AURO-RISEDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Available from:

AURO PHARMA 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:

1

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-06-19

Summary of Product characteristics

_PAGE 1 OF 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-RISEDRONATE
Risedronate Sodium Tablets
5 mg, 30 mg, 35 mg & 150 mg
Risedronate sodium (as the hemi-pentahydrate)
House standard
Bisphosphonates
AURO PHARMA INC. Date of Revision:
3700 Steeles Avenue West, Suite # 402
August 22, 2019
Woodbridge, Ontario, L4L 8K8, Canada.
Submission Control No.: 230708
_PAGE 2 OF 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
7
DRUG INTERACTIONS
.....................................................................................
14
DOSAGE AND ADMINISTRATION
................................................................. 16
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 23
PART II: SCIENTIFIC INFORMATION
................................................................... 24
PHARMACEUTICAL INFORMATION
............................................................. 24
CLINICAL TRIALS
.............................................................................................
25
DETAILED PHARMACOLOGY
........................................................................
40
TOXICOLOGY
..............................................