Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE); CALCIUM (CALCIUM CARBONATE)
PHARMASCIENCE INC
M05BB02
RISEDRONIC ACID AND CALCIUM, SEQUENTIAL
35MG; 500MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG; CALCIUM (CALCIUM CARBONATE) 500MG
ORAL
100
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0251633001; AHFS:
APPROVED
2011-02-17
PRODUCT MONOGRAPH PR PMS-RISEDRONATE PLUS CALCIUM Risedronate Sodium (as the hemi-pentahydrate) 35 mg Tablets, House Standard BONE METABOLISM REGULATOR and Calcium Carbonate 1250 mg Caplets, House Standard (Equivalent to 500 mg elemental calcium) MINERAL SUPPLEMENT PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Avenue, Suite 100, June 08, 2016 Montreal QC, H4P 2T4 www.pharmascience.com Control Number: 195294 _ _ _pms-RISEDRONATE PLUS CALCIUM - Product Monograph Page 2 of 38_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS........................................................................................................... 7 DRUG INTERACTIONS ......................................................................................................... 10 DOSAGE AND ADMINISTRATION ..................................................................................... 13 OVERDOSAGE ....................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 15 STORAGE AND STABILITY ................................................................................................. 19 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 20 PART II: SCIENTIFIC INFORMATION .................................................................................... 21 PHARMACEUTICAL INFORMA Đọc toàn bộ tài liệu