Marbonor SOLO Injection for Cattle

Main information

  • Trade name:
  • Marbonor SOLO Injection for Cattle
  • Pharmaceutical form:
  • Injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbonor SOLO Injection for Cattle
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0297/001
  • Authorization date:
  • 26-09-2012
  • EU code:
  • IE/V/0297/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MarbonorSOLO100mg/mlSolutionforInjectionforCattle.(AT,BG,CY,

FR,DE,EL,IE,PL, PT,RO, UK

Marbonor100 mg/mldosisúnicasolucióninyectableparabovino(ES)

BorofloxCattle100 mg/mlSolutionforInjection(IT)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

ActiveSubstance:

Marbofloxacin 100.0mg

Excipients:

Monothioglycerol 1.0mg

Metacresol 2.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowtoambersolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse, specifyingthetargetspecies

Treatmentofrespiratoryinfectionscausedbysusceptiblestrainsof

Pasteurellamultocida, MannheimiahaemolyticaandHistophilussomni.

4.3 Contraindications

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(cross-resistance).

Donotuseinanimalswithknownhypersensitivitytofluoroquinolonesorto

anyoftheexcipients.

4.4 SpecialWarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.Fluoroquinolonesshouldbereservedforthetreatmentof

clinicalconditionswhichhaverespondedpoorly,orareexpectedtorespond

poorly, to other classes of antimicrobials. Whenever possible,

fluoroquinolonesshouldonlybeusedbaseduponsusceptibilitytesting.Use

oftheproductdeviatingfromtheinstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistantthefluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross

resistance.

(ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductto animals

Peoplewithknownhypersensitivityto(flouro)quinolonesshouldavoidany

contactwiththeveterinarymedicinalproduct.

Iftheproductcomesintocontactwiththeskinoreyes,rinsewithcopious

amountsofwater.

Donotdrink,eatorsmokewhilstusingtheveterinarymedicinalproduct.

Washhandsafteruse.

Accidentalself-injectioncaninduceaslightirritation.

Incaseofaccidentalself-injectionoringestion,seekmedicaladvice

immediatelyandshowpackageleafletorthelabeltothephysician

4.6 Adversereactions(frequencyandseriousness)

Fluoroquinolonesareknowntoinducearthropathies.Nevertheless,thiseffect

hasneverbeenobservedwithmarbofloxacinincattle.

Administrationbytheintramuscularroutemaycausetransientlocalreactions

suchaspainandswellingattheinjectionsiteandinflammatorylesionswhich

maypersistforatleast12daysafterinjection.Nootheradverseeffectwas

observedoncattle.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofa

teratogenic,embryotoxicormaternotoxiceffectassociatedwiththeuseof

marbofloxacin.Safetyoftheproductat8mg/kghasnotbeendeterminedin

pregnantcowsorinsucklingcalveswhenusedincows.Useonlyaccordingly

to thebenefit/riskassessmentbytheresponsibleveterinarian

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddosageis8mg/kgbodyweight(2ml/25kgBW)

administeredasasingleintramuscularinjection.Iftheinjectionvolume

exceeds20 ml,itshouldbedividedbetweentwoormoreinjectionsites.

Thevialmaybebroachedupto35 times.Theusershouldchoosethemost

appropriatevialsizeaccordingto thebodyweightoftheanimal(s)to be

treated.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Nosignofoverdosagehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Signssuchasneurologicaldisordersmayoccurwhenthedoseisexceeded.Do

notexceedtherecommendeddose.

Suchsignsshouldbetreatedsymptomatically

4.11 Withdrawalperiod

MeatandOffal:3 days

Milk:72 hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeutic Group: Antibacterials for systemic use,

Fluoroquinolones

ATCVetCode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroup,whichactsbyinhibitionofDNAgyrase.Ithasa

broad-spectrumactivityinvitroagainstGram-positiveandGram-negative

bacteria.

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004from

bovinerespiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,

SpainandBelgium,isgood:MICvaluesarecomprisedbetween0.015and

0.25µg/mlforM.haemolytica(MIC

=0.124µg/ml;MIC

=0.025µg/ml),

between0.004and0.12µg/mlforP.multocida(MIC

=0.022µg/ml;MIC

=0.009µg/ml)andbetween0.015and2µg/mlforHistophilussomni.Strains

withMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC

≥4 µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.

5.2 Pharmacokineticproperties

Afterasingleintramuscularadministrationincattleattherecommendeddose

of8mg/kgbodyweight,themaximumplasmaconcentrationofmarbofloxacin

(Cmax)is7.3µg/mlreachedin=0.78h(Tmax).Thebioavailabilityof

marbofloxacinisalmost100%.Bindingtoplasmaproteinsisabout30%.

Marbofloxaciniseliminatedslowly(T1/2 

=15.60h),predominantlyinthe

activeforminurineandfaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Monothioglycerol

Metacresol

DisodiumEdetate

Gluconolactone

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:1year

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4 Specialprecautionsforstorage

Donotstoreabove25oC.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Theproductispackagedin20ml,50ml,100ml,250mland500mlamber

typeIIglassvials;60ml,100ml,250mland500mlamberco-explastic

(polypropylene)vials.

Thevialsareclosedwithchlorobutylrubberstopperssealedwithaluminium

caps.

Notallpack sizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Norbrook LaboratoriesLtd

StationWorks

Newry

CountyDown

NorthernIreland

BT356JP

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT