国: カナダ
言語: 英語
ソース: Health Canada
PACLITAXEL
IVAX PHARMACEUTICALS INCORPORATED
L01CD01
PACLITAXEL
6MG
LIQUID
PACLITAXEL 6MG
INTRAVENOUS
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0124214001; AHFS:
CANCELLED PRE MARKET
2015-10-16
PRODUCT MONOGRAPH PACLITAXEL FOR INJECTION 6 mg/mL ANTINEOPLASTIC AGENT Manufacturer: IVAX Pharmaceuticals Inc. Date of Preparation: 4400 Biscayne Blvd., April 1998 Miami, Florida, USA 33137 Date of Revision: December 20, 2005 Distributed by: IVAX Pharmaceuticals Canada Inc. Control #102197 1 Place Ville-Marie, Suite 3900 Montreal, Quebec, Canada H3B 4M7 1 PRODUCT MONOGRAPH PACLITAXEL FOR INJECTION 6 mg/mL THERAPEUTIC CLASSIFICATION ANTINEOPLASTIC AGENT PACLITAXEL FOR INJECTION SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS. PATIENTS RECEIVING PACLITAXEL FOR INJECTION SHOULD BE PRETREATED WITH CORTICOSTEROIDS, ANTIHISTAMINES, AND H 2 ANTAGONISTS (SUCH AS DEXAMETHASONE, DIPHENHYDRAMINE AND CIMETIDINE OR RANITIDINE) TO MINIMIZE HYPERSENSITIVITY REACTIONS (SEE DOSAGE AND ADMINISTRATION). _ALL CLINICAL_ _STUDIES REFERRED TO IN THIS PRODUCT MONOGRAPH WERE CONDUCTED USING_ _TAXOL® PACLITAXEL. _SEVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED BY DYSPNEA AND HYPOTENSION REQUIRING TREATMENT, ANGIOEDEMA, AND GENERALIZED URTICARIA HAVE OCCURRED IN PATIENTS RECEIVING PACLITAXEL FOR INJECTION. THESE REACTIONS ARE PROBABLY HISTAMINE MEDIATED. RARE FATAL REACTIONS HAVE OCCURRED IN PATIENTS DESPITE PRE-TREATMENT. PATIENTS WHO EXPERIENCE SEVERE HYPERSENSITIVITY REACTIONS TO PACLITAXEL FOR INJECTION SHOULD NOT BE RECHALLENGED WITH THE DRUG. ACTIONS AND CLINICAL PHARMACOLOGY PACLITAXEL FOR INJECTION is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. _In vitro_, PACLITAXEL FOR INJECTION exhibits cytotoxic activity against a wide variety of both human and rodent tumor cell lines including leukemia, non-small cell lung carcinoma, small cell lung carcinoma, colon carcinoma, CNS carcinoma, melanoma, renal carcinoma, ovarian carcinoma and breast carcinoma (see PHARMACOLOGY). The pharmacokinetics of paclitaxel have been evaluated over a wide range of doses, up to 300 完全なドキュメントを読む