Reneval 50 mg/ ml Solution for Injection for cattle, pigs, dogs and cats.

Main information

  • Trade name:
  • Reneval 50 mg/ ml Solution for Injection for cattle, pigs, dogs and cats.
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Reneval 50 mg/ml Solution for Injection for cattle, pigs, dogs and cats.
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • meloxicam
  • Therapeutic area:
  • Cats, Cattle, Dogs, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0391/001
  • Authorization date:
  • 21-12-2011
  • EU code:
  • UK/V/0391/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:February2012

AN:01748/2010

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Reneval50mg/mlSolutionforInjectionforcattle,pigs,dogsandcats.

Reneval(DK)

Renevalvet.50mg/mlSolutionforInjectionforcattle,pigs,dogsandcats.(FI,

SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlofsolutioncontains:

Activesubstance

Enrofloxacin

50.0mg

Excipients

n-Butanol

30.0mg

Forfulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearlightyellowsolutionfreefromparticulatematter.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,Pigs,DogsandCats.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle:

Diseasesoftherespiratoryandalimentarytractofbacterialormycoplasmal

origin(e.g.pasteurellosis,mycoplasmosis,coli-bacillosis,coli-septicaemiaand

salmonellosis)andsecondarybacterialinfectionssubsequenttoviral

conditions(e.g.viralpneumonia),whereclinicalexperience,supportedwhere

possiblebysensitivitytestingofthecausalorganism,indicatesenrofloxacinas

thedrugofchoice.

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Pigs:

Diseasesoftherespiratoryandalimentarytractofbacterialormycoplasmal

origin(e.g.pasteurellosis,actinobacillosis,mycoplasmosis,coli-bacillosis,coli-

septicaemiaandsalmonellosis)andmultifactorialdiseasessuchasatrophic

rhinitisandenzooticpneumonia,whereclinicalexperience,supportedwhere

possiblebysensitivitytestingofthecausalorganism,indicatesenrofloxacinas

thedrugofchoice.

DogsandCats:

Treatmentofbacterialinfectionsofthealimentary,respiratoryandurogenital

tracts,skin,secondarywoundinfectionsandotitisexternawhereclinical

experience,supportedwherepossiblebysensitivitytestingofthecausal

organism,indicatesenrofloxacinasthedrugofchoice.

4.3 Contraindications

Donotusewhenresistance/crossresistanceto(Fluoro)quinolonesisknown

tooccur.Donotuseinthecaseofknownhypersensitivitytofluoroquinolones

ortoanyoftheexcipients.Donotuseinyoungdogsduringtheirperiodof

rapidgrowth,i.e.insmallbreedsofdogslessthan8monthsofage,inbig

breedsofdogslessthan12monthsofage,ingiantbreedsofdogslessthan

18monthsofage.

Donotuseinanimalsthatareepilepticorsufferfromseizuressince

enrofloxacinmaycauseCNSstimulation.

Notforuseincatslessthan8weeksofage.

Theproductshouldnotbeusedforprophylaxis.

Donotuseinhorses.

4.4 Specialwarningsforeachtargetspecies

Cattle,pigs:

None

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Cats:

Retinotoxiceffectsincludingblindnesscanoccurwhentherecommended

doseisexceeded.

Dogs:

Occasionallyskinreactionshavebeenseenafteradministrationtokennelled

greyhounds.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Donotexceedtherecommendeddosage.

Repeatinjectionsshouldbemadeatdifferentsites.

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditions

whichhaverespondedpoorly,orareexpectedtorespondpoorly,toother

classesofantimicrobials.Wheneverpossible,fluoroquinolonesshouldonlybe

usedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolonesandmay

decreasetheeffectivenessoftreatmentwithotherquinolonesduetothe

potentialforcrossresistance.

Enrofloxacinshouldbeusedwithcautioninepilepticanimalsoranimals

affectedbyrenaldysfunction.

ii) Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals

Theproductisanalkalinesolution.

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoidcontact

withthisproduct.Avoiddirectcontactwithskinandeyeswhenhandlingthe

producttopreventsensitisationandcontactdermatitis.Washanysplashes

fromskinandeyesimmediatelywithwater.

Donoteat,drinkorsmokewhilsthandlingtheproduct.

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Careshouldbetakentoavoidaccidentalself-injection.Ifaccidentalinjection

occurs,seekmedicaladviceimmediately.

iii) Otherprecautions

None.

4.6 Adversereactions(frequencyandseriousness)

Localtissuereactionsmayoccurattheinjectionsite.

Incattleanddogs,gastrointestinaldisturbancesmayoccasionallyoccur.

