Omniscan

DRUG 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 (gadodiamide) is administered by intravenous injection. OMNISCAN (gadodiamide) is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN (gadodiamide) contains no antimicrobial preservative. OMNISCAN (gadodiamide) is a 0.5 mol/L solution 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 C16H28GdN5O9xH2O, and the following structural formula:

OMNISCAN (gadodiamide) Structural Formula Illustration

Pertinent physicochemical data for OMNISCAN (gadodiamide) are noted below:

PARAMETER

Osmolality (mOsmol/kg water) @ 37C 789
Viscosity (cP) @ 20C 2
@ 37C 1.4
Density (g/mL) @ 25C 1.14
Specific gravity @ 25C 1.15

OMNISCAN (gadodiamide) has an osmolality approximately 2.8 times that of plasma at 37C and is hypertonic under conditions of use.



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