Enrotril

Main information

  • Trade name:
  • Enrotril
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enrotril
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • sparfloxacin
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0351/001
  • Authorization date:
  • 07-12-2011
  • EU code:
  • UK/V/0351/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:July2011

AN:00150/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NorotrilMax100mg/mlSolutionforInjectionforCattle(allotherCMS)

EnrotrilMax100mg/mlSolutionforInjectionforCattle(IrelandandPortugal)

Enrotril100mg/mlSolutionforInjectionforCattle(Germany,ItalyandSpain)

EnrofloxacinN-vet(Sweden)

Respytril100mg/mlSolutionforInjectionforCattle(France)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

ActiveSubstance

Enrofloxacin 100.0mg

Excipients

Benzylalcohol(E1519) 20.0mg

butan-1-o1 30.0mg

Forfulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowsolution.

4.CLINICALPARTICULARS

4.1Targetspecies

Cattle

4.2Indicationsforuse,specifyingthetargetspecies

Indicatedforthetreatmentofbovinerespiratorydiseaseassociatedwith

Mannheimiahaemolytica,Pasteurellamultocida,Histophilussomniand

Mycoplasmaspp.whereclinicalexperience,supportedwherepossibleby

sensitivitytestingofthecausalorganism,indicatesenrofloxacinasthedrugof

choice.

Revised:July2011

AN:00150/2011

4.3Contraindications

Theproductshouldnotbeusedforprophylaxis

Donotuseincaseofdisturbancesingrowthofcartilageand/orduringinjuryof

locomotorysystemparticularlyonfunctionallyloadedjointsorduetobodyweight

loadedjoints.

4.4Specialwarningsforeachtargetspecies

Noneknown.

4.5Specialprecautionsforuse

(i)Specialprecautionsforuseinanimals

Normalsterileprecautionsshouldbetaken.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhich

haverespondedpoorly,orareexpectedtorespondpoorly,tootherclassesof

antimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedonsusceptibility

testing.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetothepotentialforcross

resistance.

(ii)Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Theproductisanalkalinesolution.

Wearglassesandgloveswhenhandlingtheproduct.

Takecaretoavoidaccidentalselfinjection.

Anyspillageontotheskinshouldbewashedoffimmediatelywithwater.

Intheeventofaccidentalsplashintotheeye,rinsewithcopiousamountsofclean

water.Ifirritationoccurs,seekmedicaladvice.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthelabeltothe

doctor.

Personswithknownhypersensitivitytothefluoroquinolonesshouldavoidcontact

withtheproduct.

Donoteat,drinkorsmokewhenhandlingtheproduct

Revised:July2011

AN:00150/2011

(iii)Otherprecautions

None.

4.6Adversereactions(frequencyandseriousness)

Transientlocalreactionsmayoccuratinjectionsite.

4.7Useduringpregnancy,lactationorlay

Laboratorystudieshavenotproducedanyevidenceofateratogenic,foetotoxic

ormaternotoxiceffects.Thesafetyofenrofloxacininpregnantandlactating

animalshasbeenshownincattle.Theproductcanbeusedduringpregnancy

andlactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

NoneKnown.

4.9Amount(s)tobeadministeredandadministrationroute

Toensurecorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

DosageandDurationofTreatment

Forrespiratoryinfectionsincattle:administerbysubcutaneousinjection

“asingledoseof7.5mg/kgbodyweight(7.5mlper100kgbodyweight)

Notmorethan15mlshouldbeadministeredatonesubcutaneousinjectionsite.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mg/kgbodyweightadministeredfor15consecutivedaysis

toleratedwithoutanyclinicalsymptoms.

Clinicalsignsseeningrossoverdosageincludelethargy,lameness,ataxia,

slightsalivationandmuscletremors.Inaccidentaloverdosethereisnoantidote

andtreatmentshouldbesymptomatic.

4.11Withdrawalperiod(s)

Meatandoffal:

14days

Milk: 84hours

Revised:July2011

AN:00150/2011

5.PHARMACOLOGICALPROPERTIES

Enrofloxacinisasynthetic,broadspectrumantimicrobialsubstance,belongingto

thefluoroquinolonegroupofantibiotics.

