COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Ampidox» 43 mg premiscela per alimenti medicamentosi per vitelli e suini fino a 60 kg p.v. (14A06633)
Estratto del provvedimento n. 591 del 21 luglio 2014 Medicinale veterinario AMPIDOX 43 mg premiscela per alimenti medicamentosi per vitelli e suini fino a 60 kg p.v. Confezioni: sacco da 25 kg - A.I.C. n. 102982028. Titolare A.I.C.: Dox-Al Italia S.p.A con sede legale e domicilio fiscale in Milano, largo Donegani n. 2 - codice fiscale 02117690152. Modifica: Variazione di tipo II - modificazione della specie di destinazione da suino. Si autorizzano le modifiche come di seguito descritte: modificazione della specie di destinazione da suino fino a 60 kg a suino. Per effetto della suddette variazione gli stampati devono essere modificati come segue: RPC - Punto 1 - Denominazione del medicinale veterinario;
AMPIDOX, 43 mg/g, premiscela per alimenti medicamentosi per vitelli e suini;
RPC - Punto 4.1 - Specie di destinazione: vitelli, suini;
RPC - Punto 4.2 - Indicazioni per l'utilizzazione specificando le specie di destinazione: suini: terapia delle infezioni dell'apparato digerente causate da germi sensibili all'ampicillina, in particolare enterite streptococcica del suinetto (Streptococcus suis), enterite stafilococcica (Staphylococcus spp.), clostridiosi (Clostridium spp.), colibacillosi (E. coli), salmonellosi (Salmonella spp.), dissenteria suina sostenuta da Brachyspira spp., enterite proliferativa sostenuta da Lawsonia intracellularis;
vitelli: terapia delle infezioni dell'apparato digerente causate da germi sensibili all'ampicillina, in particolare clostridiosi (Clostridium spp.), colibacillosi (E. coli), salmonellosi (Salmonella spp.);
RPC - Punto 4.5 - Precauzioni speciali per l'impiego. Non miscelare in mangimi liquidi. Miscelare con mangimi solidi aventi granulometria media non superiore a 700-800 µ;
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