APO-RISEDRONATE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

MAH:

APOTEX INC

ATC_code:

M05BA07

INN:

RISEDRONIC ACID

dosage:

150MG

pharmaceutical_form:

TABLET

composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150MG

administration_route:

ORAL

units_in_package:

1/30/100

prescription_type:

Prescription

therapeutic_area:

BONE RESORPTION INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0135301005; AHFS:

authorization_status:

APPROVED

authorization_date:

2011-12-28

SPC

_APO-RISEDRONATE (Risedronate Sodium tablets) _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RISEDRONATE
Risedronate Sodium Tablets
Tablets, 150 mg risedronate sodium (as risedronate sodium
hemi-pentahydrate), Oral
USP
Bisphosphonates (ATC Code: M05BA07)
APOTEX INC.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Initial Authorization:
DEC 28, 2011
Date of revision:
JUL 12, 2023
Submission Control Number: 272246
_APO-RISEDRONATE (Risedronate Sodium tablets) _
_ _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
07/2023
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
..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................... 5
4.4
Administration
..................................................................