ATCVetCode:QJ01MA90

Pharmacotherapeuticgroup:Enrofloxacin

5.1PharmacodynamicProperties

EnrofloxacinisbactericidalinactionwithactivityagainstmanyGrampositiveand

Gramnegativebacteriaandmycoplasmas.Themechanismofactionof

fluoroquinolonesisthattheyactprimarilytoinhibitbacterialDNAgyrase,an

enzymeresponsibleforcontrollingthesupercoilingofbacterialDNAduring

replication.Resealingofthedoublestrandedhelixisinhibitedresultingin

irreversibledegradationofthechromosomalDNA.

Thefluoroquinolonesalsopossessactivityagainstbacteriainthestationaryphase

byanalterationofthepermeabilityoftheoutermembranephospholipidcellwall

butareinactiveagainststrictanaerobes.

Molecularresistancetofluoroquinoloneshasbeenobservedtoarisefromtwo

principalsources,(i)alterationtoDNAgyraseortopoisomeraseIVand(ii)

alterationsindrugpermeabilityofthebacterialcell.Permeabilitychangesoccur

eitherviadecreasedpermeabilityofthehydrophilicporesorthroughalterationof

theactivetransport(efflux)pump,therebydecreasingtheintracellularcontentof

fluoroquinolones.Bothmechanismsleadtoareducedsusceptibilityofthebacteria

tofluoroquinolones.Clinicalresistanceisdependentonseveralmutations

accumulatinginastep-wisemanner.

5.2PharmacokineticParticulars

Thepharmacokineticsofenrofloxacinaresuchthatoralandparenteral

administrationleadstosimilarserumlevels.Enrofloxacinislipidsolubleand

amphotericandpossessesahighdistributionvolume.Tissuelevels2-3times

higherthanthatfoundintheserum,havebeendemonstratedinlaboratory

animalsandtargetspecies.Organsinwhichhighlevelscanbeexpectedarethe

lungs,liver,kidney,skin,boneandlymphaticsystem.Enrofloxacinalso

distributesintothecerebrospinalfluid,theaqueoushumourandthefoetusin

pregnantanimals.

Aftersubcutaneousadministrationof7.5mg/kgenrofloxacinthemeanpeak

plasmaconcentrationis0.8μg/mlachievedwithin6hours.Enrofloxacinispartly

metabolisedintheliver.Approximately45percentofthedoseisexcretedin

theurineand55percentinthefaecesasactiveandmetabolites.

Revised:July2011

AN:00150/2011

5.3EnvironmentalProperties

Incountrieswherefeedingoffallenstocktoscavengerbirdpopulationsispermitted

asaconservationmeasure(seeCommissionDecision2003/322/EC),thepossible

risktohatchingsuccessshouldbeconsideredbeforefeedingcarcassesof

livestockrecentlytreatedwiththisproduct.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol(E1519)

Arginine

n-butylalcohol

Waterforinjection

6.2Incompatibilities

Intheabsenceofcompatabilitystudies,thisproductshouldnotbemixedwith

otherVeterinaryMedicinalProducts.

6.3Shelf-life

Shelf-lifeoftheproductaspackagedforsale: 24months

Shelf-lifeafterfirstopeningthecontainer:Followingwithdrawalofthefirstdose,

usetheproductwithin28days.Discard

unusedmaterial.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Donotfreeze.

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

Containermaterial: TypeIglass

Containerclosure: Greybromobutylbung

Containercolour: Amber

Containervolume: 1x100ml,4x100mland12x100ml

1x250ml,4x250mland12x250ml

1x500ml,4x500mland12x500ml

Notallsizesmaybemarketed.

Revised:July2011

AN:00150/2011

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

Newry

CoDown

NorthernIreland

8.MARKETINGAUTHORISATIONNUMBER(S)

Vm 02000/4302

9.DATEOFFIRSTAUTHORISATION

November2010

10.DATEOFREVISIONOFTHETEXT

July2011