16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Bivalirudin for Injection is supplied as a sterile, lyophilized powder in a single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate3.
|Unit of Sale||Concentration|
Tray containing 10 Single-dose glass vials
- The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.7 to 2.6 equivalents.