VECOXAN

Main information

  • Trade name:
  • VECOXAN ORAL SUSPENSION
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VECOXAN ORAL SUSPENSION
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • diclazuril
  • Therapeutic area:
  • Sheep Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0113/001
  • Authorization date:
  • 24-07-2011
  • EU code:
  • FR/V/0113/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Vecoxan2.5 mg/mlOralSuspensionforlambsand calves

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Diclazuril 2.5 mg

Excipients:

Methylparahydroxybenzoate(E218) 1.8 mg

Propylparahydroxybenzoate(E216) 0.2mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

White, oralsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Ovine(lambs)and bovine(calves).

4.2 Indicationsforuse,specifyingthetargetspecies

Inlambs:

Preventionofcoccidiosiscaused byEimeria crandallisandEimeria ovinoidalis.

Incalves:

Preventionofcoccidiosiscaused byEimeria bovisandEimeria zuernii.

Ifthereisno recentand confirmed historyofclinicalcoccidiosis, thepresenceofcoccidiaintheflock

orherd should beconfirmed byfaecalsamplingpriorto treatment.

4.3 Contraindications

Noneknown.

4.4 Specialwarningsforeachtargetspecies

To ensureacorrectdosage, bodyweightshould bedetermined asaccuratelyaspossible.

Calves:incertaincases, onlyatransientreductionofoocystsheddingmaybeachieved.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Shakewellbeforeuse.

ThepreferredtimingoftreatmentisdirectedbytheknownepidemiologyofEimeria

spp.andthepresenceofcoccidiaintheflock orherd should beconfirmed byfaecalsamplingprior

to treatment, ifthereisno recentand confirmed historyofclinicalcoccidiosis.

Coccidiosisisanindicatorofinsufficienthygieneintheflock/pen.Itisrecommendedtoimprove

hygieneand to treatalllambsintheflock and allcalvesinapen.

Frequentandrepeateduseofantiprotozoalsmayleadtothedevelopmentofresistanceinthetarget

parasite.

To alterthecourseofanestablished clinicalcoccidialinfection, inindividualanimalsalreadyshowing

signsofdiarrhoea, additionalsupportivetherapymayberequired asdiclazurilhasno antimicrobial

activity.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteradministrationoftheproduct.

4..6Adversereactions(frequencyandseriousness)

Nonereported.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

1 mgdiclazurilperkgbodyweight(i.e. 1 mloftheoralsuspensionper2.5 kgbodyweight), ina

singleoraladministration.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inlambs:no signsofoverdosewerenoted afteradministrationof5 timestherecommended dose.

Incalves:no signsofoverdosewerenoted aftera singleadministrationof5 timestherecommended

dose. Incaseofrepeated administrationof3 to 5 timesthedose, on3 consecutivedays, asoftening

and acolourchange(dark brown)ofthefaecescanbeobserved insomecalves.Theseobservations

weretransientand disappeared withoutspecifictreatment.

4.11Withdrawalperiod(s)

Meatand offal:

Lambs:zero days

Calves:zero days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiprotozoals,Triazines

ATCVetCode:QP51AJ03

5.1 Pharmacodynamicproperties

Diclazurilisananticoccidialofthebenzeneacetonitrilegroup withoutantimicrobialactivityand has

anticoccidialactivityagainstEimeriaspecies. Dependingonthecoccidiaspecies, diclazurilhasa

coccidiocidaleffectontheasexualorsexualstagesofthedevelopmentcycleoftheparasite.

Diclazuriltreatmentwillonlyhavelimited effectontheintestinallesionscaused byparasiticstages

olderthan16 days. Treatmentwithdiclazurilcausesinterruptionofthecoccidialcycleand of

excretionofoocystsforapproximately2 weeks. Thisallowstheanimalto bridgetheperiod of

decreaseofmaternalimmunity(observed atapproximately4 weeksofage).

5.2 Pharmacokineticparticulars

Theabsorptionofdiclazurilinlambsispoorafteradministrationoftheoralsuspension.Maximum

concentrationsinplasmaarereached about24 hoursafterdosing. Theabsorptiondecreaseswiththe

animals’age.Theeliminationhalf-lifeisabout30hours.In-vitrostudiesonsheephepatocytes

demonstratedthatmetabolictransformationofdiclazurilislimited. Thiswasequallyobserved inother

animalspecies. Excretionoccursalmostcompletelyviathefaeces.

Whendiclazurilisadministered inoralsuspensionto calves, itsabsorptionispoor.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Microcrystallinecellulose (E460)

Carboxymethylcellulosesodium(E466)

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate (E216)

Citricacid monohydrate(E330)

Polysorbate20 (E432)

Sodiumhydroxide(E524)

Purified water

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagesforsale:3 years

Shelf-lifeafterfirstopeningtheimmediatepackaging:3 months

6.4.Specialprecautionsforstorage

Do notfreeze.

6.5 Natureandcompositionofimmediatepackaging

Natureofthecontainer

Highdensitypolyethylenebottle

Highdensitypolyethylenescrewcap

Highdensitypolyethylenedosingcap.

Commercialpack(s)

Boxwith200 mlcontainerwithharnessand spouted cap

Boxwith1 litrecontainerwithharnessand spouted cap

Boxwith2.5 litrecontainerwithharnessand spouted cap

Boxwith5 litre containerwithharnessand spouted cap

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunused productorwastematerialshould bedisposed ofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE