Baycox Sheep

Main information

  • Trade name:
  • Baycox Sheep
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Baycox Sheep
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • toltrazuril
  • Therapeutic area:
  • Sheep Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • NO/V/0002/001
  • Authorization date:
  • 09-02-2011
  • EU code:
  • NO/V/0002/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

2

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Baycox Sheep,50mg/mloralsuspension

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstance:

Toltrazuril 50.0mg

Excipients:

Sodiumbenzoate(E211) 2.1mg

Sodiumpropionate(E281) 2.1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsuspension

Whiteoryellowishsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

ForSheep(lambs).

4.2 Indicationsforuse

Forthepreventionofclinicalsignsofcoccidiosisandreductionofcoccidiasheddinginlambson

farmswithaconfirmedhistoryofcoccidiosiscausedbyEimeriacrandallisandEimeriaovinoidalis.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

Aswithanyantiparasiticidefrequentandrepeateduseofantiprotozoalsfromthesameclassmaylead

tothedevelopmentofresistance.

Itisrecommendedtotreatalllambsinapen.

Hygienicmeasuresmayreducetheriskofovinecoccidiosis.Itistherefore,recommendedtoimprove

concomitantlythehygienicconditionsintheconcernedfacility,particularlydrynessandcleanliness.

Toobtainmaximumbenefit,animalsshouldbetreatedbeforetheexpectedonsetofclinicalsigns,i.e.

intheprepatentperiod.

4.5 Specialprecautionsforuse

Specialprecautionforuseinanimal

3

None

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Washanysplashesfromskinoreyesimmediatelywithwater.

Forenvironmentalreasons:

Lambskeptthroughoutthewholelifespanindoorsunderanintensiverearingsystemmustnotbe

treatedbeyondtheageof6weeksorbodyweightofmorethan20kgattreatment.Manurefromthese

animalsshouldonlybeappliedtothesamepieceoflandeverythirdyear.

Themajormetaboliteoftoltrazuril,toltrazurilsulfone(ponazuril),hasbeenshowntobeboth

persistent(half-life>1year)andmobileinsoilandtobetoxictoplants.

4.6 Adversereactions

Noneknown

4.7.Useduringpregnancyorlactation

Notapplicable

4.8 Interactionswithothermedicinalproductsandotherformsofinteraction

Noneknown

4.9 Amountstobeadministeredandadministrationroute

Eachanimalshouldbetreatedwithasingleoraldoseof20mgtoltrazuril/kgbodyweight

correspondingto0.4mloralsuspensionperkgbodyweight.Toobtainmaximumbenefit,animals

shouldbetreatedbeforetheexpectedonsetofclinicalsigns,i.e.intheprepatentperiod..

Ifanimalsaretobetreatedcollectivelyratherthanindividually,theyshouldbegroupedaccordingto

theirbodyweightanddosedaccordingly,inordertoavoidunder-orover-dosing.

Toensureadministrationofacorrectdose,bodyweightshouldbedeterminedasaccuratelyas

possible.

0.4mloralsuspensionperkgbodyweight.

Theready-to-useoralsuspensionmustbeshakenbeforeuse.

4.10Overdose

Nosignsofoverdosehavebeenobservedintargetanimalsafetystudieswiththreefoldoverdoseata

singletreatmentandtwofoldoverdoseattreatmentontwoconsecutivedays.

4.11Withdrawalperiods

Meatandoffal:42days

Notauthorisedforuseinlactatingsheepproducingmilkforhumanconsumption.

5. PHARMACOLOGICALPOPERTIES

Pharmacotherapeuticgroup:Antiprotozoals,

4

ATCvetcode:QP51AJ01

5.1Pharmacodynamicproperties

Toltrazurilisatriazinonderivative.ItactsagainstcoccidiaofthegenusEimeria.Itisactingagainstall

intracellulardevelopmentstagesofcoccidiaofthemerogony(asexualmultiplication)andgamogony

(sexualphase).Allstagesaredestroyed,thusthemodeofactioniscoccidiocidal.

5.2Pharmacokineticparticulars

Afteroraladministrationtoltrazurilisslowlyabsorbedinmammals.Themainmetaboliteis

characterisedastoltrazurilsulfone.Themaximalplasmaconcentration(Cmax=62mg/L)was

observed2daysfollowingoraladministration.Theeliminationoftoltrazurilisslowwithan

eliminationhalf-lifetimeofapproximately9days.Themajorrouteofexcretionisviathefaeces.

Environmentalproperties

Themetaboliteoftoltrazuril,toltrazurilsulfone(ponazuril)isapersistent(half-life>1year)and

mobilecompoundandhasadverseeffectsonboththegrowthandemergenceofplants.Giventhe

persistentpropertiesofponazurilrepeatedspreadingofmanurefromtreatedanimalsmayleadtoan

accumulationinthesoilandconsequentlyarisktoplants.Theaccumulationofponazurilinsoil

togetherwithitsmobilityalsoleadstoariskofleachingtogroundwater.Seealsosection4.5.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

SodiumPropionate(E281)

SodiumBenzoate(E211)

DocusateSodium

SimethiconeEmulsion

Bentonite

CitricAcidAnhydrous

XanthanGum

PropyleneGlycol

Water,Purified

6.2 Incompatibilities

Noneknown

6.3 Shelf-life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions

6.5 Natureandcompositionofimmediatepackaging

Highdensitypolyethylenebottlescontaining100,250or1000mlofawhiteoryellowishsuspensionwith

abluepolypropylenescrewcapforthe100mlbottleandagreenpolypropylenescrewcapforthe250ml

and1000mlbottle.

5

.Notallpacksizesmaybemarketed”

6.6 Specialprecautionsforthedisposalofunusedmedicinalproductorwastematerialsderived

fromtheuseofsuchproducts,ifappropriate

Anyunusedveterinarymedicinalproductorwastematerialmaterialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Tobeallocated

Representative:

Tobeallocated(ifapplicable)

8. MARKETINGAUTHORISATIONNUMBER(S)

Tobeallocated

9 DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Tobeallocated

10 DATEOFREVISIONOFTHETEXT

Tobeallocated

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