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DOCETAXEL ANHYDROUS INJECTION, SOLUTION (docetaxel injection, USP) How Supplied/Storage and Handling

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 colorless to pale 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/2 mL single-dose vials in cartons containing 1 vial each
    (NDC 0409-0201-02)
  • Docetaxel Injection, USP 80 mg/8 mL multiple-dose vials in cartons containing 1 vial each
    (NDC 0409-0201-10)
  • Docetaxel Injection, USP 160 mg/16 mL multiple-dose vials in cartons containing 1 vial each
    (NDC 0409-0201-20)

16.2 Storage

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. 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.

16.3 Handling and Disposal

Docetaxel Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

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