Actimarbo 20 mg Flavoured Tablets for Dogs

Main information

  • Trade name:
  • Actimarbo 20 mg Flavoured Tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Actimarbo 20 mg Flavoured Tablets for Dogs
    Spain
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0461/002
  • Authorization date:
  • 26-06-2013
  • EU code:
  • UK/V/0461/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:August2013

AN:00514/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Actimarbo20mgFlavouredTabletsforDogs(AT,CZ,DE,ES,IT,NL,PT,SK,UK)

Actimarbo20mgTabletsforDogs(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Marbofloxacin 20.0mgpertablet

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet.

Off-whitetobeigebrownspotted,rounduncoatedtabletembossed “MV”and“20”on

eithersideofbreaklineononesideandplainonotherside.

Thetabletscanbedividedintohalves.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Fordogs,marbofloxacinisindicatedinthetreatmentof:

Skinandsofttissueinfectionscausedbysusceptiblestrainsoforganisms.

Urinarytractinfections(UTI)associatedornotwithprostatitisorepididymitiscaused

bysusceptiblestrainsoforganisms.

Respiratoryinfections,causedbysusceptiblestrainsoforganisms.

4.3Contraindications

Issued:August2013

AN:00514/2012

Page2of7

Marbofloxacinshouldnotbeusedindogsagedlessthan12months,orlessthan18

monthsforexceptionallylargebreedsofdogs,suchasGreatDanes,Briard,Bernese,

BouvierandMastiffs,withalongergrowthperiod.

Donotuseinanimalswithknownhypersensitivitytomarbofloxacinorother

(fluoro)quinolonesortoanyoftheexcipientsoftheproduct.

Donotuseincaseofconfirmedorsuspectedresistancetofluoroquinolones(cross

resistance).

Donotuseincats.Forthetreatmentofthisspecies,a5mgtabletisavailable.

4.4Specialwarningsforeachtargetspecies

AlowurinarypHcouldhaveaninhibitoryeffectontheactivityofmarbofloxacin.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Thefluoroquinoloneshavebeenshowntoinduceerosionofarticularcartilageinjuvenile

dogsandcareshouldbetakentodoseaccuratelyespeciallyinyounganimals.

Somefluoroquinolonesathighdosesmayhaveanepileptogenicpotential.Cautious

useisrecommendedindogsdiagnosedassufferingfromepilepsy.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

respondedpoorly,orareexpectedtorespondpoorlytootherclassesofantimicrobials.

Wheneverpossible,useoffluoroquinolonesshouldbebasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreaseeffectiveness

oftreatmentwithotherquinolonesduetothepotentialforcross-resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththe

veterinarymedicinalproduct.

Incaseofaccidentalingestionseekmedicaladviceimmediatelyandshowthepackage

leafletorthelabeltothephysician.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Atthetherapeuticrecommendeddosage,nosevereside-effectsaretobeexpectedin

dogs.

Mildsideeffectssuchasvomiting,softeningoffaeces,modificationofthirstortransient

increaseinactivitymayoccasionallyoccur.Thesesignsceasespontaneouslyafter

treatmentanddonotnecessitatecessationoftreatment.

Issued:August2013

AN:00514/2012

Page3of7

Hypersensitivity(allergic)reactionsmayoccurintreatedanimals.Inthecaseofallergic

reaction,thetreatmentshouldbewithdrawn.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)showednoteratogenicity,embryotoxicity

andmaternotoxicitywithmarbofloxacinattherapeuticdoses.

Thesafetyofmarbofloxacinhasnotbeenassessedinpregnantandlactatingdogs.

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarianin

pregnantandlactatinganimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Fluoroquinolonesareknowntointeractwithorallyadministeredcations(Aluminium,

Calcium,Magnesium,Iron).Insuchcases,thebioavailabilitymaybereduced.

Concomitantadministrationoftheophyllinerequirescarefulmonitoringasserumlevels

oftheophyllinemayincrease.

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

Therecommendeddoserateindogsis2mg/kg/d(1tabletfor10kgperday)insingle

dailyadministration.

