COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario «Torphadine 10 mg/ml» soluzione iniettabile per cani, gatti e cavalli. (17A02222)
Decreto n. 19 del 17 febbraio 2017 Medicinale veterinario: TORPHADINE 10 mg/ml soluzione iniettabile per cani, gatti e cavalli. Titolare A.I.C.: la societa' Le Vet Beheer B.V., Wilgenweg7 3421 TV Oudewater (Paesi Bassi). Produttore responsabile rilascio lotti: lo stabilimento Produlab Pharma B.V., Forellenweg 16, Raamsdonksveer, 4941 SJ (Paesi Bassi). Procedura decentrata n. UK/V/0588/001/DC. Confezioni autorizzate e numeri di A.I.C.: «Scatola con un flaconcino da 10 ml» - A.I.C. n. 104946013;
Scatola con un flaconcino da 20 ml
- A.I.C. n. 104946025. Composizione: 1 ml contiene: principio attivo: butorfanolo 10 mg, equivalente a 14,58 mg di butorfanolo tartrato;
eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti. Specie di destinazione: cani, gatti e cavalli. Indicazioni terapeutiche: cavallo come analgesico: per il sollievo del dolore addominale da moderato a grave associato a coliche di origine gastrointestinale;
per la sedazione: per la sedazione, dopo la somministrazione di alcuni agonisti degli adrenocettori alfa-2 (detomidina, romifidina);
cane come analgesico: per il sollievo del dolore viscerale da lieve a moderato;
per la sedazione: per la sedazione, utilizzato in combinazione con alcuni agonisti degli adrenocettori alfa-2 (medetomidina);
come premedicazione prima dell'anestesia generale: per l'uso in combinazione con acepromazina per indurre analgesia e sedazione prima dell'induzione dell'anestesia generale. Riduce inoltre il dosaggio dell'agente di induzione dell'anestesia (propofol o tiopentale);
per la premedicazione, somministrare come unico agente pre-anestetico;
per l'anestesia: per l'anestesia, quando e' utilizzato in combinazione con...
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