Enrofloxacin HCS 100 mg/ml oral solution for chickens and turkeys

Main information

  • Trade name:
  • Enrofloxacin HCS
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enrofloxacin HCS
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Chicken Food, Other Birds Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0318/001
  • Authorization date:
  • 20-02-2013
  • EU code:
  • IE/V/0318/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1.3.1 Enrofloxacin

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Enrofloxacin HCS 100mg/mloralsolutionforchickensandturkeys

Enroxil100mg/mloralsolutionforchickensandturkeys

Floxatryl100mg/mloralsolutionforchickensandturkeys

Enrofloxacin HCS 100mg/mloralsolutionforchickensandturkeys(Ireland,Germany,Belgium,

Poland,Netherlands,Italy)

Enroxil100mg/mloralsolutionforchickensandturkeys(Bulgaria)

Floxatryl100mg/mloralsolutionforchickensandturkeys(Cyprus)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mloforalsolutioncontains:

Activesubstance:

Enrofloxacin100mg

Excipients:

Benzylalcohol14mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

OralSolution.

Clear,yellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Chickenandturkey.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentoftherespiratorytractandofthedigestivetractinfectionscausedbythefollowingbacteria

susceptibletoenrofloxacin:

Chickens

Mycoplasmagallisepticum,

Mycoplasmasynoviae,

Avibacteriumparagallinarum,

Pasteurellamultocida,

Escherichiacoli.

Turkeys

Mycoplasmagallisepticum,

1.3.1 Enrofloxacin

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Mycoplasmasynoviae,

Pasteurellamultocida,

Escherichiacoli.

Enrofloxacinshouldbeusedwhereclinicalexperience,supportedwherepossiblebysensitivitytesting

ofthecausalorganism,indicatesenrofloxacinastheactivesubstanceofchoice.

4.3 Contraindications

Donotuseforprophylaxis.

Donotusewhenresistance/cross-resistanceto(fluoro)quinolonesisknowntooccur.

Donotuseinthecaseofknownhypersensitivitytotheactivesubstance,other(fluoro)quinolonesorto

anyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhentheproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhaveresponded

poorly,orareexpectedtorespondpoorly,tootherclassesofantimicrobials.

Wheneverpossible,fluoroquinoonesshouldonlybeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasetheprevalenceof

bacteriaresistanttothefluoroquinolonesandmaydecreasetheeffectivenessoftreatmentwithother

quinolonesduetothepotentialforcrossresistance.

Sinceenrofloxacinwasfirstauthorisedforuseinpoultry,therehasbeenwidespreadreductionin

susceptibilityofE.colitofluoroquinolonesandemergenceofresistantorganisms.Resistancehasalso

beenreportedinMycoplasmasynoviaeintheEU.

Beforeuse,headertanksshouldbeemptied,thoroughlycleanedandthenfilledwithaknownvolume

ofcleanwaterbeforeaddingtherequiredamountoftheproduct.Theresultingmixtureshouldbe

stirred.Beforeuse,headertanksshouldbeinspectedatregularintervalsforpresenceofdust,algae

formationandsedimentation.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Thosewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontactwiththisproduct.

Avoidcontactwithskinandeyes.

Rinseanysplashesfromskinoreyesimmediatelywithwater.

Washhandsandexposedskinafteruse.

Donoteat,drinkorsmokewhilstusingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

1.3.1 Enrofloxacin

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Donotuseinlayinghensproducingeggsforhumanconsumption.

Donotadministertolayerreplacementbirdswithin14daysofcomingintolay.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Invitro,anantagonismwasshown,whencombiningfluoroquinoloneswithbacteriostatic

antimicrobialagentssuchasmacrolidesortetracyclinesandphenicols.Thesimultaneousapplication

ofsubstancescontainingaluminiumormagnesiumcanimpairtheabsorptionofenrofloxacin.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationviathedrinkingwater.Thismaybeputdirectlyintotheheadertanks,orvia

waterproportionersystems.

Dosage:

Chickensandturkeys

10mgenrofloxacin/kgbodyweightperdayfor3–5consecutivedays.

Treatmentfor3–5consecutivedays;for5consecutivedaysinmixedinfectionsandchronic

progressiveforms.Ifnoclinicalimprovementisachievedwithin2–3days,alternativeantimicrobial

therapyshouldbeconsideredbasedonsusceptibilitytesting.

Viathedrinkingwater.Alwaysmakesurethattheentiredoseofferedhasbeenconsumed.The

medicatedwatershouldbemadeupfresheachdayjustbeforeitisofferedtotheanimals.The

drinkingwatermustbemedicatedthroughoutthetreatmentperiod,andnootherwatersourceshould

beavailable.Determinethebodyweightofthebirdsasaccuratelyaspossibleinordertoavoid

underdosing.

Useonlyfreshpre-solutions,preparedeverydaybeforestartoftreatment.Pumpingsystemsshouldbe

checkedconstantlytoassurepropermedication.Emptythewatersystemandfillitwithmedicated

waterbeforestartingthetreatment.Calculatethedailyquantity(ml)oftheproductrequiredfor

treatmentperiodasfollows:

TotalnumberofbirdsxAveragebodyweightinkgx0.1=Totalvolume(ml)perday

Theproductmaybeputdirectlyintotheheadertankorintroducedviaawaterproportionerpump.

