TEVA-NAPROXEN EC TABLET (ENTERIC-COATED)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

NAPROXEN

から入手可能:

TEVA CANADA LIMITED

ATCコード:

M01AE02

INN（国際名）:

NAPROXEN

投薬量:

375MG

医薬品形態:

TABLET (ENTERIC-COATED)

構図:

NAPROXEN 375MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2010-08-03

製品の特徴

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
...........................