Држава: Канада
Језик: Енглески
Извор: Health Canada
FLUVASTATIN (FLUVASTATIN SODIUM)
NOVARTIS PHARMACEUTICALS CANADA INC
C10AA04
FLUVASTATIN
40MG
CAPSULE
FLUVASTATIN (FLUVASTATIN SODIUM) 40MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0125247001; AHFS:
CANCELLED POST MARKET
2018-09-21
_ _ _ _ _Page 1 of 67_ PRODUCT MONOGRAPH Pr LESCOL ® Fluvastatin sodium capsules 20 and 40 mg Pr LESCOL ® XL Fluvastatin sodium extended release tablets 80 mg Lipid Metabolism Regulator Novartis Pharmaceuticals Canada Inc. Dorval, Quebec H9S 1A9 DATE OF REVISION: August 26, 2016 CONTROL NUMBER: 195234 LESCOL is a registered trademark _ _ _ _ _Page 2 of 67_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION .....................................................................3 INDICATIONS AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS .................................................................................................5 WARNINGS AND PRECAUTIONS ...............................................................................6 ADVERSE REACTIONS ................................................................................................17 DRUG INTERACTIONS ................................................................................................22 DOSAGE AND ADMINISTRATION ...........................................................................28 ACTION AND CLINICAL PHARMACOLOGY ........................................................32 STORAGE AND STABILITY........................................................................................36 SPECIAL HANDLING INSTRUCTIONS ....................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................36 PART II: SCIENTIFIC INFORMATION ...............................................................................38 PHARMACEUTICAL INFORMATION ......................................................................38 CLINICAL TRIALS ........................................................................................................39 DETAILED PHARMACOLOGY ........................................................ Прочитајте комплетан документ