COLISTINE CEVA

Main information

  • Trade name:
  • COLISTINE CEVA
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLISTINE CEVA
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • colistin
  • Therapeutic area:
  • Chicken, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0184/001
  • Authorization date:
  • 23-09-2011
  • EU code:
  • FR/V/0184/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1/4 Dokument1

SUMMARYOFPRODUCTCHARACTERISTICS

(S.P.C.)

Day 90

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

COLISTINECEVA2000000IU/ml,concentratefororalsolution,pigs,poultry[France]

COLISCOUR2000000IU/ml,concentratefororalsolution,pigs,poultry[Ireland]

COLIVET2000000IU/ml,concentratefororalsolution,pigs,poultry[Austria,Cyprus,Greece,

Portugal,Spain]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

-Colistin(assulphate).............................................................2000000IU

Excipients:

-Benzylalcohol................................................................................10mg

-Excipients......................................q.s..............................................1ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentratefororalsolution.

Clearyellowsolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigsandpoultry.

4.2 Indicationsforuse,specifyingthetargetspecies

TreatmentofinfectionsofthegastrointestinaltractcausedbyEscherichiacoliandSalmonella

susceptibletocolistin.

4.3 Contraindications

Donotuseincaseofhypersensitivitytopolypeptideantibioticsortoanyoftheexcipients.

4.4 Specialwarningsforeachtargetspecies

None.

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4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Peoplewithknownhypersensitivitytopolymyxinsshouldavoidcontactwiththeveterinarymedicinal

product.

Incaseofaccidentaleyeexposure,washwithplentyofwaterandseekmedicalattentionimmediately

andshowthelabeltothephysician.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Thesafetyofcolistinduringpregnancy,lactationorlaywasnotinvestigatedintargetspecies.However,

thecolistinispoorlyabsorbedafteroraladministration,thereforetheuseofcolistinduringpregnancy,

lactationorlayshouldnotleadtoparticularproblems.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Pigs:100000IUofcolistinperkgbodyweightperdayfor3consecutivedaysbyoralroute,

i.e.0.50mlofproductper10kgofbodyweightperdayfor3consecutivedays.

Poultry:75000IUofcolistinperkgbodyweightperdayfor3consecutivedaysbyoralroute,

i.e.37.5mlofproductpertonneofbodyweightperdayfor3consecutivedays.

Administrationviadrinkingwater.

Theuptakeofmedicatedwaterdependsonthephysiologicalandclinicalconditionsoftheanimals.In

ordertoobtainthecorrectdosagetheconcentrationofcolistinhastobeadjustedaccordingly.

Carefullycalculatethetotalbodymasstobetreatedandthetotaldailywaterconsumptionbeforeeach

treatment.

Medicatedwatershouldbemadeeveryday,immediatelypriortoprovision.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

4.11Withdrawalperiod(s)

Meatandoffal:

Pigs:1day

Broilersandlayinghens:1day

Otherpoultry:7days

Eggs:0days

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5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:intestinalantiinfectives,antibiotics.

ATCvetcode:QA07AA10.

5.1 Pharmacodynamicproperties

Colistinisapolypeptideantibioticbelongingtothepolymyxinclass.

Colistinexertsabactericidalactiononsusceptiblebacteriastrainsbydisruptionofthebacteria

cytoplasmicmembraneleadingtoanalterationofcellpermeabilityandthenaleakageofintracellular

materials.

Colistinisbactericidalandisprimarilyeffectiveagainstarangeofgramnegativebacteria,inparticular

enterobacteriaceae.

Colistinpossessesvirtuallynoactivityagainstgrampositivebacteriaandfungi.

Gram-positivebacteriaarenaturallyresistanttocolistin,asaresomespeciesofgram-negativebacteria

suchasProteusandSerratia.

However,acquiredresistanceofgram-negativeentericbacteriatocolistinisrareandexplainedbya

singlestepmutation.

5.2 Pharmacokineticparticulars

Colistinispoorlyabsorbedfromthegastro-intestinaltract.Incontrasttoverylowconcentrationof

colistininserumandtissues,highandpersistentamountsarepresentwithinthedifferentsectionsofthe

gastro-intestinaltract.

Nosignificantmetabolismisobserved.

Colistinisalmostexclusivelyeliminatedviathefaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol.

Purifiedwater.

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:3months.

Shelf-lifeafterdilutionaccordingtodirections:24hoursafterdilutionindrinkingwater.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

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6.5 Natureandcompositionofimmediatepackaging

Natureofcontainer:

-Highdensitypolyethylenebottle.

-Polypropylenescrewcapsfittedwithapolypropylenedosingdeviceandapoly(vinyl

chloride/vinylacetate)seal.

Packagesizes:

-250ml,500ml,1litre,2litresand5litres.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

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

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

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FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

29-8-2018

Vectra 3D (Ceva SantE Animale)

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Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

14-5-2018

Girolan and its associated name Apralan

Girolan and its associated name Apralan

Girolan and its associated name Apralan (Active substance: Apramycin sulfate) - Community Referrals - Art 34 - Commission Decision (2018)2989 of Mon, 14 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/122

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

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