Reneval 100 mg/ml Solution for Injection for cattle and pigs

Main information

  • Trade name:
  • Reneval 100 mg/ml Solution for Injection for cattle and pigs
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Reneval 100 mg/ml Solution for Injection for cattle and pigs
    Hungary
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0391/002
  • Authorization date:
  • 21-12-2011
  • EU code:
  • UK/V/0391/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

AN:01749/2010

Issued:February2012

Page1of8

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Reneval100mg/mlSolutionforInjectionforcattleandpigs.

Reneval(DK)

Renevalvet.100mg/mlSolutionforInjectionforcattleandpigs.(FI,SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlofsolutioncontains:

Activesubstance

Enrofloxacin

100.0mg

Excipients

n-Butanol

30.0mg

Forfulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection

Clearlightyellowsolutionfreefromparticulatematter.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattleandpigs.

4.2 Indicationsforuse,specifyingthetargetspecies

Cattle

Diseasesoftherespiratoryandalimentarytractofbacterialormycoplasmal

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

salmonellosis)andsecondarybacterialinfectionssubsequenttoviral

infections(e.g.viralpneumonia)whereclinicalexperience,supportedwhere

possiblebysensitivitytestingofthecausalorganism,indicatesenrofloxacinas

thedrugofchoice.

AN:01749/2010

Issued:February2012

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Treatmentoflocalsigns(inflammation,milkqualityandyield)associatedwith

peracute/acutemastitisinlactatingdairycattlecausedbyE.coli,whereherd

historyandprevioussensitivitytestingindicateenrofloxacinasthedrugof

choice.

Pigs

Diseasesoftherespiratoryandalimentarytractofbacterialormycoplasmal

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

salmonellosis)andmultifactorialdiseasessuchasatrophicrhinitisand

enzooticpneumoniawhereclinicalexperience,supportedwherepossibleby

sensitivitytestingofthecausalorganism,indicatesenrofloxacinasthedrugof

choice.

4.3 Contraindications

Donotusewhenresistance/crossresistanceto(Fluoro)quinolonesisknown

tooccur.Donotuseinthecaseofknownhypersensitivitytofluoroquinolones

ortoanyoftheexcipients.

Theproductshouldnotbeusedforprophylaxis.

Donotuseinhorses.

4.4 Specialwarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhenthe

productisused.Fluoroquinolonesshouldbereservedforthetreatmentof

clinicalconditionswhichhaverespondedpoorly,orareexpectedtorespond

poorly,tootherclassesofantimicrobials.Wheneverpossible,fluoroquinolones

shouldonlybeusedbasedonsusceptibilitytesting.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincrease

theprevalenceofbacteriaresistanttothefluoroquinolonesandmaydecrease

AN:01749/2010

Issued:February2012

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theeffectivenessoftreatmentwithotherquinolonesduetothepotentialfor

crossresistance.

Enrofloxacinshouldbeusedwithcautioninepilepticanimalsoranimals

affectedbyrenaldysfunction.

ii) Specialprecautionstobetakenbythepersonadministeringthe

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththisproduct.Avoiddirectcontactwithskinandeyeswhen

handlingtheproducttopreventsensitisationandcontactdermatitis.The

productisanalkalinesolution.Washanysplashesfromskinoreyes

immediatelywithwater.

Donoteat,drinkorsmokewhilsthandlingtheproduct.

Careshouldbetakentoavoidaccidentalself-injection.Ifaccidentalself

injectionoccursseekmedicaladviceimmediately.

iii) Otherprecautions

Noneknown.

4.6 Adversereactions(frequencyandseriousness)

Localtissuereactionsmayoccasionallyoccurattheinjectionsite.

Incattle,gastrointestinaldisturbancesmayoccasionallyoccur

4.7 Useduringpregnancy,lactationorlay

Thereisnorestrictionontheuseofthisproductduringpregnancyand

lactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Combinationofenrofloxacinwithphenicols,macrolideantibioticsor

tetracyclinesmayproduceantagonisticeffects.

Enrofloxacinmayinterferewiththemetabolismoftheophylline,decreasing

theophyllineclearanceresultinginincreasedplasmalevelsoftheophylline.

AN:01749/2010

Issued:February2012

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4.9 Amount(s)tobeadministeredandadministrationroute

Toensurecorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

Cattle:

Forrespiratoryandalimentaryinfectionsincattleandsecondarybacterial

infections:administerbysubcutaneousinjection.

