BLEOMYCIN FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BLEOMYCIN (BLEOMYCIN SULFATE)

Available from:

PFIZER CANADA ULC

ATC code:

L01DC01

INN (International Name):

BLEOMYCIN

Dosage:

15UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BLEOMYCIN (BLEOMYCIN SULFATE) 15UNIT

Administration route:

INTRA-ARTERIAL

Units in package:

10ML VIAL

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2002-12-02

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION USP
(as bleomycin sulphate)
15 UNITS OF BLEOMYCIN/VIAL
Sterile Powder
THERAPEUTIC CLASSIFICATION
Antineoplastic agent
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Control No.: 206646
Date of Revision:
August 8, 2017
_Product Monograph - _
_Pr_
_Bleomycin_ _for Injection USP _
_Page 2 of 30_
PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION USP
(as bleomycin sulphate)
15 units of bleomycin/vial
Sterile Powder
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
ACTION AND CLINICAL PHARMACOLOGY
Experiments with isolated DNA have shown that bleomycin binds to the
DNA molecule and
cleaves it. This results in the inhibition of DNA synthesis. There is
also evidence of lesser
inhibition of RNA and protein synthesis.
Bleomycin exhibits a wide spectrum of _in vitro_ and _in vivo_
activity. It demonstrates inhibition of
DNA
synthesis
in
_E. _
_coli, _
_B. _
_subtilis,_
Ehrlich
ascites
cells,
HeLa
cells,
PHA-stimulated
lymphocytes,
L-929
fibroblasts,
L5178Y
cells
and
Novikoff
hepatoma
ascites
cells,
at
concentrations
within
a
general
range
of
4-20
microgram/mL
under
typical
incubation
conditions.
The activity of bleomycin seems to be cell phase-specific. Cyclic and
continuous administration
of bleomycin has been shown to be more effective than bolus dosing in
_in vivo_ systems.
Bleomycin is well absorbed after parenteral (intravenous,
subcutaneous, intramuscular, and
intrapleural) but not after oral administration. Tissue distribution
was evaluated in mice and was
found to be high in skin, kidney, lung, peritoneum, lymphatics and
solid tumour and tumour cells
in ascites. Bleomycin does not cross the blood-brain barrier.
_Product Monograph - _
_Pr_
_Bleomycin_ _for Injection USP _
_Page 3 of 30_
Several tissues have demonstrated a capacity to degrade bleomycin. The
liver and GI tract show
the highest rate of inactivation. The skin, lungs and kidney show a
lower rate which may
account for the site-specific toxicity of the drug.
Bleomycin half-life varies with creat