Land: Canada
Sprog: engelsk
Kilde: Health Canada
ALENDRONIC ACID (ALENDRONATE SODIUM); VITAMIN D3 (CHOLECALCIFEROL)
TEVA CANADA LIMITED
M05BB03
ALENDRONIC ACID AND CHOLECALCIFEROL
70MG; 5600UNIT
TABLET
ALENDRONIC ACID (ALENDRONATE SODIUM) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 5600UNIT
ORAL
4
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0251575002; AHFS:
APPROVED
2013-03-25
PRODUCT MONOGRAPH PR TEVA-ALENDRONATE/CHOLECALCIFEROL alendronate sodium/cholecalciferol tablets 70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D 3 ) PR TEVA-ALENDRONATE/CHOLECALCIFEROL alendronate sodium/cholecalciferol tablets 70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D 3 ) Bone Metabolism Regulator and Vitamin D Teva Canada Limited Date of Revision: 30 Novopharm Court July 24, 2017 Toronto, Ontario M1B 2K9 Canada Submission Control No: 207329 2 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 .......................................................................... 16 OVERDOSAGE ............................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 17 STORAGE AND STABILITY ...................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................... 22 PART II: SCIENTIFIC INFORMATION ............................................................................... 24 PHARMACEUTICAL INFORMATION ...................................................................... 24 CLINICAL TRIALS ..................................... Læs hele dokumentet