CEVAZURIL 50 mg/mL Oral suspension for piglets

Main information

  • Trade name:
  • CEVAZURIL 50 mg/mL Oral suspension for piglets
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEVAZURIL 50 mg/mL Oral suspension for piglets
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • toltrazuril
  • Therapeutic area:
  • Pigs Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0195/001
  • Authorization date:
  • 13-02-2012
  • EU code:
  • FR/V/0195/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CEVAZURIL50mg/ml,oralsuspensionforpiglets

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Toltrazuril...........................50.0mg

Excipients:

Sodiumbenzoate(E211).........2.1mg

Sodiumpropionate(E281)......2.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsuspension.

Whitehomogeneoussuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Piglets.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthepreventionofclinicalsignsofcoccidiosisinneonatalpigletsonfarmswithaconfirmedhistory

ofcoccidiosiscausedbyIsosporasuis.

4.3 Contraindications

None.

4.4 Specialwarningsforeachtargetspecies

Itisrecommendedtotreatallpigletsinalitter.

Hygienicmeasuresmayreducetheriskofporcinecoccidiosis.Itistherefore,recommendedto

improveconcomitantlythehygienicconditionsintheconcernedfacility,particularlydrynessand

cleanliness.

Toalterthecourseofanestablishedclinicalcoccidialinfection,inindividualanimalsalreadyshowing

signsofdiarrhoea,additionalsupportivetherapymayberequired.

Aswithanyantiparasiticide,frequentandrepeateduseofantiprotozoalsfromthesameclassmaylead

tothedevelopmentofresistance.

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noneknown.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Washanysplashesfromskinoreyesimmediatelywithwater.

Washhandsafterproductadministration.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Thereisnointeractionincombinationwithironsupplementation.

4.9 Amountstobeadministeredandadministrationroute

Oraluse.

Individualanimaltreatment.

Eachpiglettobetreatedonday3-5oflifewithasingleoraldoseof20mgtoltrazuril/kgbodyweight

correspondingto0.4mloralsuspensionperkgbodyweight.

Theoralsuspensionmustbeshakenbeforeuse.

Treatmentduringanoutbreakwillbeoflimitedvaluefortheindividualpigletbecauseofdamageto

thesmallintestinehavingalreadyoccurred.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Athreefoldoverdoseiswelltoleratedbyhealthypigletswithoutadverseclinicalsigns.

4.11Withdrawalperiod(s)

Meatandoffal:77days.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Agentsagainstprotozoaldiseases,ATCvetcode:QP51AJ01

5.1 Pharmacodynamicproperties

Toltrazurilisatriazinonderivative.ItactsagainstcoccidiaofthegenusIsospora.Itisactingagainst

allintracellulardevelopmentstagesofcoccidia:merogony(asexualmultiplication)andgamogony

(sexualphase).Allstagesaredestroyed,thusthemodeofactioniscoccidiocidal.

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5.2 Pharmacokineticparticulars

Afteroraladministrationtoltrazurilisslowlyabsorbedwithabioavailabilityof70%.

Themaximumconcentration(Cmax)oftoltrazurilisof8.9mg/Landisobtainedafteraround24h.

Themainmetaboliteischaracterisedastoltrazurilsulfone.Theeliminationoftoltrazurilisslowwitha

terminalhalf-lifeeliminationtimearound76hours.Themajorrouteofexcretionisviathefaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumpropionate(E281)

Sodiumbenzoate(E211)

Docusatesodium

Aluminiummagnesiumsilicate

Xanthangum

Propyleneglycol

Citricacidmonohydrate

Simeticoneemulsion(containingsorbicacid)

Waterpurified

6.2 Incompatibilities

Nottobemixedwithothermedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5 Natureandcompositionofimmediatepackaging

Natureofimmediatepackaging:

Highdensitypolyethylenebottle

Polyethylenetamperevidentscrewcapwithapolyethyleneseal(100mland250mlbottle)

Polypropylenetamperevidentscrewcapwithapolyethyleneseal(1Lbottle)

Packsize

Cardboardbox100mland250ml.

1litrebottle.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

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