4.7 Useduringpregnancy,lactationorlay

Thereisnorestrictionontheuseofthisproductduringpregnancyand

lactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Combinationofenrofloxacinwithphenicols,macrolideantibioticsor

tetracyclinesmayproduceantagonisticeffects.

Enrofloxacinmayinterferewiththemetabolismoftheophylline,decreasing

theophyllineclearanceresultinginincreasedplasmalevelsoftheophylline.

4.9 Amount(s)tobeadministeredandadministrationroute

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

Cattle:

2.5mgenrofloxacinperkgbodyweight(0.5ml/10kg)dailybysubcutaneous

injectionfor3days.Thisratemaybedoubledto5mgenrofloxacinperkg

bodyweight(1.0ml/10kg)for5daysforsalmonellosisandcomplicated

respiratorydiseases.

Notmorethan10mlshouldbeadministeredattheonesubcutaneous

injectionsite.

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Pigs:

2.5mgenrofloxacinperkgbodyweight(0.5ml/10kg)dailybyintramuscular

injectionfor3days.Thisratemaybedoubledto5mgenrofloxacinperkg

bodyweight(1.0ml/10kg)for5daysforsalmonellosisandcomplicated

respiratorydiseases.

Notmorethan2.5mlshouldbeadministeredattheoneintramuscularsite.

DogsandCats:

5mgenrofloxacinperkgbodyweight(1.0ml/10kg)dailybysubcutaneous

injectiononcedailyforupto5days.

Maximumnumberofpiercingsis48forthe100mlstopperand60forthe250

mlstopper.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Donotexceedtherecommendeddose.Inaccidentaloverdosethereisno

antidoteandtreatmentshouldbesymptomatic.Nosignsofoverdosagewere

observedinpigsfollowingadministrationoftheproductatfivetimesthe

recommendedtherapeuticdose.

Intargetanimalstudies,catshavebeenshowntosufferoculardamageafter

receivingdosesofmorethan15mg/kgoncedailyfor21consecutivedays.

Dosesof30mg/kggivenoncedailyfor21consecutivedayshavebeenshownto

causeirreversibleoculardamage.At50mg/kggivenoncedailyfor21

consecutivedays,blindnesscanoccur.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal: 14days

Milk:Nottobeusedinanimalsproducingmilkforhumanconsumption.

Pig:

Meatandoffal: 10days.

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinfectivesforsystemicuse,fluoroquinolones.

ATCvet-Code:QJ01MA90

5.1 Pharmacodynamics

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilar

valuesofminimalinhibitconcentrationandminimalbactericideconcentrations.

Italsopossessesactivityagainstbacteriainthestationaryphasebyan

alterationofthepermeabilityoftheoutermembranephospholipidcellwall.

Inductionofresistanceagainstquinolonescandevelopbymutationsinthe

gyrasegeneofbacteriaandbychangesincellpermeabilitytowards

quinolones.

5.2 Pharmacokinetics

Thepharmacokineticsofenrofloxacinindogsandcatsaresuchthatoraland

parenteraladministrationleadstosimilarserumlevels.Enrofloxacinpossesses

ahighdistributionvolume.Tissuelevels2-3timeshigherthanthatfoundinthe

serumhavebeendemonstratedinlaboratoryanimalsandtargetspecies.

Organsinwhichhighlevelscanbeexpectedarethelungs,liver,kidney,skin,

boneandlymphaticsystem.Enrofloxacinalsodistributesintothecerebrospinal

fluid,theaqueoushumourandthefoetusinpregnantanimals.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

n-Butanol

Potassiumhydroxide(forpHadjustment)Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

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6.3 Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:

36months

Shelflifeafterfirstopeningtheimmediatepackaging:28days.

Discardunusedmaterial

6.4 Specialprecautionsforstorage

Donotfreeze.

Bottlesshouldremainuprightduringstorage.

6.5 Natureandcompositionofimmediatepackaging

Containermaterial: AmberGlassTypeI

Containerclosure: Greyteflonisedchlorobutylrubberstopperwithan

aluminiumcap

Containervolumes: 100ml,250ml

Noofcontainersinacarton:

1x100ml,5x100ml,10x100ml,12x100ml,15x100ml,20x100ml

1x250ml,5x250ml,10x250ml,12x250ml,15x250ml,20x250ml.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd.

RamsgateRoad

Sandwich

Kent

CT139NJ

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8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4423

9. DATEOFFIRSTAUTHORISATION

6February2012

10. DATEOFREVISIONOFTHETEXT

February2012