Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)
SANIS HEALTH INC
M05BA07
RISEDRONIC ACID
35MG
TABLET
RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 35MG
ORAL
4
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0135301003; AHFS:
APPROVED
2011-09-22
_ _ _RISEDRONATE Tablets _ _ _ _Page 1 of 51_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR RISEDRONATE Risedronate sodium (as the monohydrate) 35 mg Tablets Manufacturer’s Standard Bisphosphonates Sanis Health Inc. 1 President’s Choice Circle Brampton, Ontario L6Y 5S5 www.sanis.com Date of Revision: March 6, 2019 Submission Control No: 224337 _ _ _RISEDRONATE Tablets _ _ _ _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 ......................................................................................... 4 ADVERSE REACTIONS ........................................................................................................... 7 DRUG INTERACTIONS ......................................................................................................... 12 DOSAGE AND ADMINISTRATION ..................................................................................... 14 OVERDOSAGE ....................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 16 STORAGE AND STABILITY ................................................................................................. 20 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 21 PART II: SCIENTIFIC INFORMATION ............................................................................... 22 PHARMACEUTICAL INFORMATION .............................................................................. Baca dokumen lengkap