COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Augmentin». (16A00310)
Estratto determina V&A IP n. 2440 del 21 dicembre 2015 E' autorizzata l'importazione parallela del medicinale Augmentin 400 mg/57 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen 140 ml dall'Austria con numero di autorizzazione 1-22152, con le specificazioni di seguito indicate e a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: Importatore: Programmi Sanitari Integrati s.r.l., Via G. Lanza n. 3 - 20121 Milano. Confezione: AUGMENTIN «bambini 400 mg/57 mg/5 ml polvere per sospensione orale» flacone 140 ml con cucchiaio dosatore. Codice A.I.C.: 038291074 (in base 10) 14JKN2 (in base 32). Forma Farmaceutica: sospensione orale. 5 ml di sospensione ricostituita contengono: Principio attivo: amoxicillina triidrato corrispondente ad amoxicillina 400 mg;
potassio clavulanato corrispondente ad acido clavulanico 57 mg. Eccipienti: gomma xantano, crospovidone, carmellosa sodica, diossido di silice, silice colloidale anidro, magnesio stearato, sodio benzoato, aroma fragola, aspartame. Indicazioni terapeutiche: Augmentin e' un antibiotico che funziona uccidendo i batteri che causano infezioni. Contiene due diversi medicinali chiamati amoxicillina e acido clavulanico. L'amoxicillina appartiene ad un gruppo di medicinali chiamati «penicilline» la cui attivita' puo' a volte essere bloccata (vengono resi inattivi). L'altro componente attivo (acido clavulanico) impedisce che questo avvenga. Augmentin e' utilizzato nei neonati e nei bambini per trattare le seguenti infezioni: 400 mg/57 mg/5 ml: infezioni dell'orecchio medio e dei seni nasali;
infezioni del tratto respiratorio;
infezioni del tratto urinario;
infezioni della pelle e dei tessuti molli incluse infezioni dentali;
infezioni delle ossa e delle articolazioni. Officine di confezionamento secondario...
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