APO-TEMOZOLOMIDE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-02-2018
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Active ingredient:
TEMOZOLOMIDE
Available from:
APOTEX INC
ATC code:
L01AX03
INN (International Name):
TEMOZOLOMIDE
Dosage:
20MG
Pharmaceutical form:
CAPSULE
Composition:
TEMOZOLOMIDE 20MG
Administration route:
ORAL
Units in package:
5/20
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0138781002; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-09-24
Summary of Product characteristics
Page 1 of 55
PRODUCT MONOGRAPH
PR
APO-TEMOZOLOMIDE
TEMOZOLOMIDE CAPSULES
5 MG, 20 MG, 100 MG, 140 MG, 180 MG AND 250 MG
ANTINEOPLASTIC AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
FEBRUARY 1, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 207074
Page 2 of 55
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................
19
OVERDOSAGE
......................................................................................................................
21
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
22
STORAGE AND STABILITY
...............................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
...........................................
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