Floron 40mg/ g oral powder for Swine

Main information

  • Trade name:
  • Floron 40mg/ g oral powder for Swine
  • Pharmaceutical form:
  • Oral powder
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Floron 40mg/g oral powder for Swine
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0344/002
  • Authorization date:
  • 23-01-2013
  • EU code:
  • UK/V/0344/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:April2013

AN:00140/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Floron40mg/gOralpowderforSwine

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Florfenicol 40mg

Excipients:

PropyleneGlycol(E1520)10mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpowder.

Slightlybrownishwhitepowder.

4. CLINICALPARTICULARS

4.1Targetspecies

Pig(fatteningpigs).

4.2Indicationsforuse,specifyingthetargetspecies

Infatteningpigs:

ForthetreatmentofswinerespiratorydiseaseinindividualpigsduetoPasteurella

multocidasusceptibletoflorfenicol.

4.3Contraindications

Donotuseinboarsintendedforbreedingpurposes.

Donotadministerincasesofpreviousallergicreactionstoflorfenicol.

4.4Specialwarningsforeachtargetspecies

Thetreatedpigsshouldbeplacedunderspecialobservation.Oneachofthefive

daysoftreatment,untreatedfoodshouldnotbegivenuntilthefulldailyamountof

medicatedfeedhasbeeningestedbythepigs.

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Ifthereisnosignificantimprovementafter3treatmentdays,thediagnosisshouldbe

reviewedandifnecessarythetreatmentshouldbechanged.

Animalsshowingadecreasedappetiteand/orapoorgeneralconditionshouldbe

treatedbytheparenteralroute.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalpolicyrelatingtotheuseofantimicrobials.

Thisproductcontainsgroundlimestone,whichcanleadtoadecreaseinfood

consumptionandtoaphosphoruscalciumimbalanceinfeedintake.Thereforethe

calciumcontentofthefinalfoodshallbeconsidered.

Treatmentshouldnotexceed5days.

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Skinsensitisationmayoccur.

Avoidskincontact.

Donothandlethisproductincaseofknownsensitisationtopropyleneglycol.

Handlethisproductwithcaretoavoidexposureduringincorporationofthepowder

intofeedandadministrationoffeedtoanimals,takingallrecommendedprecautions.

Weareitheradisposablehalf-maskrespiratorconformingtoEuropeanstandardEN

149oranon-disposablerespiratortoEuropeanStandardEN140withafiltertoEN

143,chemicallyresistantgloves,protectivecoverallsandgoggleswhileincorporating

thepowderintofeed.

Wearglovesanddonotsmoke,eat,ordrinkwhenhandlingtheproductormedicated

feed.

Washhandsthoroughlywithsoapandwaterafteruseoftheproductormedicated

feed.

Rinsethoroughlywithwaterincaseofexposure.

Ifyoudevelopsymptomsfollowingexposuresuchasskinrash,youshouldseek

medicaladviceandtakethepackageleafletorthelabelwithyou.

4.6Adversereactions(frequencyandseriousness)

Commonlyobservedadverseeffectsarediarrhoeaperianalinflammationandrectal

eversion.Theseeffectsaretransient,resolvingoncessationoftreatment.Increased

serumcalciummayalsobeobserved.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedinsows

duringpregnancyandlactation.Useoftheproductduringpregnancyandlactationis

thereforenotrecommended.

Donotuseinbreedingboarsbecausetoxicitystudiesinratshaveshownadverse

effectsonthemalereproductivesystem:Seesection4.3contraindications.

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4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9Amount(s)tobeadministeredandadministrationroute

Foruseinindividualpigs.

Foruseinfeed.Theproductisrecommendedforusewithnon-pelletedfeed.

Dosage:

10mgofflorfenicolperkgbodyweight(bw)(equivalentto250mgtheveterinary

medicinalproduct)perdaymixedinaportionofthedailyfeedrationon5

consecutivedays.

