docetaxel injection, USP 20 mg/ml VIAL How Supplied/Storage and Handling

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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:

Unit of Sale

Concentration

NDC 0409-0366-01
Carton of 1 single-dose vial

20 mg/mL

NDC 0409-0367-01
Carton of 1 multiple-dose vial

80 mg/4 mL
(20 mg/mL)

NDC 0409-0368-01
Carton of 1 multiple-dose vial

160 mg/8 mL
(20 mg/mL)

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 hazardous drug. Follow applicable special handling and disposal procedures.1

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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:

Unit of Sale

Concentration

NDC 0409-0366-01
Carton of 1 single-dose vial

20 mg/mL

NDC 0409-0367-01
Carton of 1 multiple-dose vial

80 mg/4 mL
(20 mg/mL)

NDC 0409-0368-01
Carton of 1 multiple-dose vial

160 mg/8 mL
(20 mg/mL)

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 hazardous drug. Follow applicable special handling and disposal procedures.1

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