Gastrogard

Main information

  • Trade name:
  • Gastrogard Oral Paste for Equine Ulcers
  • Pharmaceutical form:
  • Oral paste
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Gastrogard Oral Paste for Equine Ulcers
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • omeprazole
  • Therapeutic area:
  • Horses Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0185/001
  • Authorization date:
  • 13-06-2011
  • EU code:
  • UK/V/0185/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2009

AN:01095/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

GastroGard37%w/woralpasteforhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains:

Activesubstance:

Omeprazole:…………………………………………370mg

Excipients:

YellowIronOxide(E172)…………………………….2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralpaste.

Smoothhomogeneousyellowtoyellow-tanpaste.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses

4.2 Indicationsforuse,specifyingthetargetspecies

Fortreatmentandpreventionofgastriculcers.

4.3 Contraindications

Donotuseinmaresproducingmilkforhumanconsumption

Seesection4.5.i.

4.4 Specialwarningsfortargetspecies

None.

Revised:December2009

AN:01095/2009

4.5 Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Notrecommendedforanimalsunder4weeksofageorweighinglessthan

70kgbodyweight.

Stress(includinghighperformancetrainingandcompetition),feeding,

managementandhusbandrypracticesmaybeassociatedwiththe

developmentofgastriculcerationinhorses.Individualsresponsiblefor

thewell-beingofhorsesshouldconsiderreducingtheulcerogenic

challengebymodifyinghusbandrypracticestoachieveoneormoreofthe

following:reducedstress,reducedfasting,increasedintakeofroughage

andaccesstograzing.

ii)Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Asthisproductmaycausehypersensitivity,avoiddirectcontactwithskin

andeyes.Useimperviousglovesanddonoteatordrinkwhenhandling

andadministeringtheproduct.Washhandsoranyexposedskinafteruse.

Incaseofcontactwitheyes,washimmediatelywithcleanrunningwater

andseekmedicaladvice.Personsdevelopingareactionaftercontactwith

theproductshouldavoidhandlingtheproductinfuture.

4.6Adversereactions(frequencyandseriousness)

Therearenoknowntreatment-relatedclinicaladverseeffects.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceof

ateratogeniceffect.

Intheabsenceofdataduringpregnancyandlactation,theuseof

GastroGardinpregnantandlactatingmaresisnotrecommended.

4.8Interactionwithothermedicinalproductsandotherformsof

interaction

Omeprazolemaydelaytheeliminationofwarfarin.Nootherinteractionwith

medicinesroutinelyusedinthetreatmentofhorsesisexpected,although

interactionwithdrugsmetabolisedbyliverenzymescannotbeexcluded.

Revised:December2009

AN:01095/2009

4.9 Amountstobeadministeredandadministrationroute

GastroGardiseffectiveinhorsesofvariousbreedsandunderdifferent

managementconditions;foalsasyoungasfourweeksofageand

weighingover70kg;andbreedingstallions.

Fororaladministration.

Treatmentofgastriculcers:oneadministrationperdayduring

28consecutivedaysatthedoserateof4mgomeprazoleperkgbody

weightfollowedimmediatelybyadosageregimenofoneadministration

perdayduring28consecutivedaysatthedoserateof1mgomeprazole

perkgbodyweight,toreducetherecurrenceofgastriculcersduring

treatment.

Shouldrecurrenceoccur,re-treatmentatadoserateof4mgomeprazole

perkgbodyweightisrecommended.

Itisrecommendedtoassociatethetreatmentwithchangesofhusbandry

andtrainingpractices.Pleaseseealsothetextundersection4.5

Preventionofgastriculcers:oneadministrationperdayatthedoserateof

1mgomeprazoleperkgbodyweight.

TodeliverGastroGardatthedoseof4mgomeprazole/kg,setthesyringe

plungertotheappropriatedosedivisionforthehorse’sweight.Eachfull

dosedivisiononthesyringeplungerdeliverssufficientomeprazoletotreat

100kgbodyweight.Thecontentsofonesyringewilltreata575kghorse

attherateof4mgomeprazoleperkgbodyweight.

TodeliverGastroGardatthedoseof1mgomeprazole/kg,setthesyringe

plungertothedosedivisionequivalenttoonequarterofthehorse’sbody

weight.Atthisdose,eachfulldosedivisiononthesyringeplungerwill

deliversufficientomeprazoletotreat400kgbodyweight.Forexample,to

treatahorseweighing400kg,settheplungerto100kg.

Replacecapafteruse.

4.10Overdose (symptoms, emergency procedures, antidotes),if

necessary

Noundesirableeffectsrelatedtotreatmentwereobservedfollowingdaily

usefor91daysatomeprazoledosagesupto20mg/kginadulthorses

andinfoalsolderthan2months.

