DOZURIL

Main information

  • Trade name:
  • Dozuril 25 mg/ml oral solution for poultry
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Dozuril 25 mg/ml oral solution for poultry
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • toltrazuril
  • Therapeutic area:
  • Chicken Broilers

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0233/001
  • Authorization date:
  • 25-04-2012
  • EU code:
  • FR/V/0233/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1.NAMEOFTHEVETERINARYMEDICINALPRODUCT

Dozuril25mg/mlsolutionforuseindrinkingwaterforchickens

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlcontains:

Activesubstance

Toltrazuril

25.0mg

Forafulllistofexcipients,seesection6.1

3.PHARMACEUTICALFORM

Solutionforuseindrinkingwater.

Clearcolourlesstobrownsolution

4.CLINICALPARTICULARS

4.1Targetspecies:

Chickens(pulletsandbreeders)

4.2Indicationsforuse,specifyingthetargetspecies

Treatmentofcoccidiosisinpulletsandbroilerbreeders.

4.3Contra-indications

None.

4.4Specialwarnings,foreachtargetspecies

Goodhygienecanreducetheriskofcoccidiosis.Itisthereforerecommendedthatany

deficienciesinhusbandryshouldbeaddressedinadditiontotreatment.Poultryhousesshould

bekeptcleananddry.

Itisrecommendedthatallindividualsinthegrouparetreated.

Forbestresults,treatmentshouldbeinitiatedbeforetheclinicalsignsofdiseasehavespread

throughoutthewholegroup.

4.5Specialprecautionsforuse

i)Specialprecautionsforuseinanimals

Aswithallanticoccidials,prolongedusemayresultinthedevelopmentofresistantstrains.

ii)Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Avoidskinandeyecontactwiththeproduct.

Wearpersonalprotectiveclothing,includingsyntheticrubbergloveswhenhandlingtheproduct.

Washanysplashesfromskinoreyesimmediatelywithwater.

Washhandsandanyexposedskinafteruse.

Donoteat,drinkorsmokewhilstusingtheproduct.

iii)Otherprecautions

None

4.6Adversereactions(frequencyandseriousness)

Notknown.

4.7Useduringpregnancyandlactationorlay

None.

4.8Interactionswithothermedicinalproductsandotherformofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Administration:Orallyviathedrinkingwater.

Dosage:7mgperkgofbodyweightperdayfor2consecutivedays,orally,thiscorrespondsto

28mloforalsolutionper100kgofbodyweightperdayor1.4mloftheproductperlitreof

drinkingwater,basedonawaterconsumptionof1litreper5kgbodyweight.

Thismedicinalproductshouldbeadministeredeithercontinuouslyover48hours,orforone8

hourperiodperdayfor2consecutivedays.

Thetotalweightofthetreatedanimalsandthedailywaterconsumptionmustbeaccurately

calculated.

Theconsumptionofwatermayvarydependinginparticularontheclinicalcondition,the

ambienttemperature,thelightingprogram,thedrinkingsystemused,theageandbreed.Ifthe

waterconsumptionismoreorlessthantheabovestandards,theconcentrationofthemedicinal

productinthedrinkingwatershouldbeadjustedaccordingly.

Useappropriateandproperlycalibrateddosingequipment.Medicatedwatershouldbetheonly

drinkingsource.

Themedicatedwaterisonlyusablefor24hoursandshouldbemadefreshlyeveryday.

Dilutionsmoreconcentratedthan3:1,000(3mlofproductto1litredrinkingwater)mayresult

inprecipitation.Predilutionandtheadministrationthroughadosingpump(proportioner)are

notrecommended.Usepreferablyabulktank.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Thefirstsignsofintolerancesuchasreducedwaterintakewereobservedbeyond5timesthe

recommendeddose.

4.11Withdrawalperiod

Meatandoffal:16days.

Eggs:Notauthorizedforuseinlayingbirdsproducingeggsforhumanconsumption.

5 PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antiprotozoals,triazines

ATCVetCode:QP51AJ01

5.1Pharmacodynamicproperties

Toltrazurilisatriazinonederivativeanticoccidial;itsmodeofactionisunknown.Itisactive

againstcoccidiaofthegenusEimeria.Itisactiveagainstallintracellulardevelopmentstages

includingschizogony(asexualmultiplication)andgametogony(sexualstage).

5.2.Pharmacokineticcharacteristics

Inpoultry,toltrazurilisabsorbedatarateofatleast50%.Theactivesubstanceisrapidly

metabolized.Themainmetaboliteisthetoltrazurilsulfone.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Trolamine

Macrogol300

6.2Incompatibilities

Donotmixwithotherveterinarymedicinalproducts.

6.3Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:4years.

Shelf-lifeafterdilutionaccordingtodirections:24hours.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcompositionoftheimmediatepackaging

1litrehigh-densitypolyethylenebottleswithhigh-densitypolyethylenescrewcapand

removablepolyethylenesealingdisk.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7.MARKETINGAUTHORISATIONHOLDER

DopharmaResearchB.V.

Zalmweg24

4941VXRaamsdonksveerTheNetherlands

research@dopharma.com

8.MARKETINGAUTHORISATIONNUMBER(S)

9.DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10.DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Underveterinaryprescription

There are no safety alerts related to this product.

16-7-2018

Procox (Bayer Animal Health GmbH)

Procox (Bayer Animal Health GmbH)

Procox (Active substance: emodepside and toltrazuril) - Centralised - Yearly update - Commission Decision (2018)4753 of Mon, 16 Jul 2018

Europe -DG Health and Food Safety