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ULTRAVIST® Injection is an iodinated contrast agent indicated for:
- 150 mg I/mL for intra-arterial digital subtraction angiography (IA-DSA)
- 300 mg I/mL for cerebral arteriography and peripheral arteriography
- 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
- 240 mg I/mL for peripheral venography
- 300 mg I/mL for excretory urography
- 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4)].
There is currently no drug history available for this drug.
ULTRAVIST(iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. The chemical name for iopromide isN,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3- benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%).
Iopromide has the following structural formula:
ULTRAVIST Injection is a nonionic sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.
ULTRAVIST Injection is available in four strengths:
150 mg I/mL provides 311.7 mg/mL iopromide
240 mg I/mL provides 498.72 mg/mL iopromide
300 mg I/mL provides 623.4 mg/mL iopromide
370 mg I/mL provides 768.86 mg/mL iopromide
During the manufacture of ULTRAVIST Injection, sodium hydroxide or hydrochloric acid may be added for pH adjustment. ULTRAVIST Injection has a pH of 7.4 (6.5–8) at 25± 2°C, is sterilized by autoclaving and contains no preservatives.
The iodine concentrations (mg I/mL) available have the following physicochemical properties:
150 mg I/mL
240 mg I/mL
300 mg I/mL
370 mg I/mL
- *Osmolality was measured by vapor-pressure osmometry. Osmolarity was calculated from the measured osmolal concentrations.
Solutions of ULTRAVIST Injection 150 mg I/mL, 240 mg I/mL, 300 mg I/mL and 370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that of plasma (285 mOsmol/kg water).