Careshouldbetakenthattheintendeddoseiscompletelyingested.

Useappropriateandproperlycalibrateddosingequipment.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseclinicalsymptomswereobservedinchickensandturkeystreatedrespectivelywithdoses

upto10and6timeshigherthanthetherapydose.

Theuseoffluoroquinolonesduringthegrowthphasecombinedwithamarkedandprolongedincrease

intheintakeofdrinkingwater,andhenceactiveingredient,possiblyduetohightemperatures,may

potentiallybeassociatedwithdamageofthearticularcartilage.

4.11Withdrawalperiod(s)

Chickens:Meatandoffal:3days.

Turkeys:Meatandoffal:3days.

Notauthorisedforuseinbirdsproducingeggsforhumanconsumption.

Donotadministertolayerreplacementbirdswithin14daysofcomingintolay.

1.3.1 Enrofloxacin

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup: quinoloneandquinoxalineantibacterials,fluoroquinolones .

ATCvetCode:QJ01MA90

5.1 Pharmacodynamicproperties

Modeofaction

TwoenzymesessentialinDNAreplicationandtranscription,DNAgyraseandtopoisomeraseIV,have

beenidentifiedasthemoleculartargetsoffluoroquinolones.Theymodulatethetopologicalstateof

DNAthroughcleavingandresealingreactions.Initially,bothstrandsoftheDNAdoublehelixare

cleaved.Then,adistantsegmentofDNAispassedthroughthisbreakbeforethestrandsareresealed.

Targetinhibitioniscausedbynon-covalentbindingoffluoroquinolonemoleculestoanintermediate

stateinthissequenceofreactions,inwhichDNAiscleaved,butbothstrandsareretainedcovalently

attachedtotheenzymes.Replicationforksandtranslationalcomplexescannotproceedbeyondsuch

enzyme-DNA-fluoroquinolonecomplexes,andinhibitionofDNAandmRNAsynthesistriggers

eventsresultinginarapid,drugconcentration-dependentkillingofpathogenicbacteria.

Antibacterialspectrum

EnrofloxacinisactiveagainstmanyGram-negativebacteria,againstGram-positivebacteriaand

Mycoplasmaspp.Invitrosusceptibilityhasbeenshowninstrainsof(i)Gram-negativespeciessuchas

Escherichiacoli,PasteurellamultocidaandAvibacterium(Haemophilus)paragallinarumand(ii)

MycoplasmagallisepticumandMycoplasmasynoviae.(Seesection4.5)

Typesandmechanismsofresistance

Resistancetofluoroquinoloneshasbeenreportedtoarisefromfivesources,(i)pointmutationsinthe

genesencodingforDNAgyraseand/ortopoisomeraseIVleadingtoalterationsoftherespective

enzyme,(ii)alterationsofdrugpermeabilityinGram-negativebacteria,(iii)effluxmechanisms,(iv)

plasmidmediatedresistanceand(v)gyraseprotectingproteins.Allmechanismsleadtoareduced

susceptibilityofthebacteriatofluoroquinolones.Cross-resistancewithinthefluoroquinoloneclassof

antimicrobialsiscommon.

5.2 Pharmacokineticparticulars

Enrofloxacinadministeredviadrinkingwatertopoultryisrapidlyandverywellabsorbedwitha

bioavailabilityofapprox.90%.Maximumplasmaconcentrationsof2mg/Larereachedwithin1.5

hoursafterasinglebolusdoserateof10mg/kgbodyweightwithatotalsystemicavailabilityof14.4

mg·hr/L.Enrofloxaciniseliminatedfromthebodywithatotalbodyclearanceof10.3mL/min·kg.If

dosedascontinuousdrinkingwatermedication(multipledosing)steady-stateconcentrationsof0.5mg

(turkeys)to0.8mg(chicken)enrofloxacinperlitreareachieved.Ahighmeanvolumeofdistribution

(5L/kg)indicatesgoodtissuepenetrationofenrofloxacin.Concentrationsintargettissueslikelungs,

liver,kidney,intestineandmuscletissue,exceedplasmaconcentrationsbyfar.Inpoultryenrofloxacin

ispoorlymetabolizedtoitsactivemetaboliteciprofloxacin(approximately5%).Enrofloxacinis

eliminatedfromthebodyatahalf-lifeof6hours.Proteinbindinginpoultryisapproximately25%.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

1.3.1 Enrofloxacin

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Hypromellose

Benzylalcohol

PotassiumHydroxide

Purified,Water

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbemixedwithother

veterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

Shelf-lifeafterdilutionorreconstitutionaccordingtodirections:24hours

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

-Cartonboxcontaining100mlambertypeIIIglassvialwithHDPEcapandLDPEsealingliner.

A25mlpolypropylenedosingcupisincluded.

-1litreHDPEbottlewithHDPEscrewcap.A50mlpolypropylenedosingcupisincluded.

-5 litreHDPEbottlewithHDPEscrewcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

HCSbvba,H.Kennisstraat53,B2650Edegem,Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Tobecompletednationally.

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