2.5mgenrofloxacinperkgbodyweight)dailybysubcutaneousinjection

for3days(2.5mlper100kgbodyweight).Thisratemaybedoubledto

5mg/kgbodyweight(5mlper100kg)for5daysforsalmonellosisand

complicatedrespiratorydisease.

Notmorethan10mlshouldbeadministeredatanyonesubcutaneous

injectionsite.

ForE.colimastitis:administerbyslowintravenousinjection.

5.0mlper100kgbodyweight(5mgenrofloxacinperkgbodyweight)

dailyfor2days.

Pigs:

Forrespiratoryandalimentaryinfectionsinpigsandsecondarybacterial

infections:administerbyintramuscularinjection.

2.5mgenrofloxacinperkgbodyweight)dailybyintramuscularinjectionfor3

days(2.5mlper100kgbodyweight).Thisratemaybedoubledto5mg/kg

bodyweight(5mlper100kg)for5daysforsalmonellosisandcomplicated

respiratorydisease.

Notmorethan2.5mlshouldbeadministeredatanyoneintramuscular

injectionsiteinstorepigsor5mlatanyoneintramuscularinjectionsitein

sows.

AN:01749/2010

Issued:February2012

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Maximumnumberofpiercingsis48forthe100mlstopperand60forthe250

mlstopper.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Donotexceedtherecommendeddose.Inaccidentaloverdosethereisno

antidoteandtreatmentshouldbesymptomatic.Nosignsofoverdosagewere

observedinpigsfollowingadministrationoftheproductatfivetimesthe

recommendedtherapeuticdose.

4.11Withdrawalperiod(s)

Cattle:Subcutaneous

Use

Meatandoffal: 10days

Milk: 84hours(7milkings)

Cattle:IntravenousUse

Meatandoffal: 4days.

Milk: 72hours(6

milkings).

Pigs:IntramuscularUse

Meatandoffal: 10days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinfectivesforsystemicuse,fluoroquinolones.

ATCvet-Code:QJ01MA90

5.1 Pharmacodynamicproperties

Enrofloxacinexertsbactericidalactivityconcentration-dependantwithsimilar

valuesofminimalinhibitconcentrationandminimalbactericideconcentrations.

Italsopossessesactivityagainstbacteriainthestationaryphasebyan

alterationofthepermeabilityoftheoutermembranephospholipidcellwall.

AN:01749/2010

Issued:February2012

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Inductionofresistanceagainstquinolonescandevelopbymutationsinthe

gyrasegeneofbacteriaandbychangesincellpermeabilitytowards

quinolones.

5.2 Pharmacokineticproperties

Thepharmacokineticsofenrofloxacinaresuchthatoralandparenteral

administrationleadstosimilarserumlevels.Enrofloxacinpossessesahigh

distributionvolume.Tissuelevels2-3higherthanthatfoundintheserum,

havebeendemonstratedinlaboratoryanimalsandtargetspecies.Organsin

whichhighlevelscanbeexpectedarethelungs,liver,kidney,skin,boneand

lymphaticsystem.Enrofloxacinalsodistributesintothecerebrospinalfluid,

theaqueoushumourandthefoetusinpregnantanimals.

Afteranintravenousdoseof5mgenrofloxacinperkgbodyweight(bw)to

lactatingdairycattle,thetotalsystemicexposureoverthedosingintervalof24

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

(2.31mg*h/L)consistedofciprofloxacin,theactivemetaboliteofenrofloxacin.

Thedrugwaswelldistributedintothebodycompartments(V

enro =1.5L/kg,

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

Inmilk,mostofdrugactivityconsistedofciprofloxacin.Overalldrug

concentrationspeakedat4.1mg/kgtwohoursaftertreatment.Overalldrug

exposureover24hwas22.1mg*h/L.Theactiveswereeliminatedfrommilk

withameanexposurehalf-lifeof2.8h.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

n-Butanol

Potassiumhydroxide(forpHadjustment)

Waterforinjections

AN:01749/2010

Issued:February2012

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6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

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.

AN:01749/2010

Issued:February2012

Page8of8

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd.,

RamsgateRoad,

Sandwich,

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4424

9. DATEOFFIRSTAUTHORISATION

7February2012

10. DATEOFREVISIONOFTHETEXT

February2012

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