BLENOXANE PWS 15UNIT POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BLEOMYCIN SULFATE

Saatavilla:

BRISTOL LABS DIVISION OF BRISTOL-MYERS SQUIBB

ATC-koodi:

L01DC01

INN (Kansainvälinen yleisnimi):

BLEOMYCIN

Annos:

15UNIT

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

BLEOMYCIN SULFATE 15UNIT

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

15 UNITS/VIAL

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0105871001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2011-10-19

Valmisteyhteenveto

PRODUCT MONOGRAPH
BLENOXANE
|
(bleomycin for injection)
LYOPHILIZED POWDER, 15 UNITS/VIALS
U.S.P.
ANTINEOPLASTIC, ANTIBIOTIC
Bristol Laboratories of Canada
Division of Bristol-Myers Squibb Canada Inc.
Date of Preparation:
Montreal, Canada.
March 20, 1981
|
TM auth. user Bristol-Myers Squibb Canada Inc.
Date of Revision:
3 December 2010
Control No.: 141156
1
PRODUCT MONOGRAPH
NAME OF DRUG
BLENOXANE
(BLEOMYCIN
for injection
)
Lyophilized Powder, 15 units/vial
U.S.P.
THERAPEUTIC CLASSIFICATION
Antineoplastic, Antibiotic
BLENOXANE (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 BLENOXANE 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
percent of an administered dose
recovered in the urine as active bleomycin. Renal dysfunction can
significantly prolong excretion.
2
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