COMUNICATO - Autorizzazione all''immissione in commercio del medicinale per uso veterinario «Veterelin 0,004 mg/ml». (11A11946)
Decreto n. 89 del 18 agosto 2011
Procedura decentrata n. PT/V/0104/001/DC.
Specialita' medicinale per uso veterinario VETERELIN 0,004 mg/ml soluzione iniettabile per bovini, cavalli, suini e conigli.
Titolare A.I.C.: Laboratorios Calier S.A. con sede in Barcelones, 26 (P.la del Ramassa') - Les Franqueses del Valles (Barcelona) - Spagna.
Produttore responsabile rilascio lotti: la societa' titolare dell'A.I.C. nello stabilimento sito in Barcelones, 26 (P.la del Ramassa') - Les Franqueses del Valles (Barcelona) - Spagna.
Confezioni autorizzate e numeri di A.I.C.:
fiala da 10 ml - A.I.C. n. 104320015;
fiala da 20 ml - A.I.C. n. 104320027;
5 fiale da 10 ml - A.I.C. n. 104320039.
Composizione: ogni ml di soluzione iniettabile contiene:
Principio attivo: Buserelin 0,004 mg (equivalenti a 0,0042 mg di Buserelin acetato).
Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti.
Specie di destinazione: bovini (mucche), cavalli (cavalle), conigli (femmine) e suini (scrofe).
Indicazioni terapeutiche:
per le vacche:
induzione dell'ovulazione o ritardato;
trattamento di anaestro;
trattamento di cisti follicolari con o senza sintomi di ninfomania;
miglioramento del tasso di concepimento nelle procedure di fecondazione artificiale, anche dopo la sincronizzazione del ciclo estrale con un analolgo PGF2α. I risultati possono pero' variare a seconda delle condizioni di allevamento.
per le cavalle:
l'induzione dell'ovulazione e, quindi, per sincronizzare l'ovulazione per una piu' ravvicinata concomitanza con l'accoppiamento delle cavalle.
trattamento delle cisti follicolari -...
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