P&S Liquid 4.950 mg/mL

Supplied

Each mL of solution contains: paclitaxel 6 mg, Cremophor EL (polyethoxylated castor oil) 527 mg, citric acid (anhydrous) 2 mg and absolute alcohol 46.5% v/v. Single dose vials of 5 mL. Multi-dose vials of 16.7 and 50 mL. Single pack cartons. Store at room temperature (15-25°C). Retain in the original package and protect from light. Once punctured, the 16.7 mL, 25 mL and 50 mL vials of Paclitaxel for Injection are stable for 28 days at room temperature (15-25°C). These presentations are labeled as multi-dose vials. Unused portions of the 5 mL single dose format should be discarded. Solutions for infusion prepared as recommended may be stored at room temperature (15-25°C) only if necessary. However, the infusion should be initiated within 24 hours of reconstitution.

If unopened vials are refrigerated, a precipitate may form which redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.