COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Gentamicina Solfato BIL» (10A14630)
Descrizione del medicinale e attribuzione numero A.I.C.
E' autorizzata l'immissione in commercio del medicinale: GENTAMICINA SOLFATO BIL, anche nella forma e confezione: «80 mg/2 ml soluzione iniettabile» 10 fiale alle condizioni e con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione.
Titolare A.I.C.: Biologici Italia Laboratories S.r.l., con sede legale e domicilio fiscale in via Cavour n. 41/43 - 20026 Novate Milanese (Milano), codice fiscale 01233940467.
Confezione: «80 mg/2 ml soluzione iniettabile» 10 fiale.
A.I.C. n. 031864034 (in base 10) 0YDF72 (in base 32).
Forma farmaceutica: soluzione iniettabile.
Validita' prodotto integro: 4 anni dalla data di fabbricazione.
Produttore del principio attivo: Fujian Fukang Pharmaceutical Co., Ltd. No.138, Xiangbanrd., Fuzhou, China.
Produttore del prodotto finito: Biologici Italia Laboratories S.r.l. stabilimento sito in via Filippo Serpero n. 2 - 20060 Masate (tutte).
Composizione: 1 fiala da 2 ml contiene:
principio attivo: gentamicina solfato 135,6 mg;
eccipienti: metile paraidrossibenzoato 1,8 mg; propile paraidrossibenzoato 0,2 mg; sodio metabisolfito 3,2 mg; acqua per preparazioni iniettabili quanto basta a 2 ml.
Indicazioni terapeutiche: infezioni da germi sensibili alla gentamicina:
forme pleuro polmonari: bronchiti, broncopolmoniti, polmonite franca-lobare, pleuriti, empiemi;
infezioni urinarie acute e croniche: cistiti, pieliti, cistopieliti, pielonefriti, calcolosi infette (del bacinetto, dell'uretere, della vescica), uretriti, prostatiti, vescicoliti;
stati settici: batteremie, setticemie, setticopiemie, sepsi neonatali;
infezioni del sistema nervoso: meningiti, meningoencefaliti, ecc.;
infezioni chirurgiche: ascessi, flemmoni, osteomieliti, infezioni traumatiche;
infezioni otorinolaringoiatriche: otiti medie purulente, sinusiti, mastoiditi, tonsilliti, faringotonsilliti;
infezioni ostetrico...
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