PRID

Main information

  • Trade name:
  • PRID
  • Pharmaceutical form:
  • Vaginal device
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRID
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • progesterone
  • Therapeutic area:
  • Cattle Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0159/001
  • Authorization date:
  • 27-05-2011
  • EU code:
  • FR/V/0159/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRIDalpha1.55gvaginaldeliverysystemforcattle[Austria,Belgium,Germany,Greece,Spain,

Finland,Luxemburg,TheNetherlands,Portugal]

PRID1.55gvaginaldeliverysystemforcattle[France]

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Progesterone..............................................................................................1.55g

Excipients:

Excipientsq.s..........................................................................................1device

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Vaginaldeliverysystem.

Aspiraldevicecoveredwithaninertelastomercontainingprogesterone.

4.CLINICALPARTICULARS

4.1Targetspecies

Cattle:cowsandheifers.

4.2Indicationsforuse,specifyingthetargetspecies

Forthecontroloftheœstruscycleincowsandheifersincluding:

- Synchronisationofœstrusincyclingcattle.Tobeusedincombinationwithaprostaglandin.

- Inductionandsynchronisationofœstrusinnoncyclingcattle.Tobeusedincombinationwith

aprostaglandin(PGF2 

)andequinechorionicgonadotrophin(eCG,inthepastcalledPMSG).

4.3Contraindications

Donotuseinpregnantcattle.

Donotuseinsexuallyimmatureheifers.

Donotusebefore35dayshavepassedsincepreviouscalving.

Donotuseinanimalssufferingfrominfectiousornon-infectiousdiseaseofthegenitaltract.

4.4Specialwarningsforeachtargetspecies

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Theprogesteronetreatmentalone,accordingtodosageregimenproposed,isnotsufficienttoinduce

oestrusandovulationinallcyclingfemales.Itisrecommendedtouseitincombinationwithan

injectionofprostaglandin.

Inordertooptimisetheprotocol,itisadvisabletodeterminecyclingovarianactivitybeforeusingthe

progesteronetreatment.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisrecommendedtowaitaminimumof35daysfollowingparturitionbeforestartingthetreatment

withthisproduct.

Specialprecautionstobetakenbythepersonadministeringthemedicinalproducttothe

animals

Glovesmustbewornwhenhandlingtheproductbothduringinsertionandremoval.

Donoteatordrinkwhenhandlingtheproduct.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Duringthecourseofthesevendaystreatment,thedevicecaninducealocalreaction

(i.e.inflammationofthevaginalwall),resultinginvulvulardischargeofamuco-purulentsecretion.

Tracesofblood,consequenttothewithdrawalofthedevicecanbeobservedin1.5%oftheanimals.

Attheremovalofthedevice,about21%ofthetreatedanimals,presentalocalreaction.Theincidence

ofthelocalreactiondecreasesrapidlywithouttreatmentand56hourslater,atthedayofinsemination,

thelocalreactionispresentinonly3.6%oftheanimals.

Thislocalreactiondoesnotimpairinseminationanddoesnotimpactthepregnancyrate.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringlactation.

Donotuseinpregnantcattleorbefore35dayshavepassedsincepreviouscalving.

Laboratorystudiesinratandrabbit,afterintramuscularorsubcutaneousadministrations,andat

repeatedhighdosesofprogesterone,haveproducedevidenceoffoetotoxiceffects.

However,progesteroneplaysanimportantroleduringpregnancyandtheadministrationofadeviceto

apregnantanimalwillnothaveanydeleteriousconsequences.

DonotuseprostaglandinF2alphainpregnantanimals.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Vaginaluse.

1.55gofprogesterone/animalfor7days.

Usinganapplicator,insertonedeviceintothevaginaoftheanimal.Theintravaginaldeviceshould

stayinplacefor7days.

Incyclingcattle,thedevicehastobeusedincombinationwithaprostaglandin,injected24hoursprior

toremovalofthedevice.

Innoncyclingcattle,aninjectionofaprostaglandinmustbedone24hourspriortoremovalofthe

deviceandaninjectionofeCGatthetimeofremoval.

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Disinfectionprocedure:

Beforeeachapplication,theapplicatormustbecleanedanddisinfected.

Insertion:

Settheproductontheapplicatorandlubricatetheextremityoftheapplicatorwithadisinfectant

cream.

Cleanthevulvaimmediatelypriortoinsertionusingasuitablepaperwipe.Holdingtheapplicatorin

onehand,spreadthelipsofthevulvawiththeotherandgentlyinserttheapplicatorintothevagina.

Thengentlypushitintotheinteriorvaginalarea,untilitreachesthecervix.

Releasethedevicefromtheapplicatorintothevagina.Leavethedevicestringextendedoutofthe

vulva.Stringlengthshouldnotexceed10cm.Ifnecessary,adjustbycuttingofftheend.

Disinfecttheapplicatorinaccordancewiththedirections.

Removal:

Remove7daysafterinsertionbygentlypullingtheexposedstring.

Timingofinsemination:

Animalsshouldbeinseminated56hoursafterremovalofthedevice.

Thedeviceisintendedforsingleuseonly.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Possibleeffectsifthedevicestaysinthevaginamorethan12dayswerenotassessed.

4.11Withdrawalperiods

Meatandoffal:zerodays

Milk:zerohours

Duringthetreatmentmeat,offalsandmilkcanbedeliveredforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

ATCVetcode:QG03DA04.

Pharmacotherapeuticgroup:Sexhormones(progestogens).

5.1Pharmacodynamicproperties

ProgesteroneinteractswithspecificintranuclearreceptorsandbindstospecificDNAsequenceonthe

genomeandthen,initiatestranscriptionofaspecificsetofgeneswhichisultimatelyresponsiblefor

thetranslationofhormonalactionintophysiologicalevents.Progesteronehasanegativefeedback

actiononthehypothalamo-pituitaryaxis,primarilyonLHsecretion.Progesteronepreventsthe

hormonalsurgefromhypophysis(FSHandLH)andsosuppressesoestrusandovulation.

5.2Pharmacokineticparticulars

Progesteroneisrapidlyabsorbedbyintravaginalroute.Circulatingprogesteroneisboundtoproteins

inblood.Progesteronebindstocorticosteroid-bindingglobulin(CBG)andtoalbumin.Progesteroneis

accumulatedinfattytissueduetoitslipophylicproperties,andintissues/organscontaining

progesteronereceptors.Liveristhemainsiteofprogesteronemetabolism.Progesteronehasahalf-life

of3hours,aCmaxof5µg/LandaTmaxof9h.Theprincipalrouteofexcretionisthefaecesandthe

secondaryrouteistheurine.

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6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimeticone

Stannousoctoate

Siliconeelastomer

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionofimmediatepackaging

Materialoftheprimarycontainer

Polyethylenesachetlowdensity.

Packsizes

Cardboardboxcontaining10sachetsof1device

Cardboardboxcontaining10sachetsof1pre-rolleddevice

Cardboardboxcontaining40sachetsof1device

Cardboardboxcontaining40sachetsof1pre-rolleddevice

Polyethyleneboxcontaining10sachetsof1device

Polyethyleneboxcontaining10sachetsof1pre-rolleddevice

Polyethyleneboxcontaining40sachetsof1device

Polyethyleneboxcontaining40sachetsof1pre-rolleddevice

Polyethyleneboxcontaining40sachetsof1deviceand1applicator

Polyethyleneboxcontaining40sachetsof1pre-rolleddeviceand1applicator.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwaste

materialsderivedfromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialsderivesfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

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