TEVA-NAPROXEN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NAPROXEN

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

M01AE02

INN (Tên quốc tế):

NAPROXEN

Liều dùng:

375MG

Dạng dược phẩm:

TABLET

Thành phần:

NAPROXEN 375MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0109634004; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-08-03

Đặc tính sản phẩm

TEVA-NAPROXEN AND TEVA-NAPROXEN EC
Page 1 of 48
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-NAPROXEN
Naproxen Tablets
Tablets, 250, 375, & 500 mg, Oral
USP
PR
TEVA-NAPROXEN EC
Naproxen Enteric-Coated Tablets
Enteric-Coated Tablets 250, 375, & 500 mg, Oral
USP
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 262390
Date of Initial Authorization:
July 19, 2010
Date of Revision:
August 22, 2022
TEVA-NAPROXEN AND TEVA-NAPROXEN EC
Page 2 of 48
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
3 SERIOUS WARNING AND PRECAUTIONS BOX
08/2022
7 WARNINGS AND PRECAUTIONS
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I:
HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
........................................................................................................................
4
2 CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 6
4
DOSAGE AND ADMINISTRATION
.....................................................................................
7
4.1
Dosing considerations
...........................