MITOMYCIN FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MITOMYCIN

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

L01DC03

INN (Διεθνής Όνομα):

MITOMYCIN

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

MITOMYCIN 20MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1997-01-08

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
Pr
MITOMYCIN FOR INJECTION
USP
(20 mg per vial)
Antineoplastic
Teva Canada limited
Date of Revision:
30 Novopharm Court
June 30, 2017
Toronto, Ontario
M1B 2K9
Canada
Control #: 202039
1
PRODUCT MONOGRAPH
Pr
MITOMYCIN
FOR INJECTION
USP
(20 mg per vial)
THERAPEUTIC CLASSIFICATION
Antineoplastic
CAUTION: MITOMYCIN FOR INJECTION 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 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 metabolic
pathways are saturated at relatively low doses, the percent of a dose
excreted in urine increases
with increasing doses. In children, excretion of intravenously
administered mitomyc