"Clinicians using neurosurgical head holders need to inspect them for wear, test them for stability, and use proper positioning techniques to prevent device slippage that can injure patients, the US Food and Drug Administration (FDA) announced tod"...
NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see CONTRAINDICATIONS.]
ULTRAVIST (iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. The chemical name for iopromide is N,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:
|ULTRAVIST INJECTION||ULTRAVIST INJECTION||ULTRAVIST INJECTION||ULTRAVIST INJECTION|
|Property||150 mg I/mL||240 mg I/mL||300 mg I/mL||370 mg I/mL|
|Osmolality*(mOsmol/kg water) @ 37°C||328||483||607||774|
|Osmolarity*(mOsmol/L) @ 37°C||278||368||428||496|
|Viscosity (cP) @ 20°C||2.3||4.9||9.2||22|
|Density (g/mL) @ 20°C||1.164||1.262||1.330||1.409|
|*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).
Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Ultravist Information
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