Ovarelin

Main information

  • Trade name:
  • Ovarelin
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ovarelin
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • gonadorelin
  • Therapeutic area:
  • Cattle Other

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0238/001
  • Authorization date:
  • 07-07-2011
  • EU code:
  • UK/V/0238/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:August2012

AN:01289/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OVARELIN50µg/ml,solutionforinjectionforcattle[AT,BE,DE,HU,IE,LU,NL,NO,PL,

PT,UK]

OVUGEN50µg/ml,solutionforinjectionforcattle[ES]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Compositionfor1ml:

Activesubstance(s):

Gonadorelin(asdiacetatetetrahydrate).50.0µg

Excipient

Benzylalcohol.15.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearcolourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle:cows,heifers.

4.2 Indicationsforuse,specifyingthetargetspecies

Treatmentofdelayedovulation(repeatbreeding).

Arepeatbreedercoworheiferisgenerallydefinedasananimalthathasbeen

inseminatedatleast2oroften3timeswithoutbecomingpregnant,despitehaving

regularnormalœstruscycles(every18-24days),normalœstrusbehaviourandno

clinicalabnormalitiesofthereproductivetract.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

None.

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AN:01289/2011

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4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Notapplicable.

ii. Specialprecautionstobetakenbythepersonadministeringthemedicinal

producttoanimals

Careshouldbetakenwhenhandlingtheproducttoavoidself-injection.

Accidentalspillageontheskinoreyesshouldbewashedoffwithplentyof

water.

UsersknowntobehypersensitivetoGnRHanalogues,shouldnotusethis

product.

4.6 Adversereactions(frequencyandseriousness)

None.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandrabbitshavenotproducedanyevidenceofa

teratogenicorembryotoxiceffects.

Observationsinpregnantcowsreceivingtheproductinearlypregnancyhavenot

shownevidenceofnegativeeffectsonbovineembryos.

Inadvertentadministrationtoapregnantanimalisunlikelytoresultinadverse

effects.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Intramuscularuse.

100µgofgonadorelin(asdiacetate)peranimalinasingleinjection.

i.e.2mloftheproductperanimal.

GnRHisinjectedduringoestrus.

Toimprovethepregnancyrates,thefollowingtimingofinjectionandinsemination

shouldbefollowed:

-injectionshouldbeperformedbetween4and10hoursafteroestrus

detection

-anintervalofatleast2hoursbetweentheinjectionofGnRHandartificial

inseminationisrecommended

-artificialinseminationshouldbecarriedoutinaccordancewiththeusualfield

recommendations,i.e.,12to24hoursafteroestrusdetection.

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4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Upto5timestherecommendeddoseandinaregimenextendedfromonetothree

dailyadministrations,nomeasurablesignsofeitherlocalorgeneralclinical

intoleranceareobserved.

4.11Withdrawalperiods

Meatandoffal: zerodays

Milk: zerohours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Gonadotropin-releasinghormones

ATCvetcode:QH01CA01

5.1 Pharmacodynamicproperties

Gonadorelin(asdiacetate)isasynthetichormonephysiologicallyandchemically

identicaltotheGonadotropinReleasingHormone(GnRH)synthesizedinammalian

species.

Gonadorelinstimulatesthesynthesisandreleaseofthepituitarygonadotropins,

luteinizinghormone(LH)andfolliclestimulatinghormone(FSH).Itsactionis

mediatedbyaspecificplasmamembranereceptor.Only20%GnRHreceptor

occupancyisrequiredtoinduce80%ofthemaximumbiologicalresponse.The

bindingofGnRHtoitsreceptoractivatesproteinkinaseC(PKC)andalsomitogen-

activatedproteinkinase(MAPK)cascadeswhichprovideanimportantlinkforthe

transmissionofsignalsfromthecellsurfacetothenucleusallowingsynthesisofthe

gonadotropinhormones.

Inrepeatbreedinganimals,oneofthemostprominentfindingsisthedelayedand

smallerpreovulatoryLHsurgeleadingtodelayedovulation.InjectionofGnRH

duringoestrusincreasesthespontaneousLHpeakandpreventsdelayinovulation

inrepeatbreedinganimals.

5.2 Pharmacokineticparticulars

Absorption

Afterintramuscularadministrationof100µgofgonadorelin(asdiacetate)tothe

animal,absorptionofGnRHisrapid.Themaximumconcentration(Cmax)of120.0

±34.2ng/litreisobtainedafter15min(Tmax).ConcentrationsofGnRHdecreased

rapidlyinplasma.

Theabsolutebioavailabilityofgonadorelin(IMversusIV)wasestimatedtobe

around89%.

Distribution

24hoursafterintramuscularadministrationof100µgofradiolabelledgonadorelin

(asdiacetate),thegreatestamountsofradioactivityintissuesweremeasuredinthe

mainorgansofexcretion:liver,kidneyandlungs.

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8or24hoursaftertheadministration,gonadorelinshowsanextensiveplasma

proteinbindingof73%.

Metabolism

Gonadorelinisanaturallyoccurringpeptidewhichisrapidlybrokendowninto

inactivemetabolites.

Elimination

Afterintramuscularadministrationofgonadorelintothedairycow,theprincipal

excretionrouteismilkfollowedbyurineandfaeces.Ahighpercentageofthe

administereddoseisexcretedascarbondioxideinexpiredair.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol

Potassiumdihydrogenphosphate

Dipotassiumphosphate

Sodiumchloride

Waterforinjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnot

bemixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4 Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecontainerintheoutercartoninordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

ColourlessglassvialtypeI(4ml).

ColourlessglassvialtypeII(10,20and50ml).

Chlorobutylstopper.

Packsizes

Boxcontaining1glassvialof4ml

Boxcontaining1glassvialof10ml

Boxcontaining1glassvialof20ml

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Boxcontaining1glassvialof50ml

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproduct

orwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

CevaAnimalHealthLtd

Unit3,AngloOfficePark

WhiteLionRoad

Amersham

Buckinghamshire

HP79FB

8. MARKETINGAUTHORISATIONNUMBER

Vm 15052/4022

9. DATEOFTHEFIRSTAUTHORISATION

28April2006

10. DATEOFREVISIONOFTHETEXT

August2012