RISEDRONATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-03-2017
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Active ingredient:
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)
Available from:
SANIS HEALTH INC
ATC code:
M05BA07
INN (International Name):
RISEDRONIC ACID
Dosage:
30MG
Pharmaceutical form:
TABLET
Composition:
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 30MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0135301001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2019-01-24
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
RISEDRONATE
Risedronate sodium (as the monohydrate)
5 mg, 30 mg, 35 mg Tablets
Manufacturer’s Standard
Bone Metabolism Regulator
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
March 16, 2017
Submission Control No.: 203183
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.................................................................................
23
DETAILED PHARMACOLOGY
.................................................
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