Enroxil 100 mg/ ml Solution for Injection

Main information

  • Trade name:
  • Enroxil 50 mg/ ml; 100 mg/ ml
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Enroxil 50 mg/ml; 100 mg/ml
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Fluoroquinolones
  • Therapeutic area:
  • Cattle Food, Pigs Food

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0234/002
  • Authorization date:
  • 12-01-2011
  • EU code:
  • UK/V/0234/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:December2011

AN:00172/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ENROXIL100mg/mlsolutionforinjectionforcattleandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Enrofloxacin 100mg

Excipient(s):

n-butylalcoholasantimicrobialpreservative 30mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearyellowsolutionpracticallyfreefromparticles.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,pigs

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:Treatmentofrespiratoryandalimentarytractdiseasesofbacterialor

mycoplasmalorigin(pasteurellosis,mycoplasmosis,coli-bacillosis,coli-septicaemia)

andsecondarybacterialinfectionssubsequenttoviralconditions(e.g.viral

pneumonia).

Pigs:Treatmentofrespiratoryandalimentarytractdiseasesofbacterialor

mycoplasmalorigin(pasteurellosis,mycoplasmosis,coli-bacillosis)andmultifactorial

diseasessuchasenzooticpneumonia.

4.3 Contraindications

Donotuseforprophylaxis.

Donotuseincaseofresistanceagainstquinolones.

Donotuseincaseofdisturbancesingrowthofcartilagesand/orduringinjuryof

locomotorysystemparticularlyonfunctionallyloadedjointsorduetobodyweight

loadedjoints.

Donotuseincaseofhypersensitivitytotheactivesubstance,ortoanyofthe

excipients.

Revised:December2011

AN:00172/2011

4.4 Specialwarningsforeachtargetspecies

Cattle:Notmorethan10mlshouldbeadministeredatonesubcutaneousinjectionsite.

Calves:Notmorethan5mlshouldbeadministeredatonesubcutaneousinjectionsite.

Pigs:Notmorethan2.5mlshouldbeadministeredatoneintramuscularinjectionsite.

Injectionsshouldbeadministeredinthebackoftheneck.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Useoftheproductshouldbebasedonsusceptibilitytestingandtakeintoaccount

officialandlocalantimicrobialpolicies.

Itisprudenttoreserveenrofloxacinforthetreatmentofclinicalconditionswhich

haverespondedpoorlytootherclassesofantimicrobials.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistanttothefluoroquinolonesandmaydecreasethe

effectivenessoftreatmentwithotherquinolonesduetopotentialforcross

resistance.

Treatmentshouldnotberepeatedifanallergicreactionoccurs.

Enrofloxacinispartiallyexcretedthroughthekidney.Incaseofthekidney’s

functionalfailureslowerexcretionshouldbetakenintoaccount.

Donotre-injectintothesameinjectionsite.

Thecapmaybesafelypuncturedupto40times.Whentreatinggroupsofanimals,

useadraw-offneedle.

Onlythe50mlvialshouldbeusedtotreatsmallpiglets.

ii.Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Directcontactwiththeskinshouldbeavoidedbecauseofsensitisation,contact

dermatitisandpossiblehypersensitivityreactions.Weargloves.Washany

splashesfromskinoreyesimmediatelywithwater.Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Localtissuereactionsmayoccasionallyoccurattheinjectionsite.

Incattle,gastrointestinaldisturbancesmayoccasionallyoccur.

4.7 Useduringpregnancy,lactationorlay

Enrofloxacincanbeusedduringpregnancyandlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Whencombinedwithtetracyclinesandmacrolideantibiotics,enrofloxacinmay

produceanantagonisticeffect.

Revised:December2011

AN:00172/2011

4.9 Amountstobeadministeredandadministrationroute

Cattle:

2.5mlper100kgbodyweight(2.5mgenrofloxacinperkgbodyweight)dailyby

subcutaneousinjectionfor3days.Thisratemaybedoubled(5mlper100kg;5

mg/kg)for5daysforcomplicatedrespiratorydisease.

Pigs:

2.5mlper100kgbodyweight(2.5mgenrofloxacinperkgbodyweight)dailyby

intramuscularinjectionfor3days.Thisratemaybedoubled(5mlper100kg;5mg/kg)

for3daysforcomplicatedrespiratorydisease.(Notmorethan2.5mlshouldbegiven

atoneintramuscularsite).

Ifthereisnoclinicalimprovementwithintwotothreedays,furthersusceptibilitytesting

andpossiblyachangeinantimicrobialtherapyshouldbeconsidered.

Donotexceedtherecommendeddose.

Normalsterileprecautionsshouldbetaken.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nodataavailable.

Donotexceedtherecommendeddose.

Treatsymptomaticallyinacaseofaccidentaloverdose.

4.11Withdrawalperiod(s)

Cattle:Meatandoffal:14days

Milk: 5days

Pigs:Meatandoffal:10days

5. PHARMACOLOGICALPROPERTIESorIMMUNOLOGICALPROPERTIES

Enrofloxacinisanantiinfectiveforsystemicusebelongingtothegroupof

fluoroquinolones.

ATCvetcode:QJ01MA90

5.1 Pharmacodynamicproperties

Enrofloxacinisasynthetic,broadspectrumantimicrobial,bactericidalinactionand

effectiveagainstawiderangeofgrampositiveandgramnegativebacteriaaswellas

mycoplasmas.ItinhibitstheenzymeDNA-gyraseinthecellnucleiduringreplicationof

bacterialDNA.Italsoactsonbacterialcellsduringstationaryphasebychangingthe

permeabilityinthephospholipidcellularmembranes.

Revised:December2011

AN:00172/2011

5.2 Pharmacokineticparticulars

Thepharmacokineticsofenrofloxacinaresuchthatbothoralandparenteral

administrationleadtosimilarserumlevels.Enrofloxacinpossessesahighdistribution

volume.Tissuelevels2-3timeshigherthanthatfoundintheserumhavebeen

demonstratedinlaboratoryanimalsandtargetspecies.Organsinwhichhighlevels

canbeexpectedarethelungs,liver,kidney,boneandlymphaticsystem.

Enrofloxacinalsodistributesintothecerebrospinalfluid,theaqueoushumourandthe

foetusinpregnantanimals.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

n-butylalcohol

Potassiumhydroxide

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

Shelf-lifeafterfirstopeningthecontainer:28days

6.4. Specialprecautionsforstorage

Donotstoreabove25

C.

Keepthecontainerintheoutercarton.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxwith1amberTypeIglassbottleof50or100mlwithagreybromobutyl

rubberstopperandaluminiumcap.

Cardboardboxwith1amberTypeIIglassbottleof50or100mlwithagreybromobutyl

rubberstopperandaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Revised:December2011

AN:00172/2011

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm 01656/4019

9. DATEOFFIRSTAUTHORISATION

Date:15March2006

10. DATEOFREVISIONOFTHETEXT

Date:December2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.