Species Weight Dose(Numberoftabletsperday)

Actimarbo

5mgtablet Actimarbo

20mgtablet Actimarbo

80mgtablet

Dog ≤5kg

2 OR ½

5- ≤10kg 1

10- ≤15kg 1½

15- ≤20kg 2 OR ½

20- ≤25kg

25- ≤30kg 3

30- ≤35kg 3½

35- ≤40kg 4 OR 1

40- ≤60kg

60- ≤80kg 2

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

inskinandsofttissueinfections,treatmentdurationisatleast5days.Dependingon

thecourseofthedisease,itmaybeextendedupto40days.

Issued:August2013

AN:00514/2012

Page4of7

inurinarytractinfections,treatmentdurationisatleast10days.Dependingonthe

courseofthedisease,itmaybeextendedupto28days.

inrespiratoryinfections,treatmentdurationisatleast7daysanddependingonthe

courseofthedisease,itmaybeextendedupto21days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosagemaycauseacutesignsintheformofneurologicaldisorders,whichshould

betreatedsymptomatically.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolone

groupwhichactsbyinhibitionofDNAgyrase.Itiseffectiveagainstawiderangeof

Grampositivebacteria(includingStreptococciandinparticularStaphylococci)and

Gramnegativebacteria(Escherichiacoli,Enterobactercloacae,Proteusspp,

Klebsiellaspp,Shigellaspp,Pasteurellaspp,Pasteurellaspp,Pseudomonasspp)as

wellasMycoplasmaspp.

Marbofloxacinisnotactiveagainstanaerobes,yeastsorfungi.Casesofresistance

havebeenobservedinStreptococcus.

Themarbofloxacininvitroactivityagainstcanineandfelinepathogensisolatedin

Germanybetween2004and2006isgood:MIC

valuesare0.5µg/mlfor

Staphylococcuspseudointermedius,0.03µg/mlforEscherichiacoliand0.06µg/mlfor

Pasteurellamultocida .StrainswithMIC≤1µg/mlaresensitivetomarbofloxacin

whereasstrainswithMIC≥4µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosalmutationwith3mechanisms:

decreaseofbacterialwallpermeability,expressionofeffluxpumpormutationof

enzymesresponsibleformoleculebinding.

Therewasnosignificantdevelopment,evolutionorspreadofresistanceinpathogenic

strainsisolatedfromdiseasesincompanionanimals,sincetheuseofmarbofloxacinon

theveterinarymarket.Theincidenceandthedegreeoftransferofgeneticresistance

maybeconsideredasverylow.

Issued:August2013

AN:00514/2012

Page5of7

Cross-resistancetobeta-lactamantibiotics,aminoglycosides,tetracyclines,macrolides

andpolypeptideantibiotics,sulfonamides,nitrofuransanddiaminopyrimidinesgenerally

doesnotoccur.However,certainmutationscausingresistancetomarbofloxacin,can

alsocauseresistanceagainstcephalosporins,tetracyclines,macrolidesand

chloramphenicol.

5.2Pharmacokineticparticulars

Afteroraladministrationindogsattherecommendeddoseof2mg/kg,marbofloxacinis

readilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/mlwithin2

hours.

Itsbioavailabilityiscloseto100%.

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

Cellulosemicrocrystalline

PovidoneK90

Purifiedwater

Crospovidone

Meatflavour

Silica,colloidalanhydrous

Magnesiumstearate

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeofhalvedtablets:7days.

Seealsosection6.4.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

Issued:August2013

AN:00514/2012

Page6of7

Incaseofusinghalvedtablets:Returnanyremaininghalftablettotheopenedblister

pocket.Usetheremaininghalftabletforthenextadministration.

Seealsosection6.3.

6.5Natureandcompositionofimmediatepackaging

Theproductispackagedinaluminium –PVC/aluminium/polyamideblister.

Boxof1blisterof10tablets

Boxof2blistersof10tablets

Boxof10blistersof10tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

EcupharNV

Legeweg157-i

8020Oostkamp

Belgium

8. MARKETINGAUTHORISATIONNUMBER

Vm32742/4010

9. DATEOFFIRSTAUTHORISATION

August2013

10.DATEOFREVISIONOFTHETEXT

August2013

Issued:August2013

AN:00514/2012

Page7of7

PROHIBITIONORSUPPLYSALEANDORUSE

Onveterinaryprescriptiononly.

APPROVED 2/08/13