eomycin. Bleomycin for Injection USP is supplied as follows:
NDC Number
0703 3154-01 15 Units per Vial Individually packaged
0703 3155-01 30 Units per Vial Individually packagedt
Stability
The sterile powder is stable under refrigeration 2° to 8°C (36° to 46°F) and should not be used after the expiration date is reached.
Bleomycin for Injection USP should not be reconstituted or diluted with 5% dextrose injection or other dextrose containing diluents. When reconstituted in 5% dextrose injection and analyzed by HPLC, Bleomycin for Injection USP demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection USP is reconstituted in 0.9% sodium chloride for injection, 0.9%, USP.
Bleomycin for Injection USP is stable for 24 hours at room temperature in 0.9 % sodium chloride injection.
Vial stoppers do not contain natural rubber latex.
REFERENCES
1. 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.
2. 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/ot m_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
Teva Pharmaceuticals USA
Sellersville, PA 18960
Rev. A 4/2012
PRINCIPAL DISPLAY PANEL
Bleomycin for Injection USP 15 Units Carton Text
NDC 0703-3154-01 Rx only
Bleomycin
for Injection USP
equivalent to
15 Units/Vial
Bleomycin
CAUTION: Cytotoxic -
Special Handling Procedures
Single Use Vial
For IV, IM, SC or
Intrapleural Use
TEVA
PRINCIPAL DISPLAY PANEL
Bleomycin for Injection USP 30 Units Carton Text
NDC 0703-3155-01 Rx only
Bleomycin
for Injection USP
equivalent to
30 Units/Vial
Bleomycin
CAUTION: Cytotoxic -
Special Handling Procedures
Single Use Vial
For IV, IM, SC or
Intrapleural Use
TEVA
Bleomycin
Bleomycin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0703-3154
Route of Administration INTRAVENOUS, INTRAMUSCULAR, INTRAPLEURAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bleomycin SULFATE (Bleomycin) Bleomycin 15 [USP'U]
Packaging
# Item Code Package Description
1 NDC:0703-3154-01 1 VIAL, SINGLE-USE in 1 CARTON
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065033 06/30/2000
Bleomycin
Bleomycin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0703-3155
Route of A
