Marfloquin 5 mg Tablets for Cats and Dogs

Main information

  • Trade name:
  • Marfloquin 5 mg Tablets for Cats and Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marfloquin 5 mg Tablets for Cats and Dogs
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0433/001
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0433/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2013

AN:01882/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marfloquin5mgtabletsforcatsanddogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin …….5mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablets.

Lightbrownishyellow,round,biconvex,marbletabletswithbevellededgesandwith

possibledarkandwhitespots,scoredononeside.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1 Targetspecies

Catsanddogs.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibleto

marbofloxacin.

Indogs:

skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis);

urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis;

respiratorytractinfections.

Incats:

skinandsofttissueinfections(wounds,abscesses,phlegmons);

upperrespiratorytractinfections.

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AN:01882/2011

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4.3 Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsfor

exceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese,Bouvier

andMastiffs,withalongergrowthperiod.

Donotuseincatsagedlessthan16weeks.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipientsoftheproduct.

4.4 Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

Pyodermaoccursmostlysecondarytoanunderlyingdisease,thus,itisadvisableto

determinetheunderlyingcauseandtotreattheanimalaccordingly.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Highdosesofsomefluoroquinolonesmayhaveepileptogenicpotential.Cautioususe

isrecommendedindogsandcatsdiagnosedassufferingfromepilepsy.However,at

thetherapeuticrecommendeddosage,nosevereside-effectsaretobeexpectedin

dogsandcats.Inparticular,nolesionsofthearticularjointswereencounteredin

clinicalstudiesattherecommendeddoserate.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

veterinarymedicinalproductisused.Fluoroquinolonesshouldbereservedforthe

treatmentofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorlytootherclassesofantimicrobials.

Wheneverpossible,useoffluoroquinolonesshouldbebasedonsusceptibility

testing.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttothe(fluoro)quinolonesandmaydecrease

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross-

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthis

product.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstor

transientincreaseinactivitymayoccasionallyoccur.Thesesignscease

spontaneouslyaftertreatmentanddonotnecessitatecessationoftreatment.

Issued:March2013

AN:01882/2011

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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(1tabletfor2.5kgperday)insingle

dailyadministration.Whereappropriate,indogsonly,theuseofcombinationsof

wholeorhalftabletsofdifferentstrengths(5mg,20mgor80mg)willallowaccurate

dosing.

Animalbodyweight

(kg) Numberoftablets

(5mgstrength) Approx.dosagerange

(mg/kg)

1 –1.5

0.5 1.7 –2.5

>1.5 –2.5 1 2.0 –3.3

>2.5 –3.5 1.5 2.1 –3.0

>3.5 –5.0 2 2.0 –2.9

>5.0 –7.0 3 2.1 –3.0

>7.0 –9

4 2.2 –2.9

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Durationoftreatment

Dogs:

inskinandsofttissueinfections,treatmentdurationisatleast5daysanddepending

onthecourseofthedisease,itmaybeextendedupto40days.

inurinarytractinfections,treatmentdurationisatleast10daysanddependingonthe

courseofthedisease,itmaybeextendedupto28days.

inrespiratoryinfections,treatmentdurationisatleast7daysanddependingonthe

courseofthedisease,itmaybeextendedupto21days.

Cats:

forskinandsofttissueinfections(wounds,abscesses,phlegmons)treatment

durationis3to5days.

forupperrespiratoryinfectionstreatmentdurationis5days.

Issued:March2013

AN:01882/2011

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,which

shouldbetreatedsymptomatically.

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.Resistancetofluoroquinolonesoccursby

chromosomalmutationwiththreemechanisms:decreaseofthebacterialwall

permeability,expressionofeffluxpumpormutationofenzymesresponsiblefor

moleculebinding.

5.2 Pharmacokineticparticulars

Afteroraladministrationindogsandcatsattherecommendeddoseof2mg/kg,

marbofloxacinisreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5

µg/mlwithin2hours

Issued:March2013

AN:01882/2011

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Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hin

dogsand10hincats)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

containing10tablets.

Boxeswiththeinstructionleafletwith10tabletsand100tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:March2013

AN:01882/2011

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4047

9. DATEOFFIRSTAUTHORISATION

06March2013

10. DATEOFREVISIONOFTHETEXT

March2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 06/03/2013

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