Eazi-Breed

Main information

  • Trade name:
  • Eazi-Breed Cidr 1380 Cattle Device
  • Pharmaceutical form:
  • Vaginal device
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Eazi-Breed Cidr 1380 Cattle Device
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0221/001
  • Authorization date:
  • 03-01-2012
  • EU code:
  • UK/V/0221/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:March2013

AN:00091/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CIDR1.38g

(InAT,BE,BG,CY,CZ,EE,FI,FR,DE,EL,HU,IE,IT,LI,LT,LU,MT,NL,PL,PT,

RO,SL,SK,ES,UK)

RelmontVet

(InDK,IS,NOandSE)

VaginalDeliverySystemforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance(s):

EachdevicecontainsProgesterone.1.38g.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Vaginaldeliverysystem.

A“T”shapedeviceconsistsofprogesteroneimpregnatedsiliconeelastomerskin

mouldedoveraninertnylonspine.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(cowsandheifers).

4.2Indicationsforuse,specifyingthetargetspecies

Forthecontroloftheoestrouscycleincyclingcowsandheifers,including:

-Synchronisationofoestrusingroupsofanimals.

-Synchronisationofdonorandrecipientanimalsforembryotransfer.

TobeusedincombinationwithprostaglandinF2 

oranalogue.

Useasrecommendednormallyresultsinoestrus48-96hoursafterdeviceremovalwith

themajorityofanimalsshowingoestruswithin48-72hours.

4.3Contraindications

Donotuse:

-incowsorheifers,withabnormalorimmaturegenitaltracts,orwithgenitalinfections.

-inpregnantcattle.

-withinthefirst35daysaftercalving.

4.4Specialwarnings

Revised:March2013

AN:00091/2012

Page2of5

Theprogesteronetreatmentalone,accordingtodosageregimenproposed,isnot

sufficienttoinduceoestrusandovulationinallcyclingfemales.Itisadvisabletoconfirm

cyclingovarianactivitybeforeusingtheprogesteronetreatment.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Animalsinpoorcondition,whetherfromillness,inadequatenutrition,orotherfactors,

mayrespondpoorlytotreatment.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Personalprotectiveequipmentconsistingofglovesshouldbewornwhenhandlingthe

veterinarymedicinalproductduringinsertionandremoval.Insertthedeviceusingthe

applicator.

Washhandsandexposedskinwithsoapandwaterafteruse.

Donoteat,drinkorsmokewhilehandlingtheproduct.

4.6Adversereactions(frequencyandseriousness)

Vaginaldischargeassociatedwithlocalirritationhasbeenobservedatremovalofthe

insert.Thisdischargegenerallyclearsbetweenthetimeofremovalandinsemination

andhasnotbeenseentoaffectconceptionratesfollowingtreatment.

4.7Useduringpregnancy,lactationorlay

Canbeusedduringlactation.

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablished,sodonotusein

pregnantcattleorwithinthefirst35daysaftercalving.Laboratorystudiesinratand

rabbit,afterintramuscularorsubcutaneousadministrations,andatrepeatedhighdoses

ofprogesterone,haveproducedevidenceoffoetotoxiceffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

1.38gofprogesteroneperanimalfor7days

ForSynchronisationofOestrusandSynchronisationofDonorandRecipientAnimalsfor

EmbryoTransfer

Onedeviceshouldbeinsertedintothevaginaofeachcoworheifertobetreated.The

vaginalinsertshouldbeleftinpositionfor7dayswithaninjectionofaluteolyticdoseof

prostaglandinF2 

oranalogueadministered24hourspriortoremoval.Inanimalsthat

respondtotreatmenttheonsetofoestrusgenerallyoccurswithin1-3daysafterremoval

oftheinsert.Cowsshouldbeinseminatedwithin12hoursoffirstobservedoestrus.

