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.
    Portugal
  • Language:
  • English

Therapeutic information

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

Other information

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

Page1of8

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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AN:01748/2010

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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

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

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