Country: Канада
Језик: Енглески
Извор: Health Canada
IDELALISIB
GILEAD SCIENCES CANADA INC
L01EM01
IDELALISIB
150MG
TABLET
IDELALISIB 150MG
ORAL
60
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0156710002; AHFS:
APPROVED
2015-03-27
Page 1 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ZYDELIG ® idelalisib tablets Tablet, 150 mg and 100 mg, oral Antineoplastic Agent Gilead Sciences Canada, Inc. Mississauga, ON L5N 2W3 www.gilead.ca Submission Control No.: 240413 Date of Initial Approval: 19 February 2015 Date of Revision: August 18, 2020 Page 2 TABLE OF CONTENTS PART I. HEALTH PROFESSIONAL INFORMATION ................................................................. 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS ........................................................................................ 5 ADVERSE REACTIONS ....................................................................................................... 10 DRUG INTERACTIONS ....................................................................................................... 17 DOSAGE AND ADMINISTRATION ..................................................................................... 18 OVERDOSAGE................................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 21 STORAGE AND STABILITY ................................................................................................. 24 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 24 PART II. SCIENTIFIC INFORMATION .................................................................................... 25 PHARMACEUTICAL INFORMATION ............................. Прочитајте комплетан документ