SANDOZ RISEDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosage:

35MG

Pharmaceutical form:

TABLET

Composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2010-07-28

Summary of Product characteristics

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_ Sandoz Risedronate (risedronate sodium) Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ RISEDRONATE
Risedronate Sodium (as the hemi-pentahydrate) Tablets
Tablets, 35 mg, oral
Bisphosphonates
(ATC Code: M05BA07)
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
July 28, 2010
Date of Revision:
February 22, 2023
Submission Control Number: 267804
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_ Sandoz Risedronate (risedronate sodium) Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
02/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
02/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Do