Virbagest

Main information

  • Trade name:
  • Virbagest 4mg/ml Oral Suspension for Pigs
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Virbagest 4mg/ml Oral Suspension for Pigs
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Altrenogest
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0237/001
  • Authorization date:
  • 27-05-2009
  • EU code:
  • UK/V/0237/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:December2012

AN.01534/2011

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VIRBAGEST4mg/mloralsolutionforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Altrenogest 4.00mg/ml

Excipients:

Butylhydroxytoluene(E321)0.07mg/ml

Butylhydroxyanisole(E320)0.07mg/ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsolutionfortop-dressinguse.

Clear,slightlyyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Pigs(nulliparousmaturesows).

4.2Indicationsforuse,specifyingthetargetspecies

Forthesynchronisationofoestrusinnulliparousmaturesows.

4.3Contraindications

Donotuseinboars.

Donotadministertopregnantsows(seesection4.7)orthosesufferingfromuterine

infection.

Donotuseincaseofhypersensitivitytotheactivesubstance.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

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AN.01534/2011

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Ensurethecorrectdoseisadministereddailyasunderdosingcanleadtotheformation

ofcysticfollicles.

Addtheveterinarymedicinalproducttothefeedimmediatelybeforefeeding.Discard

anyuneatenmedicatedfeed.

Useonlyinsexuallymaturegiltsthathavebeeninoestrus.

Partconsumedfeedmustbesafelydisposedofandnotgiventoanyotheranimal.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Womenwhoarepregnant,orsuspectedtobepregnant,shouldnotusetheproduct.

Womenofchildbearingageshouldhandletheproductwithextremecare.Theproduct

shouldnotbehandledbypersonswithknownorsuspectedprogesterone-dependent

tumoursorthrombo-embolicdisorders.

Directcontactwiththeskinshouldbeavoided.Personalprotectiveclothing(glovesand

overalls)mustbewornwhenhandlingtheproduct.Porousglovesmayletthisproduct

passthrough.Transcutaneousabsorptionmaybeevenhigherwhentheareaiscovered

byanocclusivematerial,suchaslatexorrubbergloves.Accidentalspillageontheskin

shouldbewashedoffimmediatelywithsoapandwater.Washhandsaftertreatmentand

beforemeals.

Incaseofaccidentalcontactwitheye,rinseabundantlywithwater.Getmedical

attention.

Effectsofoverexposure:Repeatedaccidentalabsorptioncouldleadtodisruptionofthe

menstrualcycle,uterineorabdominalcramping,increasedordecreaseduterine

bleeding,prolongationofpregnancyorheadache.

Peoplewithknownhypersensitivitytotheactivesubstanceshouldavoidcontactwiththe

veterinarymedicinalproduct.

4.6Adversereactions(frequencyandseriousness)

Underdosingcanleadtotheformationofcysticfollicles.

4.7Useduringpregnancy,lactationorlay

Donotadministertopregnantandlactatingsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Griseofulvinmayaltertheeffectsofaltrenogestwhenadministeredconcurrentlywiththis

product.

4.9Amountstobeadministeredandadministrationroute

Revised:December2012

AN.01534/2011

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Fororaluseasatop-dressing.

20mgaltrenogestperanimalandperday,for18consecutivedays,correspondingto5

mloftheproductperdayandperanimalfor18consecutivedaysgivenorallywithfeed

forimmediateconsumption.

Thevolumetobeadministeredshouldbemeasuredwithanappropriatedosingdevice.

Administration:

Animalsshouldbesegregatedanddosedindividually.Addtheproductasatop

dressingtothefeedimmediatelybeforefeeding.Part-consumedfeedmustbe

disposedofwithotherwastefeedandnotgiventootheranimals.

Thesynchronisationofoestrusshouldbesupervisedbyaveterinarian.Nulliparous

maturesowsshouldbesegregatednotlaterthan7daysbeforetreatment.During

treatmentanimalsshouldnotchangetheroom.

Acompleteup-takeofthemedicatedfeedshouldbeassured.

Mosttreatedgiltswillcomeintooestrus5to6daysafterthe18 th

consecutivedayof

treatment.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nodataavailable.

4.11Withdrawalperiod

Meatandoffal:9days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Sexhormonesandmodulatorsofthegenitalsystem,

progestagens.

ATCvetcode:QG03DX90

5.1Pharmacodynamicproperties

Altrenogesthasasimilaractiontothenaturalhormoneprogesterone.When

administeredorallyitsuppressesthenormalsexualcycle,preventingsignsofheatand

ovulation.Withdrawalthenallowsthenaturalhormonestobereleasedagainand

animalsreturntoheatinasynchronisedfashion.

AltrenogestisasynthetictrienicC21steroidalprogestagen,belongingtothe19-nor-

testosteroneseries.Itisanorallyactiveprogestagen.Altrenogestdecreasesblood

concentrationsoftheendogenousgonadotrophins,LHandFSH.Asaconsequence,it

inducestheregressionofalllargefollicles(>20-25mm)andthereforeblocksoestrusor

ovulation.Duringthesecondhalfofthetreatmentperiodwiththeproduct,whenalllarge

follicleshaveregressed,thereisapeakinFSHconcentrationwhichinitiatesanew

waveoffolliculargrowth.EndoftreatmentisfollowedbyasteadyriseinLH

concentration,whichsustainsfolliculargrowthandmaturation.

Revised:December2012

AN.01534/2011

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5.2Pharmacokineticparticulars

Altrenogestisrapidlyabsorbedfollowingoraladministration.Altrenogestisextensively

metabolisedintheliver.Altrenogestiseliminatedbothviabileinfaecesandviaurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Butylhydroxytoluene(E321)

Butylhydroxyanisole(E320)

Soya-beanoilrefined

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:60days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

OnePETbottlewithanunremovableplasticshellclippedorco-extrudedtothebottle,

containing450mlor900mlofproduct.Thebottleishermeticallyclosedwithchildproof

screwcapequippedbyatrisealjoint.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBACS.A.

1èreavenue-2065m –L.I.D

06516CarrosCedex

France

+33(0)492087304

Revised:December2012

AN.01534/2011

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+33(0)492087348

dar@virbac.fr

8. MARKETINGAUTHORISATIONNUMBER

Vm05653/4136

9. DATEOFFIRSTAUTHORISATION

28March2008

10. DATEOFREVISIONOFTHETEXT

December2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 21/12/2012