FOSRENOL TABLET (CHEWABLE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LANTHANUM (LANTHANUM CARBONATE HYDRATE)

제공처:

TAKEDA CANADA INC

ATC 코드:

V03AE03

INN (국제 이름):

LANTHANUM CARBONATE

복용량:

250MG

약제 형태:

TABLET (CHEWABLE)

구성:

LANTHANUM (LANTHANUM CARBONATE HYDRATE) 250MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

PHOSPHATE-REMOVING AGENTS

제품 요약:

Active ingredient group (AIG) number: 0151709001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2023-04-25

제품 특성 요약

_ _
_ _
_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
.................................................................................