Review Product Marketing Authorisation For Human Use "solution For Peritoneal Dialysis Baxters. P.a.».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Soluzione per dialisi peritoneale BaxterS.P.A.».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01413&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 16, 2015 V&A # 269 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 S.P.A.
Authorized updating of the summary of product characteristics, package leaflet, relative to medicine "solution for peritoneal dialysis Baxter S.p.a.», in the forms and packages listed below: A.I.C. n. 031508171-«1.36% Glucose, calcium lactate 1.25 MMOL/L 5 MMOL/L 37.5 ' pockets, Clear-Flex 2000 ml APD;
A.I.C. n. 031508183-«1.36% Glucose, calcium lactate 1.25 MMOL/L 5 MMOL/L 37.5 ' pockets, Clear-Flex 2000 ml CAPD;
A.I.C. n. 031508195-«3.86% Glucose, calcium lactate 1.25 MMOL/L 5 MMOL/L 37.5 ' pockets, Clear-Flex 2000 ml APD;
A.I.C. n. 031508207-«3.86% Glucose, calcium lactate 1.25 MMOL/L 5 MMOL/L 37.5 ' pockets, Clear-Flex 2000 ml CAPD;
A.I.C. n. 031508219-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508221-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508233-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508245-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508258-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508260-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508272-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508284-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508296-«2.27% Glucose, calcium 1.75 MMOL/L lactate 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508308-«2.27% Glucose, calcium 1.75 MMOL/L lactate 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508310-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508322-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508334-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508346-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508359-«2.27% Glucose, calcium 1.75 MMOL/L 5 MMOL/L lactate 37.5 ' pockets, Clear-Flex 2000 ml APD;
A.I.C. n. 031508361-«2.27% Glucose, calcium 1.75 MMOL/L 5 MMOL/L lactate, 37.5 ' Clear-Flex 2000 ml CAPD bags;
A.I.C. n. 031508373-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L» 5 pockets Clear-Flex 2000 ml APD;
A.I.C. n. 031508385-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L CAPD bags Clear-Flex 2000 5 ml ";
A.I.C. n. 031508397-«1.36% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508409-«3.86% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508411-«2.27% Glucose, calcium lactate 1.25 MMOL/L, 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508423-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508435-«2.27% Glucose, calcium 1.75 MMOL/L lactate 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508447-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508450-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508462-«2.27% Glucose, calcium 1.75 MMOL/L 4 MMOL/L lactate 37.5 ' pockets, Clear-Flex 2500 ml CAPD;
A.I.C. n. 031508474-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 37.5 MMOL/L 4 2500 ml Clear-Flex CAPD bags ';
A.I.C. n. 031508486-«1.36% Glucose, calcium lactate 1.25 MMOL/L 2 MMOL/L 37.5 ' pockets, Clear-Flex 5000 ml APD;
A.I.C. n. 031508498-«1.36% Glucose, calcium lactate 1.25 MMOL/L 2 MMOL/L "35 bags, Clear-Flex 5000 ml APD;
A.I.C. n. 031508500-«3.86% Glucose, calcium lactate 1.25 MMOL/L 2 MMOL/L "35 bags, Clear-Flex 5000 ml APD;
A.I.C. n. 031508512-«2.27% Glucose, calcium lactate 1.25 MMOL/L 2 MMOL/L "35 bags, Clear-Flex 5000 ml APD;
A.I.C. n. 031508524-«1.36%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 2 sacs Clear-Flex 5000 ml APD;
A.I.C. n. 031508536-«2.27% Glucose, calcium 1.75 MMOL/L 2 MMOL/L lactate 35 ' pockets, Clear-Flex 5000 ml APD;
A.I.C. n. 031508548-«3.86%, calcium 1.75 MMOL/L Glucose, lactate 35 MMOL/L» 2 sacs Clear-Flex 5000 ml APD;
A.I.C. n. 031508551-«1.36% Glucose, calcium 1.75 MMOL/L 2 MMOL/L, potassium, lactate 35 MMOL/L» 2 sacs Clear-Flex 5000 ml APD;
A.I.C. n. 031508563-«1.36% Glucose, calcium 1.75 MMOL/L 2 MMOL/L lactate 37.5 ' pockets, Clear-Flex 5000 ml APD;
A.I.C. n. 031508575-«2.27% Glucose, calcium 1.75 MMOL/L 2 MMOL/L lactate 37.5 ' pockets, Clear-Flex 5000 ml APD;
A.I.C. n. 031508587-«3.86% Glucose, calcium 1.75 MMOL/L 2 MMOL/L lactate 37.5 ' pockets, Clear-Flex 5000 ml 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.
Stock 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.