APO-DASATINIB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-05-2021
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Active ingredient:
DASATINIB
Available from:
APOTEX INC
ATC code:
L01EA02
INN (International Name):
DASATINIB
Dosage:
70MG
Pharmaceutical form:
TABLET
Composition:
DASATINIB 70MG
Administration route:
ORAL
Units in package:
60 BOTTLE / 30 BLISTER
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0152198003; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-11-28
Summary of Product characteristics
Page 1 of 61
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg and 100 mg
Protein Kinase Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
May 10, 2021
Submission Control No: 247860
Page 2 of 61
RECENT MAJOR LABEL CHANGES
Dosage and Administration, Dose reduction for concomitant use of
strong CYP3A4 inhibitors
05/2021
Dosage and Administration, Dose Adjustment for Adverse Reactions
05/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS
..................................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................................
4
ADVERSE REACTIONS
................................................................................................................
13
DRUG
INTERACTIONS.................................................................................................................
27
DOSAGE AND ADMINISTRATION
............................................................................................
29
OVERDOSAGE
...............................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
32
STORAGE AND STABILITY
........................................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
......................................................................................
34
DOSAGE FORMS, COMPOSITION AN
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