Marbocare flavour 80mg tablets for dogs

Main information

  • Trade name:
  • Marbocare flavour 80mg tablets for dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbocare flavour 80mg tablets for dogs
    Portugal
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0470/003
  • Authorization date:
  • 26-06-2013
  • EU code:
  • UK/V/0470/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:September2013

AN:00540/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marbocareflavour80mgtabletsfordogs(UKandIE)

MarbocareF80mgtabletsfordogs(FR)

Odimar80mgtabletsfordogs(BE,LU,NL)

MarbofloxacinWDT80mgflavouredtabletsfordogs(AT,DE)

MarbofloxacinoEmdoka80mgtabletsfordogs(ES)

MarbofloxacinaEmdoka80mgtabletsfordogs(PT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin80.0mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigebrownspottedoblongtablets,deepscorelineupperside,scorelinelowerside.

Thetabletcanbedividedintohalves.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Marbofloxacinisindicatedinthetreatmentofthefollowinginfectionscausedby

susceptiblestrainsoforganisms(Seesection5.1);

Skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis).

Urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitis.

Respiratorytractinfections.

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4.3Contraindications

Donotuseindogsagedlessthan12months,orlessthan18monthsforexceptionally

largebreedsofdogs,suchasGreatDanes,Briard,Bernese,BouvierandMastiffs,with

alongergrowthperiod.

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipients.

Donotuseincaseofconfirmedorsuspectedresistancetofluoroquinolones(cross

resistance).

4.4Specialwarnings

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilageinjuvenile

dogsandcareshouldbetakentodoseaccuratelyespeciallyinyounganimals.However

atthetherapeuticrecommendeddosage,nosevereside-effectsaretobeexpectedin

dogs.

SomefluoroquinolonesathighdosesmayhaveanepileptogenicpotentialCautioususe

isrecommendedindogsdiagnosedassufferingfromepilepsy.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorlytootherclassesofantimicrobials.

Wheneverpossible,useoffluoroquinolonesshouldbebasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreaseeffectiveness

oftreatmentwithotherquinolonesduetothepotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidusingthisproduct.

Incaseofaccidentalingestionseekmedicalattentionandshowproductlabeland/or

packageleaflettothedoctor.Washhandsafteruse.

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4.6Adversereactions(frequencyandseriousness)

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstortransient

increaseinactivitymayoccasionallyoccur.Thesesignsceasespontaneouslyafter

treatmentanddonotnecessitatecessationoftreatment.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)showednoteratogenicity,embryotoxicity

andmaternotoxicitywithmarbofloxacinattherapeuticdoses.

Thesafetyofmarbofloxacinhasnotbeenassessedinpregnantandlactatingdogs.Use

onlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarianin

pregnantandlactatinganimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,

Calcium,Magnesium,Iron).Insuchcases,thebioavailabilitymaybereduced.

Whenadministeredtogetherwiththeophylline,thehalf-lifeandthustheplasma

concentrationoftheophyllineincrease.Hence,incaseofconcurrentadministrationthe

doseoftheophyllineshouldbereduced.

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateis2mg/kg/dayinasingledailyadministration(seetable

below).Thetabletcanbedividedintohalvesasappropriate.

BodyWeight Tablets

15 –20kg ½

21 –40kg 1

41 –60kg 1½

61 –80kg 2

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Inskinandsofttissueinfections,treatmentdurationisatleast5days.Depending

onthecourseofthedisease,itmaybeextendedupto40days.

Inurinarytractinfections,treatmentdurationisatleast10days.Dependingonthe

courseofthedisease,itmaybeextendedupto28days.

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Inrespiratoryinfections,treatmentdurationisatleast7daysanddependingon

thecourseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,whichshould

betreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse;

Fluoroquinolones;Marbofloxacin.

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

groupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainstawiderangeof

Grampositivebacteria(inparticularStaphylococci,Streptococci)andGramnegative

bacteria(Escherichiacoli,Salmonellatyphimurium,Citrobacterfreundii,Enterobacter

cloacae,Serratiamarcescens,Morganellamorganii,Proteusspp,Klebsiellaspp,

Shigellaspp,Pasteurellaspp,Haemophilusspp,Moraxellaspp,Pseudomonasspp,

Brucellacanis)aswellasMycoplasmaspp.

BacterialstrainswithaMIC≤1µg/mlaresusceptible,strainswithaMICof2µg/mlare

intermediatelysusceptibleandstrainswithaMIC≥4µg/mlareresistantto

marbofloxacin(CLSI,2004).MIC

90 valuesofmarbofloxacinforstrainsof

Staphylococcus(pseudo)intermedius,EscherichiacoliandPasteurellamultocida

isolatedfromdiseasedcatsanddogsinGermanywere0.5µg/ml,0.5µg/mland0.06

µg/ml,respectively.

Resistancetofluoroquinolonesoccursmostlybychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpumpor

mutationofenzymesresponsibleformoleculebinding.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

5.2Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacinis

readilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2

hours.

Itsbioavailabilityiscloseto100%.

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Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(t½ß=14hindogs)

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone(K90)

Silica,colloidalhydrated

Crospovidone(TypeA)

CastorOil,Hydrogenated

Dessicatedporkliverpowder

DriedyeastMagnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale;3years

Shelflifeoftabletportions:96hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Unuseddividedtabletsshouldbereturnedtotheblisterpackandanydividedtablet

portionsremainingafter96hours(4days)shouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

TheproductispackagedinAluminium-PVC/aluminium/polyamideblister

Boxcontaining2blistersof6tablets(12tablets)

Boxcontaining12blistersof6tablets(72tablets)

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

EmdokaBvba

JohnLijsenstraat16

B-2321

Hoogstraten

Belgium

8. MARKETINGAUTHORISATIONNUMBER

Vm34534/4005

9. DATEOFFIRSTAUTHORISATION

04September2013

10.DATEOFREVISIONOFTHETEXT

September2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 04/09/2013