docetaxel injection, USP 10 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 colorless to pale 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 0409-0201-02
Carton of 1 single-dose vial

20 mg/2 mL
(10 mg/mL)

NDC 0409-0201-10
Carton of 1 multiple-dose vial

80 mg/8 mL
(10 mg/mL)

NDC 0409-0201-20
Carton of 1 multiple-dose vial

160 mg/16 mL
(10 mg/mL)

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

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Medication Guide

Health Professional Information

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:

Unit of Sale

Concentration

NDC 0409-0201-02
Carton of 1 single-dose vial

20 mg/2 mL
(10 mg/mL)

NDC 0409-0201-10
Carton of 1 multiple-dose vial

80 mg/8 mL
(10 mg/mL)

NDC 0409-0201-20
Carton of 1 multiple-dose vial

160 mg/16 mL
(10 mg/mL)

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

Prescribing Information
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Health Professional Information

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:

Unit of Sale

Concentration

NDC 0409-0201-02
Carton of 1 single-dose vial

20 mg/2 mL
(10 mg/mL)

NDC 0409-0201-10
Carton of 1 multiple-dose vial

80 mg/8 mL
(10 mg/mL)

NDC 0409-0201-20
Carton of 1 multiple-dose vial

160 mg/16 mL
(10 mg/mL)

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

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