COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Tilmipril 300 mg/ml» soluzione iniettabile per bovini o ovini. (14A09183)
Estratto del provvedimento n. 898 del 6 novembre 2014 Oggetto: Medicinale veterinario Tilmipril 300 mg/ml soluzione iniettabile per bovini e ovini - AIC n.104126/014 - 104126/026 - 104126/038. Titolare: Vetpharma Animal Health S.L. Les Corts, 23 - 08028 Barcellona, Spagna. Modifica: Variazione C.I.1.b. Procedura n. ES/V/0140/001/IB/002 Si autorizzano le modifiche come di seguito descritte: aggiornamento stampati in seguito a referral (procedura n. EMEA/V/A 34/82). Per effetto della suddetta variazione gli stampati devono essere modificati con l'aggiunta delle seguenti frasi: 4.2 Indicazioni per l'utilizzazione, specificando le specie di destinazione Ovini Trattamento delle infezioni del tratto respiratorio causate da Mannheimia haemolytica e Pasteurella multocida. Trattamento della pododermatite interdigitale negli ovini causata da Dichelobacter nodosus e Fusobacterium necrophorum. Trattamento della mastite acuta ovina causata da Staphylococcus aureus e Mycoplasma agalactiae. 4.4 Avvertenze speciali per ciascuna specie di destinazione Ovini Le sperimentazioni cliniche non hanno dimostrato una cura batteriologica negli ovini affetti da mastite acuta causata da Staphyloccocus aureus e Mycoplasma agalactiae. Non somministrare ad agnelli di peso inferiore ai 15 kg in quanto vi e' il rischio di tossicita' da sovradosaggio. Pesare accuratamente gli agnelli e' importante per evitare un sovradosaggio. L'uso di siringhe da 2 ml o piu' piccole facilitera' un dosaggio accurato 4.9 Posologia e via di somministrazione Ovini: Metodo di somministrazione: Pesare accuratamente gli agnelli e' importante per evitare il sovradosaggio. L'uso di siringhe da 2 ml o piu' piccole favorisce un dosaggio accurato. Prelevare la dose necessaria dal flacone e rimuovere la siringa dall'ago, lasciando l'ago nel flacone. Immobilizzare l'animale e inserire un ago separato nel tessuto sottocutaneo del sito di...
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