MITOMYCIN FOR INJECTION, USP POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MITOMYCIN

זמין מ:

HIKMA CANADA LIMITED

קוד ATC:

L01DC03

INN (שם בינלאומי):

MITOMYCIN

כמות:

20MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

MITOMYCIN 20MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0111533002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2022-10-21

מאפייני מוצר

PRODUCT MONOGRAPH
PR MITOMYCIN FOR INJECTION, USP
Sterile Lyophilized Powder for Solution for Injection
20 mg mitomycin per vial
Antineoplastic Agent
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON
L5R 3P9, Canada
Date of Preparation:
October 12, 2022
Control No.: 258438
_Product Monograph _
_Mitomycin for Injection, USP _
_ _
_Page 2 of 16 _
PRODUCT MONOGRAPH
PR MITOMYCIN FOR INJECTION, USP
20 mg mitomycin per vial
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: MITOMYCIN FOR INJECTION, USP IS A POTENT DRUG AND SHOULD BE
USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC
DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS SHOULD BE
TAKEN WEEKLY. MITOMYCIN FOR INJECTION, USP MUST BE DISCONTINUED OR
DOSAGE REDUCED UPON EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE
MARROW OR THE DEVELOPMENT OF SIGNIFICANT RENAL OR PULMONARY
TOXICITY.
ACTION AND CLINICAL PHARMACOLOGY
Mitomycin was first investigated as an antibiotic in Japan. It was
then found to be active as
an antineoplastic agent. It selectively inhibits the synthesis of
deoxyribonucleic acid (DNA).
The exact point of mitomycin attachment to DNA remains unknown. There
is a correlation
between the guanine and cytosine content of DNA and the degree of
mitomycin-induced
cross-linking. At high concentrations of the drug, cellular RNA and
protein synthesis are also
suppressed.
In humans, mitomycin is rapidly cleared from the plasma after
intravenous administration
with a biphasic plasma elimination curve. Time required to reduce the
serum concentration
by 50% after a 30 mg bolus injection is 17 minutes. After injection of
30 mg, 20 mg or 10 mg
intravenously, the maximal serum concentrations were 2.4
µg
/ mL, 1.7
µg
/ mL and 0.52
µg
/
mL, respectively.
In general, the smaller the dose, the more rapidly blood levels of
mitomycin decreased.
Clearance is affected primarily by metabolism in the liver, but
metabolism occurs in other
tissues as well.
Approximately 10% of a dose of mitomycin is excreted unchanged in the
urine. Since
me