ZYDELIG TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IDELALISIB

Tersedia dari:

GILEAD SCIENCES CANADA INC

Kode ATC:

L01EM01

INN (Nama Internasional):

IDELALISIB

Dosis:

150MG

Bentuk farmasi:

TABLET

Komposisi:

IDELALISIB 150MG

Rute administrasi :

ORAL

Unit dalam paket:

60

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0156710002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-03-27

Karakteristik produk

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
.............................