APO-DASATINIB TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DASATINIB

Disponible depuis:

APOTEX INC

Code ATC:

L01EA02

DCI (Dénomination commune internationale):

DASATINIB

Dosage:

80MG

forme pharmaceutique:

TABLET

Composition:

DASATINIB 80MG

Mode d'administration:

ORAL

Unités en paquet:

30 BOTTLE / 30 BLISTER

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2019-11-28

Résumé des caractéristiques du produit

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