国家: 加拿大
语言: 英文
来源: Health Canada
IFOSFAMIDE
BAXTER CORPORATION
L01AA06
IFOSFAMIDE
3G
POWDER FOR SOLUTION
IFOSFAMIDE 3G
INTRAVENOUS
60ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0120706001; AHFS:
APPROVED
2002-02-04
_ _ IFEX Product Monograph Page 1 of 37 PRODUCT MONOGRAPH PR IFEX (Ifosfamide for Injection) Powder for Solution, 1 g/vial and 3 g/vial Antineoplastic Agent Baxter Corporation Mississauga, Ontario Canada L5N 0C2 Date of Revision: June 27, 2018 Submission Control No.: 213560 Baxter and Ifex are trademarks of Baxter International Inc., its subsidiaries or affiliates. _ _ IFEX Product Monograph Page 2 of 37 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................20 DOSAGE AND ADMINISTRATION ..............................................................................25 OVERDOSAGE ................................................................................................................27 ACTION AND CLINICAL PHARMACOLOGY ............................................................27 STORAGE AND STABILITY ..........................................................................................28 SPECIAL HANDLING INSTRUCTIONS .......................................................................28 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................29 PART II: SCIENTIFIC INFORMATION ...............................................................................30 PHARMACEUTICAL INFORMATION ..................................................................... 阅读完整的文件