16 HOW SUPPLIED/STORAGE AND HANDLING
Concentrate for solution for infusion:
Oxaliplatin Injection, USP is supplied in clear, glass, single-dose vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free aqueous solution at a concentration of 5 mg/mL. Tartaric Acid, NF, Water for Injection, USP and Sodium Hydroxide, NF are used as inactive ingredients and/or in combination as a buffering system.
| Unit of Sale | Concentration |
|---|---|
NDC 61703-363-18 | 50 mg/10 mL |
Carton containing 1 Single-dose vial | (5 mg/mL) |
NDC 61703-363-22 | 100 mg/20 mL |
Carton containing 1 Single-dose vial | (5 mg/mL) |
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Do not freeze and protect from light (keep in original outer carton). Discard unused portion.
Oxaliplatin is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 The use of gloves is recommended. If a solution of Oxaliplatin contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin contacts the mucous membranes, flush thoroughly with water.