COMUNICATO - Autorizzazione all''immissione in commercio della specialita'' medicinale per uso veterinario «Lobotor» 100 mg/ml (09A11511)
Decreto n. 112 del 10 settembre 2009
Specialita' medicinale per uso veterinario LOBOTOR 100 mg/ml soluzione iniettabile per equini non destinati alla produzione di alimenti per il consumo umano, cani, gatti, uccelli selvatici, ornamentali ed esotici, ruminanti selvatici e da zoo.
Titolare A.I.C.: Societa' Acme S.r.l. con sede legale e domicilio fiscale in Cavriago (Reggio Emilia) - Via Portella della Ginestra, 9 - codice fiscale n. 01305480350.
Produttore responsabile e rilascio lotti: la societa' Acme Drugs S.r.l. nello stabilimento sito in Cavriago (Reggio Emilia) - Via Portella della Ginestra, 9/A.
Confezioni autorizzate e numeri di A.I.C.: flacone da 10 ml - A.I.C. n. 104135013.
Composizione: 1 ml di soluzione contiene:
Principi attivi: Ketamina base 100 mg (pari a Ketamina cloridrato 115,33 mg).
Eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti.
Specie di destinazione: Equini non destinati alla produzione di alimenti per il consumo umano, cani, gatti, uccelli selvatici, ornamentali ed esotici, ruminanti selvatici e da zoo.
Indicazioni terapeutiche:
Equini non destinati alla produzione di alimenti per il consumo umano:
contenimento e sedazione per procedure cliniche e diagnostiche;
anestesia per interventi chirurgici di breve durata (castrazione, ovarioisterectomia, laparotomia, riduzione di ernie, chirurgia ortopedica e altri);
come preanestetico, prima dell'anestesia generale (anestesia combinata).
Cani e gatti:
contenimento e sedazione di soggetti dal comportamento aggressivo per procedure cliniche e diagnostiche;
anestesia per interventi chirurgici di breve durata (castrazione, ovarioisterectomia, laparotomia, riduzione di ernie, chirurgica ortopedica e altri);
come preanestetico, prima dell'anestesia generale (anestesia combinata).
Uccelli selvatici, ornamentali ed esotici:
contenimento e sedazione per procedure cliniche e diagnostiche, cattura e...
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