Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ALENDRONIC ACID (ALENDRONATE SODIUM)
MINT PHARMACEUTICALS INC
M05BA04
ALENDRONIC ACID
10.0MG
TABLET
ALENDRONIC ACID (ALENDRONATE SODIUM) 10.0MG
ORAL
28
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0150323003; AHFS:
CANCELLED POST MARKET
2018-08-01
_Product Monograph – _ MINT-ALENDRONATE _ _ _ Page 1 of 47 _ PR O D U CT MON OGR A PH MINT-ALENDRONATE ALENDRONATE SODIUM TABLETS 5 MG, 10 MG AND 70 MG Bone Metabolism Regulator Mint Pharmaceuticals Inc. 1093 Meyerside Drive, Unit 1 Mississauga, Ontario L5T 1J6 Date of Revision: April 19, 2018 SUBMISSION CONTROL NO.: 214834 _Product Monograph – _ MINT-ALENDRONATE _ _ _ Page 2 of 47 _ 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 ......................................................................................................... 13 DOSAGE AND ADMINISTRATION ...................................................................................... 14 OVERDOSAGE ....................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 16 STORAGE AND STABILITY ................................................................................................. 21 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 21 PART II: SCIENTIFIC INFORMATION ............................................... 22 PHARMACEUTICAL INFORMATION ................................................................................. 22 CLINICAL TRIALS ......................................................... Přečtěte si celý dokument