloxacinalso

distributesintothecerobrospinalfluid,theaqueoushumourandthefoetusin

pregnantanimals.

Theeliminationofenrofloxacinisrenal,primarilythroughglomerularfiltration

andtubularsecretion.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

Maizestarch

Sodiumstarchglycolate(typeA)

Meatflavour10022

Sodiumlaurilsulphate

Basicbutylatedmethacrylatecopolymer

Dibutylsebacate

Croscarmellosesodium

Silica,colloidalanhydrous

Talc

Magnesiumstearate

6.2Incompatibilities

Noneknown.

Revised:December2009

AN:01103/2009

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Returnanyhalvedtablettotheopenedstrip-packandusewithin24hours.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Polyamide/Aluminium/Polyvinylchloridefilm(OPA/Al/PVC),heatsealedwith

aluminiumfoilcontaining10tablets/blister.Eachcardboardcartoncontains

10blisterpacks.

Polyamide/Aluminium/Polyvinylchloridefilm(OPA/Al/PVC),heatsealedwith

aluminiumfoilcontaining10tablets/blister.Eachcardboardcartoncontains

1blisterpacks.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

Telephonenumber:073312111

Faxnumber:073321537

Email:info@krka.biz

8. MARKETINGAUTHORISATIONNUMBER

Vm 01656/4008

9. DATEOFFIRSTAUTHORISATION

18June2009

10. DATEOFREVISIONOFTHETEXT

December2009