Bleomycin (Page 4 of 4)

HOW SUPPLIED

Bleomycin for Injection, USP is available as follows:

Product

No.

NDC

No.

103610

63323-136-10

15 units per vial, individually packaged.

103720

63323-137-20

30 units per vial, individually packaged.


Stability

The sterile powder is stable under refrigeration 2°C to 8°C (36°F to 46°F) and should not be used after the expiration date is reached.

Bleomycin for Injection should not be reconstituted or diluted with D5 W or other dextrose containing diluents. When reconstituted in D5 W and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection is reconstituted in Sodium Chloride for Injection, 0.9%, USP.

Bleomycin for Injection is stable for 24 hours at room temperature in Sodium Chloride.

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/otm_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.

logo

45998C

Revised: July 2010

PACKAGE LABEL — PRINCIPAL DISPLAY — Bleomycin 15 Units Vial Label

NDC 63323-136-10

103610

Bleomycin for Injection, USP

15 Units

For intravenous, intramuscular, subcutaneous, or intrapleural use.

Caution: Cytotoxic–Special handling procedures.

Single Use Vial

Rx only

103610 vial
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Bleomycin 15 Units Vial Carton Label

NDC 63323-136-10

103610

Bleomycin for Injection, USP

15 Units

For intravenous, intramuscular, subcutaneous, or intrapleural use.

Caution: Cytotoxic–Special handling procedures.

Rx only

103610 carton
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — Bleomycin 30 Units Vial Label

NDC 63323-137-20

103720

Bleomycin for Injection, USP

30 Units

For intravenous, intramuscular, subcutaneous, or intrapleural use.

Caution: Cytotoxic–Special handling procedures.

Single Use Vial

Rx only

103720 vial

PACKAGE LABEL — PRINCIPAL DISPLAY — Bleomycin 30 Units Vial Carton Label

NDC 63323-137-20

103720

Bleomycin for Injection, USP

30 Units

For intravenous, intramuscular, subcutaneous, or intrapleural use.

Caution: Cytotoxic–Special handling procedures.

Rx only

103720 carton
(click image for full-size original)
BLEOMYCIN bleomycin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-137
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLEOMYCIN SULFATE (BLEOMYCIN) BLEOMYCIN SULFATE 30 [USP'U]
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-137-20 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the CARTON (63323-137-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065185 02/13/2009
BLEOMYCIN bleomycin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-136
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLEOMYCIN SULFATE (BLEOMYCIN) BLEOMYCIN SULFATE 15 [USP'U]
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-136-10 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the CARTON (63323-136-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065185 02/13/2009
Labeler — APP Pharmaceuticals, LLC (608775388)
Establishment
Name Address ID/FEI Operations
APP Pharmaceuticals, LLC 023648251 MANUFACTURE

Revised: 07/2011 APP Pharmaceuticals, LLC

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.