COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Synulox 500 mg» (18A06746)
Estratto decreto n. 123 del 24 settembre 2018 La societa' GMM Farma s.r.l., con sede a Segrate (MI), in via Lambretta 2, c.a.p. 20090, P.I. 07363361218, e' autorizzata all'importazione parallela dalla Polonia del medicinale veterinario SYNULOX 500 mg.10 compresse appetibili, di cui all'autorizzazione n. 0614/98 citata nelle premesse, con le specificazioni di seguito indicate, a condizione che siano valide ed efficaci al momento dell'entrata in vigore del presente decreto: Confezione da commercializzare: SYNULOX 500 mg., 10 compresse appetibili;
Codice autorizzazione importazione parallela:105291013;
Forma farmaceutica: 10 compresse. Principi attivi: 1 compressa da 500 mg contiene: Amoxicillina mg. 400, come Amoxicillina Triidrato 460 mg. Acido Clavulanico mg. 100, come Potassio Clavulanato 119,2 mg. Eccipienti: Magnesio stearato, Sodio amido glicolato (tipo A), Silice colloidale anidra, Cellulosa microcristallina, eritrosina (E127), lievito essiccato. Medicinale importato, composizione quali-quantitativa acquisita dalla Polonia: 1. Qualitative and quantitative composition in terms of active ingredients and excipients: 1 tablet (1750,00 mg) contains: Name of active substance(s): 1. Amoxicillin - 400 mg (come Amoxicillina triidrato) 2. Clavulanic acid - 100 mg (come Potassio clavulanato) Name of excipient (s): Magnesium stearate;
Colloidal anhydrous silica;
Sodium carboxymethyl starch;
Dried yeast;
Erythrosine, wallflower (E 127);
Microcrystalline cellulose. Specie di destinazione: cani e gatti. Indicazioni terapeutiche: In vitro, «Synulox» e' efficace contro un'ampia gamma di batteri clinicamente importanti, fra cui: Gram positivi: Stafilococchi (compresi i ceppi produttori di beta-lattamasi), Streptococchi, Peptostreptococcus spp., Corinebatteri e Clostridi. Gram negativi: Escherichia coli (compresi i ceppi...
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