Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
MYLAN PHARMACEUTICALS ULC
M05BA07
RISEDRONIC ACID
35MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG
ORAL
4/30
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301003; AHFS:
CANCELLED POST MARKET
2017-11-14
PRODUCT MONOGRAPH PR MYLAN-RISEDRONATE Risedronate Sodium Tablets, USP 35 mg and 150 mg risedronate sodium (as the hemi-pentahydrate) Bisphosphonates Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke ON M8Z 2S6 Control No.: 194897 Date of Revision: July 14, 2016 PAGE 2 OF 48 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMAR Y PRODUCT INFORMATION ................................................................ 3 INDICATIONS AND CLINICAL USE ....................................................................... 3 CONTRAINDICATIONS .............................................................................................. 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS............................................................................................... 7 DRUG INTERACTIONS ............................................................................................. 11 DOSAGE AND ADMINISTRATION ....................................................................... 14 OVERDOSAGE ............................................................................................................. 16 ACTION AND CLINICAL PHARMACOLOGY ................................................... 16 STORAGE AND STABILITY .................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................. 20 PART II: SCIENTIFIC INFORMATION ............................................................................ 22 PHARMACEUTICAL INFORMATION ................................................................. 22 CLINICAL TRIALS ..................................................................................................... 24 DETAILED PHARMACOLOGY .............................................................................. 36 TOXICOLOGY .............................................................. Đọc toàn bộ tài liệu