Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
AURO PHARMA INC
M05BA07
RISEDRONIC ACID
35MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG
ORAL
4/28
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301003; AHFS:
APPROVED
2013-05-08
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 .............................. Aqra d-dokument sħiħ