SANDOZ DEFERASIROX TABLET FOR SUSPENSION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DEFERASIROX

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

V03AC03

INN (International Nazwa):

DEFERASIROX

Dawkowanie:

500MG

Forma farmaceutyczna:

TABLET FOR SUSPENSION

Skład:

DEFERASIROX 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

28

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HEAVY METAL ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0151733003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2017-06-08

Charakterystyka produktu

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_Pr_
_Sandoz® Deferasirox (deferasirox) Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ
® DEFERASIROX
deferasirox
Dispersible Tablets for Suspension, 125 mg, 250 mg, and 500 mg, oral
Iron chelating agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Submission Control Number: 268744
Date of Initial Authorization:
June 8, 2017
Date of Revision:
February 15, 2023
_ _
_Pr_
_Sandoz® Deferasirox (deferasirox) Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
02/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations; 4.2
Recommended Dose
and Dosage Adjustment
02/2023
5 OVERDOSAGE
02/2023
7 WARNINGS AND PRECAUTIONS; Ear/Nose/Throat;
Hepatic/Biliary/Pancreatic;
Monitoring and Laboratory Tests; Renal
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
(2 to 16
years of age)
02/2023
8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions
02/2023
PATIENT MEDICATION INFORMATION, Children and adolescents (age 2 years
to 16
years), Usual dose
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
.....................................................