PRACETAM 200 MG/G POWDER FOR USE IN DRINKING WATER FOR PIGS

Main information

  • Trade name:
  • PRACETAM 200 MG/G POWDER FOR USE IN DRINKING WATER FOR PIGS
  • Pharmaceutical form:
  • Powder for oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRACETAM 200 MG/G POWDER FOR USE IN DRINKING WATER FOR PIGS
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • paracetamol
  • Therapeutic area:
  • Pigs Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0193/001
  • Authorization date:
  • 12-03-2010
  • EU code:
  • FR/V/0193/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VETERINARYMEDICINALPRODUCT

PRACETAM20%ORALPOWDERFORPIGS

PARTI-B

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMACEUTICALFORM

Powderforuseindrinkingwater

1–NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRACETAM200 MG/GPOWDERFORUSEINDRINKINGWATERFORPIGS

2-QUALITATIVEANDQUANTITATIVECOMPOSITION

Paracetamol................................................................................ 0.2 g

Excipients

Lactosemonohydrate..................................................................qs 1,0 g

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Powderforuseindrinkingwater

Whitepowder

4.CLINICALPARTICULARS

4.1Targetspecies

Weanedpigs.

4.2Indicationsforusespecifyingthetargetspecies

Inpigs:

Symptomatictreatmentoffeverinthecontextofrespiratorydiseasesincombinationwithan

appropriateantiinfectivetherapy,ifnecessary.

4.3Contraindications

-Donotuseinanimalswithknownhypersensitivitytoparacetamolandtoanyotheringredientsof

theproduct,

-Do notuseinanimalwithseverehepaticimpairment,

-Do notuseinanimalwithsevererenalimpairment.Seealsosection4.8

-Do notuseinanimalsufferingfromdehydrationorhypovolemia

4.4Specialwarnings

Animalswithreducedwaterintakeand/ordisturbedgeneralconditionhavetobetreatedparenterally.

Incaseofcombinedviralandbacterialetiologyofthedisease,anappropriateantiinfectivetherapy

shouldbegivenconcomitantly.

4.5Specialprecautionsforuse

Specialprecautionsforusein animals

None

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

Wearappropriateprotectiveclothing,glovesandamaskandgogglestoprotectthefaceandeyes.If

theproductcomesincontactwiththeskinoreyes,flushimmediatelywithalargeamountofwater.If

symptomspersist,seekmedicaladvice.Toruleoutanyriskofingestionitisrecommendednottoeat,

ordrinkwhileusingPracetamandtowashthehandsafteruse.Inthecaseofingestionoftheproduct,

consultadoctor.

Donothandletheproductifyouarehypersensitiveto theparacetamol.

4.6Adversereactions(frequencyandseriousness)

Inrarecases,attherapeuticdoses,transientsoftfaecescanoccurandcanpersistupto8daysafterthe

withdrawalofadministration.Itdoesnothaveanyeffectongeneralconditionofanimals,andresolve

withoutanyspecifictreatment

4.7Useduringpregancy,lactationorlaying

Studiesinlaboratoryanimalshavenotdetectedanyteratogenicnorfoetotoxiceffectsattherapeutic

doses.Theadministrationoftheproductuptothreetimestherecommendeddose,duringpregnancy

orlactation,didn'tresultinadverseeffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofnephrotoxicdrugsshouldbeavoided.

4.9Amountsto beadministeredandadministrationroute

Oralroute

30mgofparacetamolperkgbodyweightandperday,aslongasthepigsaresufferingfrompyrexia

foramaximumdurationtreatmentof5 days.

Theproductwillbeorallyadministeredcontinuouslyinthedrinkingwater,equivalentto1.5goforal

powderper10 kgbodyweight.

Theintakeofmedicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inorderto

obtainacorrectdosage,theconcentrationinthedrinkingwatermustbeadjustedaccordingly.

Recommandationfordissolution:pourPracetam20%oralpowderinwaterpreferablywarm(30°Cto

35°C).Shakefiveminutesthispreparationtohomogenisethemedicatedsolution.Thenadjustthe

quantityofwaterdependingupontheconcentrationrequiredandshakeagainuntilthesolutionis

homogeneous.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationof5 timestherecommendeddoseofparacetamol,liquidfaeceswithsolid

particlesmayoccasionnallyoccur.Itdoesnothaveanyeffectongeneralbodyconditionofanimals”.

