Rx Item-Bleomycin Sulfate Inj 30 Unit Vial by Hospira Worldwide

BLEOMYCIN- bleomycin sulfate injection, powder, lyophilized, for solution
Bleomycin for Injection USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or sodium hydroxide can be used, if necessary, to adjust pH.
Bleomycin for Injection USP may be given by the intramuscular, intravenous or subcutaneous routes.
WARNINGS
Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function.
Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see ADVERSE REACTIONS, Pulmonary).
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see ADVERSE REACTIONS, Idiosyncratic Reactions).
Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy.
BECAUSE OF THE POSSIBILITY OF AN ANAPHYLACTOID REACTION, LYMPHOMA PATIENTS SHOULD BE TREATED WITH 2 UNITS OR LESS FOR THE FIRST TWO DOSES. IF NO ACUTE REACTION OCCURS, THEN THE REGULAR DOSAGE SCHEDULE MAY BE FOLLOWED.
The following dose schedule is recommended:
Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin's Disease - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of bleomycin appears to be dose related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
HOW SUPPLIED
Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. 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 packaged
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

Bleomycin 30 Unit Vial by Hospira Worldw
NDC No. 61703-0323-22 UPC/GTIN No. 3-61703-32322-4 MPN 32322 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

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Hospira Worldwide Inc.

BLEOMYCIN SULFATE INJECTI
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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