ED AFTER 14 DAYS.
Storage and Stability
ENBREL® Single-use Prefilled Syringe and ENBREL® Single-use Prefilled SureClick Autoinjector:
Do not use ENBREL® beyond the expiration date stamped on the carton or barrel label. ENBREL® must be refrigerated at 2° to 8°C (36° to 46°F). DO NOT FREEZE. Keep the product in the original carton to protect from light until the time of use. Do not shake.
ENBREL® Multiple-use Vial:
Do not use a dose tray beyond the expiration date stamped on the carton, dose tray label, vial label, or diluent syringe label. The dose tray containing ENBREL® (sterile powder) must be refrigerated at 2° to 8°C (36° to 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 if refrigerated at 2° to 8°C (36° to 46°F). Discard reconstituted solution after 14 days. PRODUCT STABILITY AND STERILITY CANNOT BE ASSURED AFTER 14 DAYS.
HOW SUPPLIED
Each ENBREL® single-useprefilled syringe and ENBREL® single-use prefilledSureClick autoinjector contains 50 mg/mL of etanercept in a single-dose syringe with a 27-gauge, ½-inch needle.
25 mg single-use prefilled syringe Carton of 4 NDC 58406-455-04
50 mg single-use prefilled syringe Carton of 4 NDC 58406-435-04
50 mg single-use prefilled SureClick autoinjector Carton of 4 NDC 58406-445-04
ENBREL® multiple-use vial is supplied in a carton containing four dose trays. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27-gauge ½-inch needle, one vial adapter, one plunger, and two alcohol swabs. Each carton contains four “Mixing Date:" stickers.
25 mg multiple-use vial Carton of 4 NDC 58406-425-34
Administration of one 50 mg ENBREL® prefilled syringe or one ENBREL® SureClick autoinjector provides a dose equivalent to two 25 mg ENBREL® prefilled syringes or two multiple-use vials of lyophilized ENBREL®, when vials are reconstituted and administered as recommended.
REFERENCES
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.
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.
Giannini EH, Ruperto N, Ravelli A, et al. Preliminary definition of improvement of juvenile arthritis. Arthritis Rheum 1997;40(7):1202.
Fredriksson T, Petersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978;157:238.
van der Linden S, Valkenburg HA, Cats A. eva luation of diagnostic criteria for ankylosing spondylitis: a proposal for modification of the New York criteria. Arthritis Rheum 1984;27(4):361-8.
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.
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 necrosi |
