Butagran Equi

Main information

  • Trade name:
  • Butagran Equi
  • Pharmaceutical form:
  • Oral powder
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Butagran Equi
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • phenylbutazone
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0394/001
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0394/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:February2013

AN:01533/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

ButagranEqui,200mg/g,oralpowderforhorses.

ButagranEqui,200mg/g(DK)

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Perg:

Activesubstance:

Phenylbutazone 200mg

Excipients:

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Oralpowder.

Whitepowder.

4.CLINICALPARTICULARS

4.1Targetspecies

Horses.

4.2Indicationsforuse,specifyingthetargetspecies

Theproductisindicatedforthetreatmentofmusculo-skeletalconditionswhere

relieffrompainandareductionintheassociatedinflammationisrequirede.g.in

lamenessassociatedwithosteoarthriticconditions,bursitis,laminitisandsoft

tissueinflammation,particularlywherecontinuedmobilityisconsidereddesirable.

Itisalsoofvalueinlimitingpost-surgicalinflammation,myositisandothersoft

tissueinflammation.

Theproductcanbeusedasananti-pyreticwherethisisconsideredadvisablee.g.

inviralrespiratoryinfections.

4.3Contraindications

Donotuseinanimalswithknownhypersensitivitytotheactiveingredient.

Useiscontraindicatedinanimalssufferingfromcardiac,hepaticorrenaldisease,

wherethereisthepossibilityofgastrointestinalulcerationorbleedingorwhere

thereisevidenceofablooddyscrasia.

4.4Specialwarningsforeachtargetspecies

Theclinicaleffectsofphenylbutazonecanbeevidentforatleastthreedays

followingcessationoftherapy.Thisshouldbeborneinmindwhenexamining

horsesforsoundness.

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FEIregardsphenylbutazoneasaprohibitedsubstance,itshouldnotbe

administeredatleast8daysbeforethecompetition.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Donotexceedthestateddoseasthetherapeuticindexofphenylbutazoneislow.

Useinanyanimallessthan6weeksofageorinagedanimalsmayinvolve

additionalrisk.Ifsuchusecannotbeavoided,animalsmayrequirecarefulclinical

management.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimalasthereisa

potentialriskofincreasedrenaltoxicity.Keepwaterreadilyavailableduringthe

treatmentperiodtoavoiddehydration.

NSAIDscancauseinhibitionofphagocytosisandhenceinthetreatmentof

inflammatoryconditionsassociatedwithbacterialinfections,appropriate

concurrentantimicrobialtherapyshouldbeinstigated.

ii.Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Avoidcontactwiththeeyes.Incaseofaccidentaleyecontact,irrigateeyeswith

plentyofcleanwater.Ifirritationpersists,seekmedicaladvice.

Careshouldbetakentoavoidinhalingoringestingthepowder.

Intheeventofaccidentalinhalationoringestionseekmedicaladviceandshow

theproductpackaging.

4.6Adversereactions(frequencyandseriousness)

IncommonwithotherNSAIDsthatinhibitprostaglandinsynthesis,theremaybe

gastricand/orrenalintolerance.Thisisusuallyassociatedwithoverdosageand

sucheventsarerare.Recoveryisusualoncessationoftreatmentandfollowing

theinitiationofsupportivesymptomatictherapy(see4.10forfurtherinformation).

Poniesareverysensitivetogastriculcerationwiththisproduct,evenat

therapeuticdoses(diarrhoea,ulcerationinthemouthandhypoproteinaemiamay

alsobeseen).

4.7 Useduringpregnancy,lactationorlay

Pregnancy:

Careshouldbeexercisedifadministeredtopregnantmares.Althoughnoadverse

effectsofphenylbutazoneonthefoetusormaintenanceofpregnancyhavebeen

reportedduringfielduse,nodefinitivesafetystudieshavebeencarriedoutinthe

mare.

Foetotoxiceffectsofphenylbutazonehavebeenrecordedinexperimentalanimal

speciesathighdoselevels.

Lactation:

Thesafetyoftheproductinlactatingmareshasnotbeendemonstrated

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Iftheadministrationofphenylbutazonetopregnantorlactatingmaresis

consideredessentialthepotentialbenefitsshouldbeweighedagainstthepotential

hazardtothemareand/orfoal.

Avoidusearoundtimeofparturition.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofpotentialnephrotoxicdrugsshouldbeavoided.

Phenylbutazoneisextensivelyboundtoplasmaproteins.Itmaydisplaceother

drugsthatarehighlyprotein-bounde.g.somesulphonamides,warfarinoritmay

itselfbedisplacedtoproduceanincreaseinnon-boundpharmacologicallyactive

concentrations,whichcanleadtotoxiceffects.

