Drug Information for ENBREL (etanercept) For Subcutaneous Injection (Immunex Corp): PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 25 MG

  • Contains 4 Dose Trays

    NDC 58406-425-34




    25 mg/vial

    Multiple-use Vial

    See package insert for full prescribing information and instructions for preparation and administration.

    25 mg/vial

    Each vial contains a sterile lyophilized preparation of 25 mg etanercept (a recombinant CHO cell-derived product), 40 mg mannitol, 10 mg sucrose, and 1.2 mg tromethamine.

    Specific activity: approximately 1.7 x 106 U/mg.

    No U.S. standard of potency. Volume after reconstitution with 1 mL diluent is 1 mL.

    Before and after reconstitution refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.

    For Subcutaneous Use Only

    Amgen® Wyeth®

    Manufactured by Immunex Corporation, Thousand Oaks, CA 91320

    U.S. License No. 1132

    Marketed by Amgen and Wyeth Pharmaceuticals

    ©2003 Immunex Corporation

    Immunex U.S. Patent Numbers: 5,395,760; 5,605,690; 5,945,397; 6,201,105; Re. 36,755

  • Drug Information Provided by National Library of Medicine (NLM).