ZYDELIG TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
18-08-2020
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Aktiva substanser:
IDELALISIB
Tillgänglig från:
GILEAD SCIENCES CANADA INC
ATC-kod:
L01EM01
INN (International namn):
IDELALISIB
Dos:
150MG
Läkemedelsform:
TABLET
Sammansättning:
IDELALISIB 150MG
Administreringssätt:
ORAL
Enheter i paketet:
60
Receptbelagda typ:
Prescription
Terapiområde:
ANTINEOPLASTIC AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0156710002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2015-03-27
Produktens egenskaper
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
.............................
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