TEVA-NAPROXEN EC TABLET (ENTERIC-COATED)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

NAPROXEN

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

M01AE02

INN (Међународно име):

NAPROXEN

Дозирање:

500MG

Фармацеутски облик:

TABLET (ENTERIC-COATED)

Састав:

NAPROXEN 500MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0109634003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2010-08-03

Карактеристике производа

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