How is Activasesupplied?
Activase® (Alteplase), is supplied as a sterile, lyophilized powder in 50 mg vials containing vacuum and in 100 mg vials without vacuum. Each 50 mg Activase (alteplase) vial (29 million IU) is packaged with diluent for reconstitution
(50 mL Sterile Water for Injection, USP): NDC 50242-044-13. Each 100 mg Activase (alteplase) vial (58 million IU) is packaged with diluent for reconstitution
(100 mL Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27. Storage Store lyophilized Activase (alteplase) at controlled room temperature not to exceed 30°C (86°F), or under refrigeration (2-8°C/36-46°F). Protect the lyophilized material during extended storage from excessive exposure to light. Do not use beyond the expiration date stamped on the vial. Manufactured by: GENENTECH, INC. 1 DNA Way, South San Francisco, CA 94080-4990. Revision Date December 2005. FDA Approval Date May 2002. FDA rev date: 1/4/2005 Last reviewed on RxList: 5/9/2008
This monograph has been modified to include the generic and brand name in many instances.