16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Docetaxel Injection, USP is supplied in single-dose or multiple-dose vials as a sterile, pyrogen-free, non-aqueous pale-yellow to brownish yellow solution. Discard unused portion of the single-dose vial.
The following strengths are available in a one-vial formulation:
- Docetaxel Injection, USP 20 mg/1 mL single-dose vials in cartons containing 1 vial each
- Docetaxel Injection, USP 80 mg/4 mL multiple-dose vials in cartons containing 1 vial each
- Docetaxel Injection, USP 160 mg/8 mL multiple-dose vials in cartons containing 1 vial each
Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.
After first use and following multiple needle entries and product withdrawals, Docetaxel Injection multiple-dose vials are stable for up to 28 days when stored between 2°C and 8°C (36°F and 46°F) and protected from light.