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ELLENCE® How Supplied/Storage and Handling (epirubicin HCl)

16 HOW SUPPLIED/STORAGE AND HANDLING

ELLENCE is available in polypropylene single-dose CYTOSAFE™ vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use, clear, red solution in the following strengths:

50 mg/25 mL Carton of one single-dose vialNDC 0009-5091-01
200 mg/100 mL Carton of one single-dose vialNDC 0009-5093-01

Discard unused portion.

Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light.

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15–25°C). Solution for injection should be used within 24 hours after removal from refrigeration.

ELLENCE is a cytotoxic drug. Follow applicable special handling and disposal procedures1 [see References (15)].

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