ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff

Main information

  • Trade name:
  • ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

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

Page1of5

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.

Revised:April2013

AN:00906/2012

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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.

Revised:April2013

AN:00906/2012

Page3of5

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

Revised:April2013

AN:00906/2012

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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

Revised:April2013

AN:00906/2012

Page5of5

9. DATEOFFIRSTAUTHORISATION

9July1990

10. DATEOFREVISIONOFTHETEXT

April2013

Approved: 29/04/2013

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

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

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

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