Ovuplant 2.1mg

Main information

  • Trade name:
  • Ovuplant 2.1mg
  • Pharmaceutical form:
  • Implant
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ovuplant 2.1mg
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • releasing hormones
  • Therapeutic area:
  • Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0259/001
  • Authorization date:
  • 17-02-2010
  • EU code:
  • UK/V/0259/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised17/06/2010 –AN00299/2009

1. NAMEOFVETERINARYMEDICINALPRODUCT

Ovuplant ®

2.1mgImplantationTabletsforHorses(Mares)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachimplantationtabletsupplies2.1mgDeslorelin(asDeslorelinAcetate).

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Implantationtablets.

Solidcylindricalimplantforsubcutaneoususe.Theimplantisapproximately2.3mmindiameterand

3.6mminlengthandissuppliedinapreloadedplasticsyringewithanattachedstainlesssteelneedle.

4. CLINICALPARTICULARS

4.1 Targetspecies

Horses(non-pregnantmares)

4.2 Indicationsforuse,specifyingthetargetspecies

Inmares:zootechnicaltreatmentfortheinductionofovulationwithin48hours,duringoestrusin

normallycyclingmares(insexualseason),withanovarianfolliclegreaterthan30mmdiameter.

4.3 Contraindications

Cf.Section4.7

4.4 Specialwarningsforeachtargetspecies

Maresshouldbeimplantedwiththeveterinarymedicinalproductwhenadevelopingovarianfollicle

greaterthan30mmindiameterhasbeendetectedbyrectalpalpationand/orultrasonography.In

largerbreeds,itmaybenecessarytowaituntilthedominantfolliclehasprogressedto35mmin

diameterbeforeadministrationoftheveterinarymedicinalproduct.

Treatedmaresshouldbebredorinseminatedwithinthenext48hours.Themareshouldbemonitored

toensurethatovulationhasoccurredandthatfurtherbreedingsarenotrequired.Ifovulationdoesnot

occurwithin48hoursofimplantation,continuebreedingaccordingtoroutinemanagement

procedures.

Ithasbeennotedthatfolliclesweresignificantlysmallerbeforeovulationfordeslorelintreatedmares

comparedwithplacebomares.However,treatmenthadnoeffectonthepercentageofmares

pregnantatdays18or50.

Foralltrialsthatevaluatedconceptionandpregnancyrate,therewerenodifferencesbetween

deslorelin-treatedandnon-treatedmaresattheendofthestudy.

Efficacyhasnotbeenestablishedformaresinvernal(spring)transitionphase.

Revised17/06/2010 –AN00299/2009

4.5 Specialprecautionsforuse

(i) Specialprecautionsforuseinanimals

Donotuseifthefoilpouchisbroken.

Onlyoneimplantshouldbeimplantedpermareduringagivenoestrus.

Theveterinarymedicinalproducthasnotbeentestedinmareslessthanthree(3)yearsofage.

Useonlyinmaresfitforreproduction.

(ii) Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

PregnantwomenshouldnotadministertheveterinarymedicinalproductasGnRHanalogueshave

beenshowntobefoetotoxicinlaboratoryanimals.

Whenadministeringtheveterinarymedicinalproduct,takecaretoavoidaccidentalself-injectionby

ensuringthatanimalsaresuitablyrestrainedandtheapplicationneedleisshieldeduntilthemomentof

implantation.

Inthecaseofaccidentalself-injection,seekmedicalassistanceimmediately,withaviewtohaving

theimplantremoved,asGnRHanaloguesmayhaveadverseeffectsonthemaleandfemale

reproductivesystems.

Althoughskincontactwiththeveterinarymedicinalproductisunlikely,shouldthisoccur,washthe

exposedareaimmediatelywithsoapandwater,asGnRHanaloguesmaybeabsorbedthroughthe

skin.

