Cerubine (daunorubicin HCl) for Injection, is available in butyl-rubber-stoppered vials, each containing 21.4 mg daunorubicin hydrochloride (equivalent to 20 mg of daunorubicin) and 100 mg of mannitol, as a sterile reddish lyophilized powder. When reconstituted with 4 mL of Sterile Water for Injection, USP, each mL contains 5 mg daunorubicin activity. NDC 55390-281-10 20 mg, single dose vials; carton of 10. REFERENCES 1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. 2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA, March 15,1985. 3. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis R Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115. 4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426-428, 1983. 5. Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca A Cancer Joumal for Clinicians Sept/Oct, 258-263, 1983. 6. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotox-ic and hazardous drugs. Am J Hosp Pharm 47:1033-1049, 1990. 7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), Am JHealth-Syst Pharm, 15:1669-1685, 1996. Manufactured by: Ben Venue Laboratories, Bedford, OH 44146. Manufactured for: Bedford Laboratories Inc, Bedford, OH 44146. June 2004. FDA Rev date: 12/13/00 Last reviewed on RxList: 8/13/2008
This monograph has been modified to include the generic and brand name in many instances.