国: カナダ
言語: 英語
ソース: Health Canada
NAPROXEN
TEVA CANADA LIMITED
M01AE02
NAPROXEN
500MG
TABLET (ENTERIC-COATED)
NAPROXEN 500MG
ORAL
100
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0109634003; AHFS:
APPROVED
2010-08-03
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 ........................... 完全なドキュメントを読む