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
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL, 25 MG
Contains 4 Dose Trays
NDC 58406-425-34
Amgen®
Enbrel®
etanercept
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
ENBREL
etanercept solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58406-435
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETANERCEPT (ETANERCEPT) ETANERCEPT 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE HYDROCHLORIDE 0.025 mmol in 1 mL
SODIUM CHLORIDE 0.1 mmol in 1 mL
SODIUM PHOSPHATE 0.025 mmol in 1 mL
SUCROSE 10 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 58406-435-04 4 SYRINGE In 1 CARTON contains a SYRINGE (58406-435-01)
1 58406-435-01 1 mL In 1 SYRINGE This package is contained within the CARTON (58406-435-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103795 10/06/2005
ENBREL
etanercept solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58406-445
Route of Administration SUBCUTANEOUS DEA Schedule
Activ |
