AURO-RISEDRONATE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Verfügbar ab:

AURO PHARMA INC

ATC-Code:

M05BA07

INN (Internationale Bezeichnung):

RISEDRONIC ACID

Dosierung:

35MG

Darreichungsform:

TABLET

Zusammensetzung:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

4/28

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-05-08

Fachinformation

Auro-Risedronate Product Monograph
Page 1 of 56
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-RISEDRONATE
Risedronate Sodium Tablets
Tablets, 5 mg, 30 mg, 35 mg and 150 mg
Risedronate sodium (as the hemi-pentahydrate), for oral use
House standard
Bisphosphonates
AURO PHARMA INC.
3700 Steeles Avenue West,
Suite # 402 Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
May 08, 2013
Date of Revision:
December 21, 2023
Submission Control Number: 278087
Auro-Risedronate Product Monograph
Page 2 of 56
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
12/2023
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
...................................................................................................................
5
1.2 Geriatrics
...................................................................................................................
5
2 CONTRAINDICATIONS
.........................................................................................................
5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.4 Administration
..............................