Страна: Канада
Язык: английский
Источник: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)
NT PHARMA CANADA LTD
M05BA07
RISEDRONIC ACID
35MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG
ORAL
4/30
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301003; AHFS:
CANCELLED PRE MARKET
2017-03-16
PRODUCT MONOGRAPH PR NTP-RISEDRONATE Risedronate sodium (as the monohydrate) 5 mg, 30 mg and 35 mg Tablets Bone Metabolism Regulator NT Pharma Canada Ltd. 5691 Main Street Stouffville, Ontario Canada, L4A 1H5 Submission Control No: 156479 Date of Revision: July 26, 2012 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 ........................................................................................................... 6 DRUG INTERACTIONS ......................................................................................................... 11 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 ............................................................................... 21 PHARMACEUTICAL INFORMATION ................................................................................. 21 CLINICAL TRIALS ................................................................................................................. 22 Прочитать полный документ