Ioversol
Drug Details
- Generic Name
- Ioversol
- Brand Names
- Optiray 320, Optiray 350, Optiray 300
- Application Number
- NDA020923
- Sponsor
- Hainan Poly Pharm.Co., Ltd.
- NDC Codes
- 10
- Dosage Forms
- POWDER, INJECTION
- Routes
- INTRA-ARTERIAL, INTRAVENOUS
- Active Ingredients
- IOVERSOL
Indications and Usage
1 INDICATIONS AND USAGE OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (300, 320 mg iodine/mL) Peripheral Arteriography (300, 320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL) Venography (300, 320, 350 mg iodine/mL) Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320 mg iodine/mL) 1.1 Intra-arterial In adults OPTIRAY 300: cerebral arteriography and peripheral arteriography. OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography. OPTIRAY 350: peripheral arteriography coronary arteriography, and left ventriculography. In pediatric patients OPTIRAY 320 and OPTIRAY 350: angiocardiography. 1.2 Intra-venous In adults OPTIRAY 300: CT imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY 320: CT imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA). In pediatric patients OPTIRAY 320: CT imaging of the head and body, and intravenous excretory urography.