Q-RISEDRONATE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

MAH:

QD PHARMACEUTICALS ULC

ATC_code:

M05BA07

INN:

RISEDRONIC ACID

dosage:

35MG

pharmaceutical_form:

TABLET

composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

administration_route:

ORAL

units_in_package:

4/30

prescription_type:

Prescription

therapeutic_area:

BONE RESORPTION INHIBITORS

leaflet_short:

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

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2015-08-21

SPC

PRODUCT MONOGRAPH
PR
Q-RISEDRONATE
Risedronate Sodium Tablets, USP
35 mg risedronate sodium (as the hemi-pentahydrate)
Bone Metabolism Regulator
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M8Z 2S6
Control No. 169750
Date of Revision:
November 27, 2013
PAGE 2 OF 43
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
................................................................................................
6
DRUG INTERACTIONS
...............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
14
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 16
STORAGE AND STABILITY
......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................... 19
PART II: SCIENTIFIC INFORMATION ..............................................................................
21
PHARMACEUTICAL INFORMATION
................................................................... 21
CLINICAL TRIALS
.......................................................................................................
23
DETAILED PHARMACOLOGY
................................................................................
34
TOXICOLOGY
....................................