ProHance

DRUG DESCRIPTION

ProHance (Gadoteridol) Injection is a nonionic contrast medium for magnetic resonance imaging (MRI), available as a 0.5M sterile clear colorless to slightly yellow aqueous solution in vials and syringes for intravenous injection.

Gadoteridol is the gadolinium complex of 10-(2-hydroxy-propyl)-1,4,7,10- tetraazacyclododecane-1,4,7-triacetic acid with a molecular weight of 558.7, an empirical formula of C17H29N4O7Gd and has the following structural formula:

ProHance (Gadoteridol) structural formula illustration

Each mL of ProHance contains 279.3 mg gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection. ProHance (gadoteridol injection solution) contains no antimicrobial preservative.

ProHance (gadoteridol injection solution) has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below:

PARAMETER
Osmolality (mOsmol/kg water @ 37 C 630
Viscosity (cP) @ 20 C 2.0
@ 37 C 1.3
Specific Gravity @ 25 C 1.140
Density (g/mL) @ 25 C 1.137
Octanol: H2O coefficient -3.68 ? 0.02

ProHance (gadoteridol injection solution) has an osmolality 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.



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