Marbiflox100 mg/ml solution for injection

Main information

  • Trade name:
  • Marbiflox100 mg/ml solution for injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Marbiflox100 mg/ml solution for injection
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Cattle, Pigs Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0222/002
  • Authorization date:
  • 26-01-2011
  • EU code:
  • FR/V/0222/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1.3.1 Marbofloxacin

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SUMMARYOFPRODUCTCHARACTERISTICS

1.3.1 Marbofloxacin

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Marbiflox20mg/mlsolutionforinjectionforcattle(calves)andpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin 20mg

Excipients:

Metacresol 2mg

Disodiumedetate 0.10mg

Monothioglycerol 0.50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(Calves).

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Inpre-ruminantandruminantcalves:

- treatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurellamultocida,

Mannheimiahaemolytica,andMycoplasmabovis.

Inpigs:

- treatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,andPasteurellamultocida.

Thisproductshouldonlybeusedbasedonsusceptibilitytesting.

4.3Contraindications

Donotuseincaseofdisturbanceingrowthofcartilageand/orduringinjuryoflocomotionsystem

particularyonfunctionallyloadedjoints.

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinoranyotherquinoloneor

toanyoftheexcipients..

4.4 Specialwarningsforeachtargetspecies

1.3.1 Marbofloxacin

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None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Fluoroquinoloneshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Wherepossible,fluoroquinolonesshouldbeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttofluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcrossresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Washhandsafteruse.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththeproduct.

Directcontactwithskinshouldbeavoidedtoreducetheriskofsensitisationandcontactdermatitis.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekamedicaladviceandshowthelabeltothedoctor.

Accidentalself-injectioncaninduceaslightirritation.

4.6 Adversereactions(frequencyandseriousness)

Administrationbythesubcutaneousroutemayinduceatransientoedema.Intramuscular

administrationmaycausepainandinflammatorylesionsattheinjectionsite.Theinflammatorylesions

persist6daysinpigsand12daysincalves.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyevidenceofateratogenic,embryotoxic

ormaternotoxiceffectassociatedwiththeuseofmarbofloxacin.

Theproductshouldbeusedaccordingtothebenefit/riskassessmentcarriedoutbytheveterinarian.

Seesection4.11forwithdrawalperiods.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Pre-ruminantandruminantcalves:

-Intramuscularorsubcutaneoususe:

2mgofmarbofloxacinperkgofbodyweightperday,i.e.1mlofsolutionper10kgofbodyweightin

asingledailyinjectionfor3to5days.Thefirstinjectionmayalsobegivenbytheintravenousroute.

Pigs:

-Intramuscularuse:

1.3.1 Marbofloxacin

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2mgofmarbofloxacinperkgofbodyweightperday,i.e.1mlofsolutionper10kgofbodyweightin

asingledailyinjectionfor3to5days.

Thedosevolumegivenatoneinjectionsiteshouldnotexceed6mlincalvesand3mlinpigs.

Asthevialcannotbebroachedmorethan20times,theusershouldchoosethemostappropriatevial

sizeaccordingtothetargetspeciestotreat.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosagehasbeenobservedwithmarbofloxacinafteradministrationof3timesthe

recommendeddose.

Overdosagesymptomsofmarbofloxacinareacuteneurologicaldisordersthatshouldbetreated

symptomatically.

4.11Withdrawalperiod(s)

Meatandoffal:

-pre-ruminantandruminantcalves:6days.

-pigs:4days.

Thisproductisnotauthorisedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones,ATCvetcode:

QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobialbelongingtothefluoroquinolonegroup.Itacts

byinhibitionofDNAgyraseandhasabroad-spectrumactivityagainstGram-positivebacteria

(especiallyStaphylococcus),andGram-negativebacteria(Escherichiacoli,Pasteurellamultocida,

MannheimiahaemolyticaandActinobacilluspleuropneumoniae,aswellasagainstmycoplasma

(MycoplasmabovisandMycoplasmahyopneumoniae).

CasesofresistancehavebeenobservedinStreptococcus.

StrainswithMIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlare

resistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:decreaseof

thebacterialwallpermeability,expressionofeffluxpumpormutationofenzymesresponsiblefor

moleculebinding.

5.2 Pharmacokineticparticulars

Followingsubcutaneousorintramuscularadministrationoftherecommendeddoseof2mg/kgin

cattleorpigs,marbofloxacinisrapidlyabsorbedandattainsitsmaximumplasmaconcentrationof

1.5µg/mlwithinlessthananhour.Itsbioavailabilityiscloseto100%.

Marbofloxacinisweaklyboundtoplasmaproteins(<10%inpigs,<30%incattle)andwidely

distributedthroughouttheorganism.Inthemajorityoftissues(liver,kidney,skin,lung,uterus),it

achievesahigherconcentrationthaninplasma.

Marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

β=5-9h)andinpigs(t

β=8-10h),

butfasterinruminantcattle(t

β=4-7h)predominantlyintheactiveforminurineandfaeces.

6. PHARMACEUTICALPARTICULARS

1.3.1 Marbofloxacin

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6.1 Listofexcipients

Gluconolactone

Disodiumedetate

Mannitol

Metacresol

Monothioglycerol

Waterforinjections

6.2 Incompatibilities

Donotmixwithothermedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Bottle(amberglassPh.Eur.typeII),bromobutlyrubberstopper,aluminiumclosure:50mlsolution

forinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutlyrubberstopper,aluminiumclosure:100mlsolution

forinjection,inabox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto,Šmarješkacesta6,8501Novomesto,Slovenia

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

1.3.1 Marbofloxacin

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PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

28-11-2018

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