FLORKEM 300 mg/ml solution for injection for cattle and pigs

Main information

  • Trade name:
  • FLORKEM 300 mg/ml solution for injection for cattle and pigs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLORKEM 300 mg/ml solution for injection for cattle and pigs
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0197/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0197/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

(S.P.C.)

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

FLORKEM300mg/mlsolutionforinjectionforcattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol........................................................300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Paleyellowtoyellowclearsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyflorfenicolsusceptiblebacteria.

Cattle:

TreatmentofrespiratorytractinfectionsduetoMannheimiahaemolytica,Pasteurellamultocidaand

Histophilussomni.

Pigs:

TreatmentofacuteoutbreaksofswinerespiratorydiseasecausedbystrainsofActinobacillus

pleuropneumoniaeandPasteurellamultocidasusceptibletoflorfenicol.

4.3 Contraindications

Donotuseinadultbullsorboarsintendedforbreedingpurposes.

Donotuseincattleproducingmilkforhumanconsumption.

Donotadministerincasesofhypersensitivitytotheactiveingredientoranyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

None.

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Wipethestopperbeforeremovingeachdose.Useadry,sterileneedleandsyringe.

Donotuseinpigletsoflessthan2kg.

Underfieldconditions,approximately30%oftreatedpigspresentedwithpyrexia(40°C)associated

witheithermoderatedepressionormoderatedyspnoeaaweekormoreafteradministrationofthe

seconddose.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeintoaccountofficialand

localantimicrobialpolicies.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidaccidentalself-injection.Incaseofaccidental

self-injection,seekmedicaladvice,andshowthepackageleafletorthelabeltothephysician.

Peoplewithknownhypersensitivitytothecomponentsoftheformulationshouldavoidcontactwiththe

product.

Washhandsafterhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Cattle:

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmayoccurduringthetreatment

period.Treatedanimalsrecoverquicklyandcompletelyuponterminationoftreatment.

Administrationoftheproductbytheintramuscularroutemaycauseinflammatorylesionsatthe

injectionsitewhichmaypersistforupto28days.

Pigs:

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-analandrectal

erythema/oedemawhichmayaffect50%oftheanimals.Theseeffectsmaybeobservedforuptoone

week.

Administrationoftheproductbytheintramuscularroutemaycauseinflammatorylesionsatinjection

sitewhichdisappearwithin28days.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-orfoeto-toxicpotentialfor

florfenicol.However,thesafetyofflorfenicolonbovineandporcinereproductiveperformanceand

pregnancyhasnotbeenassessed.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

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4.9 Amountstobeadministeredandadministrationroute

Intramuscularuse.

Theinjectionshouldbegivenintheneck.

Cattle:

20mgflorfenicolperkgbodyweight,i.e.1mlofsolutionper15kgbodyweight,twice48hoursapart.

Pigs:

15mgflorfenicolperkgbodyweight,i.e.1mlofsolutionper20kgbodyweight,twice48hoursapart.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10mlincattleand3mlinpigs.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoid

underdosing.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandtoevaluatetheresponseto

treatmentwithin48hoursafterthesecondinjection.Ifclinicalsignsofrespiratorydiseasepersist48

hoursafterthelastinjection,treatmentshouldbechangedusinganotherformulationoranother

antibioticandcontinueduntilclinicalsignshaveresolved.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inswineafterintramuscularadministrationof3timestherecommendeddoseormore,areductionin

feeding,hydrationandweightgainhasbeenobserved.Afteradministrationof5timesthe

recommendeddoseormore,vomitinghasalsobeennoted.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal:37days

Milk:Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

Pigs:

Meatandoffal:18days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCvetcode:QJ01BA90

5.1 Pharmacodynamicproperties

Florfenicolisasyntheticbroad-spectrumantibioticeffectiveagainstmostGrampositiveandGram

negativebacteriaisolatedfromdomesticanimals.

Florfenicolactsbyinhibitingbacteriaproteinssynthesisattheribosomallevel,thusisbacteriostatic.

However,invitrotestshaveshownthatflorfenicolhasabactericidalactivityagainstthemost

commonlyisolatedbacterialpathogensinvolvedinrespiratorydiseases:

- Histophilussomni,MannheimiahaemolyticaandPasteurellamultocidaisolatedfrom

cattle

- Actinobacilluspleuropneumonia,andPasteurellamultocidaisolatedfrompigs.

- Arcanobacteriumpyogenesisolatedfromcattleandpigs

AcquiredresistancetoflorfenicolismediatedbyeffluxpumpresistanceassociatedwithafloRgene.

SuchresistancehasnotyetbeenidentifiedinthetargetpathogensexceptforPasteurellamultocida.

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Crossresistancewithchloramphenicolcanoccur.Resistancetoflorfenicolandotherantimicrobialshas

beenidentifiedinthefood-bornpathogenSalmonellatyphimurium.

ForMannheimiahaemolytica,PasteurellamultocidaandHistophilussomnithefollowing

breakpointshavebeendeterminedforflorfenicolinbovinerespiratorydisease;susceptible:≤2µg/ml,

intermediate:4µg/ml,resistant:≥8µg/ml.

5.2 Pharmacokineticparticulars

Incattle

Intramuscularadministrationoftheformulationattherecommendeddoseof20mg/kgmaintains

efficaciousbloodlevelsfor48hours.Maximummeanserumconcentration(Cmax)of3.8µg/ml

occurred5.7hours(Tmax)afterdosing.Themeanserumconcentration24hoursafterdosingwas1.95

µg/ml.Themeaneliminationhalflifewas15.3hours

Inpigs

Afterintramuscularadministrationofflorfenicol,maximumserumconcentrationof4.7µg/mlisreached

after1.8hoursandtheconcentrationsdepletewithaterminalmeanhalf-lifeof14.8hours.Serum

concentrationsdropbelow1µg/ml,theMIC90forthetargetporcinepathogens,12-24hoursfollowing

IMadministrationFlorfenicolconcentrationsachievedinlungtissuereflectplasmaconcentration,with

alung:plasmaconcentrationratioofapproximately1.Afteradministrationtopigsbytheintramuscular

route,florfenicolisrapidlyexcreted,primarilyinurine.Theflorfenicolisextensivelymetabolised.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dimethylacetamide

Diethyleneglycol monoethylether

Monoethylether

Macrogol300

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

ColourlessglassvialtypeII(20–50–100–250-500ml).

Translucentmulti-layerplasticvials(50–100–250–500ml).

ChlorobutylstoppertypeII.

Packsize

Boxcontaining20,50,100,250or500mlvials.

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT