Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
SIVEM 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
2018-07-04
_RISEDRONATE Product Monograph _ _Page 1 of 35_ PRODUCT MONOGRAPH Pr RISEDRONATE Risedronate Sodium Tablets, USP (as the hemi-pentahydrate) 35 mg BONE METABOLISM REGULATOR SIVEM PHARMACEUTICALS ULC DATE OF REVISION: June 25, 2014 4705 Dobrin Saint-Laurent, Quebec H4R 2P7 Submission Control No: 175592 _RISEDRONATE Product Monograph _ _Page 2 of 35_ 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 ................................................................................................... 6 DRUG INTERACTIONS .................................................................................................... 9 DOSAGE AND ADMINISTRATION ............................................................................. 11 OVERDOSAGE ................................................................................................................ 12 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 12 STORAGE AND STABILITY ......................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 16 PART II: SCIENTIFIC INFORMATION ............................................................................... 17 PHARMACEUTICAL INFORMATION ......................................................................... 17 CLINICAL TRIALS ......................................................................................................... 18 DETAILED PHARMACOLOG Baca dokumen lengkap