Bivalirudin (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Bivalirudin for Injection is supplied as follows:
| NDC | Bivalirudin for Injection | Package Factor |
| 70860-402-10 | 250 mg Single-Dose Vial | 10 vials per carton |
Bivalirudin for Injection is a sterile, lyophilized powder in single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate*.
*The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.9 to 2.6 equivalents.
16.2 Storage
Storage Conditions
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]
Discard unused portion.
Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
17 PATIENT COUNSELING INFORMATION
Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider when they occur.
Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in China
©2019 Athenex.
July 2019
PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — VIAL LABEL
NDC 70860-402-41
Bivalirudin for Injection
250 mg per vial
For Intravenous Use Only
Single-Dose Vial
Discard unused portion
Rx only
| BIVALIRUDIN bivalirudin injection, powder, lyophilized, for solution | |||||||||||||||||
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| Labeler — Athenex Pharmaceutical Division, LLC. (080318964) |
Revised: 09/2019 Athenex Pharmaceutical Division, LLC.
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