Gastrogard Oral Paste for Equine Ulcers

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
    Austria
  • 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

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

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