מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
MITOMYCIN
BRISTOL-MYERS SQUIBB CANADA
L01DC03
MITOMYCIN
20MG
POWDER FOR SOLUTION
MITOMYCIN 20MG
INTRAVENOUS
20MG
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0111533002; AHFS:
CANCELLED POST MARKET
2006-05-29
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 קרא את המסמך השלם