Retrieved February 16, 2015 V&A # 268 of authorization determines variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on clinical or non-clinical, quality, pharmacovigilance, relatively to the medicine SOLUTION for PERITONEAL DIALYSIS BAXTER.
Authorized updating of the summary of product characteristics, package leaflet, relative to medicine "solution for peritoneal dialysis Baxter», in the forms and packages listed below: A.I.C. n. 031503182-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 2000 ml bags 5 CAPD;
A.I.C. n. 031503194-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 2000 ml bags 5 CAPD;
A.I.C. n. 031503206-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 2000 ml bags 5 CAPD;
A.I.C. n. 031503218-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 5 2000 ml bags CAPD;
A.I.C. n. 031503220-«2.27% Glucose, calcium 1.75 MMOL/L, 5 MMOL/L lactate 35 2000 ml CAPD bags»;
A.I.C. n. 031503232-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 5 2000 ml bags CAPD;
A.I.C. n. 031503244-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L 4 2500 ml CAPD bags ';
A.I.C. n. 031503257-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L 4 2500 ml bags» APD;
A.I.C. n. 031503269-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L 4 2500 ml CAPD bags ';
A.I.C. n. 031503271-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L 4 2500 ml bags» APD;
A.I.C. n. 031503283-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L 4 2500 ml bags» APD;
A.I.C. n. 031503295-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 5000 ml bags 2 APD;
A.I.C. n. 031503307-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 5000 ml bags 2 APD;
A.I.C. n. 031503319-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 40 MMOL/L» 5000 ml bags 2 APD;
A.I.C. n. 031503321-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L 5000 ml bags 2 ' APD;
A.I.C. n. 031503333-«2.27% Glucose, calcium 1.75 MMOL/L 2 MMOL/L lactate, 5000 ml bags» 35 APD;
A.I.C. n. 031503345-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L 5000 ml bags 2 ' APD.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
A.I.C. holder: Baxter S.p.a. (tax code no. 00492340583), registered office and tax domicile in piazzale dell'industria n. 20-00144 Rome (Italy).
The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in art. 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users, from period of thirty days from the date of publication in the Official Gazette of the Italian Republic of this determination. The A.I.C. holder makes it accessible to pharmacist leaflet updated within the same timeframe.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.