16 HOW SUPPLIED/STORAGE AND HANDLING
RETACRIT (epoetin alfa-epbx) injection is a sterile, clear, and colorless solution in single-dose and multiple-dose vials available as:
Unit of Sale | Strength | Each Single Unit of Use |
---|---|---|
NDC 0069-1305-10 Carton containing 10 vials | 2,000 Units/mL | NDC 0069-1305-01 1 mL Single-dose vial |
NDC 0069-1306-10 Carton containing 10 vials | 3,000 Units/mL | NDC 0069-1306-01 1 mL Single-dose vial |
NDC 0069-1307-10 Carton containing 10 vials | 4,000 Units/mL | NDC 0069-1307-01 1 mL Single-dose vial |
NDC 0069-1308-10 Carton containing 10 vials | 10,000 Units/mL | NDC 0069-1308-01 1 mL Single-dose vial |
NDC 0069-1309-10 Carton containing 10 vials | 40,000 Units/mL | NDC 0069-1309-01 1 mL Single-dose vial |
NDC 0069-1309-04 Carton containing 4 vials | 40,000 Units/mL | NDC 0069-1309-01 1 mL Single-dose vial |
NDC 0069-1318-10 Carton containing 10 vials with a freeze strip indicator | 20,000 Units/2 mL (10,000 Units/mL) | NDC 0069-1318-01 2 mL Multiple-dose vial |
NDC 0069-1318-04 Carton containing 4 vials with a freeze strip indicator | 20,000 Units/2 mL (10,000 Units/mL) | NDC 0069-1318-01 2 mL Multiple-dose vial |
NDC 0069-1311-10 Carton containing 10 vials with a freeze strip indicator | 20,000 Units/mL | NDC 0069-1311-01 1 mL Multiple-dose vial |
NDC 0069-1311-04 Carton containing 4 vials with a freeze strip indicator | 20,000 Units/mL | NDC 0069-1311-01 1 mL Multiple-dose vial |
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. When exposed to freezing temperatures, the green area of the freeze strip indicator in the carton of the multiple-dose vials will show signs of cloudy or white discoloration.
Do not shake. Do not use RETACRIT that has been shaken or frozen or if the green area of the freeze strip indicator is cloudy or white.
Store RETACRIT vials in the original carton until use to protect from light.