Suxilon Equidos 1.5 g Granules for Top Dressing

Main information

  • Trade name:
  • Suxilon Equidos 1.5 g Granules for Top Dressing
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Suxilon Equidos 1.5 g Granules for Top Dressing
    Romania
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Suxibuzone
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0372/001
  • Authorization date:
  • 18-05-2011
  • EU code:
  • UK/V/0372/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:June2011

AN:00389/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Danilonequidos1.5gGranules

Suxilon1.5gGranulesfortopdressing(onlyforUK)

Suxibuzone

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each10gsachetcontains

Activesubstance:

Suxibuzone(microencapsulated)1.5g

Excipient(s):

Quinolineyellow(E104)2.5mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Granules

Yellowandodourlessgranules.

4. CLINICALPARTICULARS

4.1Targetspecies

Horsesandponies.

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofpainandinflammationassociatedwithmusculo-skeletalconditionsinthehorse

egosteoarthriticconditions,bursitis,laminitisandsofttissueinflammation.

4.3Contraindications

Donotadministertoanimalswithrenal,hepaticorcardiacdisorders;wherethereisthe

possibilityofgastro-intestinalulcerationorbleeding,orwherethereisevidenceofablood

dyscrasiaorhypersensitivitytotheproduct.

4.4Specialwarningsforeachtargetspecies

Donotadministerpriortotakingpartinacompetition.

Duringtreatmentofveryyounganimals(lessthan12weeks)wheredevelopmentoftheir

hepaticorrenalfunctionmaybeincomplete,orinagedanimalswhichmayhavethese

functionsimpaired,aswellasinponies,additionalriskmaybeinvolved.Inthesecases,

dosesshouldbeaccuratelycalculatedandpatientsmonitoredclosely.

Issued:June2011

AN:00389/2010

Duringtreatment,donotrestricttheconsumptionofwater.Avoiduseinanydehydrated,

hypovolaemicorhypotensiveanimalsastheremaybeanincreasedriskofrenalfailure.

NSAIDscancauseinhibitionofphagocytosisandhence,inthetreatmentofinflammatory

conditionsassociatedwithbacterialinfectionsappropriateantimicrobialtherapyshouldbe

instigated.

4.5Specialprecautionsforuse

4.5.iSpecialprecautionsforuseinanimals

Duringtreatmentdonotrestricttheconsumptionofwater.

Donotexceedthestateddoseordurationoftreatment.Dosageshouldbekepttoa

minimumforalleviationofsymptoms.

4.5.iiSpecialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Wearsuitablegloves.Washhandsafteruse.

Useinawell-ventilatedarea.Avoidinhalinganydustwhenopeningsachetandmixingwith

feed.Incaseofaccidentalcontactwitheyes,washimmediatelywithplentyofcleanwater.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthislabeltothe

physician.

4.6Adversereactions(frequencyandseriousness)

Aftercontinueduse,orathighdosesgastro-intestinalchangesmayoccur.Occasionally

blooddyscrasiasandrenalalterationsmaybefound,especiallyinanimalswithrestricted

accesstowater.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancy

andlactation,thereforeuseduringtheseperiodsisnotrecommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Suxibuzoneanditsmetabolitesmaybehighlyboundtoplasmaproteinsandcompetewith

otherhighlybounddrugsegsulphonamides,warfarin;oritmayitselfbedisplacedto

produceanincreaseofnon-boundpharmacologicallyactiveconcentrationswhichcouldlead

totoxiceffects.Drugcompatibilitymustbecloselymonitoredwhenadjunctivetherapyis

required.

DonotadministertogetherwithotherNSAIDsconcurrentlyorwithin24hoursofeachother.

Concurrentadministrationofpotentiallynephrotoxicdrugsshouldbeavoided.

Issued:June2011

AN:00389/2010

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

Whenaddedtoaportionoffeedtheproductwillbeacceptedbymosthorses.

Thefollowingshouldbeusedasaguide,accordingtoindividualresponse:

Horses

Fora480kgbodyweighthorse,thecontentsof2sachetsshouldbeadministeredtwicedaily

(equivalentto12.5mgofsuxibuzone/kg/day)for2days,followedby1sachettwicedaily

(6.25mgofsuxibuzone/kg/day)for3days.

Thereafter,1sachetdaily(3.1mgofsuxibuzone/kg/day)oronalternatedays,orthe

minimumdosenecessaryforasatisfactoryclinicalresponse.

Ponies(breedsoflessthan149cmhighatthewitherswhenfullgrown)

Poniesshouldreceiveonlyhalfthedoseraterecommendedforhorses.

Fora240kgbodyweightpony,thecontentsof1sachetshouldbeadministereddaily

(equivalentto6.25mgofsuxibuzone/kg/day)for2days,followedby1/2sachetdaily(3.1

mgofsuxibuzone/kg/day)for3daysor1sachetonalternatedays.

Thereafter,reducethedosetotheminimumdosenecessaryforasatisfactoryclinical

response.

Foradministrationoflessthanonesachet,usethemeasuringscoopprovided.Onefulllevel

scoopcontains5ggranules(equivalentto1/2sachet)anduptothegreenlinelevel

contains2,5ggranules(equivalentto1/4sachet).

