TEVA-NAPROXEN SODIUM DS TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

NAPROXEN SODIUM

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

M01AE02

INN (Међународно име):

NAPROXEN

Дозирање:

550MG

Фармацеутски облик:

TABLET

Састав:

NAPROXEN SODIUM 550MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0113934002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2010-07-06

Карактеристике производа

TEVA-NAPROXEN SODIUM / TEVA-NAPROXEN SODIUM DS Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-NAPROXEN SODIUM
PR
TEVA-NAPROXEN SODIUM DS
Naproxen Sodium Tablets
Tablet, 275 mg and 550 mg, Oral
USP
ATC Code: M01AE02
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario, Canada
M1B 2K9
Date of Initial Authorization:
July 19, 2010
Date of Revision:
July 18, 2022
Submission Control No: 260925
TEVA-NAPROXEN SODIUM / TEVA-NAPROXEN SODIUM DS Page 2 of 44
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2022
3 SERIOUS WARNING AND PRECAUTIONS BOX
07/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests, Pregnancy
07/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
07/2022
7 WARNINGS AND PRECAUTIONS, Skin
07/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2022
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
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.................