RISEDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Available from:

SANIS HEALTH INC

ATC code:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosage:

150MG

Pharmaceutical form:

TABLET

Composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-06-28

Summary of Product characteristics

_RISEDRONATE (Risedronate Sodium tablets) _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate Sodium Tablets
Tablets, 150 mg risedronate sodium (as risedronate sodium
hemi-pentahydrate), Oral
USP
Bisphosphonates (ATC Code: M05BA07)
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
JUN 28, 2022
Date of revision:
SEP 19, 2023
Submission Control Number:
278754
_RISEDRONATE (Risedronate Sodium tablets) _
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_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
09/2023
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
...........................................................