PRACETAM 10% Premix for pigs

Main information

  • Trade name:
  • PRACETAM 10% Premix for pigs
  • Pharmaceutical form:
  • Premix for medicated feed
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRACETAM 10% Premix for pigs
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • NERVOUS SYSTEM
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0147/001
  • Authorization date:
  • 14-06-2011
  • EU code:
  • FR/V/0147/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

PRACETAM10 % premix formedicatedfeedingstuffforpigs 1

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VETERINARYMEDICINALPRODUCT

PRACETAM10%premixformedicatedfeedingstuff

forpigs

PARTI

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMACEUTICALFORM

Premix formedicatedfeeding stuff

PRACETAM10 % premix formedicatedfeedingstuffforpigs 2

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1-NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRACETAM10 %premix formedicatedfeeding stuffforpigs

2-QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramcontains

Activesubstance:

-Paracetamol………………………………………………………...100mg

Excipients:

Forafulllistofexcipients, seesection6.1.

3-PHARMACEUTICALFORM

Premixformedicated feedingstuff

4-CLINICALPARTICULARS

4.1-Targetspecies

Pigs(weaned pigs).

4.2-Indicationsforuse, specifyingthetargetspecies

Pigs(weaned pigs):

Symptomatictreatmentforreductionofpyrexia,inthecontextofacuteinfectiousrespiratorydiseases,in

combinationwithappropriateanti-infectivetherapy.

4.3–Contraindications

-Do notuseinanimalswithknownhypersensitivityto paracetamol.

-Donotusetheproductifthereareanimalswithhepaticorrenalimpairment,orhypovolaemic

animals.

And seethesection4.8.

4.4-Specialwarningsforeachtargetspecies

PRACETAM10 % premix formedicatedfeedingstuffforpigs 3

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Animalswithreduced appetiteand/ordisturbed generalconditionhaveto betreated parenterally.

PRACETAM10 % premix formedicatedfeedingstuffforpigs 4

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4.5-Specialprecautionsforuse

Specialprecautionsforusein animals

Theproductisapremixthatmustnotbegiventopigsbeforeithasbeenmixedwithsolidfeedatthe

minimumrateof5 kg/ton.

Specialprecautionsto betaken bytheperson administering themedicinalproductto animals

Personswithknownhypersensitivitytoparacetamolshouldavoidanycontactwiththemedicatedfeed.In

ordertoavoidcontactwithskin,mucousmembranesand/oreyesusegloves, CE-approved anti-dustmask

andprotectingspectacleswhenhandlingthemedicatedfeed.Incaseofcontactwithskinand/oreyesrinse

generouslywithcleanwater. Seek medicaladviceif, followingexposure, signssuchasskinrashorpersistent

eyeirritationdevelop.

4.6-Adversereactions(frequencyand seriousness)

No sideeffectshavebeenseenfollowingadministrationofthemedicinalproductatthetherapeuticdose.

4.7-Useduringpregnancy,lactationorlay

Thesafetyhasbeenshowninstudieswithpregnantandlactatingsowswhenusingtheproductin3 timesof

therecommended dose.

4.8-Interactionswithothermedicinalproductsand otherformsofinteraction

Concurrentadministrationofnephrotoxicdrugsshould beavoided.

Nointeractionsdescribedwithcommonlyusedantibiotics.Concomitanttreatmentshouldbeconsidered

casebycase.

Thesafetyoftheco-administrationoftheproductandfeedsupplementedwithvitamineEorpolyinsatured

fattyacidshasnotbeenestablished.Useonlyaccordinglytothebenefit/riskassessmentbytheresponsible

veterinarian.

4.9-Amountsto beadministered and administrationroute

Thedailydoseis30 mgperkgb.w. for5 consecutivedaysto beadministered infeed:

Thedosecanbeadministered indryfeed supplied intwo meals.

Theproductmaybeadministered inpelletsaswellasnon-pelleted feed.

Forthepreparationofmedicated feed:

PRACETAM10 % premix formedicatedfeedingstuffforpigs 5

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30 mgParacetamolperkgb.w. dailycorrespondsto 300 mg“Pracetam10 %Premix”perkgb.w. daily.

