FOSRENOL TABLET (CHEWABLE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LANTHANUM (LANTHANUM CARBONATE HYDRATE)

Tersedia dari:

TAKEDA CANADA INC

Kode ATC:

V03AE03

INN (Nama Internasional):

LANTHANUM CARBONATE

Dosis:

750MG

Bentuk farmasi:

TABLET (CHEWABLE)

Komposisi:

LANTHANUM (LANTHANUM CARBONATE HYDRATE) 750MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

PHOSPHATE-REMOVING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0151709003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2007-10-04

Karakteristik produk

_ _
_ _
_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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................