Acetylcysteinecanbeusedincaseofaccidentaloverdosage.

4.11Withdrawalperiod

Meatandoffal:zerodays.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:otheranalgesicsandantipyretics

ATCvetcode:QN02BE01

5.1Pharmacodynamicproperties

ParacetamoloracetaminophenorN-acetyl-para-aminophenolisaparaminophenolderivativewith

analgesicandantipyreticproperties.Itsantipyreticeffectmaybeexplainedbyitsabilitytoinhibit

braincyclo-oxygenases.ParacetamolisonlyaweakinhibitorofCOX-1synthesisand,thus,no

gastro-intestinalsideeffectsandhasnoeffectonplatelet-aggregation.

5.2Pharmacokineticcharacteristics

Absorption:Paracetamolisrapidlyandalmostcompletelyabsorbedafteroraladministration

(bioavailabilityofabout90%afteradministrationinthedrinkingwater).Peakconcentrationsare

reachedinalittlelessthan2 hoursafteringestion.

Metabolism:Paracetamolismainlymetabolisedintheliver.Thetwomajormetabolicpathwaysare

conjugationtoglucuronateandconjugationtosulphate.Thelatterrouteisrapidlysaturableat

dosageshigherthantherapeuticdoses.Aminorpathway,catalysedbycytochromeP450,leadstothe

formationoftheintermediaryreagent,N-acetyl-benzoquinoneiminewhich,undernormalconditions

ofuse,israpidlydetoxifiedbyreducedglutathioneandremovedinurineafterconjugationwith

cysteinandmercapturicacid.Onthecontrary,aftermassiveintoxication,thequantityofthistoxic

metaboliteisincreased.

Elimination:Paracetamolismainlyeliminatedintheurine.Inthepig,63%oftheingesteddoseis

eliminatedbythekidneysin24hoursmainlyconjugatedtoglucuronateandsuphate.Lessthan5%is

eliminatedinunchangedform.Theeliminationhalf-lifeisapproximately4hours.

Environmentalproperties

Noneknow.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackageforsale:24months.

Shelflifeafterfirstopeningtheimmediatepackaging:21 days

Shelflifeafterdilutioninthedrinkingwateraccordingtodirections:24 hours.

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanystorageconditions

6.5Natureandcompositionofimmediatepackaging

-Bagpolyesther/Aluminium/Polyamide/Polyethyleneof1kg,5kgand10kg

Notallpack sizemaybemarketed

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialderivedfromsuchveterinarymedicinalproductshouldbe

disposedofinaccordancewithnationalrequirements.

7.MARKETINGAUTORISATIONHOLDER

SOGEVALLaboratories

200, routedeMayenne

BP2227

53022 Lavalcedex9

FRANCE

Tel.:(33)02-43-49-51-51

Fax:(33)02-43-53-97-00

e-mail:sogeval@sogeval

8.MARKETINGAUTHORISATIONNUMBERS

-Bagof1 kg:

-Bagof5kg:

-Bagof10kg:

8.DATEOFFIRSTAUTHORISATION:

9.DATEOFREVISIONOFTHETEXT:

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

VETERINARYUSE

VETERINARYMEDICINALPRODUCT

PRACETAM20%ORALPOWDERFORPIG

ANNEXOFPARTI-B

PACKAGELEAFLETPROJECT

Bag of1 kg, 5kg, 10kg

PharmaceuticalForm

Powderforuseindrinkingwater

PACKAGELEAFLET

PRACETAM200 MG/GPOWDERFORUSEINDRINKINGWATERFORPIGS

1.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDERANDOF

THEMANUFATURINGAUTHORISATIONHOLDERRESPONSIBLEFORBATCH

RELEASE,IFDIFFERENT

SOGEVALLaboratoires

200 routedeMayenne–BP2227

53022 LAVALCedex9

FRANCE

2.NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRACETAM200 MG/GPOWDERFORUSEINDRINKINGWATERFORPIGS

3.STATEMENTOFACTIVESUBSTANCE(S)ANDOTHERINGREDIENT(S)

Paracetamol..................................................................................... 0,20 g

ExcipientQSP.............................................................................qs 1,00 g

4.INDICATION(S)

Inpigs:

Symptomatictreatmentoffeverinthecontextofrespiratorydiseasesincombinationwithan

appropriateantiinfectivetherapy,ifnecessary.

