Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
FLUVOXAMINE MALEATE
LABORATOIRE RIVA INC.
N06AB08
FLUVOXAMINE
100MG
TABLET
FLUVOXAMINE MALEATE 100MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0122450001; AHFS:
CANCELLED POST MARKET
2021-05-12
_RIVA-FLUVOX – Product Monograph _ _ _ _Page 1 of 50 _ PRODUCT MONOGRAPH PR RIVA-FLUVOX (Fluvoxamine Maleate Tablets) 50 mg and 100 mg Manufacturer Standard Antidepressant /Antiobsessional Agent LABORATOIRE RIVA INC. 660 Boul. Industriel, Blainville, Québec J7C 3V4 www.labriva.com Date of Revision: February 6, 2020 Control No.: 235581 _RIVA-FLUVOX – Product Monograph _ _ _ _Page 2 of 50 _ 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 ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................18 DOSAGE AND ADMINISTRATION ..............................................................................25 OVERDOSAGE ................................................................................................................26 ACTION AND CLINICAL PHARMACOLOGY .............................................................27 STORAGE AND STABILITY ..........................................................................................29 DOSAGE FORMS, COMPOSITION AND PACKAGING..............................................29 PART II: SCIENTIFIC INFORMATION ................................................................................30 PHARMACEUTICAL INFORMATION ..........................................................................30 CLINICAL TRIALS ....................................................................................... Baca dokumen lengkap