Shotaflor 300 mg/ml Solution for Injection for Pigs

Main information

  • Trade name:
  • Shotaflor 300mg/ml Injektionslösung für Schweine
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Shotaflor 300mg/ml Injektionslösung für Schweine
    Germany
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0316/001
  • Authorization date:
  • 18-05-2011
  • EU code:
  • UK/V/0316/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:September2013

AN:00535/2012

Page1of4

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Shotaflor300mg/mlsolutionforinjectionforpigs

Florfenicol

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol…………300mg

Excipient(s):

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection

Alightyellowtoyellow,clear,viscousliquid.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofacuteoutbreaksofrespiratorydiseasecausedbystrainsof

ActinobacilluspleuropneumoniaeandPasteurellamultocidasusceptibletoflorfenicol.

4.3Contraindications

Donotadministertoboarsintendedforbreeding.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Seealsosection4.7.

Donotuseincaseofresistancetotheactivesubstance.

4.4Specialwarningsforeachtargetspecies

None.

Revised:September2013

AN:00535/2012

Page2of4

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Wipethestopperbeforeremovingeachdose.Useadry,sterilesyringeand16-

gaugeneedle.

Donotuseinpigletsoflessthan2kg.

Theproductshouldbeusedinconjunctionwithsusceptibilitytestingandtakeinto

accountofficialandlocalantimicrobialpolicies.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttoflorfenicolandmaydecreasetheeffectivenessof

treatmentwithotheramfenicols,duetothepotentialforcrossresistance.

Useasuitabledraw-offneedleorautomaticdosingsyringetoavoidexcessive

puncturingoftheclosure.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Inthecaseofself-injection,seekmedicaladviceandshowthelabeltothedoctor.

Donotusetheproductinknowncasesofsensitivitytoflorfenicol,propyleneglycol

and/orpolyethyleneglycols.

Incaseofaccidentalcontactwitheyes,rinseimmediatelywithplentyofwater.

4.6Adversereactions(frequencyandseriousness)

Commonlyobservedadverseeffectsaretransientdiarrhoeaand/orperi-analand

rectalerythema/oedemawhichmayaffect50%oftheanimals.Theseeffectscanbe

observedforoneweek.

Transientswellinglastingupto5daysmaybeobservedatthesiteofinjection.

Inflammatorylesionsattheinjectionsitemaybeseenupto28days.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-orfoeto-

toxicpotentialforflorfenicol.However,thesafetyoftheproductinsowsduring

pregnancyandlactationhasnotbeendemonstrated.Useoftheproductduring

pregnancyandlactationisnotthereforerecommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Notinvestigated.

4.9Amountstobeadministeredandadministrationroute

15mg/kgbodyweight(1mlper20kg)byintramuscularinjectionintotheneckmuscle

twiceat48hourintervalsusingadry,sterile16-gaugeneedle.

Thevolumeadministeredperinjectionsiteshouldnotexceed3ml.

Itisrecommendedtotreatanimalsintheearlystagesofdiseaseandtoevaluatethe

responsetotreatmentwithin48hoursafterthesecondinjection.

Ifclinicalsignsofrespiratorydiseasepersist48hoursafterthelastinjection,

treatmentshouldbechangedusinganotherformulationoranotherantibioticand

continueduntilclinicalsignshaveresolved.

Revised:September2013

AN:00535/2012

Page3of4

Toensureacorrectdosagebodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inswineafteradministrationof3timestherecommendeddoseormoreareduction

infeeding,hydrationandweightgainhasbeenobserved.

Afteradministrationof5timestherecommendeddoseormorevomitinghasalso

beennoted.

4.11Withdrawalperiod(s)

Meatandoffal: 18days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,ATCVetCode:

QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisabroad-spectrumsyntheticantibioticactiveagainstmostGram-positive

andGram-negativebacteriaisolatedfromdomesticanimals.Florfenicolactsby

inhibitionofproteinsynthesisattheribosomallevelandisbacteriostatic.However,

bactericidalactivityhasbeendemonstratedin-vitroagainstActinobacillus

pleuropneumoniaeandPasteurellamultocida.

In-vitrotestinghasshownthatflorfenicolisactiveagainstthebacterialpathogens

mostcommonlyisolatedinrespiratorydiseasesinpigs,includingActinobacillus

pleuropneumoniaeandPasteurellamultocida.

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistanceassociated

withafloRgene.Suchresistancehasnotyetbeenidentifiedinthetargetpathogens

exceptforPasteurellamultocida.Crossresistancewithchloramphenicolcanoccur.

5.2Pharmacokineticparticulars

Afterasingleintramuscularadministrationoftherecommendeddoseof15mg/kg

maximumplasmaconcentrationsof2.08µg/mlwerereachedafter2hours.

Theharmonicmeaneliminationhalflifewas10.37hours.

Afteradministrationtopigsbytheintramuscularroute,florfenicolisrapidlyexcreted,

primarilyinurine.Theflorfenicolisextensivelymetabolised.

Serumconcentrationspersistabove1µg/mlfor12to24hoursfollowingIM

administration.Florfenicolconcentrationsachievedinlungtissuereflectplasma

concentrations,withalung:plasmaconcentrationratioofapproximately1.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethylsulfoxide

Propyleneglycol

Macrogol400

Revised:September2013

AN:00535/2012

Page4of4

6.2Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproductshouldnot

bemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

50,100and250mlTypeIamberglassbottleclosedwithabromobutylrubber

stopperandaluminiumseal.

1bottle(50ml)incardboardbox.

1bottle(100ml)incardboardbox.

1bottle(250ml)incardboardbox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

VirbacS.A.

1èreavenue

2065mLID

06516CarrosCedex

France

8. MARKETINGAUTHORISATIONNUMBER

Vm05653/4144

9. DATEOFFIRSTAUTHORISATION

05February2008

10.DATEOFREVISIONOFTHETEXT

September2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable APPROVED 19/09/13

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