5. CONTRAINDICATIONS

-Donotuseinanimalswithknownhypersensitivitytoparacetamolandtoanyotheringredientsof

theproduct,

-Do notuseinanimalwithseverehepaticimpairment,

-Do notuseinanimalwithsevererenalimpairment.SeealsosectionDruginteractions

-Do notuseinanimalsufferingfromdehydrationorhypovolemia

6. ADVERSEREACTIONS

Inrarecases,attherapeuticdoses,transientsoftfaecescanoccurandcanpersistupto8daysafterthe

withdrawalofadministration.Itdoesnothaveanyeffectongeneralconditionofanimals,andresolve

withoutanyspecifictreatment

Ifyounoticeanyseriouseffectsoreffectsnotmentionedinthisleaflet,pleaseinformyourveterinary

surgeon.

7. TARGETSPECIES

Weanedpigs.

8. METHODANDROUTE(S)OFADMINISTRATION

Oralroute

30mgofparacetamolperkgbodyweightandperday,aslongasthepigsaresufferingfrompyrexia

foramaximumdurationtreatmentof5 days.

Theproductwillbeorallyadministeredcontinuouslyinthedrinkingwater,equivalentto1.5goforal

powderper10 kgbodyweight.

Theintakeofmedicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inorderto

obtainacorrectdosage,theconcentrationinthedrinkingwatermustbeadjustedaccordingly.

9. ADVICEONCORRECTADMINISTRATION

Recommandationfordissolution:pourPracetam20%oralpowderinwaterpreferablywarm(30°Cto

35°C).Shakefiveminutesthispreparationtohomogenisethemedicatedsolution.Thenadjustthe

quantityofwaterdependingupontheconcentrationrequiredandshakeagainuntilthesolutionis

homogeneous.

10. WITHDRAWALPERIOD

Meatandoffal:zerodays.

11. SPECIALSTORAGECONDITIONS

Keep outofthereachandthesightofchildren

Thisveterinarymedicinalproductdoesnotrequireanystorageconditions

Donotuseaftertheexpirydatestatedonthebag

Shelflifeafterfirstopeningtheimmediatepackaging:21 days

Shelflifeafterdilutioninthedrinkingwateraccordingtodirections:24 hours.

12.SPECIALWARNING(S)

Animalswithreducedwaterintakeand/ordisturbedgeneralconditionhavetobetreatedparenterally.

Incaseofcombinedviralandbacterialetiologyofthedisease,anappropriateantiinfectivetherapy

shouldbegivenconcomitantly.

SPECIALPRECAUTIONSTOBETAKENBYTHEPERSONADMINISTERINGTHE

PRODUCTTOANIMALS

Wearappropriateprotectiveclothing,glovesandamaskandgogglestoprotectthefaceandeyes.If

theproductcomesincontactwiththeskinoreyes,flushimmediatelywithalargeamountofwater.If

symptomspersist,seekmedicaladvice.Toruleoutanyriskofingestionitisrecommendednottoeat,

ordrinkwhileusingPracetamandtowashthehandsafteruse.Inthecaseofingestionoftheproduct,

consultadoctor.

Donothandletheproductifyouarehypersensitiveto theparacetamol.

DRUGINTERACTIONSANDOTHERFORMSOFINTERACTION

Concurrentadministrationofnephrotoxicdrugsshouldbeavoided.

OVERDOSE(SYMPTOMS,EMERGENCYPROCEDURES,ANTIDOTES)

Afteradministrationof5timestherecommendeddoseofparacetamol,liquidfaeceswithsolid

particlesmayoccasionallyoccur.Itdoesnothaveanyeffectongeneralbodyconditionofanimals.

Acetylcysteinecanbeusedincaseofaccidentaloverdosage.

USEDURINGPREGANCY,LACTATIONORLAYING

Studiesinlaboratoryanimalshavenotdetectedanyteratogenicnorfoetotoxiceffectsattherapeutic

doses.Theadministrationoftheproductuptothreetimestherecommendeddose,duringpregnancy

orlactation,didn'tresultinadverseeffects.

13.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSORWASTE

MATERIALS,IFANY

Anyunusedproductorwastemedicinalderivedfromsuchveterinarymedicinalproductshouldbe

disposedofinaccordancewithnationalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

ORALROUTE

FORANIMALTREATMENTONLY

PACKAGESIZE

-Bagof1 kg:

-Bagof5kg:

-Bagof10kg:

Notallpack sizemaybemarketed

BATCHNUMBER:

EXPIRYDATE:

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