Virbagest 4mg/ml Oral Suspension for Pigs

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
    Spain
  • 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

Revised:December2012

AN.01534/2011

Page2of5

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

Page3of5

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

Page4of5

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

Page5of5

+33(0)492087348

dar@virbac.fr

8. MARKETINGAUTHORISATIONNUMBER

Vm05653/4136

9. DATEOFFIRSTAUTHORISATION

28March2008

10. DATEOFREVISIONOFTHETEXT

December2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

Approved: 21/12/2012

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

There are no news related to this product.