Country: Canada
Language: English
Source: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
AURO PHARMA INC
M05BA07
RISEDRONIC ACID
30MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 30MG
ORAL
28
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301001; AHFS:
APPROVED
2013-05-08
_PAGE 1 OF 51 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-RISEDRONATE Risedronate Sodium Tablets 5 mg, 30 mg, 35 mg & 150 mg Risedronate sodium (as the hemi-pentahydrate) House standard Bisphosphonates AURO PHARMA INC. Date of Revision: 3700 Steeles Avenue West, Suite # 402 August 22, 2019 Woodbridge, Ontario, L4L 8K8, Canada. Submission Control No.: 230708 _PAGE 2 OF 51 _ 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 ..................................................................................... 14 DOSAGE AND ADMINISTRATION ................................................................. 16 OVERDOSAGE ................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ............................................... 18 STORAGE AND STABILITY ............................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 23 PART II: SCIENTIFIC INFORMATION ................................................................... 24 PHARMACEUTICAL INFORMATION ............................................................. 24 CLINICAL TRIALS ............................................................................................. 25 DETAILED PHARMACOLOGY ........................................................................ 40 TOXICOLOGY .............................................. Read the complete document