BLEOMYCIN FOR INJECTION USP POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BLEOMYCIN (BLEOMYCIN SULFATE)

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

L01DC01

INN (Kansainvälinen yleisnimi):

BLEOMYCIN

Annos:

15UNIT

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

BLEOMYCIN (BLEOMYCIN SULFATE) 15UNIT

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2019-08-01

Valmisteyhteenveto

_Bleomycin for Injection USP _
_Page 1 of 15_
PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION USP
Lyophilized Powder
15 units of bleomycin/vial (supplied as bleomycin sulfate)
Sterile
Antineoplastic, Antibiotic
Sandoz Canada Inc. Date of Preparation: April 21, 2011
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No:130320
_Bleomycin for Injection USP _
_Page 2 of 15_
PRODUCT MONOGRAPH
PR
BLEOMYCIN FOR INJECTION USP
Lyophilized Powder
15 units
of bleomycin
/vial
(supplied as bleomycin sulfate)
Sterile
Antineoplastic, Antibiotic
BLEOMYCIN FOR INJECTION (BLEOMYCIN SULFATE) 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 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.
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