COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Izovac ND IB IBD» - vaccino inattivato in emulsione iniettabile per galline ovaiole e riproduttori. (17A04360)
Decreto n. 79 del 25 maggio 2017 Medicinale veterinario ad azione immunologica IZOVAC ND IB IBD - vaccino inattivato in emulsione iniettabile per galline ovaiole e riproduttori. Titolare A.I.C.: la societa' Izo S.r.l. a socio unico, con sede legale e domicilio fiscale in Via San Zeno, 99/A - 25124 Brescia. Produttore responsabile rilascio lotti: lo stabilimento Izo S.r.l. a socio unico, con sede legale e domicilio fiscale in Via San Zeno, 99/A - 25124 Brescia. Confezioni autorizzate e numeri di A.I.C.: astuccio contenente 1 flacone da 1000 dosi - A.I.C. n. 105031013;
scatola contenente 10 flaconi da 1000 dosi - A.I.C. n. 105031025. Composizione: ogni dose (0.5 ml) di vaccino contiene: principio attivo: virus della Pseudopeste Aviare inattivato: ceppo Ulster ≥
16 HI.U.* virus della Bronchite Infettiva Aviare inattivato: ceppo M41 ≥
64 HI.U.** virus della Malattia di Gumboro inattivato: ceppo Winterfield 2512 RP≥1*** *HI.U. = Unita' specifiche del test di inibizione dell'emoagglutinazione con 1/50 di dose. **HI.U. = Unita' specifiche del test di inibizione dell'emoagglutinazione. ***RP = Potenza Relativa (Test ELISA) per confronto con vaccino di riferimento. Adiuvante: Paraffina liquida leggera 253 mg/dose. Conservante: Sodioetilmercuriotiosalicilato 50µg/dose. Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: galline ovaiole e polli riproduttori. Indicazioni terapeutiche: vaccinazione di richiamo (vaccinazione booster) dei polli riproduttori e delle galline ovaiole, per l'immunizzazione attiva contro la Malattia di Newcastle...
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