ZYDELIG TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

IDELALISIB

Dostupno od:

GILEAD SCIENCES CANADA INC

ATC koda:

L01EM01

INN (International ime):

IDELALISIB

Doziranje:

150MG

Farmaceutski oblik:

TABLET

Sastav:

IDELALISIB 150MG

Administracija rute:

ORAL

Jedinice u paketu:

60

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2015-03-27

Svojstava lijeka

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