Fenflor

Main information

  • Trade name:
  • Fenflor 300 mg/ ml Solution for Injection for Cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fenflor 300 mg/ml Solution for Injection for Cattle
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0292/002
  • Authorization date:
  • 02-03-2012
  • EU code:
  • UK/V/0292/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

RevisedMarch2013

AN:01145/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fenflor300mg/mlsolutionforinjectionforcattle

Florfenicol

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol 300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Alightyellowtoyellow,clear,viscousliquid.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle.

4.2Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyflorfenicolsusceptiblebacteria.

Preventiveandtherapeutictreatmentofrespiratorytractinfectionsincattle

duetoMannheimiahaemolytica,PasteurellamultocidaandHistophilussomni.

Thepresenceofthediseaseintheherdshouldbeestablishedbefore

preventivetreatment.

4.3Contraindications

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Seealsosection4.7.

Donotuseincaseofresistancetotheactivesubstance.

4.4Specialwarningsforeachtargetspecies

None.

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4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Swabseptumbeforeremovingeachdose.Useadry,sterilesyringe

andneedle.

Theproductshouldbeusedinconjunctionwithsusceptibilitytesting

andtakeintoaccountofficialandlocalantimicrobialpolicies.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Donotusetheproductinknowncasesofsensitivitytopropyleneglycol.

4.6Adversereactions(frequencyandseriousness)

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmay

occurduringthetreatmentperiod.Thetreatedanimalsrecoverquicklyand

completelyuponterminationoftreatment.

Administrationoftheproductbytheintramuscularroutemaycauseswellingat

theinjectionsitewhichmaypersistfor14days.Inflammationattheinjection

sitemaypersistupto32daysafteradministration.

Administrationoftheproductbythesubcutaneousroutemaycauseswelling

andinflammationattheinjectionsitewhichmaypersistatleastfor41days.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-or

foetotoxicpotentialforflorfenicol.

However,theeffectofflorfenicolonbovinereproductiveperformanceand

pregnancyhasnotbeenassessed.Useonlyaccordinglytothebenefit/risk

assessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Fortreatment:

IMroute:20mg/kgbodyweight(1ml/15kg)tobeadministeredtwice48hours

apartusinga16gaugeneedle.

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonly

usinga16gaugeneedle.

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Forprevention:

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonly

usinga16gaugeneedle.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10ml.

Theinjectionshouldonlybegivenintheneck.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

4.11Withdrawalperiods

Meatandoffal:byIM(at20mg/kgbodyweight,twice): 30days

bySC(at40mg/kgbodyweight,once): 44days

Milk:Notpermittedforuseinlactatinganimalsproducingmilkforhuman

consumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCVetcode:QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmost

Gram-positiveandGram-negativebacteriaisolatedfromdomesticanimals.

Florfenicolactsbyinhibitingproteinsynthesisattheribosomallevelandis

bacteriostatic.Laboratorytestshaveshownthatflorfenicolisactiveagainstthe

mostcommonlyisolatedbacterialpathogensinvolvedinbovinerespiratory

diseasewhichincludeMannheimiahaemolytica,Pasteurellamultocida

andHistophilussomni.

Florfenicolisconsideredtobeabacteriostaticagent,butinvitrostudiesof

florfenicoldemonstratedbactericidalactivityagainstMannheimiahaemolytica,

PasteurellamultocidaandHistophilussomni.

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistance

associatedwithafloRgene.Suchresistancehasnotyetbeenidentifiedinthe

targetpathogensexceptforPasteurellamultocida.Crossresistancewith

chloramphenicolcanoccur.Resistancetoflorfenicolandotherantimicrobials

hasbeenidentifiedinthefood-bornepathogenSalmonellatyphimurium.

5.2 Pharmacokineticparticulars

Intramuscularadministrationattherecommendeddoseof20mg/kgmaintains

efficaciousbloodlevelsincattlefor48hours.Maximummeanplasma

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concentrat ion(Cmax)of3.86μg/mloccursat5hours(Tmax),afterdosing.

Themeanplasmaconcentration24hoursafterdosingwas1.56μg/ml.

Theharmonicmeaneliminationhalflifewas18.8hours.

Aftersubcutaneousadministrationoftherecommendeddoseof40mg

florfenicol/kgb.w.,maximumplasmaconcentration(Cmax)ofapproximately

3.5μg/mloccursapproximately7.0hours(Tmax)afterdosing.Themean

plasmaconcentration24hoursafterdosingisapproximately 2μg/ml.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethylsulfoxide

Propyleneglycol

Macrogol400

6.2Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproduct

shouldnotbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatecontainer:28days

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

6.5Natureandcompositionofimmediatepackaging

50,100and250mlTypeIamberglassbottleclosedwithabromobutylrubber

stopperandaluminiumseal.

1bottle(50ml)incardboardbox.

1bottle(100ml)incardboardbox.

1bottle(250ml)incardboardbox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

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7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01656/4026

9. DATEOFFIRSTAUTHORISATION

Date:4July2007

10.DATEOFREVISIONOFTHETEXT

Date:March2013

APPROVED 22/03/2013