Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
TEVA CANADA LIMITED
N06AB10
ESCITALOPRAM
10MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG
ORAL
30/100/250/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435002; AHFS:
CANCELLED POST MARKET
2018-06-12
_ _ _ _ ACT ESCITALOPRAM_ _ _ _ _ _ _ _ _ Page 1 of 52_ PRODUCT MONOGRAPH PR ACT ESCITALOPRAM Escitalopram Oxalate Tablets 5 mg, 10 mg & 20 mg escitalopram as escitalopram oxalate Professed Standard ANTIDEPRESSANT Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Revision: April 19, 2018 Control No.: 214495 _ _ ACT ESCITALOPRAM _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 ................................................................................. 4 ADVERSE REACTIONS ................................................................................................. 11 DRUG INTERACTIONS ................................................................................................. 21 DOSAGE AND ADMINISTRATION ............................................................................. 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 30 STORAGE AND STABILITY ......................................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 32 PART II: SCIENTIFIC INFORMATION ............................................................................... 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ......................................................................................................... 34 DETAILED PHARMACOLOGY .................................................................................... 36 TOXICOLOGY ............... Đọc toàn bộ tài liệu