ution is intended for further dilution with Lactated Ringer's Injection, USP, to a concentration range of 1.3 to 3.0 mg/mL in intravenous infusion bags for rapid drip infusion. DO NOT ADMINISTER VIA IV PUSH. The infusion solutions have a pH of 3.5 to 5.5. The infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). DISCARD UNUSED SOLUTIONS.
After completing the infusion of Zinecard, and prior to a total elapsed time of 30 minutes (from the beginning of the Zinecard infusion), the intravenous injection of doxorubicin should be given.
Incompatibility
Zinecard should not be mixed with other drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Handling and Disposal
Caution in the handling and preparation of the reconstituted solution must be exercised and the use of gloves is recommended. If Zinecard powder or solutions contact the skin or mucosae, immediately wash thoroughly with soap and water.
Procedures normally used for proper handling and disposal of anticancer drugs should be considered for use with Zinecard. Several guidelines on this subject have been published.1–4 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
How is Zinecard Supplied
Zinecard (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.
NDC 0013-8717-62
250 mg single dose vial with a red flip-top seal, packaged in single vial packs.
NDC 0013-8727-89
500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
REFERENCES
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172–1193.
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
Rx only
LAB-0060-8.0
June 2012
PRINCIPAL DISPLAY PANEL - 250 mg Vial Label
250 mg*
NDC 0013-8717-62
Single-Dose Vial
Zinecard®
dexrazoxane for injection
250 mg*
Sterile, Pyrogen-Free
Lyophilizate
For intravenous use only
Rx only
Pfizer Injectables
PRINCIPAL DISPLAY PANEL - 250 mg Vial Carton
250 mg*
NDC 0013-8717-62
Rx only
Single-Dose Vial
Zinecard®
dexrazoxane for
injection
250 mg*
Sterile, Pyrogen-Free
Lyophilizat
For intravenous use only
Pfizer Injectables
PRINCIPAL DISPLAY PANEL - 500 mg Vial Label
500 mg*
NDC 0013-8727-89
Single-D |
