ZYDELIG TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-08-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
IDELALISIB
Fáanlegur frá:
GILEAD SCIENCES CANADA INC
ATC númer:
L01EM01
INN (Alþjóðlegt nafn):
IDELALISIB
Skammtar:
150MG
Lyfjaform:
TABLET
Samsetning:
IDELALISIB 150MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
ANTINEOPLASTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0156710002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2015-03-27
Vara einkenni
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
.............................
Lestu allt skjalið
