Florfenicol 300 mg/ml Solution for Injection for Cattle and Pigs

Main information

  • Trade name:
  • Florfenicol 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:
  • Florfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0386/001
  • Authorization date:
  • 21-06-2011
  • EU code:
  • UK/V/0386/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:December2011

AN:01064/2010

Page1of6

SummaryofProductCharacteristics

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Colfen300mg/mlSolutionforInjectionforCattleandPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol…………300mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Alightyellowtoyellow,clear,viscousliquidpracticallyfreefromparticles.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:diseasescausedbyflorfenicolsusceptiblebacteria.

Preventiveandtherapeutictreatmentofrespiratorytractinfectionsincattledueto

Mannheimiahaemolytica,PasteurellamultocidaandHistophilussomni.The

presenceofthediseaseintheherdshouldbeestablishedbeforepreventive

treatment.

Pigs:treatmentofacuteoutbreaksofrespiratorydiseasecausedbystrainsof

ActinobacilluspleuropneumoniaeandPasteurellamultocidasusceptibletoflorfenicol.

4.3 Contraindications

Donotadministertoboarsandadultbullsintendedforbreedingpurposes.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseincasesofknownresistancetotheactivesubstance.

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4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Swabthestopperbeforeremovingeachdose.Useadry,sterilesyringeandneedle.

Thisproductisself-preservinganddoesnotcontainapreservative.

Donotuseinpigletsoflessthan2kg.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Incaseofaccidentalself-injection,seekmedicaladviceandshowthelabeltothe

doctor.

Donotusetheproductinknowncasesofsensitivitytopropyleneglycoland

polyethyleneglycols.

Incaseofaccidentalcontactwitheyes,rinseimmediatelywithplentyofwater.

4.6Adversereactions(frequencyandseriousness)

Cattle

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmayoccur

duringthetreatmentperiod.Thetreatedanimalsrecoverquicklyandcompletely

uponterminationoftreatment.

Administrationoftheproductbytheintramuscularroutemaycauseswellingatthe

injectionsite.Inflammationattheinjectionsitemaypersistupto32daysafter

administration.

Administrationoftheproductbythesubcutaneousroutemaycauseswellingand

inflammationattheinjectionsitewhichmaypersistatleastfor41days.

Pigs

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-analand

rectalerythema/oedemawhichmayaffect50%oftheanimals.Theseeffectscanbe

observedforoneweek.

Transientswellinglastingupto5daysmaybeobservedatthesiteofinjection.

Inflammatorylesionsattheinjectionsitemaybeseenupto28days.Underfield

conditionsapproximately30%oftreatedpigspresentedwithpyrexia(40°C)

associatedwitheithermoderatedepressionormoderatedyspneaaweekormore

afteradministrationoftheseconddose.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-or

foetotoxicpotentialforflorfenicol.

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Cattle:theeffectofflorfenicolonbovinereproductiveperformanceandpregnancy

hasnotbeenassessed.Useonlyaccordinglytothebenefit/riskassessmentbythe

responsibleveterinarian.

Pigs:thesafetyoftheproductinsowsduringpregnancyandlactationhasnotbeen

demonstrated.Useoftheproductduringpregnancyandlactationisthereforenot

recommended.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Cattle:

Fortreatment:

IMroute:20mg/kgbodyweight(1ml/15kg)tobeadministeredtwice48hoursapart

usinga16gaugeneedle.

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonlyusinga16

gaugeneedle.

Forprevention:

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonlyusinga16

gaugeneedle.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10ml.

Theinjectionshouldonlybegivenintheneck.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Pigs:

15mg/kgbodyweight(1mlper20kg)byintramuscularinjectionintotheneckmuscle

twiceat48-hourintervalsusingadry,sterile16-gaugeneedle.

Thevolumeadministeredperinjectionsiteshouldnotexceed3ml.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandtoevaluatethe

responsetotreatmentwithin48hoursafterthesecondinjection.

