RIVA-ALENDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Available from:

LABORATOIRE RIVA INC.

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID (ALENDRONATE SODIUM) 5MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0150323004; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-05-30

Summary of Product characteristics

_RIVA-ALENDRONATE (alendronate sodium tablets) _
_Page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-ALENDRONATE
Alendronate Sodium Tablets
Tablets, 5 mg, 10 mg and 70 mg, Oral
House Standard
Bone Metabolism Regulator
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
DATE OF INITIAL AUTHORIZATION:
September 9, 2005
Submission Control Number: 265066
DATE OF REVISION:
July
8, 2022
_RIVA-ALENDRONATE (alendronate sodium tablets) _
_Page 2 of 51 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
07/2022
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
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
..............................................................................................................
6
5
OVERDOSAGE
.............