ACT SERTRALINE CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Sẵn có từ:

ACTAVIS PHARMA COMPANY

Mã ATC:

N06AB06

INN (Tên quốc tế):

SERTRALINE

Liều dùng:

100MG

Dạng dược phẩm:

CAPSULE

Thành phần:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/250

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123417002; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-07-09

Đặc tính sản phẩm

Page 1 of 53
PRODUCT MONOGRAPH
P
PR
ACT SERTRALINE
Sertraline as Sertraline Hydrochloride
Capsules, 25 mg, 50 mg and 100 mg
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Control No.: 198893
Date of Revision:
October 24, 2016
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
..............................................................................5
ADVERSE REACTIONS
..............................................................................................
13
DRUG INTERACTIONS
..............................................................................................
21
DOSAGE AND ADMINISTRATION
...........................................................................
26
OVERDOSAGE
............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 29
STORAGE AND STABILITY
......................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
....................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 32
PART II: SCIENTIFIC INFORMATION
............................................................................
33
PHARMACEUTICAL
INFORMATION.......................................................................
33
CLINICAL
TRIALS................................................................................................