Enbrel - Indications & Dosage

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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

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

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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.