MUTAMYCIN INJ 20MG/VIAL POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

MITOMYCIN

Mevcut itibaren:

BRISTOL-MYERS SQUIBB CANADA

ATC kodu:

L01DC03

INN (International Adı):

MITOMYCIN

Doz:

20MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

MITOMYCIN 20MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

20MG

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2006-05-29

Ürün özellikleri

1
PRODUCT MONOGRAPH
MUTAMYCIN *
(mitomycin)
Injection, 5 and 20 mg
Antineoplastic Agent
Bristol-Myers Squibb Canada
2365 Côte de Liesse Rd
Date of Preparation:
Montreal, Canada.
October 25, 2005
*
TM of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Control#: 101901
1
PRODUCT MONOGRAPH
NAME OF DRUG
MUTAMYCIN *
(mitomycin)
Injection, 5 and 20 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: MUTAMYCIN (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.
MUTAMYCIN MUST BE DISCONTINUED OR DOSAGE REDUCED UPON EVIDENCE OF
ABNORMAL
DEPRESSION
OF
THE
BONE
MARROW,
OR
THE
DEVELOPMENT
OF
SIGNIFICANT RENAL OR PULMONARY TOXICITY.
ACTIONS AND CLINICAL PHARMACOLOGY
Mitomycin was investigated at first 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. At high concentrations
of the drug, cellular RNA and
protein synthesis are also suppressed.
Mitomycin is rapidly cleared from the plasma after intravenous
administration with a biphasic plasma
elimination curve. Mitomycin is widely distributed but does not appear
to cross the blood brain barrier.
After intravenous injection of 30, 20 or 10 mg of mitomycin, the
maximal serum concentrations were 2.4,
1.7 and 0.52
:
g/mL respectively. Serum half-life after a 30 mg bolus injection is 17
minutes. Clearance is
effected primarily by metabolism in the liver, but metabolism occurs
in other tissues as well. In general, the
smaller the dose, the more rapidly blood levels of mitomycin
decreased.
2
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 administer