Country: Կանադա
language: անգլերեն
source: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)
TEVA CANADA LIMITED
M05BA07
RISEDRONIC ACID
30MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 30MG
ORAL
30
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301001; AHFS:
APPROVED
2011-06-02
_ _ TEVA-RISEDRONATE _ _ Page 1 of 54 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-RISEDRONATE Risedronate sodium tablets Tablets, 5 mg, 30 mg, 35 mg and 150 mg (as the monohydrate), Oral Teva Standard Bisphosphonates (ATC Code: M05BA07) Teva Canada Limited 30 Novopharm Court Toronto, ON M1B 2K9 Canada www.tevacanada.com Date of Initial Authorization: October 10, 2013 Date of Revision: April 18, 2023 Submission Control Number: 269246 _ _ TEVA-RISEDRONATE _ _ Page 2 of 54 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 04/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2023 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................................... read_full_document