Quiflor 100 mg/ ml solution for injection for cattle and pigs (sows)

Main information

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

Documents

Localization

  • Available in:
  • Quiflor 100 mg/ml solution
    Germany
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0366/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0366/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01322/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Quiflor100mg/mlSolutionforInjectionforCattleandPigs(Sows)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin100mg

Excipients:

Disodiumedetate0.10mg

Monothioglycerol 1mg

Metacresol 2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattleandpigs(sows).

4.2Indicationsforuse,specifyingthetargetspecies

Cattle

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,MannheimiahaemolyticaandMycoplasmabovis.

TreatmentofacutemastitiscausedbyEscherichiacolistrainssensitiveto

marbofloxacinduringthelactationperiod.

Sows

TreatmentofMetritisMastitisAgalactiaSyndromecausedbybacterialstrains

sensitivetomarbofloxacin.

Theproductshouldonlybeusedbasedonsusceptibilitytesting.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinor

anyotherquinoloneortoanyoftheexcipients.

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Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccount

whentheproductisused.Fluoroquinolesshouldbereservedforthe

treatmentofclinicalconditionswhichhaverespondedpoorly,orare

expectedtorespondpoorly,tootherclassesofantimicrobials.Whenever

possible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.Useoftheproductdeviatingfromtheinstructionsgiveninthe

SPCmayincreasetheprevalenceofbacteriaresistanttothe

fluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwith

otherquinolonesduetothepotentialforcrossresistance.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Accidentalself-injectioncaninduceaslightirritation.

4.6Adversereactions(frequencyandseriousness)

Administrationbytheintramuscularroutemaycausetransientlocalreactions

suchaspainandswellingattheinjectionsiteandinflammatorylesionswhich

persistatleast12daysafterinjection.However,incattle,subcutaneousroute

wasshowntobebettertoleratedlocallythanintramuscularroute.Therefore,the

subcutaneousrouteisrecommendedinheavycattle.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rats,rabbits)didnotshowanyteratogenic,

embryotoxiceffectsoranymaternaltoxicityofmarbofloxacin.

Safetyoftheproducthasbeenshownincowsduringgestationandinsuckling

pigsandcalveswhenusedincowsandsows.

Inthecaseofuseinthecowduringlactation,seeparagraph4.11.Withdrawal

Periods.

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Maybeusedinpregnantandlactatingcowsandsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis2mg/kg/day(1ml/50kg)inasingledailyinjection

byintramuscular,subcutaneousorintravenousroutesincattleandby

intramuscularrouteinpigs.

Treatmentdurationsare3daysinpigsand3to5daysincattle.

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible,toavoidunderdosing.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itis

recommendedthatadraw-offneedlebeusedtoreducethenumberoftimesthe

septumispunctured.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosemaycausesignsintheformofacuteneurologicaldisorderswhich

wouldhavetobetreatedsymptomatically.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal:6days

Milk:36hours

Pigs:

Meatandoffal:4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,

Fluoroquinolones.

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffective

againstawiderangeofGrampositivebacteria(inparticularStaphylococci)and

Gramnegativebacteria(Escherichiacoli,Salmonellatyphymurium,

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Campylobacterjejuni,Citrobacterfreundii,Enterobactercloacae,Proteusspp.,

Klebsiellaspp.,

Actinobacilluspleuropneumoniae,Bordetellabronchiseptica,Mannheimia

haemolytica,Pasteurellamultocida,Histophilusspp.,Moraxellaspp.,

Pseudomonasaeruginosa)aswellasMycoplasma(Mycoplasmabovis,

Mycoplasmadispar,Mycoplasmahyopneumoniae).

ResistanceinStreptococcusmayoccur.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousadministrationincattleandpigsattherecommendeddose

of2mg/kg,marbofloxacinisreadilyabsorbedanditsbioavailabilityiscloseto

100%.Itisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%in

cattle),extensivelydistributedandinmosttissues(liver,kidney,skin,lung,

bladder,uterus,digestivetract)itachieveshigherconcentrationsthanin

plasma.

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).

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.

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Donotfreeze.

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

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Krka,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm

01656/4059

9. DATEOFFIRSTAUTHORISATION

Date:14December2011

10.DATEOFREVISIONOFTHETEXT

Date:January2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

Approved:

23/01/13