Страна: Канада
Език: английски
Източник: Health Canada
FLUVOXAMINE MALEATE
DOMINION PHARMACAL
N06AB08
FLUVOXAMINE
50MG
TABLET
FLUVOXAMINE MALEATE 50MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0122450002; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH Pr DOM-FLUVOXAMINE Fluvoxamine Maleate Tablets, BP 50 mg & 100 mg ANTIDEPRESSANT/ANTIOBSESSIONAL AGENT DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Revision: October 07, 2016 Submission Control No.: 198564 _ _ _Dom-FLUVOXAMINE Product Monograph _ _Page 2 of 52_ 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 ................................................................................................................27 ACTION AND CLINICAL PHARMACOLOGY ............................................................28 STORAGE AND STABILITY ..........................................................................................30 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................30 PART II: SCIENTIFIC INFORMATION ...............................................................................31 PHARMACEUTICAL INFORMATION ..........................................................................31 CLINICAL TRIALS ..........................................................................................................32 DETAILED PHARMACOLOGY ..................................... Прочетете целия документ