Drug Information for ENBREL (etanercept) For Subcutaneous Injection (Immunex Corp): PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - PREFILLED AUTOINJECTOR, 50 MG

  • Contains 4 Single-use Prefilled Autoinjectors

    NDC 58406-445-04



    SureClick® Autoinjector

    50 mg/mL

    Single-use Prefilled Autoinjector

    50 mg

    Attention: Not for use in pediatric patients under 138 lbs.

    For Subcutaneous Use Only

    Sterile Solution – No Preservative

    Refrigerate at 2° to 8°C (36° to 46°F). DO NOT FREEZE.

    Each single-use prefilled autoinjector contains 0.98 mL of a clear and colorless solution containing 50 mg/mL etanercept and is formulated at pH 6.3 ± 0.2, with 1% sucrose, 100 mM sodium chloride, 25 mM L-arginine hydrochloride, and 25 mM sodium phosphate.

    Specific activity: approximately 1.7 x 106 U/mg.

    Manufactured by Immunex Corporation, Thousand Oaks, CA 91320

    U.S. License No. 1132

    Marketed by Amgen and Wyeth Pharmaceuticals

    ©2004 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).