Equinor Oral Paste for Horses

Main information

  • Trade name:
  • Equinor Oral Paste for Horses
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equinor Oral Paste for Horses
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • omeprazole
  • Therapeutic area:
  • Horses Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0308/001
  • Authorization date:
  • 26-06-2013
  • EU code:
  • IE/V/0308/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

Equinor370mg/gOralPasteforHorses

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Oralpaste.

Ayellowtotanoilypaste

4CLINICALPARTICULARS

4.1TargetSpecies

Horses

4.2Indicationsforuse,specifyingthetargetspecies

Fortreatmentofgastriculcersandthepreventionofrecurrenceofgastriculcers.

4.3Contraindications

Donotuseinmaresproducingmilkforhumanconsumption

Seesection4.5

4.4Specialwarningsforeachtargetspecies

Theveterinarianshouldconsidertheneedforperformingrelevantdiagnostictestsbeforeselectionofthetreatment

Eachgramcontains:

Activesubstance:

Omeprazole 370mg

Excipients:

YellowIronOxide(E172) 2 mg

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Notrecommendedforanimalsunder4weeksofageorweighinglessthan70kgbodyweight.

Stress(includinghighperformancetrainingandcompetition),feeding,managementandhusbandrypracticesmaybe

associatedwiththedevelopmentofgastriculcerationinhorses.Individualsresponsibleforthewell-beingofhorses

shouldconsiderreducingtheulcerogenicchallengebymodifyinghusbandrypracticestoachieveoneormoreofthe

following:reducedstress,reducedfasting,increasedintakeofroughageandaccesstograzing.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Asthisproductmaycauseirritantandhypersensitivityreactions,avoiddirectcontactwithskinandeyes.Use

imperviousglovesanddonoteatordrinkwhenhandlingandadministeringtheproduct.Washhandsoranyexposed

skinafteruse.Incaseofcontactwitheyes,washimmediatelywithcleanrunningwaterandseekmedicaladvice.

Personsdevelopingareactionaftercontactwiththeproductshouldavoidhandlingtheproductinfuture.

4.6Adversereactions(frequencyandseriousness)

Therearenoknowntreatment-relatedclinicaladverseeffects.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofateratogeniceffect.

Intheabsenceofdataduringpregnancyandlactation,theuseofOmeprazoleinpregnantorlactatingmaresisnot

recommended.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Omeprazolemaydelaytheeliminationofwarfarin.Nootherinteractionwithmedicinesroutinelyusedinthetreatment

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4.9Amountstobeadministeredandadministrationroute

Omeprazoleiseffectiveinhorsesofvariousbreedsandunderdifferentmanagementconditions;foalsasyoungasfour

weeksofageandweighingover70kg;andbreedingstallions.

Fororaladministration.

Treatmentofgastriculcers:oneadministrationperdayduring28consecutivedaysatthedoserateof4mgOmeprazole

perkgbodyweight(1divisionofthesyringe/50kgBW)followedimmediatelybyadosageregimenofone

administrationperdayduring28consecutivedaysatthedoserateof1mgOmeprazoleperkgbodyweight,toreduce

therecurrenceofgastriculcersduringtreatment.

Shouldrecurrenceoccur,re-treatmentatadoserateof4mgOmeprazoleperkgbodyweight(1divisionofthe

syringe/50kgBW)isrecommended.

Itisrecommendedtoassociatethetreatmentwithchangesofhusbandryandtrainingpractices.Pleaseseealsothetext

undersection4.5

Preventionofrecurrenceofgastriculcers:oneadministrationperdayatthedoserateof1mgOmeprazoleperkgbody

weight.

TodeliverOmeprazoleatthedoseof4mgOmeprazole/kg,setthesyringeplungertotheappropriatedosedivisionfor

thehorse’sweight.EachdivisiononthesyringeplungerdeliverssufficientOmeprazoletotreat50kgbodyweight.

Thecontentsofonesyringewilltreata700kghorseattherateof4mgOmeprazoleperkgbodyweight.

TodeliverOmeprazoleatthedoseof1mgOmeprazole/kg,setthesyringeplungertothedosedivisionequivalentto

onequarterofthehorse’sbodyweight.Forexample,totreatahorseweighing400kg,settheplungerto100kg.Atthis

dose,eachdivisiononthesyringeplungerwilldeliversufficientOmeprazoletotreat200kgbodyweight.

