PYRIPROXYFEN 1 % PREMIX FOR DOG

Main information

  • Trade name:
  • PYRIPROXYFEN 1 % PREMIX FOR DOG
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PYRIPROXYFEN 1 % PREMIX FOR DOG
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Other ectoparasiticides for systemic use
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0136/001
  • Authorization date:
  • 07-03-2006
  • EU code:
  • FR/V/0136/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SPCRENEWALfinalversionApril2006

SUMMARYOFPRODUCTCHARACTERISTICS

1. Nameoftheveterinarymedicinalproduct

PYRIPROXYFEN1%PREMIXFORDOGVIRBAC.

2. Qualitativeandquantitativecomposition

Pyriproxyfen……………………………0.01g

Excipient Q.S. 1g

Forafulllistofexcipientsseepoint6.1

3. Pharmaceuticalform

Premixformedicatedfeed

4. Clinicalparticulars

4.1.Targetspecies

Dogs

4.2.Indicationsforuse,specifyingthetargetspecies

Preventionoffleamultiplicationbysterilisingtheeggs

4.3.Contraindications

Noneknown

4.4.Specialwarningsforeachtargetspecies

Ifthereareseveraldogsinasamehome,thetreatmentshouldbeadministeredtoallofthem.

Asthisfeedcontainspyriproxyfen,amedicinalproduct,dogsshouldnotbegivenmorefeedthanis

recommended:i.e.,donotexceedtherecommendeddailyamountof100gramsofmedicatedfeed

per10kgbodyweightperday.

Allanimalsinthehomeshouldbetreatedwithasuitablefleacontrolpreparation,atthesametime

thattheproductisadministeredtothedogs.

4.5.Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Ifthereisanexistingfleainfestationwhentheanimalistreatedorifthereareoccasionalflea

infestationsduringtreatment,adultfleasmustbeeliminatedwithappropriateinsecticidalmedicines.

Thismedicinalpremixisintendedforthemanufacturingofsolidmedicinalfoodsandcannotbeused

asitis.Themixingrateofthemedicinalpremixwiththesolidfoodcannotbelowerthan5kg/tonne

ii)Specialprecautionstobetakenbythepersonadministeringthemedicinalproductsto

animals

Whenincorporatingtheproductintofeed,itisrecommendedthatworkersshouldwearappropriate

dustmasks

iii)Otherprecautions

4.6.Adversereactions(frequencyandseriousness)

SPCRENEWALfinalversionApril2006

Noneknown

4.7.Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimals(rat,mouse,rabbit)didnotrevealanyteratogenicorembryotoxiceffects

attributabletopyriproxyfen.Thesafetyofthismedicinalfoodinnursingandpregnantbitcheshasbeen

demonstrated.Theuseofthemedicinalfoodinnursingandpregnantbitchesisthereforepossible

4.8.Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

4.9.Amount(s)tobeadministeredandadministrationroute

500μgofpyriproxyfenperkgbodyweightperday,asasingleadministration.Thisisequivalentto100

gofmedicatedfeedperdayforadogweighing10kg.

Ingeneral,thefirstadministrationshouldtakeplacejustbeforetheassumedfirstinfestationperiod.

Thetreatmentshouldbecarriedonuntiltheusualinfestationperiodends.Treatmentmaybe

extendedbeyondthisperiod,topreventanyriskofreinfestations.

Iftheadministrationistemporarilystopped(foramaximumof2days,e.g.fortheweek-end,the

holidaysortemporaryappetitereduction,etc.),thedogremainsprotected.

4.10.Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noundesirableeffecthasbeenshownwhenthemedicinalfoodisadministeredatdosesupto10

timestherecommendeddose

4.11.Withdrawalperiod(s)

Notapplicable

5. Pharmacologicalproperties

Pharmacotherapeuticgroup:ectoparasiticideforsystemicuse

ATCVetcode:QP53RX

5.1.Pharmacodynamicproperties

Pyriproxyfenisaninsectgrowthinhibitorwhichimitatesthejuvenilehormone.Itstopseggsandlarvae

developingandpreventstheappearanceofnewadultfleas.Itactsbyabsorptionbyadultfleas,

sterilisingtheeggsduringtheirmaturationbeforebeinglaid

5.2.Pharmacokineticparticulars

Theproductisfororaluseonlyaftermixingintofeed.

Pyriproxyfenisabsorbedviatheintestinaltractinsufficientquantitytoexertasystemicactivityon

matureadultfemalefleas.Thisactivitytakesplacewithinanhourfollowing thedog’sfirstmeal.

Afterthefirstoraladministrationof10g/kgoftheproduct(correspondingtoadoseof500µg/kgof

Pyriproxyfen),C

of21.5±4.0ng/mlwasobtainedat4.0±1.3hourspost-doseandthe24h-AUC

(betweentwoadministrations)was145.2±34.0ng.h/mL.

Meaneliminationhalf-lifeofPyriproxyfenwas10.0±3.4hours.Absolutebioavailabilitywas49±10%.

Nosignificantdifferencewasobservedwhencomparingpharmacokineticparametersobtainedafter

thefirstandthesixthdaysofadministration.Therefore,noaccumulationofpyriproxyfeninplasmais

expectedafter6daystreatmentofmedicatedfeed.

SPCRENEWALfinalversionApril2006

Environmentalproperties

6. Pharmaceuticalparticulars

6.1.Listofexcipients

Propyleneglycoldicaprylate/dicaprate

Wholemealwheat(assupport

)

6.2.Incompatibilities

Noneknown.

6.3.Shelf-life

Premixformedicatedfeed:beforeopeningthebags:15months.

Medicatedfeed:beforeopeningthebags:9months

6.4.Specialprecautionsforstorage

Donotstorethemedicatedfeedabove30°C.

Keepthecontainerintheoutercarton.

6.5.Natureandcompositionofimmediatepackaging

Lowdensitypolyethylenebag

Boxof1.5kgbag

Boxof22.5kgbag

Barrelof1.5kgbag

Barrelof22.5kgbag

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts,ifappropriate

Thisproductisdangeroustofishandaquaticlife.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

7. Marketingauthorisationholder

VIRBAC

BP27

06511CARROSCEDEX

8. Marketingauthorisationnumber(s)

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

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19-6-2018

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