国: カナダ
言語: 英語
ソース: Health Canada
CISPLATIN
OMEGA LABORATORIES LIMITED
L01XA01
CISPLATIN
1MG
SOLUTION
CISPLATIN 1MG
INTRAVENOUS
50ML/100ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0113245002; AHFS:
APPROVED
2014-03-06
Cisplatin Injection Page 1 sur 15 PRODUCT MONOGRAPH PR CISPLATIN INJECTION CONCENTRATED STERILE SOLUTION FOR INJECTION 1.0 MG/ML (50 mg/50 mL, 100 mg/100 mL) Omega Standard Antineoplastic Agent MUST BE DILUTED BEFORE ADMINISTRATION Omega Laboratories, Ltd. 11 177, Hamon Montréal, Canada H3M 3E4 CONTROL # : 152337_ _ Date of Preparation: March 5, 2014 Cisplatin Injection Page 2 sur 15 PRODUCT MONOGRAPH PR CISPLATIN INJECTION 1.0 MG/ML (50 mg/50 mL, 100 mg/100 mL) THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION: CISPLATIN IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. ACTION AND CLINICAL PHARMACOLOGY Cisplatin has biochemical properties similar to those of bifunctional alkylating agents producing inter-strand and intra-strand cross-links in DNA. It is apparently not cell-cycle specific. PHARMACOKINETICS Following bolus injection, or intravenous infusion over 2 to 7 hours, of doses ranging from 50 to 100 mg/m 2 , plasma cisplatin half-life is approximately 30 minutes. The ratios of cisplatin to total, free (ultrafilterable) platinum in the plasma range from 0.4 to 1.1 after a dose of 100 mg/m 2 . Cisplatin does not undergo instantaneous and reversible binding to plasma proteins characteristic of normal drug-protein binding. However, the platinum from cisplatin becomes bound to plasma proteins. These complexes are slowly eliminated with a half-life of 5 days or more. Following cisplatin doses of 20 to 120 mg/m 2 , the concentrations of platinum are highest in liver, prostate and kidney, somewhat lower in bladder, muscle, testicle, pancreas and spleen and lowest in bowel, adrenal, heart, lung, cerebrum and cerebellum. Platinum is present in tissues for as long as 180 days after the last administration. With the exception of intracerebral 完全なドキュメントを読む