{"effective_time":"20250310","health_care_provider_letter":["Health Care Provider Letter Extraneal DHCP Letter 1 Extraneal DHCP Letter 2 Extraneal DHCP Letter 3 Extraneal DHCP Letter 4 Extraneal DHCP Letter 5 Extraneal DHCP Letter 6"],"id":"3009b143-a24d-b37e-e063-6294a90aa00b","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL JB9923L 2500 mL DIN 02240806 2D barcode (01)00085412150116 Extraneal 7.5% Icodextrin Peritoneal Dialysis Solution FOR INTRAPERITONEAL ADMINISTRATION APPROX 90 mL EXCESS / EXCES APPROX DE 90 mL NONPYROGENIC / STERILE / APYROGENE APPROX pH 5.2 PER/PAR 1000 mL ICODEXTRIN / ICODEXTRINE – 75 g SODIUM CHLORIDE / CHLORURE DE SODIUM USP – 5.35 g SODIUM LACTATE / LACTATE DE SODIUM – 4.48 g CALCIUM CHLORIDE DIHYDRATE / DIHYRATE DE CHLORURE DE CALCIUM USP - 257 mg MAGNESIUM CHLORIDE HEXAHYDRATE / HEXAHYDRATE DE CHLORURE DE MAGNESIUM USP – 51 mg IN WATER FOR INJECTIONS / DANS DE L’EAU POUR INJECTION USP THEORETICAL OSMOLARITY 284 mOsmol/L / OSMOLARITE THEORIQUE 284 mOsmol/L APPROX mmol/L Na – 132 Ca – 1.75 Mg – 0.25 Cl – 96 LACTATE – 40 NOT TO BE USED FOR INTRAVENOUS INFUSION FOR DOSAGE ADMINISTRATION AND DETAILED DIRECTIONS FOR USE SEE PACKAGE INSERT / PRODUCT MONOGRAPH AVAILABLE UPON REQUEST / DO NOT USE UNLESS SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED / DISCARD UNUSED PORTION / STORE AT 15°C TO 25°C / DO NOT FREEZE / KEEP OUT OF REACH OF CHILDREN Extraneal Solution d’Icodextrine à 7,5 % pour Dialyse Péritonéale POUR ADMINISTRATION PAR VOIE INTRAPERITONEALE NE PAS ADMINSTRER PAR PERFUSION INTRAEINEUSE / CONSULTER LA NOTICE D’EMBALLAGE POUR CONNAITRE LES RENSEIGNEMENTS SUR LA POSOLOGIE L’ADMINISTRATION ET LE MODE D’EMPLOI MONOGRAPHIE DU PRODUIT DISPONIBLE SUR DEMANDE / NE PAS EMPLOYER SI LA SOLUTION EST TROUBLE OU SI LE SAC EST ENDOMMAGE / JETER TOUTE PORTION INUTILISEE / GARDER ENTRE 15 °C / PROTEGER DU GEL / GARDER HORS DE LA PORTEE DES ENFANTS PVC CONTAINER / CONTENANT DE PVC BAXTER AND EXTRANEAL ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET EXTRANEAL SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 Non Latex Symbol 88-70-20-372 500 500 250 250 Store at/Garder entre 15° C to/et 25° C 5-2500 mL IN/DANS 3000 mL JB-99-23LP ICODEXTRIN 7.5% ICODEXTRINE EXTRANEAL™ PD SOLUTION SOLUTION POR DP LOT: WWWWWWWWW EXP: 2099 99 2d Barcode (01)50085412150111 Extraneal Representative Container Label Extraneal Representative Carton Label"],"set_id":"d6b5c4a7-deee-4c97-b000-666a5a893098","spl_product_data_elements":["EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride WATER HYDROCHLORIC ACID SODIUM HYDROXIDE ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION"],"version":"2"}