Marbotab 20 mg Tablets for Dogs and Cats

Main information

  • Trade name:
  • Marbotab 20 mg Tablets for Dogs and Cats
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbotab 20 mg Tablets for Dogs and Cats
    Hungary
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0431/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • UK/V/0431/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:March2013

AN:01688/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MarbotabP20mgtabletsfordogsandcats

ListofagreednamesintheMemberStateswhereproductisauthorized.

Italy,Germany,France,TheNetherlands,

Belgium,Hungary MarbotabP20mgtabletsfordogsand

cats

Denmark MarbotabP,20mgtablets,fordogsand

cats

UnitedKingdom,Ireland,Poland,Spain,

Austria Marbotab20mgtabletsfordogsandcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin 20mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Beigetabletswithwhitespeckled,cross-snap-tab.

Thetabletscanbedividedintoquarters.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs,cats

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofinfectionscausedbystrainsofmicroorganismssusceptibleto

marbofloxacin.

Indogs:

Skinandsofttissueinfections(skinfoldpyoderma,impetigo,folliculitis,

furunculosis,cellulitis);

Urinarytractinfections(UTI)associatedornotwithprostatitis;

Respiratorytractinfections.

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AN:01688/2011

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Incats:

Skinandsofttissueinfections(wounds,abscesses,phlegmons);

Upperrespiratorytractinfections.

Seesection5.1,Pharmacodynamicpropertiesforfurtherinformationonspecific

targetpathogens.

4.3 Contraindications

Marbofloxacinshouldnotbeusedindogsagedlessthan12months,orlessthan18

monthsforexceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese

BonvierandMastiffs,withalongergrowthperiod.

Donotuseincatsagedlessthan16weeks.

Donotuseincasesofhypersensitivitytofluoroquinolonesoranyoftheexcipientsof

theproduct.

Donotuseincaseofresistanceagainstquinolones,since(almost)completecross-

resistanceexistsagainstandotherfluoroquinolones.

Notsuitableforinfectionsresultingfromstrictanaerobes,yeastorfungi.

4.4Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilagein

juveniledogsandcareshouldbetakentodoseaccuratelyespeciallyinyoung

animals.

Thefluoroquinolonesarealsoknownfortheirpotentialneurologicalsideeffects.

Cautionsuseisrecommendedindogsandcatsdiagnosedassufferingfrom

epilepsy.

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproduct

isused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.

UseoftheproductdeviatingfromtheinstructionsgivenintheSmPCmayincrease

theprevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross

resistance.

Issued:March2013

AN:01688/2011

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Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Incaseofaccidentalingestionseekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.Weargloveswhenhandlingordividing

tablets.Washhandsafteruse.

Peoplewithknownhypersensitivitytofluoroquinolonesshouldavoidusingthis

product.

4.6Adversereactions(frequencyandseriousness)

Atthetherapeuticrecommendeddosage,nosevereside-effectsaretobeexpected.

Mildsideeffectssuchasvomiting,allergicreactions,softeningoffaeces,modification

ofthirstortransientincreaseinactivitymayoccasionallyoccur.Thesesignscease

spontaneouslyaftertreatmentanddonotnecessitatecessationoftreatment.

Nolesionsoftheparticularjointswereencounteredinclinicalstudiesatthe

recommendeddoserate.

However,jointpainand/orneurologicalsymptoms(ataxia,aggressiveness,

convulsion,depression)mayoccurinrareoccasions.

Allergicreactionshavebeenobserved(temporaryskinreactions)duetothe

histaminereleasethatmayoccur.

4.7Useduringpregnancy,lactationorlay

Safetyinpregnantandlactatingdogsandcatshavenotbeenestablished.Studiesin

pregnantratsandrabbitsshowednosideeffectsonpregnancy.

Useinpregnantandlactatinganimalsshouldbeinaccordancewiththebenefit/risk

assessmentperformedbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(aluminium,

calcium,magnesium,iron).Insuchcases,thebioavailabilitymaybereduced.

