PMS-DULOXETINE CAPSULE (DELAYED RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

N06AX21

INN (Tên quốc tế):

DULOXETINE

Liều dùng:

30MG

Dạng dược phẩm:

CAPSULE (DELAYED RELEASE)

Thành phần:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152350001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-05-02

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
PMS-DULOXETINE
Duloxetine Delayed-Release Capsules, House Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
October 29, 2021
SUBMISSION CONTROL NO: 253685
_ _
_pms-DULOXETINE Product Monograph _
_Page 2 of 84_
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
..................................................................................................18
DRUG INTERACTIONS
..................................................................................................37
DOSAGE AND ADMINISTRATION
..............................................................................40
OVERDOSAGE
................................................................................................................43
ACTION AND CLINICAL PHARMACOLOGY
............................................................44
STORAGE AND STABILITY
..........................................................................................47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................48
PART II: SCIENTIFIC INFORMATION
................................................................................49
PHARMACEUTICAL INFORMATION
..........................................................................49
CLINICAL TRIALS
......................................................................................