Isovue Imaging Bulk Package Package Insert, NDA 20-327
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چکیده
DESCRIPTION ISOVUE (Iopamidol Injection) is a stable, aqueous, sterile, and nonpyrogenic solution for intravascular administration. Each bottle is to be used as an Imaging Bulk Package for dispensing multiple single doses of iopamidol injection for multiple patients, using an automated contrast injection system or contrast management system approved or cleared for multidose/multipatient use with this contrast agent in this Imaging Bulk Package. Each mL of ISOVUE-300 (Iopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. Each mL of ISOVUE-370 (Iopamidol Injection 76%) provides 755 mg iopamidol with 1 mg tromethamine and 0.48 mg edetate calcium disodium. The solution contains approximately 0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine per mL.
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