Fenflor 300 mg/ ml Solution for Injection for Pigs

Main information

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

Documents

Localization

  • Available in:
  • Fenflor 300 mg/ml Solution for Injection for Pigs
    Germany
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0291/001
  • Authorization date:
  • 14-04-2010
  • EU code:
  • UK/V/0291/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:March2013

AN:01142/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fenflor300mg/mlsolutionforinjectionforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol300mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Alightyellowtoyellow,clear,viscousliquid.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofacuteoutbreaksofrespiratorydiseasecausedbystrainsof

ActinobacilluspleuropneumoniaeandPasteurellamultocidasusceptibleto

florfenicol.

4.3Contraindications

Donotadministertoboarsintendedforbreeding.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseinthecasesofknownresistancetotheactivesubstance.

4.4 Specialwarnings

None

Revised:March2013

AN:01142/2012

4.5Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Wipethestopperbeforeremovingeachdose.Useadry,sterilesyringe

andneedle.

Donotuseinpigletsoflessthan2kg.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingand

takeintoaccountofficialandlocalantimicrobialpolicies.

Useasuitabledraw-offneedleorautomaticdosingsyringetoavoid

excessivepuncturingoftheclosure.

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Inthecaseofself-injection,seekmedicaladviceandshowthelabeltothe

doctor.

Donotusetheproductinknowncasesofsensitivitytoflorfenicol,

propyleneglycolandpolyethyleneglycols.

Incaseofaccidentalcontactwitheyes,rinseimmediatelywithplentyof

water.

4.6Adversereactions(frequencyandseriousness)

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-analand

rectalerythema/oedemawhichmayaffect50%oftheanimals.Theseeffectscan

beobservedforoneweek.

Transientswellinglastingupto5daysmaybeobservedatthesiteofinjection.

Inflammatorylesionsattheinjectionsitemaybeseenupto28days.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-or

foeto-toxicpotentialforflorfenicol.However,thesafetyoftheproductinsows

duringpregnancyandlactationhasnotbeendemonstrated.Useoftheproduct

duringpregnancyandlactationisthereforenotrecommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9Amountstobeadministeredandadministrationroute

15mg/kgbodyweight(1mlper20kg)byintramuscularinjectionintotheneck

muscletwiceat48hourintervalsusingadry,sterile16-gaugeneedle.

Thevolumeadministeredperinjectionsiteshouldnotexceed3ml.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandtoevaluate

theresponsetotreatmentwithin48hoursafterthesecondinjection.

Ifclinicalsignsofrespiratorydiseasepersist48hoursafterthelastinjection,

treatmentshouldbechangedusinganotherformulationoranotherantibioticand

continueduntilclinicalsignshaveresolved.

Revised:March2013

AN:01142/2012

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inswineafteradministrationof3timestherecommendeddoseormorea

reductioninfeeding,hydrationandweightgainhasbeenobserved.

Afteradministrationof5timestherecommendeddoseormorevomitinghasalso

beennoted.

4.11Withdrawalperiod

Meatandoffal: 18days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCVetCode:QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticactiveagainstmostGram-

positiveandGram-negativebacteriaisolatedfromdomesticanimals.Florfenicol

actsbyinhibitionofproteinsynthesisattheribosomallevelandisbacteriostatic.

However,bactericidalactivityhasbeendemonstratedin-vitroagainst

ActinobacilluspleuropneumoniaeandPasteurellamultocida.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingActinobacillus

pleuropneumoniaeandPasteurellamultocida.

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistance

associatedwithafloRgene.Intargetpathogens,suchresistancehasonlybeen

identifiedinPasteurellamultocida.Crossresistancewithchloramphenicolcan

occur.

5.2Pharmacokineticparticulars

Afterasingleintramuscularadministrationoftherecommendeddoseof15mg/kg

maximumplasmaconcentrationsof2.08µg/mlwerereachedafter2hours.

Theharmonicmeaneliminationhalflifewas10.37hours.

Afteradministrationtopigsbytheintramuscularroute,florfenicolisrapidly

excreted,primarilyinurine.Theflorfenicolisextensivelymetabolised.

Serumconcentrationspersistabove1µg/mlfor12to24hoursfollowingIM

administration.Florfenicolconcentrationsachievedinlungtissuereflectplasma

concentrations,withalung:plasmaconcentrationratioofapproximately1.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethylsulfoxide

Propyleneglycol

Macrogol400

Revised:March2013

AN:01142/2012

6.2Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductshould

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

6.5Natureandcompositionofimmediatepackaging

50,100and250mlTypeIamberglassbottleclosedwithabromobutylrubber

stopperandaluminiumseal.

1bottle(50ml)incardboardbox.

1bottle(100ml)incardboardbox.

1bottle(250ml)incardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Disposeofanyunusedproductandemptycontainersinaccordancewith

guidancefromyourlocalwasteregulationauthority.

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm01656/4027

9. DATEOFFIRSTAUTHORISATION

Date:04/07/2007

10.DATEOFREVISIONOFTHETEXT

Date:March2013

Approved:21/03/2013