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vidaza(azacitidine)injection, powder, lyophilized, for suspe(十三)
2013-10-25 00:06:15 来源: 作者: 【 】 浏览:9063次 评论:0
d Disposal.
Do not save any unused portions for later administration.

HOW SUPPLIED

Vidaza (azacitidine for injectable suspension) is supplied as a lyophilized powder in 100 mg single-use vials packaged in cartons of 1 vial (NDC 67211-102-01).

Storage

Store unreconstituted vials at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) (See USP Controlled Room Temperature).

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be applied. Several guidelines on this subject have been published1-8. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

REFERENCES

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society; 1999:32-41.
  2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.
  3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1592.
  4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
  5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
  6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
  7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
  8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996;53:1669-1685.

Manufactured for: Pharmion Corporation

Boulder, CO 80301

Manufactured by: Ben Venue Laboratories, Inc.

Bedford, OH 44146

Edition Date: August 31, 2004
VID-P01


Vidaza (azacitidine)
PRODUCT INFO
Product Code 67211-102 Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route Of Administration SUBCUTANEOUS DEA Schedule  
INGREDIENTS
Name (Active Moiety) Type Strength
azacitidine(azacitidine) Active 100MILLIGRAMIn4MILLILITER
mannitol Inactive  
IMPRINT INFORMATION
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