国家: 加拿大
语言: 英文
来源: Health Canada
MITOMYCIN
TEVA CANADA LIMITED
L01DC03
MITOMYCIN
5MG
POWDER FOR SOLUTION
MITOMYCIN 5MG
INTRAVENOUS
10ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0111533003; AHFS:
CANCELLED POST MARKET
2017-02-10
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 阅读完整的文件