PMS-RISEDRONATE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Saadav alates:

PHARMASCIENCE INC

ATC kood:

M05BA07

INN (Rahvusvaheline Nimetus):

RISEDRONIC ACID

Annus:

35MG

Ravimvorm:

TABLET

Koostis:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Manustamisviis:

ORAL

Ühikuid pakis:

30

Retsepti tüüp:

Prescription

Terapeutiline ala:

BONE RESORPTION INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2010-07-27

Toote omadused

_pms-RISEDRONATE (Risedronate Sodium Tablet) _
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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
............................................................................................................