COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Klacid» (15A09018)
Estratto determina V&A IP n° 2120_del 10 novembre 2015 E' autorizzata l'importazione parallela del medicinale KLACID 500 mg por. tbl. film. 14 potahovanych tablet blister PVC/PVDC/AI dalla Repubblica Ceca con numero di autorizzazione 15/374/97-C, il quale deve essere posto in commercio con le specificazioni di seguito indicate, a condizione che siano valide ed efficaci alla data di entrata in vigore della presente Determinazione. Importatore: GMM Farma S.r.l. CIS di Nola Isola 8, Lotti 8105/10 - 80035 Nola;
Confezione: KLACID "500 mg compresse rivestite" 14 compresse Codice AIC: 044121010 (in base 10) 1B2GXL (in base 32) Forma Farmaceutica: compresse rivestite Ogni compressa contiene: Principio attivo: claritromicina 500 mg;
Eccipienti: Croscarmellosio sodico, cellulosa microcristallina, gel di silice, povidone, acido stearico, magnesio stearato, talco;
soluzione ricoprente: ipromellosa, idrossipropilcellulosa, glicole propilenico, sorbitan monoleato, titanio diossido (E-171), acido sorbico, vanillina, E-104. Indicazioni terapeutiche: Trattamento di infezioni causate da patogeni sensibili alla claritromicina. Infezioni del tratto rino-faringeo (tonsilliti, faringiti), dei seni paranasali. Infezioni del tratto respiratorio inferiore: bronchiti, polmoniti batteriche e polmoniti atipiche. Infezioni della pelle: impetigine, erisipela, follicolite, foruncolosi e ferite infette. Infezioni micobatteriche, localizzate o diffuse, sostenute da Mycobacterium avium o Mycobacterium intracellulare. Infezioni localizzate dovute a Mycobacterium chelonae, fortuitum o kansasii. La claritromicina, in presenza di riduzione dell'acidita' gastrica, e' indicata nell'eradicazione dell'Helicobacter pylori, producendo un conseguente decremento della ricorrenza dell'ulcera peptica. Klacid 500 mg compresse rivestite e' indicato negli adulti e...
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