Fenflor 40mg/g Premix for medicated Feeding Stuff for Swine

Main information

  • Trade name:
  • Fenflor 40mg/g Premix for medicated Feeding Stuff for Swine
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fenflor 40mg/g Premix for medicated Feeding Stuff for Swine
    Spain
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0344/001
  • Authorization date:
  • 28-04-2010
  • EU code:
  • UK/V/0344/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised03/09/2010 –AN00780/2009

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fenflor300mg/mlsolutionforinjectionforcattle

Florfenicol

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol 300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Alightyellowtoyellow,clear,viscousliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

4.2 Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyflorfenicolsusceptiblebacteria.

PreventiveandtherapeutictreatmentofrespiratorytractinfectionsincattleduetoMannheimia

haemolytica,PasteurellamultocidaandHistophilussomni.Thepresenceofthediseaseintheherd

shouldbeestablishedbeforepreventivetreatment.

4.3 Contraindications

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Seealsosection4.7.

Donotuseincaseofresistancetotheactivesubstance.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Swabseptumbeforeremovingeachdose.Useadry,sterilesyringeandneedle.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeintoaccountofficialand

localantimicrobialpolicies.

Revised03/09/2010 –AN00780/2009

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Careshouldbetakentoavoidaccidentalself-injection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthelabeltothedoctor.

Donotusetheproductinknowncasesofsensitivitytopropyleneglycol.

4.6 Adversereactions(frequencyandseriousness)

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmayoccurduringthetreatment

period.Thetreatedanimalsrecoverquicklyandcompletelyuponterminationoftreatment.

Administrationoftheproductbytheintramuscularroutemaycauseswellingattheinjectionsite

whichmaypersistfor14days.Inflammationattheinjectionsitemaypersistupto32daysafter

administration.

Administrationoftheproductbythesubcutaneousroutemaycauseswellingandinflammationatthe

injectionsitewhichmaypersistatleastfor41days.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-orfoetotoxicpotentialfor

florfenicol.

However,theeffectofflorfenicolonbovinereproductiveperformanceandpregnancyhasnotbeen

assessed.Useonlyaccordinglytothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Fortreatment:

IMroute:20mg/kgbodyweight(1ml/15kg)tobeadministeredtwice48hoursapartusinga16gauge

needle.

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonlyusinga16gaugeneedle.

Forprevention:

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonlyusinga16gaugeneedle.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10ml.

Theinjectionshouldonlybegivenintheneck.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyaspossibletoavoidunder

dosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

Revised03/09/2010 –AN00780/2009

4.11Withdrawalperiods

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

bySC(at40mg/kgbodyweight,once):44days

Milk:Notpermittedforuseinlactatinganimalsproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,ATCVetcode:QJ01BA90

5.1 Pharmacodynamicproperties

FlorfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmostGram-positiveandGram-

negativebacteriaisolatedfromdomesticanimals.Florfenicolactsbyinhibitingproteinsynthesisatthe

ribosomallevelandisbacteriostatic.Laboratorytestshaveshownthatflorfenicolisactiveagainstthe

mostcommonlyisolatedbacterialpathogensinvolvedinbovinerespiratorydiseasewhichinclude

Mannheimiahaemolytica,PasteurellamultocidaandHistophilussomni.

Florfenicolisconsideredtobeabacteriostaticagent,butinvitrostudiesofflorfenicoldemonstrated

bactericidalactivityagainstMannheimiahaemolytica,PasteurellamultocidaandHistophilussomni.

AcquiredresistancetoflorfenicolismediatedbyeffluxpumpresistanceassociatedwithafloRgene.

SuchresistancehasnotyetbeenidentifiedinthetargetpathogensexceptforPasteurellamultocida.

Crossresistancewithchloramphenicolcanoccur.Resistancetoflorfenicolandotherantimicrobials

hasbeenidentifiedinthefood-bornepathogenSalmonellatyphimurium.

5.2 Pharmacokineticparticulars

Intramuscularadministrationattherecommendeddoseof20mg/kgmaintainsefficaciousbloodlevels

incattlefor48hours.Maximummeanplasmaconcentration(Cmax)of3.86μg/mloccursat5hours

(Tmax),afterdosing.Themeanplasmaconcentration24hoursafterdosingwas1.56μg/ml.

Theharmonicmeaneliminationhalflifewas18.8hours.

Aftersubcutaneousadministrationoftherecommendeddoseof40mgflorfenicol/kgb.w.,maximum

plasmaconcentration(Cmax)ofapproximately3.5μg/mloccursapproximately7.0hours(Tmax)

afterdosing.Themeanplasmaconcentration24hoursafterdosingisapproximately2μg/ml.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Dimethylsulfoxide

Propyleneglycol

Macrogol400

6.2 Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductshouldnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatecontainer:28days

Revised03/09/2010 –AN00780/2009

6.4 Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

50,100and250mlTypeIamberglassbottleclosedwithabromobutylrubberstopperandaluminium

seal.

1bottle(50ml)incardboardbox.

1bottle(100ml)incardboardbox.

1bottle(250ml)incardboardbox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Krkad.d.,Novomesto

Smarjeskacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4026

9. DATEOFFIRSTAUTHORISATION

4July2007

10. DATEOFREVISIONOFTHETEXT

3September2010

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