RISEDRONATE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Tilgjengelig fra:

PRO DOC LIMITEE

ATC-kode:

M05BA07

INN (International Name):

RISEDRONIC ACID

Dosering :

35MG

Legemiddelform:

TABLET

Sammensetning:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Administreringsrute:

ORAL

Enheter i pakken:

4

Resept typen:

Prescription

Terapeutisk område:

BONE RESORPTION INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-04-22

Preparatomtale

______________________________________________________________________________________________
_
_ Risedronate (risedronate sodium) Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate Sodium Tablets
Tablets, 35 mg risedronate sodium (as the hemi-pentahydrate), oral
Bisphosphonates
(ATC Code: M05BA07)
Pro Doc Ltée
2925 boul. Industriel
Laval, QC
H7L 3W9
Submission Control Number: 275305
Date
of Initial Authorization:
SEP
30, 2010
Date of
Revision:
JUN 02, 2023
______________________________________________________________________________________________
_
_ Risedronate (risedronate sodium) Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
06/2023
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
......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose