APO-DASATINIB TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DASATINIB

Disponibil de la:

APOTEX INC

Codul ATC:

L01EA02

INN (nume internaţional):

DASATINIB

Dozare:

80MG

Forma farmaceutică:

TABLET

Compoziție:

DASATINIB 80MG

Calea de administrare:

ORAL

Unități în pachet:

30 BOTTLE / 30 BLISTER

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-11-28

Caracteristicilor produsului

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