Страна: Канада
мова: англійська
Джерело: Health Canada
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)
SANDOZ CANADA INCORPORATED
M05BB03
ALENDRONIC ACID AND CHOLECALCIFEROL
70MG; 5600UNIT
TABLET
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 5600UNIT
ORAL
4
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0251575002; AHFS:
CANCELLED POST MARKET
2023-07-28
_ _ _Sandoz Alendronate/Cholecalciferol _ _Page 1 of 46_ PRODUCT MONOGRAPH Pr SANDOZ ALENDRONATE/CHOLECALCIFEROL alendronate sodium/cholecalciferol tablets 70 mg alendronate (as alendronate sodium) + 140 mcg cholecalciferol (5600 IU vitamin D 3 ) Bone Metabolism Regulator and Vitamin D Sandoz Canada Inc. 145 Jules-Léger Boucherville, Québec J4B 7K8 Date of Revision: July 18, 2017 Submission Control No: 206959 _ _ _Sandoz Alendronate/Cholecalciferol. _ _Page 2 of 46_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 14 DOSAGE AND ADMINISTRATION ............................................................................. 15 OVERDOSAGE ................................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 17 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 23 PART II: SCIENTIFIC INFORMATION .............................................................................. 24 PHARMACEUTICAL INFORMATION ......................................................................... 24 CLINICAL TRIALS ......... Прочитайте повний документ