Ubiflox Cattle 100 mg/ ml Solution for Injection for Cattle

Main information

  • Trade name:
  • Ubiflox Cattle 100 mg/ ml Solution for Injection for Cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ubiflox Cattle 100 mg/ml Solution for Injection for Cattle
    Italy
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0362/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0362/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:October2011

AN:00045/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

UbifloxCattle100mg/mlsolutionforinjectionforcattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin 100mg

Excipients:

Disodiumedetate0.10mg

Monothioglycerol 1mg

Metacresol 2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle.

4.2Indicationsforuse,specifyingthetargetspecies

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,MannheimiahaemolyticaandHistophilussomni.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinorany

otherquinoloneortoanyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

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4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wherepossible,fluoroquinolonesshouldbeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttofluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross

resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwith

theproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthelabeltothe

doctor.

Accidentalself-injectioncaninduceaslightirritation.

4.6Adversereactions(frequencyandseriousness)

Fluroquinolonesareknowntoinducearthropathies.Nevertheless,thiseffecthas

neverbeenobservedwithmarbofloxacinincattle.

Administrationbytheintramuscularroutemaycausetransientlocalreactionssuchas

painandswellingattheinjectionsiteandinflammatorylesionswhichmaypersistfor

atleast12daysafterinjection.Nootheradverseeffectwasobservedoncattle.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyevidenceofa

teratogenic,embryotoxicormaternotoxiceffectassociatedwiththeuseof

marbofloxacin.Safetyoftheproductat8mg/kghasnotbeendeterminedinpregnant

cowsorinsucklingcalveswhenusedincows.Usethereforeaccordingtothe

benefit/riskassessmentcarriedoutbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

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AN:00045/2010

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4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis8mg/kgbodyweighti.e.2ml/25kgbodyweightina

singleintramuscularinjection.

Ifthevolumetobeinjectedismorethan20ml,itshouldbedividedbetweentwoor

moreinjectionsites.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedas

accuratelyaspossible,toavoidunderdosing.

Thecapmaybesafelypuncturedupto25times.Theusershouldchoosethemost

appropriatevialsizeaccordingtothetargetspeciestotreat.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.Overdosemaycausesignssuchasacuteneurological

disorderswhichshouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Meatandoffal:3days

Milk:72hours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,Fluoroquinolones

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroup,whichactsbyinhibitionofDNAgyrase.Ithasabroad-

spectrumactivityinvitroagainstGram-positiveandGram-negativebacteria.

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004frombovine

respiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,Spainand

Belgium,isgood:MICvaluesarecomprisedbetween0.015and0.25µg/mlforM.

haemolytica(MIC

=0.124µg/ml;MIC

=0.025µg/ml),between0.004and0.12

µg/mlforP.multocida(MIC

=0.022µg/ml;MIC

=0.009µg/ml)andbetween

0.015and2µg/mlforHistophilussomni.Stra inswithMIC≤1µg/mlaresensitiveto

marbofloxacinwhereasstrainswithMIC≥4µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofeffluxpump

ormutationofenzymesresponsibleformoleculebinding.

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5.2Pharmacokineticparticulars

Afterasingleintramuscularadministrationincattleattherecommendeddoseof8

mg/kg,themaximumplasmaconcentrationofmarbofloxacin(Cmax)is7.3µg/ml

reachedin=0.78h(Tmax).Bindingtoplasmaproteinsisabout30%.Marbofloxacin

iseliminatedslowly(T1/2β=15.60h),predominantlyintheactiveforminurineand

faeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconolactone

Disodiumedetate

Metacresol

Monothioglycerol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminiumclosure:

100mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminiumclosure:

250mlsolutionforinjection,inabox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

MiklichLaboratoriosS.L.

CalleCuevasBajas

s/n –Of.23

EdificioPicasso

29004Málaga

Spain

8. MARKETINGAUTHORISATIONNUMBER

Vm35084/4002

9. DATEOFFIRSTAUTHORISATION

10October2011

10.DATEOFREVISIONOFTHETEXT

October2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.