Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
RISEDRONATE SODIUM; CALCIUM (CALCIUM CARBONATE)
WARNER CHILCOTT CANADA CO
M05BB02
RISEDRONIC ACID AND CALCIUM, SEQUENTIAL
35MG; 500MG
TABLET
RISEDRONATE SODIUM 35MG; CALCIUM (CALCIUM CARBONATE) 500MG
ORAL
7/28
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0251633001; AHFS:
CANCELLED POST MARKET
2015-11-19
_ _ PRODUCT MONOGRAPH Pr ACTONEL PLUS CALCIUM Risedronate Sodium (as the hemi-pentahydrate) 35 mg Tablets USP Bone Metabolism Regulator and Calcium Carbonate 1250 mg Tablets USP Mineral Supplement Warner Chilcott Canada Co. PO Box 4367, Station A Toronto, ON M5W 3N7 Marketed with sanofi-aventis Canada Inc. Laval, QC H7L 4A8 Date of Revision: February 19, 2013 SUBMISSION CONTROL NO: 160238 2 TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ............................................................................3 INDICATIONS AND CLINICAL USE ..................................................................................3 CONTRAINDICATIONS .......................................................................................................4 WARNINGS AND PRECAUTIONS ......................................................................................4 ADVERSE REACTIONS ........................................................................................................7 DRUG INTERACTIONS ......................................................................................................10 DOSAGE AND ADMINISTRATION ..................................................................................13 OVERDOSAGE .....................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY.................................................................15 STORAGE AND STABILITY ..............................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION ..............................................................................20 CLINICAL TRIALS ....................................... Belgenin tamamını okuyun