TARO-DASATINIB TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DASATINIB

Tersedia dari:

TARO PHARMACEUTICALS INC

Kode ATC:

L01EA02

INN (Nama Internasional):

DASATINIB

Dosis:

70MG

Bentuk farmasi:

TABLET

Komposisi:

DASATINIB 70MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-05-21

Karakteristik produk

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
.........................................................................................