Donotuseincombinationwithtetracyclines,macrolidesbecauseofthe

potentialantagonisteffect.

Whenadministeredtogetherwiththeophylline,thehalf-lifeandthustheplasma

concentrationoftheophyllineincrease.Hence,thedoseoftheophyllineshouldbe

reduced.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministration.Therecommendeddoserateis2mg/kg/dinasingledaily

administration.Toensureacorrectdosagebodyweightshouldbedeterminedas

accuratelyaspossibletoavoidunderdosing.Tabletsmaybedividedalongscore

linestofacilitateaccuratedosing.

Issued:March2013

AN:01688/2011

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Durationoftreatment:

Dogs:

Inskinandsofttissueinfections,treatmentdurationisatleast5days.Dependingon

thecourseofthedisease,itmaybeextendedupto40days.

Inurinarytractinfectionsnotrelatedtoprostatitisorepididymitis,treatmentduration

isatleast10days.Inothercases,dependingonthecourseofthedisease,itmaybe

extendedupto28days.

Inrespiratoryinfections,treatmentdurationisatleast7days.Dependingonthe

courseofthedisease,itmaybeextendedupto21days.

Cats:Forskinandsofttissueinfections(wounds,abscesses,phlegmons)treatment

durationis3to5days.

Forupperrespiratoryinfections,treatmentdurationis5days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycausecartilagedamageinthejointsandacutesignsintheformof

neurologicaldisorders,whichshouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolone

ATCvetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroup,whichactsbyinhibitionofDNAgyrase.Itiseffectiveagainsta

widerangeofGrampositivebacteria(Staphylococci(S.aureusandS.intermedius)

andStreptococci)andGramnegativebacteria(Escherichiacoli,Citrobacterfreundii,

Enterobactercloacae,Proteusspp,Klebsiellapneuminiae,Pasteurellamulticida,

Pseudomonasaeruginosa,Bordetellabronchiseptica)aswellasMycoplasmaspp.

CasesofresistancehavebeenobservedinStreptococcus.

StrainswithMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥

4µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.

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AN:01688/2011

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5.2Pharmacokineticparticulars

Afteroraladministrationindogsandcatsattherecommendeddoseof2mg/kg,

marbofloxacinisreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5

µg/mlwithin2hours.

Itsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%),extensivelydistributedandin

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

concentrationsthaninplasma.Marbofloxaciniseliminatedslowly(eliminationhalf-life

is14hoursindogsand10hoursincats)predominantlyintheactiveforminurine

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

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Cellulose,powdered

Crospovidone

Colloidalanhydroussilica

Calciumbehenate

Yeast,deactivated

Artificialbeefflavour(PC-0125)

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelflifeoftheveterinaryproductaspackagedforsale:2years.

Shelflifeofquarteredtablets:72hours.

6.4.Specialprecautionsforstorage

Storetheblistersintheoriginalcontainer.

Ifthetabletsaredivided,theremainingquartersshouldbekeptintheblisterpack.

Anyquarteredtabletsremainingafter72hoursshouldbediscarded.

6.5Natureandcompositionofimmediatepackaging

Aluminium-polyamide/Aluminium/PVCblisterpackscontaining10tablets.

Theblisterpacksareavailableincartonsof20,50,100and200tablets.

Notallpacksizesmaybemarketed.

Issued:March2013

AN:01688/2011

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6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. MARKETINGAUTHORISATIONHOLDER

CP-PharmaHandelsgesellschaftmbH

Ostlandring13

31303Burgdorf

Germany

8. MARKETINGAUTHORISATIONNUMBER

Vm20916/4018

9. DATEOFFIRSTAUTHORISATION

27March2013

10.DATEOFREVISIONOFTHETEXT

March2013

PROHIBITIONORSUPPLYSALEANDORUSE

Tobesuppliedonlyonveterinaryprescription.

Approved:27/03/2013