ZINTESTIN

Main information

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

Documents

Localization

  • Available in:
  • ZINTESTIN
    Italy
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • ES/V/0191/001
  • Authorization date:
  • 27-07-2012
  • EU code:
  • ES/V/0191/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

B.2.LABEL-LEAFLET

ZINTESTIN1000mg/gPremixformedicatedfeedingstuffforpigs

Symbol(placedontheupperrightcorner):“

NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERAND

OFTHEMANUFACTURINGAUTHORISATIONHOLDERRESPONSIBLEFOR

BATCHRELEASE

Marketingauthorizationholder:

VETPHARMAANIMALHEALTH,S.L.

LesCorts,23

08028BARCELONA

Spain

Manufacturerresponsibleforbatchrelease:

LABORATORIOSCALIER,S.A INDUSTRIALVETERINARIA,S.A.

C/Barcelonés,26 –PladeRamassà

Esmeralda,19

LESFRANQUESESDELVALLÉS

(Barcelona) 08950ESPLUGUESDE

LLOBREGAT(Barcelona)

NAMEOFTHEVETERINARYMEDICINALPRODUCT

ZINTESTIN1000mg/gPremixformedicatedfeedingstuffforpigs

Zincoxide

STATEMENTOFACTIVESUBSTANCEANDOTHERINGREDIENTS

Eachgramcontains:

Activesubstance:

Zincoxide 1000mg

Excipients: None

INDICATION

Piglets:Preventionofpostweaningdiarrhoea.

CONTRAINDICATIONS

Notdescribed.

ADVERSEREACTIONS

Theadministrationofthemedicatedpremixmaycausethatfaecestakeonawhite-

yellowishcolourthatsubsideswhentreatmentiswithdrawn.Ifyounoticeanyserious

effectsorothereffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

TARGETSPECIES

Pigs(piglets)

DOSAGEFOREACHSPECIES,ROUTEANDMETHODOFADMINISTRATION

Oraladministrationmixedwiththefeed.

Piglets:85mgofZincOxide/kgofbodyweightandday,for14postweaningdays

(equivalentto3.1kgoftheproduct/tonoffeedorequivalentto2500gofzinc/ton

offeed).

ADVICEONCORRECTADMINISTRATION

Feedintakedependsontheclinicalconditionoftheanimal,thustheconcentrationin

thefeedshouldbeadjustedtoassurethecorrectdosage.Mixwelltoensure

homogeneousdistribution.

Themedicatedfeedshouldbetheonlysourceoffeedduringthe14dayspost

weaningatthemost.

WITHDRAWALPERIOD

Pigs(Piglets):Meat:9days

SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Storeintheoriginalcontainerclosed.

Shelf-lifeafterincorporationinpelletedfeed:3months

Shelf-lifeafterfirstopeningtheimmediatepackaging:Immediateuse

SPECIALWARNINGS

Specialwarningsforeachtargetspecies

Biologicalparameters(alkalinephosphatase,theactivityof 

-amylase)maybe

alteredbytheadministrationofthemedicatedpremix.Thisdisordersubsideswhen

treatmentiswithdrawn.

Specialprecautionsforuseinanimals

Zincmayaccumulateinthesoil.Itisrecommendedtorotatethelandtowhichthe

slurryisapplied/incorporatedatleasteverytwoyears.

Themaximumtemperatureofmedicatedfeedpelletingshouldbe55ºC.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Avoiddirectcontactwiththeskinandmucousmembranesbywearingappropriate

protectiveclothing.Contaminatedclothingshouldberemovedandwashedbefore

beingreused.

Wearprotectivegogglesandimpermeableglovesduringtheincorporationand

handlingofthepremix.

Avoidtheinhalationoftheproductbywearingadisposablehalf-maskrespirator

conformingtoEuropeanStandardEN140withafilterEN143whenmixingor

handlingthefeed.

Incaseofsignificantpowderinhalation,leavethecontaminatedairzoneandbreathe

freshair.Ifdiscomfortpersists,seekmedicaladvice.

Incaseofskincontact,washtheexposedareawithsoapandwater.

Incaseofeyecontact,rinsewithplentyofwater.Seekmedicalattentionifirritation

persists.

Incaseofaccidentalingestion,drinkplentyofwater,seekmedicaladviceandshow

thepackageleafletorthelabeltothephysician.

Washhandsafteruse.

Useduringpregnancy,lactationorlay

Theproductisintendedtobeusedinpiglets,soitsuseduringpregnancyand

lactationisnotapplicable.

Interactionwithothermedicinalproductsandotherformsofinteraction

Theoralbioavailabilityofzincmayvarydueto thision’scapacitytointeractwith

otherions(calcium,copper,iron,cadmium).

Overdose

Noadversereactionstothisveterinarymedicinalproductwereobservedwhenitwas

administeredatapproximatelytwicetherecommendeddose(200mgofZnO/kg

b.w./day)fortwicetheadministrationperiod(28days).

Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.

Askyourveterinarysurgeonhowtodisposeofmedicinesnolongerrequired.

Thesemeasuresshouldhelptoprotecttheenvironment.

[IT]:

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirementsandplacedintoappropriatesystemsforcollectionanddisposalof

unusedorexpiredmedicinalproducts.

DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

01/12/2010

OTHERINFORMATION

25-kgBags

EXPIRYDATE

EXP:

MARKETINGAUTHORISATIONNUMBER

MANUFACTURER’SBATCHNUMBER

Batch:

Foranimaltreatmentonly –tobesuppliedonlyonveterinaryprescription

Keepoutofthereachandsightofchildren

“Warning:pleasereadcarefullythespecialprecautionsforuse”

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