Noundesirableeffectsrelatedtotreatment(inparticularnoadverseeffect

onthesemenqualityorreproductivebehaviour)wereobservedfollowing

Revised:December2009

AN:01095/2009

dailyusefor71daysatanomeprazoledosageof12mg/kginbreeding

stallions.

Noundesirableeffectsrelatedtotreatmentwereobservedfollowingdaily

usefor21daysatanomeprazoledosageof40mg/kginadulthorses.

4.11Withdrawalperiod(s)

Horse:

Meatandoffal:1day

Notpermittedforuseinmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Drugsforpepticulcer,Protonpumpinhibitors

ATCvetcode:QA02BC01

5.1 Pharmacodynamicproperties

Instudieslastingupto28days,treatmentwithGastroGardatthedose

rateof1mgomeprazoleperkgbodyweightperdayhasbeenshownto

helppreventtheoccurrenceofgastriculcersinhorsesexposedto

ulcerogenicconditions.

Omeprazoleisaprotonpumpinhibitorbelongingtothesubstituted

benzimidazoleclassofcompounds.Itisanantacid,fortreatmentofpeptic

ulcers.

Omeprazolesuppressesgastricacidsecretionbyspecificinhibitionofthe

-ATPaseenzymesystematthesecretorysurfaceoftheparietalcell.

TheH +

-ATPaseenzymesystemistheacid(proton)pumpwithinthe

gastricmucosa.BecauseH +

-ATPaseisthefinalstepinvolvedin

controlofacidsecretion,omeprazoleblockssecretionirrespectiveofthe

stimulus.OmeprazoleirreversiblybindstothegastricparietalcellH +

ATPaseenzymethatpumpshydrogenionsintothelumenofthestomach

inexchangeforpotassiumions.

At8,16and24hoursafterdosinghorseswithomeprazoleat4mg/kg/day

orally,pentagastrin-stimulatedgastricacidsecretionwasinhibitedby99%,

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

Thefulleffectontheinhibitionofacidsecretionisreachedbyfivedays

afterthefirstadministration.

Revised:December2009

AN:01095/2009

5.2 Pharmacokineticparticulars

Themedianbioavailabilityofomeprazoleafteroraladministrationasa

pasteis10.5%(range4.1to12.7%).Theabsorptionisrapidwithtimeto

maximumplasmaconcentrations(Tmax)ofapproximatelyonehourafter

dosing.Meanpeakconcentration(Cmax)rangesfrom385ng/mlto

693ng/mlafterdosingwith4mg/kg.Thereisasignificantfirst-passeffect

followingoraladministration.Omeprazoleisrapidlymetabolised

principally into glucuronides of demethylated and hydroxylated

omeprazole sulphide (urinary metabolites) and methyl sulphide

omeprazole(biliarymetabolite)aswellasintoreducedomeprazole(both).

Afteroraladministrationat4mg/kg,omeprazoleisdetectableinplasma

for9hoursaftertreatment,andinurineashydroxyomeprazoleandO-

desmethylomeprazoleat24hoursbutnotat48hours.Omeprazoleis

eliminatedquickly,mainlybyurinaryroute(43to61%ofthedose),andto

asmallerextentbyfaecalroute,withaterminalhalf-liferangingfrom

approximately0.5to8hours.

Afterrepeatedoraladministration,thereisnoevidenceofaccumulation.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

YellowIronOxide(E172)

Monoethanolamine

Potassiumsorbate

CassiaOil

SodiumStearate

CalciumStearate

HydrogenatedCastorOil

PropyleneGlycolOctanoateDecanoate

SesameOil

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2

years.

Shelflifeafterfirstopeningtheimmediatepackaging:28days

Revised:December2009

AN:01095/2009

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.Replacecapafteruse.

6.5Natureandcompositionofimmediatepackaging

Immediatepackage

Immediatepackaging:10mlsyringecontaining6.16gofpastecomposed

ofwhitepolypropylenesyringesbarrelwithawhiteLDPEcap,arubber

rodtipandapolypropyleneplungerrod,withdosedivisionscalibratedby

bodyweight.

Outerpackageandsalespresentations

-Cartonboxof1syringe

-Cartonboxof7syringes

-Bulkpackof72syringes.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofin

accordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

MerialAnimalHealthLimited

POBox327

SandringhamHouse

HarlowBusinessPark

Harlow

Essex

CM195TG

8. MARKETINGAUTHORISATIONNUMBER(S)

08327/4205

Revised:December2009

AN:01095/2009

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

09January2003

10. DATEOFREVISIONOFTHETEXT

December2009

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