Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
APOTEX INC
M05BA07
RISEDRONIC ACID
150MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 150MG
ORAL
1/30/100
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301005; AHFS:
APPROVED
2011-12-28
_APO-RISEDRONATE (Risedronate Sodium tablets) _ _ _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-RISEDRONATE Risedronate Sodium Tablets Tablets, 150 mg risedronate sodium (as risedronate sodium hemi-pentahydrate), Oral USP Bisphosphonates (ATC Code: M05BA07) APOTEX INC. 150 Signet Drive Toronto Ontario M9L 1T9 Date of Initial Authorization: DEC 28, 2011 Date of revision: JUL 12, 2023 Submission Control Number: 272246 _APO-RISEDRONATE (Risedronate Sodium tablets) _ _ _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 07/2023 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 .................................................................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ........................................................... 5 4.4 Administration .................................................................. Đọc toàn bộ tài liệu