Authorisation For The Medicinal Product For Usoveterinario «Sogecoli» Soluzioneorale 2 Million Iu/ml Concentrate For Calves, Lambs, Pigs, Chickens And Turkeys.
Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Sogecoli 2.000.000 UI/ml» concentrato per soluzioneorale per vitelli, agnelli, suini, polli e tacchini.
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01488&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Decree No. 15 of February 10, 2015 decentralised procedure # FR/V/0268/01/DC.
Medicinal product for veterinary use SOGECOLI 2 million IU/ml concentrate for oral solution for calves, lambs, pigs, chickens and turkeys.
A.I.C. holder: SOGEVAL-200 Avenue de Mayenne-Zone Industrielle des Touches-53022 Laval-France.
Manufacturer responsible for batch release: Sogeval-200 Avenue de Mayenne-Zone Industrielle des Touches-53000-Laval-France Laboratoires Biove 3 Rue de Lorraine, 62510 Arques-France;
Authorised pack sizes and numbers of 100 ml bottle-A.I.C. A.I.C.: # 104675018;
Bottle of 250 ml-A.I.C. # 104675020;
Bottle of 500 ml-A.I.C. # 104675032;
Drums: 1 l-A.I.C. # 104675044;
Can of 5 l-A.I.C. # 104675057.
Composition: each ml contains: active ingredient: Colistin (as sulphate) 2 million IU.
Excipients: so as stated in the documentation of pharmaceutical techniques acquired to acts.
Target species: cattle (calves)-sheep (Lamb)-pigs-chickens-turkeys.
Medical indications: Calves-agnelli-pigs-chickens-turkeys: treatment of gastrointestinal infections caused by non-invasive e. coli susceptible to colistin.
Waiting time: calves, lambs and pigs: meat and offal 1 day;
Chickens and turkeys: meat and offal: 1 day;
Eggs: zero days.
Validity: validity of the veterinary medicinal product as packaged for sale: 18 months.
Period of validity after first opening the immediate packaging: 3 months.
Period of validity after dilution in drinking water according to directions: 24 hours.
Period of validity after dilution in milk or reconstituted milk according to directions: 6 hours.
Dispensing scheme: to be supplied only upon presentation of medical veterinary prescription in triplicate not repeatable.
Effectiveness of the Decree: immediate effect.
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