TARO-DEFERASIROX (TYPE J) TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DEFERASIROX

Boleh didapati daripada:

TARO PHARMACEUTICALS INC

Kod ATC:

V03AC03

INN (Nama Antarabangsa):

DEFERASIROX

Dos:

360MG

Borang farmaseutikal:

TABLET

Komposisi:

DEFERASIROX 360MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HEAVY METAL ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0151733006; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-11-05

Ciri produk

_Taro-Deferasirox (Type J) Page 1 of 54 _
_ _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DEFERASIROX (TYPE J)
deferasirox
Tablets, 90 mg, 180 mg, 360 mg; oral
Iron chelating agent
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Date of Initial Authorization:
November 05, 2020
Date of Revision:
June 16, 2023
Submission Control No: 268760
_Taro-Deferasirox (Type J) Page 2 of 54 _
_ _
_ _
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
06/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations; 4.2
Recommended Dose
and Dosage Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS; Ear/Nose/Throat;
Hepatic/Biliary/Pancreatic;
Monitoring and Laboratory Tests; Renal
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
(2 to 16
years of age)
06/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.....................................................................................................
2
TABLE OF CONTENTS
.....................................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics
............................................................................................................................
4
1.2 Geriatrics
............................................................................................................................
4
2
CONTRAINDICATIONS
.............................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................................
5
Serious Warnings and Precautions
..............................................................................................