Pracetam 20% oral solution

Main information

  • Trade name:
  • Pracetam 20% oral solution
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pracetam 20% oral solution
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0181/001
  • Authorization date:
  • 20-12-2011
  • EU code:
  • FR/V/0181/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

VETERINARYMEDICINALPRODUCT

PRACETAM200 MG/MLSOLUTIONFORUSEINDRINKINGWATERFORPIGS

PARTI-B

SUMMARYOFPRODUCTCHARACTERISTICS

PHARMACEUTICALFORM

Solutionforusein-drinkingwater

1–NAMEOFTHEVETERINARYMEDICINALPRODUCT

PRACETAM200MG/MLSOLUTIONFORUSEINDRINKING

WATERFORPIGS

2-QUALITATIVEANDQUANTITATIVECOMPOSITION

Paracetamol................................................................................ 200mg

Excipients

Macrogol300..............................................................................qsp 1.0 ml

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM

Solutionforusein-drinkingwater.

Clearviscoussolution,slightlypinkishtopinkish.

Colourmayintensifyovertime.

4.CLINICALPARTICULARS

4.1Targetspecies

Pigs.

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

i)Specialprecautionsforusein animals

None

ii)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.Sotheproductmaybeadministeredduringpregnancyand

lactation.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofnephrotoxicdrugsshouldbeavoided.

4.9Amountsto beadministeredandadministrationroute

Indrinkingwateruse

30mgofparacetamolperkgbodyweightandperday,for5days,orally,administeredinthedrinking

water,equivalentto1.5 mloforalsolutionper10 kgbodyweightandperdayfor5 days.

Theintakeofmedicateddrinkingwaterdependsontheclinicalconditionoftheanimals.Inorderto

obtainacorrectdosage,theconcentrationinthedrinkingwatermustbeadjustedaccordingly.

Recommandationfordissolution:

Theproducteasilydissolvedinambienttemperaturewater(20°Cto 25°C) .

Whenusingtheproductthroughwaterproportioner,adjusttheproportionerfrom5%to3%.Donot

settleproportionersunder3%.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Afteradministrationof5 timestherecommendeddoseofparacetamol,liquidfaeceswithsolid

particlesmayoccasionnallyoccur.Itdoesnothaveanyeffectongeneralbodyconditionofanimals.

Acetylcysteinecanbeusedincaseofaccidentaloverdosage.

4.11Withdrawalperiod

Meatandoffal:0 day.

5.PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:OtherAnalgesicsandAntipyretics

ATCvetcode:QN02BE01

5.1Pharmacodynamicproperties

ParacetamoloracetaminophenorN-acetyl-p-aminophenolisaparaminophenolderivativewith

analgesicandantipyreticproperties.

5.2Pharmacokineticcharacteristics

Absorption:Paracetamolisrapidlyandalmostcompletelyabsorbedafteroraladministration

(bioavailabilityofabout90%afteradministrationinthedrinkingwater).Peakconcentrationsare

reachedinalittlelessthan2 hoursafteringestion.

Metabolism:Paracetamolismainlymetabolisedintheliver.Thetwomajormetabolicpathwaysare

conjugationtoglucuronateandconjugationtosulphate.Thelatterrouteisrapidlysaturableat

dosageshigherthantherapeuticdoses.Aminorpathway,catalysedbycytochromeP450(CYP),leads

totheformationoftheintermediaryreagent,N-acetyl-benzoquinoneiminewhich,undernormal

conditionsofuse,israpidlydetoxifiedbyreducedglutathioneandremovedinurineafterconjugation

withcysteinandmercapturicacid.Onthecontrary,aftermassiveintoxication,thequantityofthis

toxicmetaboliteisincreased.

Elimination:Paracetamolismainlyeliminatedintheurine.Inthepig,63%oftheingesteddoseis

eliminatedbythekidneysin24hoursmainlyconjugatedtoglucuronateandsuphate.Lessthan5%is

eliminatedinunchangedform.Theeliminationhalf-lifeisapproximately5 hours.

Environmentalproperties

Noneknow.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol300.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2 years.

Afterfirstopening:1 year.

Afterdilutioninthedrinkingwater:24 hours.

6.4Specialprecautionsforstorage

Storebelow25

C

6.5Natureandcompositionofimmediatepackaging

-Highdensitypolyethylenebottle

-Highdensitypolyethylenescrewcap

-Polyethylene-aluminium-wax-paper-lowdensitypolyethyleneseal(1-lbottle)

-Polyethylene-PET-aluminium-wax-cardboardseal(2-l,5-land10-lbottles)

6.6.Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

derivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

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

9.DATEOFFIRSTAUTHORISATION:

10.DATEOFREVISIONOFTHETEXT:

09/04/2009

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FDA - U.S. Food and Drug Administration

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety