TARO-DEFERASIROX TABLET FOR SUSPENSION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DEFERASIROX

Dostupné s:

TARO PHARMACEUTICALS INC

ATC kód:

V03AC03

INN (Mezinárodní Name):

DEFERASIROX

Dávkování:

250MG

Léková forma:

TABLET FOR SUSPENSION

Složení:

DEFERASIROX 250MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

HEAVY METAL ANTAGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0151733002; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2017-06-26

Charakteristika produktu

_TARO-DEFERASIROX (DEFERASIROX) _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_PAGE 1 OF 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-DEFERASIROX
deferasirox
Dispersible Tablets for Suspension, 125 mg, 250 mg, or 500 mg, Oral
Iron chelating agent
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
Submission Control No: 268762
Date of Initial Authorization:
JUN 26, 2017
Date of Revision:
JUN 21, 2023
_TARO-DEFERASIROX (DEFERASIROX) _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_PAGE 2 OF 56 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2023
4 DOSAGE AND ADMINISTRATTION; 4.2 Recommended Dose and Dosage
Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS
06/2023
7 WARNINGS AND PRECAUTIONS; 7.1.3 Pediatrics
06/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
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
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4. 1
DOSING CONSIDERATIONS
......................................................................