Quiflor 20 mg/ ml solution for injection

Main information

  • Trade name:
  • Quiflor 20 mg/ ml solution for injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Quiflor 20 mg/ml solution for injection
    Italy
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0365/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0365/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01322/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Quiflor20mg/mlSolutionforInjectionforCattleandPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin20mg

Excipients:

Metacresol 2mg

Disodiumedetate0.10mg

Monothioglycerol 0.50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(pre-ruminantcalvesupto100kgb.w).

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Cattle(pre-ruminantcalvesupto100kgb.w)

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,MannheimiahaemolyticaandMycoplasmabovis.

Fatteningpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

Theveterinarymedicinalproductshouldonlybeusedbasedonsusceptibility

testing.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinor

anyotherquinoloneortoanyoftheexcipients.

Revised:January2013

AN:01322/2012

Page2of5

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhen

theproductisused.Fluoroquinolesshouldbereservedforthetreatment

ofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorly,tootherclassesofantimicrobials.Wheneverpossible,

fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Use

oftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolonesand

maydecreasetheeffectivenessoftreatmentwithotherquinolonesdueto

thepotentialforcrossresistance

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Accidentalself-injectioncaninduceaslightirritation.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Administrationbysubcutaneousandintramuscularroutemayinducetransitory

oedema.Administrationbytheintramuscularroutemaycausepainreactionand

inflammatorylesionsatthesiteofinjection.Inflammatorylesionspersist6days

inpigsand12daysincalves.

4.7Useduringpregnancy,lactationorlay

Maybeusedinpregnantandlactatingcowsandsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:January2013

AN:01322/2012

Page3of5

4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis2mg/kg/day(1ml/10kg)inasingledailyinjection

bysubcutaneousorintramuscularroutesincattle(thefirstinjectionmayalsobe

givenbyintravenousroute),andbyintramuscularrouteinpigs.

Treatmentdurationisasfollows:

- cattle,IM,SCroute:3to5days

- pigs,IMroute:3to5days

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible,toavoidunderdosing.

Thedosevolumegivenatoneinjectionsiteshouldnotexceed6mlincalves

and3mlinpigs.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itis

recommendedthatadraw-offneedlebeusedtoreducethenumberoftimesthe

septumispunctured.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosemaycauseacutesignsintheformofneurologicaldisorderswhich

shouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Meatandoffal

Preruminatingcalves(up

to100kgbodyweight 6days

Pigs 4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,

Fluoroquinolones.

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffective

againstawiderangeofGrampositivebacteria(inparticularStaphylococci)and

Gramnegativebacteria(Escherichiacoli,Salmonellatyphymurium,

Campylobacterjejuni,Citrobacter,Enterobacter,Proteusspp.,Klebsiellaspp.,

Actinobacilluspleuropneumoniae,Bordetellabronchiseptica,Mannheimia

haemolytica,Pasteurellamultocida,Histophilusspp.,Moraxellaspp.,

Revised:January2013

AN:01322/2012

Page4of5

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

Mannitol

Metacresol

Monothioglycerol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

Revised:January2013

AN:01322/2012

Page5of5

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 01656/4060

9. DATEOFFIRSTAUTHORISATION

Date:19December2011

10.DATEOFREVISIONOFTHETEXT

Date:January2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

Approved:

23/01/13