COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario «Cevaprost, 250 µg/ml soluzione iniettabile per bovini». (18A03308)
Estratto decreto n. 53 del 17 aprile 2018 Medicinale veterinario CEVAPROST, 250 µg/ml soluzione iniettabile per bovini. Titolare A.I.C.: la societa' Ceva Salute Animale S.p.A. con sede in viale Colleoni, 15 - 20864 Agrate Brianza (MB) cod. fisc. 09032600158. Produttore responsabile rilascio lotti: lo stabilimento Vetem S.p.A. con sede in lungomare Pirandello, 8 - 92014 Porto Empedocle (AG). Confezioni autorizzate e numeri di A.I.C.: scatola con 1 flacone da 10 ml - A.I.C. n. 105125013;
scatola con 1 flacone da 20 ml - A.I.C. n. 105125025;
scatola con 10 flaconi da 20 ml - A.I.C. n. 105125037. Composizione: 1 ml contiene: principio attivo: cloprostenolo 250,0 µg (equivalente a cloprostenolo sodico 263,0 µg). eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: bovini. Indicazioni terapeutiche: per bovini. Come molecola omologo-sintetica della prostaglandina F2α
(PGF2α), CEVAPROST e' un agente luteolitico molto potente, in grado di provocare nella bovina una regressione funzionale del corpo luteo (luteolisi), a cui fa seguito un ritorno al ciclo estrale e alla normale ovulazione. Note: esiste un periodo refrattario di 4-5 giorni post-ovulazione, nel quale la bovina risulta insensibile all'azione luteolitica delle prostaglandine. CEVAPROST e' costituito da un principio attivo dotato di un buon margine di sicurezza e privo di attivita' negativa sulla fertilita'. Non sono stati segnalati effetti indesiderati o dannosi sulla progenie originata da bovine trattate con cloprostenolo. CEVAPROST puo' essere adottato sia come un agente terapeutico per il trattamento di diverse condizioni cliniche della bovina, sia per la sincronizzazione dei calori in animali sani. Le indicazioni terapeutiche di CEVAPROST sono le seguenti: a) calore silente: Questa condizione e' particolarmente frequente nelle bovine da latte forti produttrici, che presentano cicli ovarici normali ma con manifestazioni comportamentali, tuttavia, assai poco evidenti, transitorie o addirittura assenti. Questi animali possono essere trattati solo dopo accertamento, per esplorazione rettale, dell'attivita' ciclica e della presenza del corpo luteo e quindi fecondati al momento dell'estro, se evidente, o comunque dopo 72 e 96 ore dal trattamento con CEVAPROST. Qualora la bovina fosse stata trattata in assenza di corpo luteo, si rende necessaria un'altra iniezione di CEVAPROST a distanza di 11 giorni dalla prima;
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