Mycoflor Injectable, Florfenicol (D:C.I) 30 % Soluton for Injection

Main information

  • Trade name:
  • Mycoflor Injectable, Florfenicol (D:C.I) 30 % Soluton for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Mycoflor Injectable, Florfenicol (D:C.I) 30 % Soluton for Injection
    Romania
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0385/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0385/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:December2011

AN:00749/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Mycoflor300mg/mlsolutionforinjectionforpigs

Florfenicol

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains

Activesubstance:

Florfenicol.300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection

Clear,lightyellowtoyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Pigs:Treatmentofacuteoutbreaksofrespiratorydiseasecausedbystrainsof

ActinobacilluspleuropneumoniaeandPasteurellamultocidasusceptibleto

florfenicol

4.3 Contraindications

Donotuseinadultboarsintendedforbreedingpurposes.

Donotadministertoanimalswithknownhypersensitivitytoflorfenicolortoany

oftheexcipientsoftheproduct

Donotuseincaseofknownresistancetoflorfenicol

Donotadministerintravenously

Refertosection4.11

4.4 Specialwarningsforeachtargetspecies

Donotexceedtherecommendedtreatmentdoseortherecommendedduration

oftreatment

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Theproductshouldonlybeusedinpigletsoflessthan2kgafterabenefit:risk

assessmentbyaveterin arysurgeon’.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtake

intoaccountofficialandlocalantimicrobialpolicies.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Thestoppermustbecleanedbeforeremovingeachdose.Useadry,sterile

syringeandneedle.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.Incaseofself-

injection,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

Avoiddirectcontactwithskin,mouthandeyes.Ifeyeexposureoccurs,

flusheyesimmediatelywithcleanwater.Ifskinexposureoccurs,wash

theaffectedareawithcleanwater.Ifaccidentalingestionoccurs,rinse

themouthwithplentyofwaterandseekmedicaladviceimmediately.

Washhandsafteruse.

Peoplewithknownhypersensitivitytoflorfenicolshouldavoidcontact

withtheproduct.

4.6Adversereactions(frequencyandseriousness)

Pigs

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-anal

andrectalerythema/oedemawhichmayaffect50%oftheanimals.These

effectscanbeobservedforoneweek.

Transientswellinglastingupto5daysmaybeobservedatthesiteofinjection.

Inflammatorylesionsattheinjectionsitemaybeseenforupto28days.

Underfieldconditionsapproximately30%oftreatedpigspresentedwithpyrexia

C)associatedwitheithermoderatedepressionormoderatedyspneaa

weekormoreafteradministrationoftheseconddose.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryspecieshavenotproducedanyevidenceofteratogenicor

foetotoxiceffects.Safetyduringpregnancyandlactationhasnotbeen

investigatedinthetargetspecies.Useonlyaccordinglytothebenefit/risk

assessmentbytheresponsibleveterinarian.

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4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Nodataavailable.

4.9 Amountstobeadministeredandadministrationroute

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Thevialcannotbebroachedmorethan25times.

PIGS

IMinjectionof15mg/kgBW(1ml/20kg)intotheneckmuscletwice48hour

apart.

Thevolumeadministeredperinjectionsiteshouldnotexceed3ml.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandto

evaluatetheresponsetotreatmentwithin48hoursafterthesecondinjection.If

clinicalsignsofrespiratorydiseasepersist48hoursafterthelastinjection,

treatmentshouldbechangedusinganotherformulationoranotherantibiotic

andcontinueduntilclinicalsignshaveresolved.

4.10Overdose (symptoms, emergency procedures, antidotes), if

necessary

Inswine,afteradministrationof3timestherecommendeddoseormorea

reductioninfeeding,hydrationandweightgainhasbeenobserved.After

administrationof5timestherecommendeddoseormorevomitinghasalso

beennoted.

4.11Withdrawalperiod(s)

Pigs:

Meatandoffal:18days

5. PHARMACOLOGICALPROPERTIES

Pharmacoterapeuticgroup:Antibacterialsforsystemicuse,amphenicols,

Florfenicol

ATCvetcode:QJ01BA90.

5.1 Pharmacodynamicproperties

FlorfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmostGram-

positiveandGram-negativebacteriaisolatedfromdomesticanimals.

Florfenicolactsbyinhibitingproteinsynthesisattheribosomallevelandis

bacteriostatic.Laboratorytestshaveshownthatflorfenicolisactiveagainstthe

mostcommonlyisolatedbacterialpathogensinvolvedinbovinerespiratory

diseasewhichincludeMannheimiahaemolytica,Pasteurellamultocidaand,

Histophilussomni.

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Florfenicolisconsideredtobeabacteriostaticagent,butinvitrostudiesof

florfenicoldemonstratebactericidalactivityagainstMannheimiahaemolytica,

Pasteurellamultocida,HistophilussomniandActinobacilluspleuropneumoniae.

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistance

associatedwithaflogene.Crossresistancewithchloramphenicoland

thiamphenicolcanoccur

5.2 Pharmacokineticparticulars

PIGS

Afterintramuscularadministrationoftherecommendeddoseof15mg/kg,

maximumserumconcentrationof2.48µg/mlisreachedafter2.0hoursandthe

concentrationsdepletewithaterminalhalf-lifeof14.9hours.Serum

concentrationsdropbelow1µg/ml,theMIC90forthetargetporcinepathogens,

12-24hoursfollowingIMadministrationFlorfenicolconcentrationsachievedin

lungtissuereflectplasmaconcentration,withalung:plasmaconcentrationratio

ofapproximately1.Afteradministrationtopigsbytheintramuscularroute,

florfenicolisrapidlyexcreted,primarilyinurine.Theflorfenicolisextensively

metabolised

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

N-Methylpyrrolidone

Glycerolformal

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4.Specialprecautionsforstorage

Storethebottleintheoutercartoninordertoprotectfromdirectsunlight.

6.5Natureandcompositionofimmediatepackaging

Vialsizes:100and250ml

-ColourlessTypeIIglassvialsclosedwithbromobutylrubberclosuresandan

aluminiumcap.

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-Polypropylenevialsclosedwithbromobutylrubberclosuresandanaluminium

cap.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

SPVeterinaria,S.A.

Ctra.Reus

VinyolsKm4.1Aptdo.60

43330Riudoms

Spain

8. MARKETINGAUTHORISATIONNUMBER

Vm36967/4000

9. DATEOFFIRSTAUTHORISATION

21December2011

10. DATEOFREVISIONOFTHETEXT

December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.