PMS-RISEDRONATE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

제공처:

PHARMASCIENCE INC

ATC 코드:

M05BA07

INN (International Name):

RISEDRONIC ACID

복용량:

35MG

약제 형태:

TABLET

구성:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

BONE RESORPTION INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0135301003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2010-07-27

제품 특성 요약

_pms-RISEDRONATE (Risedronate Sodium Tablet) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-RISEDRONATE
Risedronate Sodium Tablets
Tablets, 35 mg and 150 mg risedronate sodium (as the
hemi-pentahydrate), Oral
USP
Bisphosphonates
PHARMASCIENCE INC.
6111 Ave. Royalmount
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 269451
Date of Initial Authorization
JUL 27, 2010
Date of Revision:
FEB 01, 2023
_pms-RISEDRONATE (Risedronate Sodium Tablet) _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
N/A
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
.......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
...................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4
Administration
............................................................................................................