Quiflor S 100 mg/ ml solution for injection

Main information

  • Trade name:
  • Quiflor S 100 mg/ ml solution for injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Quiflor S 100 mg/ml solution for injection
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0367/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0367/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01322/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

QuiflorS100mg/mlSolutionforInjectionforCattle(UnitedKingdom,Austria,

Belgium,Germany,Denmark,Greece,France,ItalyIreland,Netherlands,

Portugal)

QuiflorSingleDose100mg/mlSolutionforInjectionforCattle(Spain)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin100mg

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.

Thisproductshouldonlybeusedbasedonsusceptibilitytesting.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinor

anyotherquinoloneortoanyoftheexcipients.

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

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4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhen

theproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinical

conditionswhichhaverespondedpoorly,orareexpectedtorespond

poorly,tootherclassesofantimicrobials.

Wherepossible,fluoroquinolonesshouldbeusedbasedonsusceptibility

testing.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttofluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothe

potentialforcrossresistance.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Accidentalself-injectioncaninduceaslightirritation.

4.6Adversereactions(frequencyandseriousness)

Fluroquinolonesareknowntoinducearthropathies.Nevertheless,thiseffect

hasneverbeenobservedwithmarbofloxacinincattle.

Administrationbytheintramuscularroutemaycausetransientlocalreactions

suchaspainandswellingattheinjectionsiteandinflammatorylesionswhich

maypersistforatleast12daysafterinjection.Nootheradverseeffectwas

observedoncattle.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyevidenceofa

teratogenic,embryotoxicormaternotoxiceffectassociatedwiththeuseof

marbofloxacin.Safetyoftheproductat8mg/kghasnotbeendeterminedin

pregnantcowsorinsucklingcalveswhenusedincows.Usetherefore

accordingtothebenefit/riskassessmentcarriedoutbytheresponsible

veterinarian.

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4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis8mg/kgbodyweighti.e.2ml/25kgbodyweight

inasingleintramuscularinjection.

Ifthevolumetobeinjectedismorethan20ml,itshouldbedividedbetweentwo

ormoreinjectionsites.

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible,toavoidunderdosing.

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-

spectrumactivityinvitroagainstmycoplasma,Gram-positiveandGram-

negativebacteria.

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

=

0.009µg/ml)andbetween0.015and2µg/mlforHistophilussomni.Strainswith

MIC≤1µg/mlaresensitivetomarbofloxacinwhereasstrainswithMIC≥4

µg/mlareresistanttomarbofloxacin.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.

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5.2Pharmacokineticparticulars

Afterasingleintramuscularadministrationincattleattherecommendeddoseof

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

µg/mlreachedin=0.78h(Tmax).Bindingtoplasmaproteinsisabout30%.

Marbofloxaciniseliminatedslowly(T1/2 β=15.60h),predominantlyintheactive

forminurineandfaeces.

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.

6.5Natureandcompositionofimmediatepackaging

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

closure:100mlsolutionforinjection,inabox.

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

closure:250mlsolutionforinjection,inabox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

Krka,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm 01656/4061

9. DATEOFFIRSTAUTHORISATION

Date:19December2011

10.DATEOFREVISIONOFTHETEXT

Date:January2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

Approved:

23/01/13