Forthepreparationofthemedicated feed thebodyweightoftheanimalsto betreated and theiractualdaily

intakeoffeedshouldbetakeninto dueaccount. To providetherequired amountofactivesubstanceperkg

medicated feed thepremixhasto beincorporated into thefeed accordingto thefollowingformula:

300 mg“Pracetam10 %” averagebodyweight(kg)

perkgb.w. daily X oftheanimalsto betreated

---------------------------------------------------------------------------------------------= mg“Pracetam

10 %”

averagedailyfeed intakeperanimal(kg) perkgfeed

Themixingshould beperformed inan(authorised)feedingstuffmanufacturewithadequatemixingapparatus.

4.10-Overdose(symptoms, emergencyprocedures, antidotes), ifnecessary

No adverseeffectshavebeendemonstrated inpigsadministered up to 10xtherecommended dose.

Acetylcysteinecanbeused incaseofaccidentaloverdosage

4.11-Withdrawalperiod

Meatand offal:1 day.

5-PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:otheranalgesicsand antipyretics

ATCvetcode: QN02BE01

5.1Pharmacodynamicproperties

Paracetamol,oracetaminophenisaparaamino-phenolderivativewithanalgesicand antipyreticproperties.

Itsantipyreticeffectmaybeexplainedbyitsabilitytoinhibitbraincyclo-oxygenases. Paracetamolisonlya

weakinhibitorofCOX-1synthesisand,thus,hasnogastrointestinalside-effectsandhasnoeffecton

platelet-aggregation.

5.2Pharmacokineticparticulars

Absorptionanddistribution:AfterasingleoraladministrationofPRACETAMinfeed,at15mg/kg,the

bioavailabilityis76%,thepeakofparacetamolconcentration(cmax), 3.6 µg/ml, isreached 2.4 hoursafter

theadministration.

Metabolism:Paracetamolismetabolisedmostlyintheliver.Thetwomajormetabolicpathwaysare

glucuronideconjugationandsulphateconjugation.Aminorpathwaycatalysed byCYP(cytochromeP450)

PRACETAM10 % premix formedicatedfeedingstuffforpigs 6

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leadstotheformationoftheintermediaryreagent,N-acetylbenzoquinoneiminewhich,israpidlydetoxified

byreduced glutathioneand removed inurineafterconjugationwithcysteinand mercapturicacid.

Elimination:Paracetamolisessentiallyeliminatedthroughurine(70%ofasingledoseiseliminated viaurine

within24hours)undertheformofparacetamolglucuronide(80%).Theotherformsofeliminationare

cystein(10 %), unchanged paracetamoland sulphate.

6-PHARMACEUTICALPARTICULARS

6.1-Listofexcipients

Cornglutenfeed

6.2-Incompatibilities

Noneknown.

6.3-Shelf-life

-Shelf-lifeoftheveterinarymedicinalproductaspackaged forsale:2years

-Shelf-lifeafterincorporationinto feed:5 months.

6.4-Specialprecautionforstorage

-Storeinadryplace

-Keep intheoriginalcontainer

6.5-Natureand compositionofimmediatepackaging

-Lowdensitypolyethylene-paper-paperbag.

Bagsof10 and 25 kg

Notallpack sizesmaybemarketed

6.6-Specialprecautionsforthedisposalofunused veterinarymedicinalproductorwastematerialsderived

fromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialfromsuchveterinarymedicinalproductshould

bedisposed ofinaccordancewithlocalrequirements.

7-MARKETINGAUTHORISATIONHOLDER

SOGEVALLaboratories

PRACETAM10 % premix formedicatedfeedingstuffforpigs 7

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200 RoutedeMayenne–BP2227

53022 LAVALCEDEX9

France

8-MARKETINGAUTHORISATIONNUMBER(S)

9-DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION:

10-DATEOFREVISIONOFTHETEXT

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Considerationshould begivento officialguidanceontheincorporationofmedicated premixesinfinalfeeds.

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