FORCYL SWINE

Main information

  • Trade name:
  • FORCYL SWINE
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FORCYL SWINE
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0220/002
  • Authorization date:
  • 27-06-2012
  • EU code:
  • FR/V/0220/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FORCYLSWINE160mg/mlsolutionforinjectionforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Marbofloxacin................................160mg

Excipients:

Benzylalcohol(E1519)………………...15mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowgreenishtoyellowbrownishsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs:fatteningpigs,weanedpiglets,sows.

4.2 Indicationsforuse,specifyingthetargetspecies

Infatteningpigs:-TreatmentofrespiratorytractinfectionscausedbysusceptiblestrainsofPasteurella

multocida.

Inweanedpiglets:-TreatmentofintestinalinfectionscausedbysusceptiblestrainsofE.coli

Inpost-partumsows:

-Treatmentofmetritismastitisagalactiasyndrome(formofpostpartumdysgalactiaesyndrome,

PPDS)causedbystrainsofE.colisusceptibletomarbofloxacin.

4.3 Contraindications

Donotuseinanimalswithknownhypersensitivitytofluoroquinolonesortoanyoftheexcipients.

Tolimitdevelopmentofresistance,donotusefluoroquinolonesasprophylaxisormetaphylaxisto

preventdiarrhoeaatweaning.

4.4 Specialwarningsforeachtargetspecies

Donotuseincaseswherethepathogeninvolvedisresistanttootherfluoroquinolones(cross

resistance).

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthisproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly,tootherclassofantimicrobials.Whereverpossible,useof

theproductshouldonlybebasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgiveninthisSPCmayincreasetheprevalenceof

bacteriaresistanttothefluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcrossresistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Peoplewithknownhypersensitivityto(fluoro)quinolonesandbenzylalcoholshouldavoidanycontact

withtheproduct.

Washhandsafteruse.Iftheproductcomesintocontactwiththeskinoreyes,rinsewithcopious

amountsofwater.

Careshouldbetakentoavoidaccidentalself-injection.Intheeventofaccidentalself-administration,

theusershouldimmediatelyseekprofessionalmedicalcare.

Accidentalself-injectioncaninduceaslightirritation.

4.6 Adversereactions(frequencyandseriousness)

Localreactionscanbeobservedattheinjectionsite,whichdisappearwithin36days.

Painattheinjectionsitehasbeencommonlyreported.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofateratogenic,embryotoxicor

maternotoxiceffect.Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedat8

mg/kginpregnantsowsorinsucklingpigletswhenusedinsows.Useonlyaccordingtothe

benefit/riskassessmentcarriedoutbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Therecommendeddosageis8mg/kgbodyweight/day(1ml/20kgBW)inasingleintramuscular

injectioninthesideofthepigneck.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Lesionsofthejointcartilage,potentiallyleadingtodifficultiesinmovement,wereobservedinsome

animalstreatedatthreetimestherecommendeddoseandtreatmentduration.

4.11Withdrawalperiod(s)

Meatandoffal:9days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antibacterialsforsystemicuse

ATCVetcode:QJ01MA93

5.1 Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothefluoroquinolonegroup,which

actsbyinhibitionofDNAgyrase.Ithasabroad-spectrumactivityinvitroagainstGram-positive

bacteriaand,Gram-negativebacteria.

Between2005and2009,theactivityofmarbofloxacinagainstPasteurellamultocida(n=641)and

Escherichiacoli(n=1245)isolatedfromswinediseasesinEuropewasforP.multocida:MICrange:

0,004-2μg/ml,MIC

:0.015µg/mlMIC

:0,038μg/ml,forE.coli(digestiveinfections):MICrange

0,008-32µg/ml;MIC

:0,025µg/ml;MIC

:0,571µg/ml,forE.coli(MMAsyndrome):MICrange

0,008-32µg/ml;MIC

:0,023µg/ml;MIC

:0,322µg/ml.MarbofloxacinMICdistributionamongE.coli

strainsisolatedfromdigestiveorMMAsyndromearesimilarwithatrimodaldistribution.

Theactivityofmarbofloxacinagainstthetargetbacterialspeciesisbactericidalconcentration-

dependant.

AdecreaseofsusceptibilityofCampylobacterspp.againstfluoroquinoloneswasobservedsince1999.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththreemechanisms:decreaseof

thebacterialwallpermeability,expressionofeffluxpumpormutationofenzymesresponsiblefor

moleculebinding.Todate,onlysporadiccaseshavebeenreportedforplasmidmediated

fluoroquinoloneresistanceinanimals.Dependingontheunderlyingresistancemechanismcross-

resistancetoother(fluoro)quinolonesandco-resistancetootherantimicrobialclassescanoccur.

5.2 Pharmacokineticparticulars

Afteradministrationofanintramusculardoseof8mg/kg,thefollowingmeanpharmacokinetic

parameterswereobserved:

Parameter Pigs Weanedpigs

T

max 0.95h 0.93h

C

max 6.295µg/mL 5.550µg/mL

AUC

INF 114.7µg.h/mL 79.89µg.h/mL

T½lz 15.14h 13.23h

F 91.53% 89.57%

=maximalplasmaticconcentration;T

=meanobservedoccurrencetimeoftheCmax;AUC

=areaundertheconcentration-time

curveextrapolatedtoinfinity;T½lz=meaneliminationhalf-life;Fmeanabsolutebioavailability;

Marbofloxacinisextensivelydistributed.UterustissueconcentrationsinsowsreachCmaxof9.346

µg/gintheuterinebodyobservedatTmaxof1.00hafteradministrationandtheAUClastwas105.4

µg.h/g.Bindingtoplasmaproteinsisweak,about4%.Inpigs,theeliminationispredominantlyasthe

activeforminurineandfaeces.

Marbofloxaciniseliminatedslightlyfasterinpost-weaningpigletsthaninheavieranimals.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol

Glucono-delta-lactone

Waterforinjection

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelflifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Detailsoftheprimarypackaging:

AmbertypeIIglassvials

Chlorobutylrubberstopper

Aluminiumcaporflipcap

Packsizes:

Cardboardboxcontainingone50mlvial

Cardboardboxcontainingone100mlvial

Cardboardboxcontainingone250mlvial

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

product shouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VETOQUINOLSA

MAGNYVERNOIS

F-70200LURE

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

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