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
    Romania
  • Language:
  • English

Therapeutic information

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

Other information

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

Page1of5

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.

Issued:April2013

AN:00140/2012

Page2of5

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.

Issued:April2013

AN:00140/2012

Page3of5

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

Issued:April2013

AN:00140/2012

Page4of5

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

Issued:April2013

AN:00140/2012

Page5of5

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

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

There are no news related to this product.