{"effective_time":"20200430","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":"9a47af92-3ef7-4b27-93f0-a9b2bc6b138d","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label CODE ABB1306U 50 mL CONTAINER SINGLE DOSE 0.9% SODIUM CHLORIDE IN WATER SODUIM CHLORIDE FOR INJECTION BAXTER VIAFLEX CONTAINER MINI-BAG SOLUTION 0.9% INJECTABLE FORMULA EACH 100 mL CONTAINS 0.9 g SODIUM CHLORIDE WATER FOR PREPARATION OF INJECTABLES QS 100 mL APPROXIMATE pH 5 THE 50 mL CONTAINER CONTAINS 7.7 mEq SODIUM 7.7 mEq CHLORIDE 308 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 °C DO NOT STORE ONCE MIXED CAUTION DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD REQUIRES MEDICAL PRESCRIPTION DO NOT LEAVE WITHIN REACH OF CHILDREN SOME DRUGS MAY BE INCOMPATIBLE WHEN DRUGS ARE INTRODUCED USE ASEPTlC TECHNIQUES AND COMPLETELY MIX REPORT ADVERSE REACTION TO FARMACOVIGILANCIA@COFEPRIS.GOB.MX REG No 70508 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 1000 Baxter Logo BAXTER MINI-BAG AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC LOT EXP 0 25 Container Label CODE ABB1307U 100 mL CONTAINER SINGLE DOSE 0.9% SODIUM CHLORIDE IN WATER FOR INJECTION BAXTER VIAFLEX CONTAINER MINI-BAG SODIUM CHLORIDE SOLUTION 0.09% INJECTABLE FORMULA EACH 100 mL CONTAINS 0.9 g SODIUM CHLORIDE WATER FOR PREPARATION OF INJECTABLES QS 100 mL APPROXIMATE pH 5 THE 100 Ml CONTAINER CONTAINS 15.4 mEq SODIUM 15.4 mEq CHLORIDE 308 MILLIOSMOLES APPROXIMATED PER LITER DOSAGE AS DIRECTED BY A PHYSICIAN ROUTE OF ADMINISTRATION INTRAVENOUS READ PACKAGE INSERT SO 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 PROOUCT 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 °C DO NOT STORE ONCE MIXED CAUTION DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD REQUIRES MEDICAL PRESCRIPTION DO NOT LEAVE WITHIN REACH OF CHILDREN SOME DRUGS MAYBE INCOMPATIBLE WHEN DRUGS ARE INTRODUCED USE ASEPTIC TECHNIQUE AND COMPLETELY MIX REPORT ADVERSE REACTION TO FARMACOVIGILANCIA@COFEPRIS.GOB.MX REG No 70508 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 32 999 Baxter Logo BAXTER MINI-BAG AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC LOT EXP 0 25 50 75 Sodium Chloride ABB1306U Representative Container Label Sodium Chloride ABB1307U Representative Container Label"],"set_id":"08ac2020-d7a8-4f33-8483-8c528d47542a","spl_product_data_elements":["SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER"],"version":"4"}