Equinixin 2.5% w/w Granules for Horses

Main information

  • Trade name:
  • Equinixin 2.5% w/w Granules for Horses
  • Pharmaceutical form:
  • Granules for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equinixin 2.5% w/w Granules for Horses
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • flunixin
  • Therapeutic area:
  • Horses

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0374/001
  • Authorization date:
  • 23-08-2011
  • EU code:
  • UK/V/0374/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2011

AN:00483/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Equinixin25mg/gGranulesforHorses(UK)

Flunixin25mg/gGranulesforHorses

FlunixineGranules25mg/gforHorses(FR)

Flunixinvet25mg/gGranulesforHorses(FI)

Flunimeg250mgGranulesforHorses(DK)

FlunixinN-vet25mg/gGranulesforHorses(SE)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each10gsachetcontains:

ActiveSubstance

Flunixin 250mg

(asflunixinmeglumine)

Excipients

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Granules.

Whitetocreamcolouredgranules

4. CLINICALPARTICULARS

4.1Targetspecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Forthealleviationofinflammationandpainassociatedwithmusculo-skeletal

disorders

4.3Contraindications

Donotuseinanimalssufferingfromcardiac,hepaticorrenaldisease,wherethereis

thepossibilityofgastrointestinalulcerationorbleeding,wherethereisevidenceofa

blooddyscrasiaorhypersensitivitytotheproduct

4.4Specialwarningsforeachtargetspecies

None.

Revised:August2011

AN:00483/2011

4.5Specialprecautionsforuse

i. SpecialPrecautionsforuseinanimals:

Donotexceedtherecommendeddoseorthedurationoftreatment.

Useinanyanimallessthan6weeksofageorinagedanimalsmayinvolve

additionalrisk.

Ifsuchusecannotbeavoidedanimalsmayrequireareduceddosageand

carefulclinicalmanagement.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimalasthereisa

potentialriskofincreasedrenaltoxicity.

ii.Specialprecautionstobetakenbythepersonadministeringtheproducttothe

animals:

Avoidinhalation,contactwitheyesanddirectcontactwithskin.

Incaseofspillageontoskinwashimmediatelywithwater.

Inthecaseofaccidentalcontactwitheyes,rinseimmediatelywithplentyof

waterandseekmedicaladvice.

Toavoidpossiblesensitisationreactions,avoidcontactwiththeskin.Gloves

shouldbewornduringapplication.Washhandsafteruse.

Theproductmaycausereactionsinsensitiveindividuals.Ifyouhaveknown

hypersensitivityfornon-steroidalanti-inflammatoryproductsdonothandlethe

product.Reactionsmaybeserious.

4.6Adversereactions(frequencyandseriousness)

Untowardeffectsincludegastrointestinalirritation,ulcerationand,indehydratedor

hypovolaemicanimals,potentialforrenaldamage.Ifadversereactionsoccur,

treatmentshouldbediscontinuedandtheadviceofaveterinarianshouldbesought.

4.7Useduringpregnancy,lactationorlay

Studiesinlaboratoriesanimalshaveshownevidenceoffoetotoxiceffectsofthe

flunixinafteroraladministration(rabbitandrat)andintramuscularadministration(rat)

atmaternotoxicdosesaswellasanincreaseinthegestationperiod.Studiesto

demonstratesafetyinpregnantmareshavenotbeenconducted.Donotadminister

theproducttopregnantmares.

4.8Interactionswithothermedicinalproductsandotherformsofinteraction

Donotadministerothernon-steroidalanti-inflammatorydrugs(NSAID)or

glucocorticosteroidsconcurrently,orwithinatleast24hoursofadministrationofthis

product.Thetreatment-freeperiodshouldtakeintoaccountthepharmacokinetic

propertiesoftheproductsused.Concurrentuseofotheractivesubstancesthathave

ahighdegreeofproteinbindingmaycompetewiththisproduct,whichmayleadto

toxiceffects.

Gastrointestinaltractulcerationmaybeexacerbatedbycorticosteriodsinpatients

givenNSAIDs.

Concurrentadministrationofpotentiallynephrotoxicdrugsshouldbeavoided.

ItispreferablethatNSAID’swhichinhibitprostaglandinsynthesisarenot

administeredtoanimalsundergoinggeneralanaesthesiauntilfullyrecovered.

Revised:August2011

AN:00483/2011

4.9Amounttobeadministeredandadministrationroute

Fororaladministrationonly.

Thedoserateis1.1mgflunixinperkgbodyweighti.e.one10gsachetper227kg

(500lb)bodyweightoncedailyforupto5consecutivedaysaccordingtoclinical

response.

Thisproductisadministeredbysprinklingonasmallamountoffood.Addtofeed

immediatelybeforeadministration.Discardanyremainingmedicatedfeed.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Flunixinmeglumineisanon-steroidalanti-inflammatorydrug.Overdosageis

associatedwithgastrointestinaltoxicity.

4.11Withdrawalperiods

Meatandoffal:15Days

Milk:Notpermittedforuseinlactatingmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Non-steroidalanti-inflammatory

ATCvetCode:QM01AG90

5.1Pharmacodynamicproperties

Flunixinmeglumineisarelativelypotentnon-narcotic,non-steroidalanalgesicwith

anti-inflammatoryandanti-pyreticproperties.

Flunixinmeglumineactsasareversiblenon-selectiveinhibitorofcyclo-oxygenase

(bothCOX1andCOX2forms),animportantenzymeinthearachidonicacid

cascadepathwaywhichisresponsibleforconvertingarachidonicacidtocyclic

endoperoxides.Consequently,synthesisofeicosanoids,importantmediatorsofthe

inflammatoryprocessinvolvedincentralpyresis,painperceptionandtissue

inflammation,isinhibited.Throughitseffectsonthearachidonicacidcascade,

flunixinalsoinhibitstheproductionofthromboxane,apotentplateletpro-aggregator

andvasoconstrictorwhichisreleasedduringbloodclotting.Flunixinexertsits

antipyreticeffectbyinhibitingprostaglandinE2synthesisinthehypothalamus.

Althoughflunixinhasnodirecteffectonendotoxinsaftertheyhavebeenproduced,it

reducesprostaglandinproductionandhencereducesthemanyeffectsofthe

prostaglandincascade.Prostaglandinsarepartofthecomplexprocessesinvolvedin

thedevelopmentofendotoxicshock.

5.2Pharmacokineticproperties

AfterasingleadministrationofEquinixinGranulestohorsesat1.1mg/kgofflunixin,

maximumplasmaconcentrationofflunixin(2.51µg/ml)isreachedinabout1hour.

Revised:August2011

AN:00483/2011

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PovidoneK30

Crospovidone

PregelatinisedStarch(Maize)

Lactosemonohydrate

Sucrose

PeppermintFlavour

CelluloseMicrocrystalline

6.2Incompatibilities

Noneknown

6.3Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafteradditiontofeed:Useimmediately

6.4Specialprecautionsforstorage

Donotstoreabove25

C.Keepthesachetintheoutercarton.

6.5Natureandcompositionofimmediatepackaging

Cartonsof10laminatedfoil(C1S/LDPE/Alu/SP)sachetseachcontaining10g

granules

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproducts

orwastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

NEWRY

Co.Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm 02000/4241

Revised:August2011

AN:00483/2011

9. DATEOFFIRSTAUTHORISATION

Date:9March2006

10.DATEOFREVISIONOFTHETEXT

Date:August2011