DESCRIPTION
OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is to be administered by intravenous injection.
OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each mL contains 287 mg gadodiamide, 12 mg caldiamide sodium and water for injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.5 mol/Lsolution of aqua[5,8-bis(carboxymethyl) -11-[2-(methylamino)-2-oxoethyl]- 3-oxo-2,5,8,11-tetraazatridecan-13- oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9•xH2O, and the following structual formula.
Pertinent physicochemical data for OMNISCAN are noted below:
|
PARAMETER |
|
Osmolality (mOsmol/kg water) |
@ 37ˇăC |
789 |
|
Viscosity (cP) |
@ 20ˇăC |
2.0 |
| |
@ 37ˇăC |
1.4 |
|
Density (g/mL) |
@ 25ˇăC |
1.14 |
|
Specific gravity |
@ 25ˇăC |
1.15 |
|
OMNISCAN has an osmolality approximately 2.8 times that of plasma at 37ˇăC and is hypertonic under conditions of use. |
|
