TARO-DASATINIB TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DASATINIB

Dostupné z:

TARO PHARMACEUTICALS INC

ATC kód:

L01EA02

INN (Medzinárodný Name):

DASATINIB

Dávkovanie:

70MG

Forma lieku:

TABLET

Zloženie:

DASATINIB 70MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0152198003; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-05-21

Súhrn charakteristických

Page 1 of 65
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib
Protein-tyrosine kinase inhibitor
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Revision:
March 19, 2021
Submission Control No: 245318
Page 2 of 65
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
.............................................................................................
14
DRUG INTERACTIONS
.............................................................................................
28
DOSAGE AND ADMINISTRATION
..........................................................................
30
OVERDOSAGE
...........................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 33
STORAGE AND STABILITY
.....................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
................................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 35
PART II: SCIENTIFIC INFORMATION
..........................................................................
37
PHARMACEUTICAL INFORMATION
......................................................................
37
CLINICAL TRIALS
.........................................................................................