Florfenikel

Main information

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

Documents

Localization

  • Available in:
  • Florfenikel
    Hungary
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0379/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0379/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:February2012

AN:00791/2010

Page1of4

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

NL,CZ,FR,DE,IE,IT,PL,BE,BG,CY,GR,HU,LU,PT,RO,SK:FLORFENIKEL300

mg/mlsolutionforinjectionforpigs

ES,DK:KELAFLOR300mg/mlsolutionforinjectionforpigs

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstance:

Florfenicol300mg

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

SolutionforInjection.

Clear,lightyellowtoyellowsolution.

4.CLINICALPARTICULARS

4.1TargetSpecies

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyflorfenicolsusceptiblebacteria.

Pigs:Treatmentofacuteoutbreaksofswinerespiratorydiseasecausedbystrainsof

ActinobacilluspleuropneumoniaeandPasteurellamultocidasusceptibletoflorfenicol.

4.3Contraindications

Donotuseinboarsintendedforbreedingpurposes.

Donotuseinpigletsoflessthan2kg.

Donotadministertoanimalswithknownhypersensitivitytoflorfenicolortoanyofthe

excipients.

Donotadministerintravenously.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Issued:February2012

AN:00791/2010

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Thestoppermustbecleanedbeforeremovingeachdose.Useadry,sterilesyringeand

needle.

(ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductto

animals

Careshouldbetakentoavoidaccidentalself-injection.Incaseofself-injection,seek

medicaladviceimmediatelyandshowthepackageleafletorthelabeltothephysician.

Avoiddirectcontactwithskin,mouthandeyes.Ifeyeexposureoccurs,flusheyes

immediatelywithcleanwater.Ifskinexposureoccurs,washtheaffectedareawithclean

water.Ifaccidentalingestionoccurs,rinsethemouthwithplentyofwaterandseek

medicaladviceimmediately.

Washhandsafteruse.

Peoplewithknownhypersensitivitytoflorfenicolshouldavoidcontactwiththeproduct.

(iii)Otherprecautions

None

4.6Adversereactions(frequencyandseriousness)

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-analandrectal

erythema/oedemawhichmayaffect50%oftheanimals.Theseeffectscanbeobserved

foroneweek.

Transientswellinglastingupto5daysmaybeobservedatthesiteofinjection.

Inflammatorylesionsattheinjectionsitemaybeseenupto28days.

Underfieldconditions,approximately30%oftreatedpigsmaypresentwithpyrexia

(40oC)associatedwitheithermoderatedepressionormoderatedyspnoeaaweekor

moreafteradministrationoftheseconddose.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryspecieshavenotproducedanyevidenceofteratogenicor

foetotoxiceffects.Safetyduringpregnancyandlactationhasnotbeeninvestigatedin

thetargetspecies.Useonlyaccordinglytothebenefit/riskassessmentbythe

responsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9Amountstobeadministeredandadministrationroute

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossible

toavoidunderdosing.Thevialcannotbebroachedmorethan25times.

IMinjectionof15mg/kgBW(1ml/20kg)intotheneckmuscletwice48hourapart.

Thevolumeadministeredperinjectionsiteshouldnotexceed3ml.Subsequent

injectionsmustbegivenatdifferentsites.

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AN:00791/2010

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Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandtoevaluatethe

responsetotreatmentwithin48hoursafterthesecondinjection.Ifclinicalsignsof

respiratorydiseasepersist48hoursafterthelastinjection,treatmentshouldbechanged

usinganotherformulationoranotherantibioticandcontinueduntilclinicalsignshave

resolved.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inswineafteradministrationof3timestherecommendeddoseormoreareductionin

feeding,hydrationandweightgainhasbeenobserved.Afteradministrationof5times

therecommendeddoseormorevomitinghasalsobeennoted.

4.11WithdrawalPeriod(s)

Meatandoffal:18days

5.PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacoterapeuticgroup:Antibacterialsforsystemicuse,amphenicols,Florfenicol

ATCvetcode:QJ01BA90

5.1Pharmacodynamicproperties

FlorfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmostGram-positive

andGram-negativebacteriaisolatedfromdomesticanimals.Florfenicolactsby

inhibitingproteinsynthesisattheribosomallevelandisbacteriostatic.

However,bactericidalactivityhasbeendemonstratedinvitroagainstmostcommon

bacterialpathogensinvolvedinrespiratorydisease:

- Actinobacilluspleuropneumoniaisolatedinpigs.

- Pasteurellamultocidaisolatedincattleandpigs .

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistanceassociatedwith

aflogene.Crossresistancewithchloramphenicolcanoccur.

5.2Pharmacokineticproperties

Afterintramuscularadministrationoftherecommendeddoseof15mg/kg,maximum

serumconcentrationof2.48µg/mlisreachedafter2.0hoursandtheconcentrations

depletewithaterminalhalf-lifeof14.9hours.

Serumconcentrationsdropbelow1µg/ml,theMIC90forthetargetporcinepathogens,

12-24hoursfollowingIMadministrationFlorfenicolconcentrationsachievedinlung

tissuereflectplasmaconcentration,withalung:plasmaconcentrationratioof

approximately1.Afteradministrationtopigsbytheintramuscularroute,florfenicolis

rapidlyexcreted,primarilyinurine.Theflorfenicolisextensivelymetabolised.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

N-Methylpyrrolidone

Glycerolformal

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AN:00791/2010

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6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Followingwithdrawalofthefirstdose,usetheproductwithin28days.

6.4Specialprecautionsforstorage

Storethebottleintheoutercartoninordertoprotectfromdirectsunlight.

6.5Natureandcompositionofimmediatepackaging

Vialsizes:100and250ml

-ColourlessTypeIIglassvialsclosedwithbromobutylrubberclosuresandan

aluminiumcap.

-Polypropylenevialsclosedwithbromobutylrubberclosuresandanaluminiumcap.

Vialsareindividuallypackedincartonbox.

Six,tenortwelveofthesearegroupedasclinicalpack.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproducts

orwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.MARKETINGAUTHORISATIONHOLDER

KELAN.V.

St.Lenaartseweg48

2320Hoogstraten

Belgium

8.MARKETINGAUTHORISATIONNUMBER

Vm06126/4001

9.DATEOFTHEFIRSTAUTHORISATION

27February2012