Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
NORA PHARMA INC
N06AB06
SERTRALINE
100MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417002; AHFS:
CANCELLED POST MARKET
2023-04-01
_ESCITALOPRAM Tablets _ _Page 1 of 53 _ PRODUCT MONOGRAPH PR ESCITALOPRAM TABLETS Escitalopram Oxalate Tablets 10 and 20 mg escitalopram (as escitalopram oxalate) Manufacturer’s Standard ANTIDEPRESSANT / ANTIOBSESSIONAL NORA PHARMA INC. 1565, Lionel-Boulet Boul. Varennes, Québec J3X 1P7 Control #: 263886 Date of Preparation: June 2, 2022 _ESCITALOPRAM Tablets _ _Page 2 of 53 _ 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 ......................................................................................................... 10 DRUG INTERACTIONS.......................................................................................................... 23 DOSAGE AND ADMINISTRATION...................................................................................... 29 OVERDOSAGE ........................................................................................................................ 31 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 32 STORAGE AND STABILITY ................................................................................................. 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 33 PART II: SCIENTIFIC INFORMATION .......................................................................................... 35 PHARMACEUTICAL INFORMATION ................................................................................. Đọc toàn bộ tài liệu