Administration

Revised:March2013

AN:00091/2012

Page3of5

Adeviceapplicatorshouldbeusedforadministration,followingtheprocedure

describedbelow:

1.Ensurethattheapplicatoriscleananddippedinanon-irritantantisepticsolution

beforeuse.

2.Wearingsteriledisposableplasticgloves,foldthearmsofthedeviceandload

intotheapplicator.Thearmsofthedeviceshouldprotrudeslightlyfromtheend

oftheapplicator.Careshouldbetakentoavoidunnecessaryorprolonged

handlingoftheproducttominimisetransferoftheactivesubstancetothe

operator'sgloves.

3.Applyasmallquantityofobstetricallubricanttotheendoftheloadedapplicator.

4.Liftthetailandcleanthevulvaandperineum.

5.Gentlyinserttheapplicatorintothevagina,firstinaverticaldirectionandthen

horizontallyuntilsomeresistanceisencountered.

6.Makesuretheremovalstringisfree,pressthehandleoftheapplicatorandallowthe

barreltomovebacktowardsthehandle.Thisreleasesthearmsofthedevice,which

willthenretainthedeviceintheanteriorvagina.

7.Withthedevicecorrectlypositioned,withdrawtheapplicator,leavingtheremoval

stringhangingfromthevulva.

8.Theapplicatorshouldbecleanedanddisinfectedbeforebeingusedonanother

animal.

Removal

Thedevicemayberemovedbygentlypullingonthestring.Onoccasionsthestringmay

notbevisiblefromtheoutsideoftheanimal,insuchcasesitmaybelocatedinthe

posteriorvaginausingaglovedfinger.Withdrawalofthedeviceshouldnotrequire

force.Ifanyresistanceisencounteredaglovedhandshouldbeusedtoeaseremoval.

Ifthereisanydifficultyinremovalfromtheanimalbeyondthatitemisedaboveveterinary

advicemustbesought.

Thedeviceisintendedforsingleuseonly.

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

Notapplicable.

4.11Withdrawalperiod(s)

Meatandoffal:zerodays.

Milk:zerohours.

Duringthetreatmentmilkcanbeusedforhumanconsumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:GenitoUrinarySystemandSexHormones,ATCvetcode:

QG03DA04

5.1Pharmacodynamicproperties

Revised:March2013

AN:00091/2012

Page4of5

Thevaginaldeliverysystemdeliversprogesteroneatacontrolledrateacrossthevaginal

mucosaintothebloodstream.Thissuppressesthereleaseofgonadotrophinreleasing

hormoneandconsequentlyluteinisinghormonefromtheanteriorpituitaryinhibiting

folliclematurationandsocontrollingtheoestrouscycle.Afterremovalofthedevice,

circulatingbloodlevelsofprogesteronefallprecipitouslywithin6hours,allowingfollicle

maturation,behaviouraloestrusandovulation.

5.2Pharmacokineticparticulars

Thepharmacokineticprofileofprogesteronewhenadministeredasasingledevicewas

characterisedbyamaximumconcentration(C

)inplasmaofapproximately4.33

ng/mlachievedat1.19hourspost-dosing(T

)andanAreaUndertheCurve(AUC  )of

19.47ng/ml.hr.Peakconcentrationswerefollowedbyadeclineinsystemicexposure

withanapparenteliminationhalf-life(t

)of0.298hours.Afterremovalofthedevice,

circulatingbloodlevelsofprogesteronefallprecipitouslywithin6hours.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Siliconeelastomer

Nylonspine

PolyesterTail

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcompositionofimmediatepackaging

Thedevicesarepackedinheat-sealedlow-densitypolyethylenesachetsinunitsof10

persachet.Sachetsarere-sealable(zip-line).

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

Revised:March2013

AN:00091/2012

Page5of5

PfizerLtd.

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBER

Vm00057/4256

9. DATEOFFIRSTAUTHORISATION

20February2008

10.DATEOFREVISIONOFTHETEXT

March2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

Approved: 14/03/2013

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