4.6 Adversereactions(frequencyandseriousness)

Localisedswellingandmildfibrosisatthesiteofimplantationhasbeenobservedinsomemares,

accompaniedbyaslightincreaseinsensitivitytotouchandanelevatedskintemperature.These

effectsaretransientandusuallyresolvewithouttreatmentwithin2to5days.

Somemaresimplantedwiththeveterinarymedicinalproduct(deslorelin)mayexperiencean

increaseddioestrousperiodfollowinguse.

4.7 Useduringpregnancy,lactationorlay

Donotuseduringpregnancy.GnRHanalogueshavebeenshowntobefoetotoxicinlaboratory

animalswhenadministeredduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised17/06/2010 –AN00299/2009

4.9 Amountstobeadministeredandadministrationroute

Oneimplantshouldbeadministeredbysubcutaneousimplantationinthelateralneckregionmidway

betweentheheadandshoulder.

Preparetheimplantationsitebythoroughlycleaningtheskinwithanappropriatedisinfectant.Insert

theentirelengthoftheneedlesubcutaneouslyandfullydepressthesyringeplunger.Slowlywithdraw

theneedlewhilepressingtheskinattheinsertionsite.Examinethesyringeandneedletoascertain

thattheimplanthasnotremainedwithinthesyringeorneedle.Itmaybepossibletopalpatethe

implantinsitu.

Theimplantisabsorbedanddoesnotrequireremoval.

Donotattempttore-usetheimplanter.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Insafetyandtolerancestudies,theonlysystemicadverseeffectseeninmaresreceivingupto10

implantssimultaneouslywassuppressionofovarianactivity.

4.11 Withdrawalperiods

Meatandoffal:7days.

Donotuseinmaresproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Group:Gonadotropin-releasinghormones

ATCvetcode:QH01CA93

5.1 Pharmacodynamicproperties

Deslorelinisasyntheticoligopeptideanalogueofgonadotropinreleasinghormoneusedtoadvance

ovulationinoestrusmares.Themechanismofactionofdeslorelincorrespondswiththatofnaturally

occurringGnRH,stimulatingthereleaseoffolliclestimulatinghormoneandluteinisinghormone(LH)

fromthepituitarygland.TheincreasedcirculatingconcentrationofLHpromotesovulationinmares

withadevelopingfolliclegreaterthan30mmindiameter.Theuseofanimplantformulationwhich

releasesdeslorelinoverashorttimeperiodresultsinapre-ovulatorypeakofLHwithinanarrow

timeframe,therebyinducingovulationwithin48hoursinahighproportionofmares.The

advancementofovulationinthiswaydecreasesthedurationofoestrusandallowscloser

synchronisationofmatingwithovulation.

5.2 Pharmacokineticparticulars

Nodirectmeasurementofdeslorelinreleaseinvivohasbeencarriedoutinthetargetspecies.Due

tothemodeofactionandrapidmetabolismofdeslorelin,directmeasurementofthesubstancein

plasmaisnotpracticable.Toovercomethis,indirectmarkersofdeslorelinhavebeenusedby

assayingbloodconcentrationsofLHandFSH.TheobservationofincreasedLHandFSH

concentrationsinbloodat12–48hoursafterimplantationprovidesindirectevidencethatreleaseof

deslorelinisoccurring.

Revised17/06/2010 –AN00299/2009

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Calciumhydrogenphosphatedihydrate

Hydrogenatedvegetableoil

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(2°C-8°C).

6.5 Natureandcontentsofimmediatepackaging

Theimplantissuppliedpreloadedinapolypropylenesyringewithanattachedstainlesssteel

needle.Eachpreloadedimplanterissuppliedinasealedfoilpouch.5ofthesearepackagedina

cardboardcarton.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

UK:Vm10434/4063

IE:VPA10799/017/001

9. DATEOFRENEWALOFTHEAUTHORISATION

14January2010

10. DATEOFANYREVISIONOFTHETEXT

Revised17/06/2010 –AN00299/2009

17June2010