FOSRENOL TABLET (CHEWABLE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

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Ficha técnica Ficha técnica (SPC)
06-04-2023

Ingredientes activos:

LANTHANUM (LANTHANUM CARBONATE HYDRATE)

Disponible desde:

TAKEDA CANADA INC

Código ATC:

V03AE03

Designación común internacional (DCI):

LANTHANUM CARBONATE

Dosis:

500MG

formulario farmacéutico:

TABLET (CHEWABLE)

Composición:

LANTHANUM (LANTHANUM CARBONATE HYDRATE) 500MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

PHOSPHATE-REMOVING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0151709002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2007-10-04

Ficha técnica

                                _ _
_ _
_FOSRENOL_
_®_
_ Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FOSRENOL®
lanthanum carbonate hydrate
Chewable tablets, 250 mg, 500 mg, 750 mg, and 1000 mg, oral
Phosphate binder
ATC code: V03A E03
Takeda Canada Inc.
22 Adelaide Street West,
Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Authorization:
December 14, 2012
Date of Revision:
April 06, 2023
Submission Control Number:
270959
FOSRENOL® and the FOSRENOL Logo are registered trademarks of Shire
International Licensing BV, a
Takeda company. TAKEDA® and the TAKEDA Logo are registered trademarks
of Takeda Pharmaceutical
Company Limited, used under license.
_ _
_ _
_ _
_FOSRENOL_
_®_
_ Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
[To update, right-click anywhere in the Table of Contents and select
“Update Field”, “Update entire
table”, click OK.]
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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