VECOXAN oral suspensio

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
    Spain
  • 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

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24-5-2018

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23-5-2018

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FDA - U.S. Food and Drug Administration

23-5-2018

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FDA - U.S. Food and Drug Administration

22-5-2018

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FDA - U.S. Food and Drug Administration

20-3-2018

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25-9-2017

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Danish Medicines Agency

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

13-3-2017

EuropharmaDK regains its authorisation

EuropharmaDK regains its authorisation

The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

Danish Medicines Agency

3-1-2017

Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products

Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products

Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).

Danish Medicines Agency

10-6-2016

Operation targets illegal medicines

Operation targets illegal medicines

Global medicine operation just completed. Operation Pangea resulted in 393 arrests and the suspension of more than 4,900 websites.

Danish Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

17-2-2014

Danish Pharmacovigilance Update 19 December 2013

Danish Pharmacovigilance Update 19 December 2013

In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.

Danish Medicines Agency

25-5-2018

Medical devices and IVDs: Suspensions from the ARTG

Medical devices and IVDs: Suspensions from the ARTG

Revocation of suspension of Device Embolisation Device ARTG entries 281030 and 281033

Therapeutic Goods Administration - Australia