Ubiflox 100 mg/ ml Solution for Injection for Cattle and Pigs (Sows)

Main information

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

Documents

Localization

  • Available in:
  • Ubiflox 100 mg/ml Solution for Injection for Cattle and Pigs (Sows)
    Portugal
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0361/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0361/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2012

AN:01598/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERSITICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Ubiflox100mg/mlSolutionforInjectionforCattleandPigs(Sows)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin100mg

Excipients:

Disodiumedetate 0.10mg

Monothioglycerol 1mg

Metacresol 2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattleandpigs(sows).

4.2Indicationsforuse,specifyingthetargetspecies

Cattle

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,Mannheimiahaemolytica,MycoplasmabovisandHistophilussomni.

TreatmentofacutemastitiscausedbyEscherichiacolistrainssensitiveto

marbofloxacinduringthelactationperiod.

Sows

TreatmentofMetritisMastitisAgalactiaSyndrome(postpartumdysgalactiae

syndrome,PDS)causedbybacterialstrainssensitivetomarbofloxacin.

4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactivesubstanceorto

anyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

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4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccount

whentheproductisused.Fluoroquinolesshouldbereservedforthe

treatmentofclinicalconditionswhichhaverespondedpoorly,orare

expectedtorespondpoorly,tootherclassesofantimicrobials.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.Useoftheproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothe

fluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialforcrossresistance.

Theefficacydatashowedthattheproducthasinsufficientefficacyforthe

treatmentofacuteformsofmastitisinducedbyGram-positivebacteria.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeveterinarymedicinalproduct.

Careshouldbetakentoavoidaccidentalselfinjection;itcaninducea

slightirritation.

Incaseofaccidentalselfinjection,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothedoctor.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Administrationbytheintramuscularroutemaycausetransientlocalreactions

suchaspainandswellingattheinjectionsiteandinflammatorylesionswhich

persistatleast12daysafterinjection.However,incattle,subcutaneousroute

wasshowntobebettertoleratedlocallythanintramuscularroute.Therefore,the

subcutaneousrouteisrecommendedinheavycattle.

Nootherundesirableeffectshavebeenobservedincattleandpigs.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceof

teratogenic,foetotoxicormaternotoxiceffects.

Doseof2mg/kgbodyweight:

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Thesafetyoftheveterinarymedicinalproducthasbeenestablishedincows

duringgestationandsucklingpigsandcalveswhenusedincowsandsows.

Theproductcanthereforebeusedinpregnantandlactatingcowsandsowsat

thisdose.

Doseof8mg/kgbodyweight:

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedin

pregnantcowsorinsucklingcalveswhenusedincows.Therefore,thisdose

regimenshouldonlybeusedaccordingtothebenefit/riskassessmentbythe

responsibleveterinarian.

Incaseofuseinlactatingcows,seesection4.11.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Cattle:

Respiratoryinfections:

Thisproductmaybeadministeredasasingledosegivenononedayonlyoras

amultipledoseinjectiongivenover3 –5days.

Singledose-Intramuscularuse:

Therecommendeddosageis8mg/kgbodyweighti.e.2ml/25kgbodyweightin

asingleinjectionwiththeexceptionofthesituationslistedbelow.Ifthevolume

tobeinjectedismorethan20ml,itshouldbedividedbetweentwoormore

injectionsites.

Multipledose-Intramuscular,intravenousorsubcutaneoususe:

Therecommendeddosageis2mg/kgbodyweighti.e.1ml/50kginasingle

dailyinjectionfor3-5days.Thisdosingregimenshouldbeusedfortreatmentof

specificcases(suchasthosewhichrequireintravenoustreatment,forinstance

incaseofMycoplasma).

Acutemastitis:

-Intramuscular,intravenousorsubcutaneoususe:

Therecommendeddosageis2mg/kgi.e.1ml/50kgbodyweightinasingle

dailyinjection,for3-5days.

Pigs(sows):

-Intramuscularuse:

Therecommendeddosageis2mg/kgi.e.1ml/50kgbodyweightinasingledaily

injection,for3days.

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible,toavoidunderdosing.

Thecapmaybesafelypuncturedupto25times.Theusershouldchoosethe

mostappropriatevialsizeaccordingtothetargetspeciestotreat.

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Inbothcattleandpigs,injectionsshouldpreferablybegivenintheneck.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosesexceedingthismaycausesignsintheformofacuteneurological

disorderswhichwouldhavetobetreatedsymptomatically.

4.11Withdrawalperiod(s)

Cattle:

Intramuscularuse(8mg/kgsingledose)

Meatandoffal:3days

Milk:72hours

Intramuscular,intravenousorsubcutaneoususe(2mg/kgsingledailyinjection,

for3to5days):

Meatandoffal:6days

Milk:36hours

Pigs(sows):

Meatandoffal:4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,

Fluoroquinolones

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Ithasabroad-

spectrumactivityinvitroagainstGram-negative(Pasteurellamultocida,

Mannheimiahaemolytica,Histophilussomni,E.coli)andagainstGram-positive

bacteriaandMycoplasma.ResistanceinStreptococcusmayoccur.

Themarbofloxacininvitroactivityagainstpathogensisolatedin2004from

bovinerespiratorydiseasesduringaclinicalfieldtrialinFrance,Germany,

SpainandBelgium,isgood:MICvaluesarecomprisedbetween0.015and0.25

µg/mlforM.haemolytica(MIC

=0.124µg/ml;MIC

=0.025µg/ml),between

0.004and0.12µg/mlforP.multocida(MIC

=0.022µg/ml;MIC

=0.009

µg/ml)andbetween0.015and2µg/mlforHistophilussomni. StrainswithMIC≤

1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4µg/mlare

resistanttomarbofloxacin.

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Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousorintramuscularadministrationincattleandintramuscular

administrationinpigsattherecommendeddoseof2mg/kgbw,marbofloxacin

isreadilyabsorbedandreachesmaximalplasmaconcentrationsof1.5µg/ml

withinlessthan1houranditsbioavailabilityiscloseto100%.

Itisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%incattle),

extensivelydistributedandinmosttissues(liver,kidney,skin,lung,bladder,

uterus,digestivetract)itachieveshigherconcentrationsthaninplasma.

Incattle,marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

1/2 β=5-9

h)predominantlyintheactiveforminurine(3/4)andfaeces(1/4).

Inpigs,marbofloxaciniseliminatedslowly(t

1/2 β=8-10h)predominantlyinthe

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

Afterasingleintramuscularadministrationincattleattherecommendeddoseof

8mg/kgbw,themaximumplasmaconcentrationofmarbofloxacin(Cmax)is7.3

µg/mlreachedin0.78hours(Tmax).Marbofloxaciniseliminatedslowly(T1/2

terminal=15.60hours),predominantlyintheactiveforminurineandfaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconolactone

Disodiumedetate

Metacresol

Monothioglycerol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

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6.5Natureandcompositionofimmediatepackaging

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:50mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:100mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:250mlsolutionforinjection,inabox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicalproductorwastematerialsderivedfromsuch

veterinarymedicalproductshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KrkaDd

ŠmarješkaCesta6

NovoMesto

6501

Slovenia

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01656/4055

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:12October2011

10.DATEOFREVISIONOFTHETEXT

Date:September2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

Approved:

23/01/13