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DOCETAXEL 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 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
    (NDC 0409-0366-01)
  • Docetaxel Injection, USP 80 mg/4 mL multiple-dose vials in cartons containing 1 vial each
    (NDC 0409-0367-01)
  • Docetaxel Injection, USP 160 mg/8 mL multiple-dose vials in cartons containing 1 vial each
    (NDC 0409-0368-01)

16.2 Storage

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.

16.3 Handling and Disposal

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

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