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 vial||NDC 0009-5091-01|
|200 mg/100 mL Carton of one single-dose vial||NDC 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)].