SERTRALINE CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Sẵn có từ:

COBALT PHARMACEUTICALS COMPANY

Mã ATC:

N06AB06

INN (Tên quốc tế):

SERTRALINE

Liều dùng:

50MG

Dạng dược phẩm:

CAPSULE

Thành phần:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123417001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2017-09-01

Đặc tính sản phẩm

PRODUCT MONOGRAPH
P
PR
_ _SERTRALINE
Sertraline as Sertraline Hydrochloride
Capsules, 25 mg, 50 mg and 100 mg
ANTIDEPRESSANT
/ ANTIPANIC / ANTIOBSESSIONAL AGENT
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
Canada L5N 2B8
Control No.: 135927
Date of Preparation:
January 25, 2010
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 . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 10
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 18
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 23
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 24
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 25
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 28
SPECIAL HANDLING INSTRUCTIONS . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . 28
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 28
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 30
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 30
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . .