Enbrel

[etanercept]

ENBREL® multiple-use vial: Do not use a dose tray beyond the expiration date stamped on thecarton, dose tray label, vial label, or diluent syringe label. The dose tray containing ENBREL®(sterile powder) must be refrigerated at 2°-8°C (36°-46°F). DO NOT FREEZE. Reconstituted solutions of ENBREL® prepared with the supplied Bacteriostatic Water for Injection,USP (0.9% benzyl alcohol), using a 25-gauge needle, may be stored for up to 14 days ifrefrigerated at 2°-8°C (36°-46°F). Discard reconstituted solution after 14 days.

PRODUCT STABILITY AND STERILITY CANNOT BE ASSURED AFTER 14 DAYS.

HOW SUPPLIED

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ENBREL® single-use prefilled syringe is supplied in a carton containing four prefilled syringes(NDC 58406-435-04). Each prefilled syringe contains 0.98 mL of 50 mg/mL of etanercept in asingle-dose syringe with a 27 gauge, ½ inch needle. Administration of one 50 mg/mL prefilled syringe of ENBREL® provides a dose equivalent to two 25 mg vials of lyophilized ENBREL®,when vials are reconstituted and administered as recommended.

ENBREL® multiple-use vial is supplied in a carton containing four dose trays (NDC58406-425-34). Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mLSterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27-gauge ½inch needle, one vial adapter, one plunger, and two alcohol swabs. Each carton contains four“Mixing Date:” stickers.
Rx Only

REFERENCES
1. Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995 - Status and Review. In: Spilker B, ed. “Quality of Life and Pharmacoeconomics in Clinical Trials.” 2nd ed. Philadelphia, PA. Lippincott-Raven 1996;227.

2. Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J. Clin Epidemiol 1998;51(11):903.

3. Giannini EH, Ruperto N, Ravelli A, et al. Preliminary definition of improvement of juvenile arthritis. Arthritis Rheum 1997;40(7):1202.

4. Fredriksson T, Petersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978;157:238.

5. van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: a proposal for modification of the New York criteria. Arthritis Rheum 1984;27(4):361-8.

6. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis.
Arthritis Rheum 2001;44(8):1876-86.

7. Van Oosten BW, Barkhof F, Truyen L, et al. Increased MRI activity and immune activation in two multiple sclerosis patients treated with the monoclonal anti-tumor necrosis factor antibody cA2. Neurology 1996;47:1531.

8. Arnason BGW, et al. (Lenercept Multiple Sclerosis Study Group). TNF neutralization in MS:Results of a randomized, placebo-controlled multicenter study. Neurology 1999;53:457.

9. Fisher CJ Jr, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med 1996;334(26):1697.

10. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 11 Registries, 1992-1999.

11. Mellemkjaer L, Linet MS, Gridley G, et al. Rheumatoid Arthritis and Cancer Risk. European Journal of Cancer 1996;32A(10):1753-1757.

12. Baecklund E, Ekbom A, Sparen P, et al. Disease Activity and Risk of Lymphoma in Patients With Rheumatoid Arthritis: Nested Case-Control Study. BMJ 1998;317: 180-181.
Manufactured by:

Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
Marketed by Amgen and Wyeth Pharmaceuticals
© 2004 Immunex Corporation. All rights reserved.
Issue Date: 09/27/2004
Immunex U.S. Patent Numbers:
5,395,760; 5,605,690; 5,945,397; 6,201,105; 6,572,852; Re. 36,755

ENBREL®
(etanercept)
Single-Use Prefilled Syringe

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