PMS-RISEDRONATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

M05BA07

SNN (starptautisko nepatentēto nosaukumu):

RISEDRONIC ACID

Deva:

35MG

Zāļu forma:

TABLET

Kompozīcija:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30

Receptes veids:

Prescription

Ārstniecības joma:

BONE RESORPTION INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-07-27

Produkta apraksts

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