APO-DASATINIB TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DASATINIB

Pieejams no:

APOTEX INC

ATĶ kods:

L01EA02

SNN (starptautisko nepatentēto nosaukumu):

DASATINIB

Deva:

80MG

Zāļu forma:

TABLET

Kompozīcija:

DASATINIB 80MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30 BOTTLE / 30 BLISTER

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0152198005; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-11-28

Produkta apraksts

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