Efex 100mg Chewable Tablets for Dogs

Main information

  • Trade name:
  • Efex 100mg Chewable Tablets for Dogs
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Efex 100mg Chewable Tablets for Dogs
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Dogs Non Food

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0441/003
  • Authorization date:
  • 20-02-2013
  • EU code:
  • UK/V/0441/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

AN:00347/2013

Revised:August2013

Page 1 of 6

SUMMARYOFTHEPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Efex100mgchewabletabletsfordogs

Efexvet100mgchewabletabletsfordogs(FI,SE)

Axorvet100mgchewabletabletsfordogs(NO)

Axor100mgchewabletabletsfordogs(DK)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Activesubstance:

Marbofloxacin.100.0mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Clover-shapedscoredbeigetablet.Thetabletcanbedividedintofourequalparts

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Indogs

Marbofloxacinisindicatedinthetreatmentof:

-skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis)causedbysusceptiblestrainsoforganisms.

-urinarytractinfections(UTI)causedbysusceptiblestrainsoforganisms

associatedornotwithprostatitisorepididymitis.

-respiratorytractinfectionscausedbysusceptiblestrainsoforganisms.

4.3Contraindications

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Donotuseindogsagedlessthan12months,orlessthan18monthsforgiant

breedsofdogswithalongergrowthperiod.

Donotuseincasesofhypersensitivityto(fluoro)quinolones.

4.4Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

4.5Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Thechewabletabletsareflavoured.Inordertoavoidanyaccidentalingestion,

storetabletsoutofreachoftheanimals.

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilagein

juveniledogsandcareshouldbetakentodoseaccuratelyespeciallyinyoung

animals.

Thefluoroquinolonesarealsoknownfortheirpotentialneurologicalsideeffects.

Cautioususeisrecommendedindogsandcatsdiagnosedassufferingfrom

epilepsy.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorlytootherclassesof

antimicrobials.Wheneverpossible,useoffluoroquinolonesshouldbebasedon

susceptibilitytesting.Useoftheproductdeviatingfromtheinstructionsgivenin

theSPCmayincreasetheprevalenceofbacteriaresistanttothe

fluoroquinolonesandmaydecreaseeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcross-resistance.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesorothercomponentsof

theformulationshouldavoidusingthisproduct.Incaseofaccidentalingestion

seekmedicalattentionandshowproductlabeland/orpackageleaflettothe

doctor.Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectsthatdonotnecessitatecessationoftreatmentsuchasvomiting,

softeningoffaeces,modificationofthirstortransientincreaseinactivitymay

occasionallyoccur.Thesesignsceasespontaneouslyaftertreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,rabbit)showednoembryotoxicity,

teratogenicityandmaternotoxicitywithmarbofloxacinattherapeuticdoses.

Howevernospecificstudieshavebeencarriedoutinpregnantandlactating

dogs.

Inpregnantandlactatinganimals,useonlyaccordingtothebenefit/risk

assessmentbytheresponsibleveterinarian.

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4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations

(Aluminium,Calcium,Magnesium,Iron).Insuchcases,thebioavailabilitymaybe

reduced.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserum

levelsoftheophyllinemayincrease.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration

Therecommendeddoserateis2mg/kg/d(1tabletfor50kgperday)insingle

dailyadministration.

Dogs:

-inskinandsofttissueinfections,treatmentdurationisatleast5days.

Dependingonthecourseofthedisease,itmaybeextendedupto40days.

-inurinarytractinfections,treatmentdurationisatleast10days.Dependingon

thecourseofthedisease,itmaybeextendedupto28days.

-inrespiratoryinfections,treatmentdurationisatleast7daysanddependingon

thecourseofthedisease,itmaybeextendedupto21days.

Bodyweight

(kg) Tablet

10.0-12.5 ¼

12.6 –25.0

½

25.1 –37.5 ¾

37.6 –50.0

1

50.1 –62.5 1¼

62.6 –75.0

75.1 –87.5 1¾

87.6 –100.0

2

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Thechewabletabletsmaybeacceptedbydogsorcanbeadministereddirectly

intothemouthoftheanimals.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,which

shouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,fluoroquinolones

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionoftopoisomeraseII(DNAgyrase)

andtopoisomeraseIV.Ithasabroad-spectrumactivityinvitroagainstGram-

positivebacteria(inparticularStaphylococci,Streptococci)and,Gram-negative

bacteria(Escherichiacoli,Enterobactercloacae,Proteusspp,Klebsiellaspp,

Shigellaspp,Pasteurellaspp,Pseudomonasspp)aswellasMycoplasmaspp.

AreportonmicrobiologicalsusceptibilityincludingtwoEuropeanfieldsurveys

coveringhundredsofcanineandfelinepathogenssensitivetomarbofloxacinwas

publishedon2009

Micro-organisms MIC(µg/ml)

Staphylococcus

intermedius 0,23-0,25

Escherichiacoli 0,125-0,25

Pasteurellamultocida 0,04

Pseudomonas

aeruginosa 0,94

CasesofresistancehavebeenobservedinStreptococcus.StrainswithMIC≤1

µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlare

resistanttomarbofloxacin.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

Theactivityofmarbofloxacinagainstthetargetbacterialspeciesisbactericidal

concentration-dependant.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.Todate,only

sporadiccaseshavebeenreportedforplasmidmediatedfluoroquinolone

resistanceinanimals.Dependingontheunderlyingresistancemechanismcross-

resistancetoother(fluoro)quinolonesandco-resistancetootherantimicrobial

classescanoccur.

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5.2Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,

marbofloxacinisreadilyabsorbedandreachesmaximalplasmaconcentrationsof

1.5µg/mlwithin2hours

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedand

inmosttissues(liver,kidney,skin,lung,bladder,digestivetract)itachieveshigher

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hin

dogs)predominantlyintheactiveforminurine(2/3)andfaeces(1/3).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Copovidone

Silica,colloidalanhydrous

Croscarmellosesodium

Hydrogenatedcasteroil

Pigliverpowder

Maltedyeast

Cellulosemicrocrystalline

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

Blister:PVC-TE-PVDC –aluminiumheatsealed:24months

Blister:PA-AL-PVC –aluminiumheatsealed:36months

Shelf-lifeafterfirstopeningtheimmediatepackaging:72hours:

6.4.Specialprecautionsforstorage

Blister:PVC-TE-PVDC –aluminiumheatsealed: Donotstoreabove30°C

Blister:PA-AL-PVC –aluminiumheatsealed:Thisveterinarymedicinalproduct

doesnotrequireanyspecialtemperaturestorageconditions.

Tabletportionsshouldbestoredintheblisterpack

Anytabletportionsremainingafter72hoursshouldbediscarded

Keeptheblisterintheoutercarton.

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6.5Natureandcompositionofimmediatepackaging

(Polyvinylchloride-Thermo-elast-Polyvinylidenechloride –aluminiumheat

sealed)containing6tabletsperblister

(Polyamide-Aluminium-Polyvinylchloride –aluminiumheatsealed)

containing6tabletsperblister

Cardboardboxof6tabletscontaining1blisterof6tablets

Cardboardboxof12tabletscontaining2blistersof6tablets

Cardboardboxof120tabletscontaining20blistersof6tablets

Cardboardboxof240tabletscontaining40blistersof6tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

SOGEVAL

200avenuedeMayenne

ZoneIndustrielledesTouches

53000LAVAL

FRANCE

Tel:33243495151

Fax:33243539700

E-mail: sogeval@sogeval.fr

8. MARKETINGAUTHORISATIONNUMBER

20749/4032

9. DATEOFFIRSTAUTHORISATION

August2013

10 DATEOFREVISIONOFTHETEXT

August2013

Approved:01/08/2013