COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Levofloxacina Tecnigen Italia». (15A03342)
Estratto determina n. 439/2015 del 17 aprile 2015 Medicinale: LEVOFLOXACINA TECNIGEN ITALIA Titolare AIC: Premium Pharma, S. L. Avda. de Bruselas, 13, 3º D. Edificio America. Poligono Arroyo de la Vega, Alcobendas, 28108 Madrid, Spagna Confezione "500 mg compressa rivestita con film" 5 compresse AIC n. 042803027 (in base 10) 18U7UM (in base 32) Forma farmaceutica: Compresse rivestite con film. Composizione: Ogni compressa rivestita con film contiene: Principio attivo: 500 mg di levofloxacina, come levofloxacina emiidrata. Eccipienti: Nucleo della compressa Cellulosa microcristallina 102 Ipromellosa Crospovidone Sodio stearil fumarato Rivestimento della compressa (OPADRY 03B27148 BEIGE): Ipromellosa 6 cP Biossido di titanio Macrogol 400 Talco Ossido di ferro giallo Ossido di ferro rosso Ossido di ferro nero Produzione principio attivo: Assia Chemical Industries Ltd. - Teva-Tech site Neot-Hovav Eco-Industrial Park, Emek Sara, P.O. Box 2049, Be'er Sheva 8412316 Israele Produzione, confezionamento primario e secondario, controllo e rilascio lotti: West Pharma - Produções de Especialidades Farmacêuticas S.A. Rua João de Deus, n. 11, Venda Nova, 2700 - 486 Amadora Portogallo Confezionamento primario e secondario, controllo lotti, rilascio lotti: Atlantic Pharma - Produções Farmacêuticas S.A. Rua da Tapada Grande, n. 2, Abrunheira, 2710-089 Sintra Portogallo Indicazioni terapeutiche: Levofloxacina TecniGen Italia e' indicato negli adulti nel trattamento delle infezioni riportate di seguito: •
Sinusite batterica acuta •
Riacutizzazione acuta di bronchite cronica •
Polmoniti acquisite in comunita' •
Infezioni complicate della pelle e dei tessuti molli Per le infezioni sopra menzionate Levofloxacina TecniGen Italia deve essere usato solo quando e' considerato inappropriato l'uso di agenti antibatterici comunemente raccomandati per il trattamento iniziale di queste infezioni. •
Pielonefrite e infezioni complicate delle vie urinarie •
Prostatite batterica cronica •
Cistite non complicata •
Inalazione di antrace: profilassi dopo l'esposizione e...
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