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Single Vial Docetaxel Injection - ION Solutions

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Figure 5 - TAX327 Survival K-M Curves<br />

15 REFERENCES<br />

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs<br />

in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health<br />

Service, Centers for Disease Control and Prevention, National Institute for Occupational<br />

Safety and Health, DHHS (NIOSH) Publication No. 2004-165.<br />

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational<br />

Exposure to Hazardous Drugs. OSHA, 1999.<br />

http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html<br />

3. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling<br />

Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193<br />

4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy<br />

guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing<br />

Society.<br />

16 HOW SUPPLIED/STORAGE AND HANDLING<br />

16.1 How Supplied<br />

<strong>Docetaxel</strong> <strong>Injection</strong> is supplied in single use or multi-use vials as a sterile, pyrogen-free, nonaqueous<br />

solution. The following strengths are available:<br />

• <strong>Docetaxel</strong> <strong>Injection</strong> 20 mg/2 mL single use vials in cartons containing 1 vial each<br />

(NDC 0409-0201-02)<br />

• <strong>Docetaxel</strong> <strong>Injection</strong> 80 mg/8 mL multi-use vials in cartons containing 1 vial each<br />

(NDC 0409-0201-10)<br />

• <strong>Docetaxel</strong> <strong>Injection</strong> 160 mg/16 mL multi-use vials in cartons containing 1 vial each<br />

(NDC 0409-0201-20)<br />

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