TEVA-RISEDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 5MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0135301002; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-06-02

Summary of Product characteristics

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TEVA-RISEDRONATE
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Page 1 of 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-RISEDRONATE
Risedronate sodium tablets
Tablets, 5 mg, 30 mg, 35 mg and 150 mg (as the monohydrate), Oral
Teva Standard
Bisphosphonates (ATC Code: M05BA07)
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
October 10, 2013
Date of Revision:
April 18, 2023
Submission Control Number: 269246
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TEVA-RISEDRONATE
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Page 2 of 54
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2023
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
....................................................................................................................
5
1.2
Geriatrics
.....................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4
Administration...................................