Replacecapafteruse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noundesirableeffectsrelatedtotreatmentwereobservedfollowingdailyusefor91daysatOmeprazoledosagesupto

20mg/kginadulthorsesandinfoalsolderthan2months.

Noundesirableeffectsrelatedtotreatment(inparticularnoadverseeffectonthesemenqualityorreproductive

behaviour)wereobservedfollowingdailyusefor71daysatanOmeprazoledosageof12mg/kginbreedingstallions.

Noundesirableeffectsrelatedtotreatmentwereobservedfollowingdailyusefor21daysatanOmeprazoledosageof

40mg/kginadulthorses.

4.11WithdrawalPeriod(s)

Horse:Meatandoffal:1day

Notauthorisedforuseinmaresproducingmilkforhumanconsumption.

5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Drugsforacidrelateddisorders,Protonpumpinhibitors

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5.1Pharmacodynamicproperties

Instudieslastingupto28days,treatmentwithOmeprazoleatthedoserateof1mgOmeprazoleperkgbodyweight

perdayhasbeenshowntohelppreventtheoccurrenceofgastriculcersinhorsesexposedtoulcerogenicconditions.

Omeprazoleisaprotonpumpinhibitorbelongingtothesubstitutedbenzimidazoleclassofcompounds.Itisanantacid,

fortreatmentofpepticulcers.

OmeprazolesuppressesgastricacidsecretionbyspecificinhibitionoftheH +

-ATPaseenzymesystematthe

secretorysurfaceoftheparietalcell.TheH +

-ATPaseenzymesystemistheacid(proton)pumpwithinthegastric

mucosa.BecauseH +

-ATPaseisthefinalstepinvolvedincontrolofacidsecretion,Omeprazoleblockssecretion

irrespectiveofthestimulus.OmeprazoleirreversiblybindstothegastricparietalcellH +

-ATPaseenzymethat

pumpshydrogenionsintothelumenofthestomachinexchangeforpotassiumions.

At8,16and24hoursafterdosinghorseswithOmeprazoleat4mg/kg/dayorally,pentagastrin-stimulatedgastricacid

secretionwasinhibitedby99%,95%and90%andbasalsecretionwasinhibitedby99%,90%and83%.

Thefulleffectontheinhibitionofacidsecretionisreachedbyfivedaysafterthefirstadministration.

5.2Pharmacokineticproperties

ThemedianbioavailabilityofOmeprazoleafteroraladministrationasapasteis10.5%(range4.1to12.7%).The

absorptionisrapidwithtimetomaximumplasmaconcentrations(Tmax)ofapproximately1.25hoursafterdosing.

Meanpeakconcentration(Cmax)rangesfrom0.055µg/mlto0.307µg/mlafterdosingwith4mg/kg.Thereisa

significantfirst-passeffectfollowingoraladministration.Omeprazoleisrapidlymetabolisedprincipallyinto

glucuronidesofdemethylatedandhydroxylatedOmeprazolesulphide(urinarymetabolites)andmethylsulphide

Omeprazole(biliarymetabolite)aswellasintoreducedOmeprazole(both).Afteroraladministrationat4mg/kg,

Omeprazoleisdetectableinplasmafor9hoursaftertreatmentandinurineashydroxyOmeprazoleandO-desmethyl

Omeprazoleat24hoursbutnotat48hours.Omeprazoleiseliminatedquickly,mainlybyurinaryroute(43to61%of

thedose),andtoasmallerextentbyfaecalroute,withaterminalhalf-liferangingfromapproximately0.5to8hours.

Afterrepeatedoraladministration,thereisnoevidenceofaccumulation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

YellowIronOxide(E172)

Ethanolamine

CinnamonLeafOil

LiquidParaffin

6.2Incompatibilities

Notapplicable.

6.3Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

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6.4Specialprecautionsforstorage

Donotstoreabove30 o

Replacecapafteruse.

6.5Natureandcompositionofimmediatepackaging

Immediatepackage

Immediatepackaging:7mlsyringecontaining7.57gofpastecomposedofpolyethylenebarrel,plungerandendcap,

withpolypropylenedosingrings

Outerpackageandsalespresentations

Cartonboxof1syringe

Cartonboxof7syringes

Bucketof72syringes.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductshouldbe

disposedofinaccordancewithlocalrequirements

7MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLtd

StationWorks,

Newry,

Co.Down,BT356JP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER(S)

VPA10999/157/001

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

July2013

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