MITOMYCIN FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

MITOMYCIN

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

L01DC03

INN (International Nazwa):

MITOMYCIN

Dawkowanie:

5MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

MITOMYCIN 5MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

10ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0111533003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2017-02-10

Charakterystyka produktu

PRODUCT MONOGRAPH
Pr
MITOMYCIN FOR INJECTION
USP
(5 mg and 20 mg per vial)
Antineoplastic
Teva Canada limited
Date of Preparation: September 10, 2012
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
Control #: 158248
1
PRODUCT MONOGRAPH
Pr
MITOMYCIN
FOR INJECTION
USP
(5 mg and 20 mg per vial)
THERAPEUTIC CLASSIFICATION
Antineoplastic
CAUTION: MITOMYCIN 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 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
F
g/mL, 1.7
F
g/mL and 0.52
F
g/mL,
respectively.
In general, the smaller the dose, the more rapidly blood levels of
mitomycin decreased.
Clearance is effected 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 mitomycin