Enroxil Max Solution for Injection

Main information

  • Trade name:
  • Enroxil Max Solution for Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enroxil Max Solution for Injection
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0312/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0312/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2013

AN:01156/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EnroxilMax100mg/mlsolutionforInjectionforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Enrofloxacin100mg

Excipients:

Benzyl

alcohol

(E1519) 20mg

Butylalcohol 30mg

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,yellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle.

4.2Indicationsforuse,specifyingthetargetspecies

TreatmentofbovinerespiratorydiseaseassociatedwithMannheimia

haemolytica,Pasteurellamultocida,HistophilussomniandMycoplasmaspp.

whereclinicalexperience,supportedwherepossiblebysensitivitytestingof

thecausalorganism,indicatesenrofloxacinasthedrugofchoice.

Treatmentoflocalsigns(inflammation,milkqualityandyield)associatedwith

peracute/acutemastitisinlactatingdairycattlecausedbyE.coli,whereherd

historyandprevioussensitivitytestingindicateenrofloxacinasthedrugof

choice.

4.3Contraindications

Donotuseforprophylaxis.

Donotadministerincaseofhypersensitivitytotheactivesubstanceortoany

oftheexcipients.

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4.4Specialwarningforeachtargetspecies

None.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Normalsterileprecautionsshouldbetaken.

Thesafetyoftheproducthasnotbeenestablishedincalveswhen

administeredbytheintravenousrouteanduseofthisrouteof

administrationincalvesisthereforenotrecommended.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccount

whentheproductisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinical

conditionswhichhaverespondedpoorly,orareexpectedtorespond

poorly,tootherclassesofantimicrobials.

Wheneverpossible,fluoroquinolonesshouldonlybeusedbasedon

susceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolones

andmaydecreasetheeffectivenessoftreatmentwithotherquinolones

duetothepotentialforcrossresistance.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductisanalkalinesolution.Anyspillageontotheskinshould

bewashedoffimmediatelywithwater.

Intheeventofaccidentalsplashintotheeye,rinsewithcopious

amountsofcleanwater.Ifirritationoccurs,seekmedicaladvice.

Donoteat,drinkorsmokewhilstusingtheproduct.

Careshouldbetakentoavoidaccidentalself-injection.Incaseof

accidentalselfinjection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeveterinarymedicinalproduct.

4.6Adversereactions(frequencyandseriousness)

Transientlocalreactionsmayoccuratinjectionsite.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringpregnancyandlactation.

4.8Interactionwithothermedicinalproductsandotherformofinteraction

Noneknown.

Revised:January2013

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4.9Amountstobeadministeredandadministrationroute

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

Dosageanddurationoftreatment:

Forrespiratoryinfectionsincattle:administerbysubcutaneousinjection:

Asingledoseof7.5mg/kgbodyweight(7.5mlper100kgbodyweight)

Notmorethan15mlshouldbeadministeredatonesubcutaneousinjectionsite.

ForE.colimastitisincattle:administerbyslowintravenousinjection.

5.0mlper100kgbodyweight(5mgenrofloxacinperkgbodyweight)dailyfor2

days.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Adoseof25mg/kgbodyweightadministeredfor15consecutivedaysis

toleratedwithoutanyclinicalsymptoms.

Clinicalsignsseeningrossoverdosageincludelethargy,lameness,ataxia,

slightsalivationandmuscletremors.Inaccidentaloverdosethereisnoantidote

andtreatmentshouldbesymptomatic.

4.11Withdrawalperiods

Subcutaneoususe:

Meatandoffal: 14days

Milk: 84hours

Intravenoususe:

Meatandoffal: 4days

Milk: 72hours

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCVetCode:QJ01MA90

5.1Pharmacodynamicproperties

ItisbactericidalinactionwithactivityagainstmanyGrampositiveandGram

negativebacteriaandmycoplasmas.Themechanismofactionofthe

quinolonesisuniqueamongantimicrobials –theyactprimarilytoinhibit

bacterialDNAgyrase,anenzymeresponsibleforcontrollingthesupercoilingof

bacterialDNAduringreplication.Resealingofthedoublestrandedhelixis

inhibitedresultinginirreversibledegradationofthechromosomalDNA.The

fluoroquinolonesalsopossessactivityagainstbacteriainthestationaryphase

byanalterationofthepermeabilityoftheoutermembranephospholipidcellwall

butareinactiveagainststrictanaerobes.

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Molecularresistancetofluoroquinoloneshasbeenobservedtoarisefromtwo

principalsources,(i)alterationtoDNAgyraseortopoisomeraseIVand(ii)

alterationsindrugpermeabilityofthebacterialcell.Bothmechanismsleadtoa

reducedsusceptibilityofthebacteriatofluoroquinolones.Clinicalresistanceis

dependentonseveralmutationsaccumulatinginastep-wisemanner.

5.2Pharmacokineticparticulars

Thepharmacokineticsofenrofloxcacinissuchthatoralandparenteral

administrationleadstosimilarserumlevels.Enrofloxacinislipidsolubleand

amphotericandpossessesahighdistributionvolume.Tissuelevels2-3higher

thanthatfoundintheserum,havebeendemonstratedinlaboratoryanimals

andtargetspecies.Organsinwhichhighlevelscanbeexpectedarethelungs,

liver,kidney,skin,boneandlymphaticsystem.Enrofloxacinalsodistributesinto

thecerebrospinalfluid,theaqueoushumourandthefoetusinpregnantanimals.

Aftersubcutaneousadministrationof7.5mg/kgthemeanpeakplasma

concentrationis0.8µg/mlachievedwithin6hours.Enrofloxacinispartly

metabolizedintheliver.Approximately45percentofthedoseisexcretedin

theurineand55percentinthefaecesasactiveandmetabolites.

Afteranintravenousdoseof5mgenrofloxacinperkgbodyweight(bw)to

lactatingdairycattle,thetotalsystemicexposureoverthedosingintervalof24

hwasat7.1mg*h/L.Incattleserum,approximately30%ofdrugexposure(2.31

mg*h/L)consistedofciprofloxacin,theactivemetaboliteofenrofloxacin.The

drugwaswelldistributedintothebodycompartments(Venro=1.5L/kg,Vcipro

=8.51L/kg).Totalbodyclearancewas0.71L/h/kg.

Inmilk,mostofdrugactivityconsistedofciprofloxacin.Overalldrug

concentrationspeakedat4.1mg/kgtwohoursaftertreatment.Overalldrug

exposureover24hwas22.1mg*h/L.Theactiveswereeliminatedfrommilk

withameanexposurehalf-lifeof2.8h.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzylalcohol(E1519)

Butylalcohol

L-Arginine

Waterforinjection

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackageforsale:5years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

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6.4Specialprecautionsforstorage

Keepthecontainerintheoutercartoninordertoprotectfromlight.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

AmberglassType2multi-dosevialsof100mlwithbromobutylrubber

stopper.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements

7.MARKETINGAUTHORISATIONHOLDER

KrkaDd

ŠmarješkaCesta6

NovoMesto

8501

Slovenia

8.MARKETINGAUTHORISATIONNUMBER

Vm

01656/4006

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Date:01August2007

10.DATEOFTHEREVISIONOFTHETEXT

Date:January2013

Prohibitionofsale,supplyand/oruse:

Notapplicable.

Approved:

30/01/13