RISEDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosage:

35MG

Pharmaceutical form:

TABLET

Composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-06-02

Summary of Product characteristics

______________________________________________________________________________________________
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_ Product Monograph – RISEDRONATE Page 1 of 41 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate Sodium Tablets
Tablets, 35 mg, Risedronate Sodium (as the hemi-pentahydrate), oral
Bisphosphonates
(ATC Code: M05BA07)
Submission Control Number: 275211
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Initial Authorization:
SEP 09, 2013
Date of Revision:
JUN 02, 2023
______________________________________________________________________________________________
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_ Product Monograph – RISEDRONATE Page 2 of 41 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
06/2023
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
....................................................................................................
5
4
DOSAGE AND ADMINISTRATION ....................................................................................
5
4.1
Dosing Considerations
............................................................................