AA-RISEDRONATE DR TABLET (DELAYED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

MAH:

AA PHARMA INC

ATC_code:

M05BA07

INN:

RISEDRONIC ACID

dosage:

35MG

pharmaceutical_form:

TABLET (DELAYED-RELEASE)

composition:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

BONE RESORPTION INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2023-09-08

SPC

_Page 1 of 42_
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-RISEDRONATE DR
Risedronate Sodium Delayed-Release Tablets
Delayed-Release Tablets, 35 mg (as the hemi-pentahydrate), Oral
Bisphosphonates (ATC Code: M05BA07)
Submission Control Number:
278226
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
SEP
08, 2023
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets) _
_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
Not Applicable
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
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration.......................................................................................................
5
4.5
Missed Dose
.........................................