Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44)
Bracco Diagnostics Inc
INTRAVASCULAR
PRESCRIPTION DRUG
ISOVUE (Iopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography. None.
ISOVUE-250 (Iopamidol Injection 51%) Ten 200 mL Pharmacy Bulk Packages (NDC 0270-1317-41) Store at 20-25° C (68-77° F). [See USP]. Protect from light.
New Drug Application
ISOVUE 250- IOPAMIDOL INJECTION, SOLUTION ISOVUE 300- IOPAMIDOL INJECTION, SOLUTION ISOVUE 370- IOPAMIDOL INJECTION, SOLUTION BRACCO DIAGNOSTICS INC ---------- ISOVUE PHARMACY BULK PACKAGE- NOT FOR DIRECT INFUSION ISOVUE -250 IOPAMIDOL INJECTION 51% ISOVUE -300 IOPAMIDOL INJECTION 61% ISOVUE -370 IOPAMIDOL INJECTION 76% NOT FOR INTRATHECAL USE ISOVUE 250, 300 and 370 are NOT FOR INTRATHECAL USE. See Indications, and Dosage and Administration sections for further details on proper use DIAGNOSTIC NONIONIC RADIOPAQUE CONTRAST MEDIA For Angiography Throughout the Cardiovascular System, Including Cerebral and Peripheral Arteriography, Coronary Arteriography and Ventriculography, Pediatric Angiocardiography, Selective Visceral Arteriography and Aortography, Peripheral Venography (Phlebography), and Adult and Pediatric Intravenous Excretory Urography DESCRIPTION ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device. Each mL of ISOVUE-250 (Iopamidol Injection 51%) provides 510 mg iopamidol with 1 mg tromethamine and 0.33 mg edetate calcium disodium. The solution contains approximately 0.036 mg (0.002 mEq) sodium and 250 mg organically bound iodine per mL. 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. The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE (I Lugege kogu dokumenti