ZYDELIG TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

IDELALISIB

Prieinama:

GILEAD SCIENCES CANADA INC

ATC kodas:

L01EM01

INN (Tarptautinis Pavadinimas):

IDELALISIB

Dozė:

150MG

Vaisto forma:

TABLET

Sudėtis:

IDELALISIB 150MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

60

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2015-03-27

Prekės savybės

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