Ifclinicalsignsofrespiratorydiseasepersist48hoursafterthelastinjection,

treatmentshouldbechangedusinganotherformulationoranotherantibioticand

continueduntilclinicalsignshaveresolved.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Donotbroachthevialmorethan25times.Useasuitabledraw-offneedleor

automaticdosingsyringetoavoidexcessivepuncturingoftheclosure.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Cattle

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmayoccur

duringthetreatmentperiod.Thetreatedanimalsrecoverquicklyandcompletely

uponterminationoftreatment.

Pigs

Afteradministrationof3timestherecommendeddoseormoreareductionin

feeding,hydrationandweightgainhasbeenobserved.

Afteradministrationof5timestherecommendeddoseormorevomitinghasalso

beennoted.

4.11Withdrawalperiod(s)

Cattle

Meatand

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

bySC(at40mg/kgbodyweight,once):44days

Milk: Notpermittedforuseinlactatinganimalsproducingmilkforhuman

consumption.

Pigs

Meatand

offal: 18days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCVetCode:QJ01BA90

5.1 Pharmacodynamicproperties

FlorfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmostGram-

positiveandGram-negativebacteriaisolatedfromdomesticanimals.Florfenicolacts

byinhibitingproteinsynthesisattheribosomallevelandisbacteriostatic.However,

bactericidalactivityhasbeendemonstratedin-vitroagainstActinobacillus

pleuropneumoniae,Pasteurellamultocida,MannheimiahaemolyticaandHistophilus

somni.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingActinobacillus

pleuropneumoniaeandPasteurellamultocida.Laboratorytestshavealsoshownthat

florfenicolisactiveagainstthemostcommonlyisolatedbacterialpathogensinvolved

inbovinerespiratorydiseasewhichincludeMannheimiahaemolytica,Pasteurella

multocidaandHistophilussomni.

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Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistanceassociated

withafloRgene.Suchresistancehasnotyetbeenidentifiedinthetargetpathogens

exceptforPasteurellamultocidaandActinobacilluspleuropneumoniae.Cross

resistancewithchloramphenicolcanoccur.

Resistancetoflorfenicolandotherantimicrobialshasbeenidentifiedinthefood-

bornepathogenSalmonellatyphimuriumandco-resistancewiththethird-generation

cephalosporinshasbeenobservedinrespiratoryanddigestiveEscherichiacoli.

5.2 Pharmacokineticparticulars

Cattle

Intramuscularadministrationattherecommendeddoseof20mg/kgmaintains

efficaciousbloodlevelsincattlefor48hours.Maximummeanplasmaconcentration

(Cmax)of3.86μg/mloccursat5hours(Tmax)afterdosing.Themeanplasma

concentration24hoursafterdosingwas1.56μg/ml.

Theharmonicmeaneliminationhalflifewas18.8hours.

Aftersubcutaneousadministrationoftherecommendeddoseof40mgflorfenicol/kg

b.w.,maximumplasmaconcentration(Cmax)ofapproximately3.5μg/mloccurs

approximately7.0hours(Tmax)afterdosing.Themeanplasmaconcentration24

hoursafterdosingisapproximately2μg/ml.

Theharmonicmeaneliminationhalflifewas39.7hours.

Pigs

Aftersingleintramuscularadministrationoftherecommendeddoseof15mg/kgto

pigsmaximummeanplasmaconcentration(Cmax)of2.08μg/mloccursat2hours

(Tmax)afterdosing.

Theharmonicmeaneliminationhalflifewas10.37hours.

Afteradministrationtopigsbytheintramuscularroute,florfenicolisrapidlyexcreted,

primarilyinurine.Florfenicolisextensivelymetabolised.

Serumconcentrationspersistabove1μg/mlfor12to24hoursfollowingIM

administration.Florfenicolconcentrationsachievedinlungtissuereflectplasma

concentrations,withalung:plasmaconcentrationratioofapproximately1.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Propyleneglycol

Dimethylsulfoxide

Macrogol400

6.2Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductshouldnot

bemixedwithotherveterinarymedicinalproducts.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

50ml,100mland250mlTypeIamberglassvialswithbromobutylrubberclosure

andaluminiumoversealincardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLimited,

Sandwich,Kent,

CT139NJ,UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4422

9. DATEOFFIRSTAUTHORISATION

28December2011

10 DATEOFREVISIONOFTHETEXT

December2011