SPL Set ID: e8b76200-c0aa-491b-aad7-e22d2f68496f

ProHance, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, nonpyrogenic injectable solution. Each mL contains 279.3 mg (0.5 mmol/mL) gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection; pH adjusted with hydrochloric acid and/or sodium hydroxide. ProHance contains no antimicrobial preservative. 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 C 17 H 29 N 4 O 7 Gd and has the following structural formula: ProHance has a pH of 6.5 to 8.0. Pertinent physiochemical parameters are provided below: Osmolality 630 mOsmol/kg water at 37 °C Viscosity 1.3 cP at 37 °C Density 1.137 g/mL at 25 °C ProHance has an osmolality that is 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use. ProHance Structure