Nazione: Canada
Lingua: inglese
Fonte: Health Canada
CARBOPLATIN
STRIDES PHARMA CANADA INC
L01XA02
CARBOPLATIN
10MG
SOLUTION
CARBOPLATIN 10MG
INTRAVENOUS
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0117892002; AHFS:
APPROVED
2020-05-20
PRODUCT MONOGRAPH PR CARBOPLATIN INJECTION, BP CONCENTRATED STERILE SOLUTION FOR INJECTION 10 MG/ML CARBOPLATIN ANTINEOPLASTIC AGENT Concentrate – must be diluted before use Strides Pharma Canada Inc. Date of revision: 1565, Boul. Lionel-Boulet May 20, 2020 Varennes, Quebec Canada J3X 1P7 Submission Control No.: 237832 2 PR CARBOPLATIN INJECTION, BP 10 MG/ML STERILE THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION CAUTION: CARBOPLATIN 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 MUST BE DONE REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. ACTIONS AND CLINICAL PHARMACOLOGY Carboplatin has biochemical properties similar to that of cisplatin, thus producing predominantly interstrand DNA, crosslinks. In patients with creatinine clearances of 60 mL/min or greater given Carboplatin injection at doses of 300 to 500 mg/m 2 , the plasma concentrations of Carboplatin decline in a biphasic manner with mean alpha and beta half- lives of 1.6 h and 3.0 h. respectively. The total body clearance, apparent volume of distribution, and mean residence time for Carboplatin is 73 mL/min, 16 L, and 3.5 h. respectively. The Cmax and AUC increase linearly with dose. Therefore, over the range of doses studied, Carboplatin exhibits linear, pharmacokinetics in patients with creatinine clearances ≥ 60 mL /min. Repeated dosing during four consecutive days did not produce an accumulation of platinum in plasma. Following administration of carboplatin, reported values for the terminal elimination half-lives of free ultrafilterable platinum and carboplatin in man are approximately 6 hours and 1.5 hours respectively. During the initial phase, most of the free ultrafilterable platinum is present as carboplatin. The terminal half-life for total plasma platinum is 24 hours. Approximately 87% of plasma platinum is protein bound w Leggi il documento completo