Administration:

Inordertoensurecorrectdosingandtopreventunderdosing,thebodyweightshall

becalculatedaspreciselyaspossible.Thenecessaryamountoftheproductshallbe

weighedonacalibratedscale.

Thecorrectdosagecanbecalculatedasfollows:

250mgofthe

veterinarymedicinal

productperkgbody

weightandday X bodyweightofthepig

(kg)

Specialcarehastobetakenthatthetotaldoseisingested.

Thepowdershouldbemixedintosomeofthefeedtoensureitisthoroughly

distributed.Thismixturemustbeadministeredbeforetheactualfeed.Themaximum

concentrationis500mgflorfenicol/kgfeed,higherconcentrationsmayleadtopoor

palatabilityanddecreasedfoodconsumption.

Incasesofseverediseaseorinappetencetheanimalsshouldbetreatedbythe

parenteralroute.

Fortreatmentofgroupsofpigs,useanappropriatepremixincorporatedinto

medicatedfeedingstuffbyanauthorisedfeedmanufacturer.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intheeventofoverdose,areductioninfoodandwaterconsumption,togetherwitha

decreaseinbodyweightmaybeobserved.Theremaybeanincreaseinrefusedfeed

andanincreaseinserumcalcium.

4.11Withdrawalperiods

Meatandoffal:14days

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5. PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Antibacterialsforsystemicuse,Amphenicols

ATCvetcode:QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticinthephenicolgroupthatisactive

againstmostGram-positiveandGram-negativebacteriaisolatedfromdomestic

animals.Florfenicolactsbyinhibitionofproteinsynthesisattheribosomalleveland

isbacteriostatic.However,bactericidalactivityhasbeendemonstratedin-vitro

againstPasteurellamultocidawhenflorfenicolispresentatconcentrationsabovethe

MICfor4to12hours.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingPasteurella

multocida.

Atotalof193Pasteurellamultocidaisolatesfromtherespiratorytractofswinewere

collectedbetween2002and2003inFrance,Spain,Greece,Germany,theUnited

KingdomandBelgium.TheMinimalInhibitoryConcentration(MIC)offlorfenicol

againstthetargetpathogenrangedfrom0.25to1µg/mlwithaMIC

of0.5µg/ml.

Theonlymechanismsofchloramphenicolresistancethatareknowntohave

significantclinicalrelevanceareCAT-mediatedinactivationandefflux-pump

resistance.Ofthese,onlysomeoftheeffluxmediatedresistancewouldalsoconfer

resistancetoflorfenicolandthushavethepotentialtobeaffectedbyflorfenicolusein

animals.

5.2Pharmacokineticparticulars

Afteradministrationof10mg/kgb.w.topigsunderexperimentalconditions,mean

maximalserumconcentrationsofapproximately7.4µg/mlwerereachedwithin1.5

hoursafterdosing.Theterminalhalf-lifewasbetweenapproximately2and4hours.

Afterasingletreatmenttheserumconcentrationsofflorfenicolremainedabove1

µg/mlfor6to12hours.

Florfenicoliswellabsorbedwhenadministeredorallyandfollowingdistributionitis

rapidlyeliminatedintheurineandfaecesinaratioof3:1.Afractionisexcreted

unchangedandtherestismetabolisedinto5majormetabolites.

Afterparenteraldosingofflorfenicoltopigs,ithasbeenshownthatlung

concentrationsaresimilartoserumconcentrations.

6 PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PropyleneGlycol(E1520)

GroundLimestone

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6.2Incompatibilities

Noneknown.

6.3Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningtheimmediatepackaging:3months

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

6.5Natureandcompositionofimmediatepackaging

PET/AL/PEfoilsealedbagcontaining250g , 1kgor3kgoforalpowder.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4053

9. DATEOFFIRSTAUTHORISATION

10April2013

10. DATEOFREVISIONOFTEXT

April2013

Approved: 10/04/2013