{"effective_time":"20191112","health_care_provider_letter":["HEALTH CARE PROVIDER LETTER DHCP Letter - Image 01 DHCP Letter - Image 02 DHCP Letter - Image 03 DHCP Letter - Image 04 DHCP Letter - Image 05"],"id":"6f72b3bc-fb60-4835-bc6f-680dee00521e","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CODE ABB0086U 50 mL CONTAINER SINGLE DOSE VIAFLEX CONTAINER 5% DEXTROSE IN WATER FOR INJECTION BAXTER GLUCOSE SOLUTION 5 % INJECTABLE STERILE AND NONPYROGENIC FORMULA EACH 100 mL CONTAINS 5 G ANHYDROUS GLUCOSE WATER FOR PREPARATION OF INJECTABLES QS 100 mL THE 50 mL CONTAINER CONTAINS 2.5 g GLUCOSE APPROXIMATE pH 4 277 MILLIOSMOLES APPROXIMATED PER LITER DOSAGE AS DIRECTED BY A PHYSICIAN ROUTE OF ADMINISTRATION INTRAVENOUS READ PACKAGE INSERT DO NOT ADMINISTER IF THE SOLUTION IS NOT TRANSPARENT OR IF IT CONTAINS PARTICLES IN SUSPENSION OR SEDIMENTS SQUEEZE THE INTERIOR BAG AND INSPECT IT DISCARD IF YOU FIND LEAKS WHICH MAY HAVE COMPROMISED THE STERILITY IF ALL THE PRODUCT IS NOT ADMINISTERED DISCARD THE REMAINING SOLUTION DO NOT ADMINISTER IF THE CLOSURE HAS BEEN COMPROMISED DO NOT USE THIS UNIT FOR SERIES CONNECTIONS DISPOSE THE UNIT AFTER USE STORE UNIT IN OVERPOUCH UNTIL READY TO USE AT ROOM TEMPERATURE NOT MORE THAN 25 ºC DO NOT FREEZE DO NOT STORE ONCE MIXED CAUTION DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD USE CAUTION WHEN ADMINISTERING THIS MEDICATION SOME ADDITIVES MAY BE INCOMPATIBLE WHEN ADDITIVES ARE INTRODUCED USE ASEPTIC TECHNIQUE AND COMPLETELY MIX REQUIRES MEDICAL PRESCRIPTION DO NOT LEAVE WITHIN REACH OF CHILDREN REPORT ADVERSE REACTION TO FARMACOVIGILANCIA@COFEPRIS.GOB.MX REG No 70521 SSA IV MADE IN MEXICO BY BAXTER SA DE CV AV DE LOS 50 METROS No 2 CIVAC CP 62578 JIUTEPEC MORELOS MEXICO 88 80 32 1001 Baxter Logo BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC LOT EXP 0 25 CODE ABB0087U 100 mL CONTAINER SINGLE DOSE VIAFLEX CONTAINER 5% DEXTROSE IN WATER FOR INJECTION BAXTER GLUCOSE SOLUTION 5 % INJECTABLE STERILE AND NONPYROGENIC FORMULA EACH 100 mL CONTAINS ANHYDROUS 5 g GLUCOSE WATER FOR PREPARATION OF INJECTABLES QS 100 mL THE 100 mL CONTAINER CONTAINS 5.0 g GLUCOSE APPROXIMATE pH 4.0 277 MILLIOSMOLES APPROXIMATED PER LITER DOSAGE AS DIRECTED BY A PHYSICIAN ROUTE OF ADMINISTRATION INTRAVENOUS READ PACKAGE INSERT DO NOT ADMINISTER IF THE SOLUTION IS NOT TRANSPARENT OR IF IT CONTAINS PARTICLES IN SUSPENSION OR SEDIMENTS SQUEEZE THE INTERIOR BAG AND INSPECT IT DISCARD IF YOU FIND LEAKS WHICH MAY HAVE COMPROMISED THE STERILITY IF ALL THE PRODUCT IS NOT ADMINISTERED DISCARD THE REMAINING SOLUTION DO NOT ADMINISTER IF THE CLOSURE HAS BEEN COMPROMISED DO NOT USE THIS UNIT FOR SERIES CONNECTIONS DISPOSE THE UNIT AFTER USE STORE UNIT IN OVERPOUCH UNTIL READY TO USE AT ROOM TEMPERATURE NOT MORE THAN 25 ºC DO NOT FREEZE DO NOT STORE ONCE MIXED CAUTION DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD USE CAUTION WHEN ADMINISTERING THIS MEDICATION SOME ADDITIVES MAY BE INCOMPATIBLE WHEN ADDITIVES ARE INTRODUCED USE ASEPTIC TECHNIQUE AND COMPLETELY MIX REQUIRES MEDICAL PRESCRIPTION DO NOT LEAVE WITHIN REACH OF CHILDREN REPORT ADVERSE REACTION TO FARMACOVIGILANCIA@COFEPRIS.GOB.MX REG No 70521 SSA IV MADE IN MEXICO BY BAXTER SA DE CV AV DE LOS 50 METROS No 2 CIVAC CP 62578 JIUTEPEC MORELOS MEXICO 88 80 32 1002 Baxter Logo BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC LOT EXP 0 25 50 75 Drug Shortage 5% Dextrose Container Label 0338-9521-11 Drug Shortage 5% Dextrose Representative 100 mL Lbl 0338-9527-72"],"set_id":"940b1b3e-8c77-470a-9169-208a114387a7","spl_product_data_elements":["Dextrose dextrose monohydrate DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE Dextrose dextrose monohydrate DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE"],"version":"3"}