PAIN RELIEVER & SLEEP AID TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Sẵn có từ:

APOTEX INC

Mã ATC:

M01AE57

INN (Tên quốc tế):

NAPROXEN AND DIPHENHYDRAMINE

Liều dùng:

25MG; 220MG

Dạng dược phẩm:

TABLET

Thành phần:

DIPHENHYDRAMINE HYDROCHLORIDE 25MG; NAPROXEN SODIUM 220MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

OTC

Khu trị liệu:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0257270001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-10-08

Đặc tính sản phẩm

Page 1 of 47
PRODUCT MONOGRAPH
PAIN RELIEVER & SLEEP AID
Naproxen Sodium 220 mg and Diphenhydramine Hydrochloride 25mg Tablets
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Preparation:
September 30, 2020
Control No. 230683
Page 2 of 47
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................................
4
ADVERSE REACTIONS
.............................................................................................................................
7
DRUG INTERACTIONS
...........................................................................................................................
12
DOSAGE AND ADMINISTRATION
.......................................................................................................
14
OVERDOSAGE...........................................................................................................................................
15
ACTION AND CLINICAL
PHARMACOLOGY......................................................................................
15
STORAGE AND STABILITY
...................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
18
PART II: SCIENTIFIC INFORMATION
.............................................................................................
20
PHARMACEUTICAL INFORMATION
........