Hay,aspartofthediet,maydelaytheabsorptionofsuxibuzoneandsotheonsetofclinical

effect.Itisadvisablenottofeedhayimmediatelypriorto,orwiththismedicinalproduct.

Seealso4.4.

Ifnoclinicalresponseisevidentafter4-5days,discontinuetreatmentandreconsiderthe

diagnosis.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofcontinuousoverdose,thefollowingsignsmaybeobserved:

Thirst,depression,anorexiaandweightloss.

Gastrointestinaldisorders(irritation,ulcers,diarrhoeaandbloodinthefaeces).

Alteredbloodprofilesandhaemorrhages.

Hypoproteinemiawithventraloedemacausinghemoconcentration,hypovolemicshock

andcirculatorycollapse.

Renalfailureandfluidretention.

Ifsignsofintoleranceappear,discontinuetreatmentandestablishsymptomatictherapy.

Aslowintravenousperfusionofasolutionofsodiumbicarbonate,whichleadstourine

alkalinisation,increasestheclearanceoftheproduct.

Issued:June2011

AN:00389/2010

4.11Withdrawalperiod(s)

Nottobeusedinanimalsintendedforhumanconsumption.

Treatedhorsesmayneverbeslaughteredforhumanconsumption.

Thehorsemusthavebeendeclaredasnotintendedforhumanconsumptionundernational

horsepassportlegislation.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflamatoryandantirheumaticproducts,non-steroids,

butylpyrazolidines,suxibuzone.

ATCvetcode:QM01AA90

5.1Pharmacodynamicproperties

SuxibuzoneisaNon-SteroidalAnti-inflammatoryDrug(NSAID)syntheticallyderivedfrom

pyrazolonewithanti-inflammatory,antipyreticandanalgesicpropertieswithlowulcerogenic

potential.

Whenmixedwithconcentratefeed,theproductwasshowntobepalatabletohorses.

Itsmechanismofactionisbasedontheinhibitionofthecyclooxygenase(enzymewhich

catalyzesthesynthesisofprostaglandins,prostacyclinesandthromboxanesfrom

arachidonicacid).Thetherapeuticeffectsaremainlyduetotheinhibitionofthebiosynthesis

ofprostaglandines,whichactasperipheralmediatorsofpainandtriggerthesynthesisof

endogenpyrogensandmediatorsintheinflammatoryprocess.Italsoinhibitsplatelet

aggregation.

Thetherapeuticeffectofsuxibuzonereliesentirelyontheactivityofitsactivemetabolites.

Strong anti-inflammatory activity has been shown for phenylbutazone and

oxyphenbutazone.Thethirdmetabolite 

-hydroxyphenilbutazoneisconsideredtobe

pharmacologicallyinactive.

5.2Pharmacokineticparticulars

Afteroraladministrationsuxibuzoneisreadilyabsorbedandmostofitismetabolisedbythe

hepaticmicrosomalsystemproducingphenylbutazone,oxyphenbutazoneand 

hydroxyphenylbutazone.Nounalteredparentcompoundcanbedetectedinplasmaafter

oraladministrationofsuxibuzonetohorsesorponies.Theseactivemetaboliteshaveahigh

degreeofaffinityforplasmaproteinsandareeliminatedmainlythroughurine,as

glucoronideconjugates,butalso,inasmallpercentage,throughfaeces.Lessthan1%is

eliminatedthroughsalivaandmilk.

Aftertheadministrationofasingle6.25mg/kgoraldoseoftheparentcompound

phenylbutazonereachesitsmaximumplasmaconcentration(10µg/ml)at4-5-hoursafter

administration.Oxyphenbutazonereachesitsmaximum(2.1µg/ml)at15hoursafter

administration.Bothmetaboliteshaveaneliminationhalflifeof5-6h.

AshappenswithotherNSAID´sthedurationoftheclinicalresponseismuchlongerthanthe

plasmahalf-life.Significantconcentrationsofbothactivemetabolitesarefoundinsynovial

fluidforatleast24hoursafteradministration.

Issued:June2011

AN:00389/2010

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Quinolineyellow(E104)

Mannitol

Sucrose

PovidoneK-30

Sodiumsaccharin

EthylCellulose20

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:4years

Shelflifeafterfirstopeningofthesachet:7days.

6.4.Specialprecautionsforstorage

Afteropeningasachetre-sealaswellaspossiblebetweendoses.

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

Cartoncontaining18x10gor60x10gcoatedpaper,aluminiumfoilandpolyethylene

sachetswith5gspoon(whenlevel)and2.5gincrementdosingdevice.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

Issued:June2011

AN:00389/2010

7. MARKETINGAUTHORISATIONHOLDER

LaboratoriosDr.ESTEVE,S.A.

Avda.MaredeDéudeMontserrat,221

08041 –Barcelona

Spain

8. MARKETINGAUTHORISATIONNUMBER

Vm08498/4006

9. DATEOFFIRSTAUTHORISATION

14June2011

10 DATEOFREVISIONOFTHETEXT

June2011