Concurrenttherapywithothertherapeuticagentsshouldbeundertakenwith

cautionduetotheriskofmetabolicinteractions.Phenylbutazonemayinterfere

withthemetabolismofotherdrugse.g.warfarin,barbiturates,withresultant

toxicity.

Thereisevidencetoindicatethatthepharmacokineticsofpenicillinand

gentamicinproductsmaybeaffectedbyconcurrentadministrationofproducts

containingphenylbutazonewithapossiblereductionoftherapeuticefficacy,since

tissuepenetrationmaybereduced.Thedistributionofotherdrugsgiven

concurrentlymayalsobeaffected.

DonotadministerotherNSAIDsconcurrentlyorwithin24hoursofeachother.

Phenylbutazoneinduceshepaticmicrosomalenzymeactivity.

4.9Amountstobeadministeredandadministrationroute

Fororaladministration.

Foreach450kgofbodyweightthefollowingdosageguideshouldbeused

accordingtoindividualresponse:

Day1:Twosachetsor10gofproducttwicedaily(equivalentto4.4mgof

phenylbutazone/kgofBWoneachoccasion).

Day2-4:Onesachetor5gofproducttwicedaily(equivalentto2.2mgof

phenylbutazone/kgofBWoneachoccasion)followedbyonesachetor5gof

productdaily(2.2mgofphenylbutazone/kgofBWdaily)oronalternatedaysas

required.

Ifnoresponseisevidentafter4-5days,discontinuetreatment.Haymaydelaythe

absorptionofphenylbutazoneandsotheonsetofaclinicaleffect.Itisadvisable

nottoadministerhayimmediatelypriorto,orduringtheadministrationofthe

product.

Foreaseofadministrationtheproductmaybemixedwithalimitedquantityof

branoroats.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Overdosingmayresultingastricandlargeintestinalulcerationandgeneral

enteropathy.Renalpapillarydamagemayalsooccurwithimpairedrenalfunction.

Subcutaneousoedema,especiallyunderthejawmaybecomeevidentdueto

plasmaproteinloss.

Thereisnospecificantidote.Ifsignsofpossibleoverdosageoccur,treatthe

animalsymptomatically.

4.11Withdrawalperiods

Notforuseinhorsesintendedforhumanconsumption.

Treatedhorsesmayneverbeslaughteredforhumanconsumption.

Thehorsemusthavebeendeclaredasnotintendedforhumanconsumption

undernationalhorsepassportlegislation.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anti-inflammatoryandantirheumaticproducts,

non-steroids

ATCvet-code:QM01AA01

5.1Pharmacodynamicproperties

Phenylbutazoneisapyrazolonenon-steroidalanti-inflammatorydrug(NSAID)with

analgesic,anti-inflammatoryandanti-pyreticactivity.Thesepharmacodynamic

effectsareachievedbytheinhibitionofprostaglandinsynthetase(cyclo-

oxygenase).

5.2Pharmacokineticproperties

Theplasmaeliminationhalflifeofphenylbutazoneinthehorsevariesfrom3.5-

8.0hours.Normallypeakplasmalevelsareachievedapproximately2-3hours

afteradministration.Oralbioavailabilityishighbutconcurrentfeedingofhaycan

delaythetimetopeakconcentration,decreasesthepeakplasmaconcentrations

andsodelaytheonsetofaclinicaleffect.

Phenylbutazonebindsheavilytoplasmaalbumin.

Phenylbutazoneismetabolisedinthelivertooxyphenbutazone,whichalsohas

similarpharmacologicalactivity.Furthermetabolismtakesplacetogamma-

hydroxyphenylbutazoneExcretionismainlyviatheurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlucoseMonohydrate

Methylhydroxypropylcellulose(Hypromellose)

6.2Incompatibilities

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Donotmixthisproductwithanyotherveterinarymedicinalproduct.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelflifeafterfirstopeningtheimmediatepackaging:useimmediatelyafter

opening.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcompositionofimmediatepackaging

-Heat-sealedPET/LDPE/aluminiumfoil/LDPElaminatedsachetof5gramsof

product;

-Heat-sealedaluminiumfoil/LDPE/paper/LDPElaminatedsachetof5gramsof

product.

-Sachetsarepackedinacardboardboxcontaining100sachetsforsingleuse.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveer,TheNetherlands

research@dopharma.com

8. MARKETINGAUTHORISATIONNUMBER

Vm28365/4004

9. DATEOFTHEFIRSTAUTHORISATION

08February2013

10.DATEOFREVISIONOFTHETEXT

February2013

Approved: 08/02/2013