ZincoTec

Main information

  • Trade name:
  • Zincotec Premix for Medicated Feedingstuff
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zincotec Premix for Medicated Feedingstuff
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • zinc oxide
  • Therapeutic area:
  • Pigs Food

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0488/001
  • Authorization date:
  • 13-12-2012
  • EU code:
  • UK/V/0488/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:April2013

AN:00906/2012

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SUMMARYOFPRODUCTSCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ZincoTecZincOxide100%PremixforMedicatedFeedingStuff

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

ZincOxide Quantitativecomposition

%w/w

100

3. PHARMACEUTICALFORM

Premixformedicatedfeedingstuff

Asoft,whiteoryellowish,dry,amorphouspowder

4. CLINICALPARTICULARS

4.1 Targetspecies Pigsupto10weeksofage.

4.2 Indicationsforuse,specifyingthetargetspecies-Forthetreatmentand

controlofdiarrhoeainyoungpigs.

4.3 Contraindications Noneknown.

4.4 Specialwarningsforeachtargetspecies Noneknown.

4.5 Specialprecautionsforuse

i.Specialprecautionsforuseinanimals –Noneknown.

ii.

Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Weareitheradisposablehalf-maskrespiratorconformingtoEuropean

StandardEN149oranon-disposablerespiratortoEuropeanStandard

EN140withafiltertoEN143whenmixingorhandlingthefeed.

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Avoidcontactwiththeeyesbywearingprotectivegogglesorsafety

glasses.Incaseofaccidentaleyecontact,irrigatethoroughlywith

largequantitiesofwater.

Avoidcontactwiththeskinbywearingprotectiveclothingincluding

impermeablegloves.Incaseofaccidentalskincontactwashthe

exposedskinwithsoapandwater.

Contaminatedclothingshouldberemovedandwashedbeforebeing

reused.

Incaseofaccidentalingestion,drinkplentyofwaterandseekmedical

attention.

Washhandsafteruse.

iii.

Otherprecautions –Noneknown.

4.6 Adversereactions(frequencyandseriousness) Noneknown.

4.7 Useduringpregnancy,lactationorlay Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Fororaladministrationonly.

Forincorporationintodryfeedataregistered/licensedfeedmill.Formore

information:

IntheUKreferto“VMGNNo3,GuidanceforRetailers”

InIrelandseekadvicefromtheDepartmentofAgriculture,Foodand

theMarine

Administer2900-3100mg/kgZincotec(whichprovides2320-2489mg/kg

elementalzinc)sothattheamountofzincalreadypresentinthefeed

(naturallyoccurringzincplusaddednutritionalzinc)istakenaccountofto

ensurethatthefinalfeedcontains2500mg/kgofelementalzinc.

Toensureadequatedistributionoftheproductinthefinalfeeditis

recommendedthatitbepremixedwithasuitablequantityoffeedingredients

beforeblendingintothefinalfeed.Thefinalfeedshouldbefedastheonly

feedforupto14days.

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4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noknownproblems.

4.11 Withdrawalperiod(s) Animalsmustnotbeslaughteredforhuman

consumptionduringtreatment.Animalsmaybeslaughteredforhuman

consumptiononlyafter28daysfromtheendoftreatment.

5. PHARMACOLOGICALPROPERTIES:ATCVetCodeQA07XA91

5.1 Pharmacodynamicproperties

ThemodeofactionofZincOxideinthetreatmentandcontrolofdiarrhoeain

pigshasnotbeendetermined.Ithasbeenshowntohaveafavourableeffect

onthegutmicroflorabyhelpingtopreventthereductionindiversityof

microflorathatoccurredintheintestinesofcontrolpigsduringthesecond

weekafterweaning.

5.2 Pharmacokineticproperties

Absorption-Zincisanessentialtraceelementforlivestockrequiredforthe

maintenanceofdailybodilyfunction.ZincOxideisknowntoberelatively

poorlyabsorbedandtherapeuticlevelshaveincreasedbloodlevelsbythe

factorofonlytwo.

Distribution –TherapeuticlevelsofZincOxidefedforfourweeksafter

weaninghavebeenshowntoincreasezinclevelsintheliverandkidneyof

pigsbyfactorsofapproximatelyfiveandtwo,respectively.Noincreasein

musclelevelswerenoted.

Biotransformation-Zincisatraceelementessentialfordailymetabolismin

thebody.Sincetherapeuticlevelsarepoorlyabsorbed,itisbelievedthat

mostisvoidedunchangedinthefaeces.

Elimination –MostzincfromZincOxideisexcretedwithoutabsorption.

Environmentalproperties

Zincoxideismainlyexcretedinthefaeceswithasmallproportionexcretedin

theurine.Thesubstanceisnotbiotransformedandmayenterthe

environmentintheformofslurryandmanure.Theimpactonthetotal

environmentalzincburdenhasbeenassessedandisnotexpectedtobe

greatwhentheproductisusedasdirected.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

None

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6.2 Incompatibilities

Noneknown

6.3 Shelflife

(i)Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale-2years.

(ii)Shelflifeoftheveterinarymedicinalproductafterincorporationintomeal

orpelletedfeed-3months

6.4 Specialprecautionsforstorage

Storeinacool,dryplace

Donotstoreabove25 o C

Storeintightlyclosedoriginalcontainer

Storeawayfrom,food,drinkandanimalfeedingstuffs

6.5 Natureandcompositionofimmediatepackaging:

25kgmulti-plypapersacksarefilledviaasidevalve,whichistuckedinto

formaclosureandisglued.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts,if

appropriate:

Anyunusedveterinarymedicinalproductorwastematerialsderivedfrom

suchveterinarymedicinalproductsshouldbedisposedofinaccordancewith

localrequirements.

7. MARKETINGAUTHORISATIONHOLDER:

ProvimiLimited

EasternAvenue

Lichfield

Staffordshire

WS137SE

8. MARKETINGAUTHORISATIONNUMBER

Vm03941/4000

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AN:00906/2012

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9. DATEOFFIRSTAUTHORISATION

9July1990

10. DATEOFREVISIONOFTHETEXT

April2013

Approved: 29/04/2013