TEVA-NAPROXEN EC TABLET (ENTERIC-COATED)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

NAPROXEN

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

M01AE02

INN (nemzetközi neve):

NAPROXEN

Adagolás:

500MG

Gyógyszerészeti forma:

TABLET (ENTERIC-COATED)

Összetétel:

NAPROXEN 500MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-08-03

Termékjellemzők

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