Land: Kanada
Språk: engelska
Källa: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
PRO DOC LIMITEE
M05BA07
RISEDRONIC ACID
35MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG
ORAL
4
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301003; AHFS:
APPROVED
2020-04-22
______________________________________________________________________________________________ _ _ 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 Läs hela dokumentet