Marfloxin 80 mg Tablets for Dogs

Main information

  • Trade name:
  • Marfloxin 80 mg Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marfloxin 80 mg Tablets for Dogs
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0430/003
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0430/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:April2013

AN:01881/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marfloxin80mgtabletsfordogs

Quiflox80mgtabletsfordogs

Quifloxvet80mgtabletsfordogs

Marbiflox80mgtabletsfordogs

Marfloxin80mgtabletsfordogs(Austria,Belgium,Bulgaria,Estonia,Germany,

Greece,Italy,Ireland,Netherlands,Poland,Portugal,Romania,Slovenia,Spain,

UnitedKingdom)

Quiflox80mgtabletsfordogs(CzechRepublic,Hungary,Latvia,Lithuania,Slovak

Republic)

Quifloxvet80mgtabletsfordogs(Sweden,Finland,Norway)

Marbiflox80mgtabletsfordogs(Denmark,France)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin.80mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Lightbrownishyellow,capsuleshaped,biconvex,marbletabletswithpossibledark

andwhitespotsandscoredonthebothsides.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibleto

marbofloxacinindogs:

skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis);

urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis;

respiratorytractinfections.

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4.3 Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsfor

exceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese,Bouvier

andMastiffs,withalongergrowthperiod.

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipientsoftheproduct.

4.4 Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

Pyodermaoccursmostlysecondarytoanunderlyingdisease,thus,itisadvisableto

determinetheunderlyingcauseandtotreattheanimalaccordingly.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Highdosesofsomefluoroquinolonesmayhaveepileptogenicpotential.Cautioususe

isrecommendedindogsdiagnosedassufferingfromepilepsy.However,atthe

therapeuticrecommendeddosage,nosevereside-effectsaretobeexpectedin

dogs.Inparticular,nolesionsofthearticularjointswereencounteredinclinical

studiesattherecommendeddoserate.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

veterinarymedicinalproductisused.Fluoroquinolonesshouldbereservedforthe

treatmentofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorlytootherclassesofantimicrobials.Wheneverpossible,useof

fluoroquinolonesshouldbebasedonsusceptibilitytesting.Useoftheproduct

deviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttothe(fluoro)quinolonesandmaydecreaseeffectivenessof

treatmentwithotherquinolonesduetothepotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthis

product.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstor

transientincreaseinactivitymayoccasionallyoccur.Thesesignscease

spontaneouslyaftertreatmentanddonotnecessitatecessationoftreatment.

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4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,rabbit)showednoembryotoxicity,teratogenicity

andmaternotoxicitywithmarbofloxacinattherapeuticdoses.Howevernospecific

studieshavebeencarriedoutinpregnantorlactatingcatsanddogs.Therefore,in

theseclassesofanimals,useonlyaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,

Calcium,Magnesium,Iron).Insuchcases,thebioavailabilityofmarbofloxacinmay

bereduced.Concurrentadministrationoftheophyllineproductsmaybefollowedby

inhibitedtheophyllineclearance.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateis2mg/kg/day(1tabletfor40kgperday)insingle

dailyadministration.Whereappropriate,theuseofcombinationsofwholeorhalf

tabletsofdifferentstrengths(80mg,20mgor5mg)willallowaccuratedosing:

Animalbodyweight

(kg) Numberoftablets

(80mg+20mg

strengths) Approx.dosagerange

(mg/kg)

17 –20

0.5 2.0 –2.4

>20 –25 0.5+0.5 2.0 –2.5

>25 –30 0.5+1 2.0 –2.4

>30 –40 1 2.0 –2.7

>40 –50 1+1 2.0 –2.5

>50 1.5 ≤2.4

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Durationoftreatment:

inskinandsofttissueinfections,treatmentdurationisatleast5daysand

dependingonthecourseofthedisease,itmaybeextendedupto40days.

inurinarytractinfections,treatmentdurationisatleast10daysanddepending

onthecourseofthedisease,itmaybeextendedupto28days.

inrespiratoryinfections,treatmentdurationisatleast7daysanddepending

onthecourseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,which

shouldbetreatedsymptomatically.

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4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyraseandoftopoisomerase

IV.ItiseffectiveagainstawiderangeofGrampositivebacteria(including

StreptococciandinparticularStaphylococci,)andGramnegativebacteria

(Escherichiacoli,

Citrobacterfreundii,Proteusspp.,Klebsiellaspp,Shigellaspp.,Pasteurellaspp.,

Pseudomonasspp.)aswellasMycoplasmaspp.

Asecondaryliteraturereportofmicrobiologicalsusceptibilitydatawhosesource

includedtwoEuropeanfieldsurveys,eachinvolvinghundredsofcanineandfeline

pathogenssusceptibletomarbofloxacin,waspublishedin2009.

Microorganism MIC

(µg/ml)

Staphylococcus

intermedius 0.23-0.25

Escherichiacoli 0.125-0.25

Pasteurellamultocida 0.04

Pseudomonas

aeruginosa 0.94

Susceptibilitybreakpointshavebeendeterminedas≤1µg/mlforsensitive,2µg/ml

forintermediateand≥4µg/mlforresistantbacterialstrains.

Marbofloxacinisnotactiveagainstanaerobes,yeastorfungi.Casesofresistance

havebeenobservedinStreptococcus.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

5.2 Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacin

isreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2

hours

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

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AN:01881/2011

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concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hin

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone(K90)

Yeastpowder

Meatflavour

Crospovidone

Castoroil,hydrogenated

Silica,ColloidalAnhydrous

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelflifeofhalf-tablets:5days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchloride-aluminium-orientedpolyamide/Aluminiumcoldformedblister

containing6tablets.

Boxeswiththeinstructionleafletwith12tabletsand72tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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AN:01881/2011

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7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4046

9. DATEOFFIRSTAUTHORISATION

25April2013

10. DATEOFREVISIONOFTHETEXT

April2013

Approved: 25/04/2013