COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tylan®Solubile», polvere per soluzione orale per polli da carne e galline ovaiole, tacchini, suini e vitelli. (19A02488)
Estratto provvedimento n. 166 del 19 marzo 2019 TYLAN®SOLUBILE polvere per soluzione orale per polli da carne e galline ovaiole, tacchini, suini e vitelli;
n. A.I.C. 100108;
Confezioni: tutte. Titolare A.I.C.: Eli Lilly Italia S.p.a. via Gramsci, 733 50019 Sesto Fiorentino (FI). Oggetto del provvedimento: Tylan®solubile polvere per soluzione orale per polli da carne e galline ovaiole, tacchini, suini e vitelli. Confezioni: barattoli da 110 g - A.I.C. n. 100108012;
sacco da 1,100 kg - A.I.C. n. 100108024;
variazione di tipo di variazione tipo II - C.I.4, 2;
variazioni di tipo IA - B.II.b.2.a, B.II.b.2.c.1;
variazione di tipo IA - A.7. Si autorizzano le modifiche come di seguito descritte: modifica della durata del trattamento da 1-3 giorni a 3-5 giorni nella malattia cronica respiratoria per la specie «polli da carne» e «galline ovaiole»;
aggiunta del sito Elanco France S.A.S. 26 rue de 1a Chapelle, 68330 Huningue, France per l'attivita' di rilascio dei lotti di prodotto finito, oltre al sito attualmente autorizzato Eli Lilly and Company Limited, Speke Operations (UK);
eliminazione del sito Eurovet Animal Health B.V, Netherlands, per l'attivita' di rilascio dei lotti di prodotto finito. Per effetto della suddetta variazione si modificano il punto 4.9 e 10 dell'RCP, come di seguito indicato: 4.9 Posologia e via di somministrazione polli da carne e galline ovaiole: malattia cronica respiratoria (MCR): somministrare Tylan Solubile nell'acqua da bere ad una concentrazione di 0,5 g per litro, pari a circa 100 mg di tilosina per kg di peso vivo in base all'eta' ed al consumo di acqua dell'animale, per un periodo da tre a cinque giorni. enterite necrotica: somministrare Tylan Solubile nell'acqua da bere ad una concentrazione di 0,1 g per litro, pari a 20-50 mg di tilosina per kg di peso vivo in base all'eta' ed al consumo di acqua dell'animale, per un periodo di tre giorni. tacchini: somministrare Tylan Solubile nell'acqua da bere ad una concentrazione...
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