Страна: Канада
мова: англійська
Джерело: Health Canada
NAPROXEN SODIUM
APOTEX INC
M01AE02
NAPROXEN
275MG
TABLET
NAPROXEN SODIUM 275MG
ORAL
100/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113934001; AHFS:
MARKETED
1989-12-31
_APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_ Page 1 of 48 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-NAPRO-NA PR APO-NAPRO-NA DS Naproxen Sodium Tablets Tablets, 275 mg and 550 mg, Oral USP Non-Steroidal Anti-Inflammatory Drug (NSAID) APOTEX INC. 150 Signet Drive, Toronto, Ontario M9L 1T9 Submission Control No: 260918 Date of Initial Authorization: DEC 31, 1989 Date of Revision: August 17, 2022 _APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_ Page 2 of 48 _ _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS [08/2022] 3 SERIOUS WARNING AND PRECAUTIONS BOX [08/2022] 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, _Pregnancy _ [08/2022] 7 WARNINGS AND PRECAUTIONS, Psychiatric [08/2022] 7 WARNINGS AND PRECAUTIONS, Skin [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 ................................................................. 5 4 DOSAGE AND ADMINISTRATION .............................................................................. Прочитайте повний документ