Información de la droga para 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

Enbrel^®

etanercept

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