BLEOMYCIN FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BLEOMYCIN (BLEOMYCIN SULFATE)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

L01DC01

INN (International Name):

BLEOMYCIN

Dosage:

15UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BLEOMYCIN (BLEOMYCIN SULFATE) 15UNIT

Administration route:

INTRAMUSCULAR

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0133328001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-10-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION
Lyophilized Powder
bleomycin sulfate equivalent to 15 units bleomycin/vial
USP
ANTINEOPLASTIC, ANTIBIOTIC
FRESENIUS KABI CANADA LTD.
Date of Revision
45 Vogell Rd, Suite 200
June 1, 2016
Richmond Hill, ON L4B 3P6
Control No.: 195028
_Bleomycin for Injection-PM-ENG-v2.0-non-annotated _
_Page 2 of 16 _
PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION
Lyophilized Powder
bleomycin sulfate equivalent to 15 units bleomycin/vial
USP
THERAPEUTIC CLASSIFICATION
ANTINEOPLASTIC, ANTIBIOTIC
BLEOMYCIN FOR INJECTION SHOULD BE ADMINISTERED UNDER THE SUPERVISION
OF A QUALIFIED
PHYSICIAN EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS.
ADEQUATE
DIAGNOSTIC AND TREATMENT FACILITIES SHOULD BE AVAILABLE TO ALLOW
APPROPRIATE
MANAGEMENT OF THERAPY AND POSSIBLE COMPLICATIONS.
PATIENTS RECEIVING BLEOMYCIN FOR INJECTION 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.
ACTIONS AND CLINICAL PHARMACOLOGY
Although the exact mechanism of action of bleomycin is unknown,
available evidence
indicates that the main mode of action is inhibition of DNA synthesis
with some evidence
of inhibition of RNA and protein synthesis.
The major route of excretion of bleomycin is the kidney, with 60 to
70% of an
administered dose recovered in the urine as active bleomycin. Renal
dysfunction can
significantly prolong excretion.
In patients with a creatinine clearance of > 35 mL per minute, the
serum or plasma
terminal elimination half-life of bleomycin is approximately 115
minutes. In patients
with a creatinine clearance of < 35 mL per minute, the plasma or serum
terminal
elimination half-life increases exponentially as the creatinine
clearance decreases.
When administered intrapleurally in the treatment of malignant pleural
effusion,
bleomycin acts as a sclerosing agent. Following intrapleural
administration, resultant
bleomycin plasma concentrations suggest a sys