COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Soluzione per emodialisi concentrata con acetato Galenica Senese». (13A04251)
Estratto determinazione V &
A n. 732 del 3 maggio 2013 Medicinale: SOLUZIONE PER EMODIALISI CONCENTRATA CON ACETATO GALENICA SENESE - A.I.C. 031459. Titolare A.I.C.: Industria Farmaceutica Galenica Senese S.r.l. (codice fiscale 00050110527) con sede legale e domicilio fiscale in via Cassia Nord 351 - 53014 Monteroni D'Arbia (Siena) Italia. Variazione A.I.C.: autorizzazione nuove confezioni in sostituzione. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicato. 1) Le confezioni del medicinale «Soluzione per emodialisi concentrata con acetato Galenica Senese» (A.I.C. 031459) sono definite come di seguito indicato. a) La confezione 031459011 - sacca rigida 5000 ml e' sostituita dalle seguenti confezioni: 050 «Glucosio 1 g/l, Calcio 1,75 mmol/l, Potassio 1,5 mmol/l» sacca rigida 5000 ml;
composizione: 1000 ml contengono: glucosio monoidrato 39,60 g, sodio cloruro 218,83 g, potassio cloruro 4,03 g, calcio cloruro diidrato 9,26 g, magnesio cloruro esaidrato 5,49 g, sodio acetato triidrato 186,17 g, acqua per preparazioni iniettabili q.b. a 1000 ml;
062 «Glucosio 1 g/l, Calcio 1,75 mmol/l, Potassio 2 mmol/l» sacca rigida 5000 ml;
composizione: 1000 ml contengono: glucosio monoidrato 38,50 g, sodio cloruro 204,54 g, potassio cloruro 5,215 g, calcio cloruro diidrato 8,995 g, magnesio cloruro esaidrato 5,34 g, sodio acetato triidrato 190,50 g, acqua per preparazioni iniettabili q.b. a 1000 ml;
074 «Glucosio 1 g/l, Calcio 1,75 mmol/l, Potassio 2 mmol/l» sacca rigida 5000 ml;
composizione: 1000 ml contengono: glucosio monoidrato 77,0 g, sodio cloruro 204,54 g, potassio cloruro 7,83 g, calcio cloruro diidrato 8,995 g, magnesio cloruro esaidrato 5,34 g, sodio acetato triidrato 190,50 g, acqua per preparazioni iniettabili q.b. a 1000 ml;
086 «Glucosio 1 g/l, Calcio 2 mmol/l, Potassio 1 mmol/l» sacca rigida 5000 ml;
composizione: 1000 ml...
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