NAPRELAN TABLET (EXTENDED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

NAPROXEN (NAPROXEN SODIUM)

זמין מ:

ALKERMES INC

קוד ATC:

M01AE02

INN (שם בינלאומי):

NAPROXEN

כמות:

500MG

טופס פרצבטיות:

TABLET (EXTENDED-RELEASE)

הרכב:

NAPROXEN (NAPROXEN SODIUM) 500MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

60

סוג מרשם:

Prescription

איזור תרפויטי:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2017-02-17

מאפייני מוצר

1
PRODUCT MONOGRAPH
Pr
NAPRELAN
®
Naproxen Sodium
375 and 500 mg Controlled Release Tablets
(equivalent to 375 and 500 mg of naproxen base)
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Control #: 192110
Manufactured by: Alkermes, Inc.
852 Winter Street
Waltham, Massachusetts, USA
Distributed by: Sunovion Pharmaceuticals Canada Inc.
6790 Century Avenue, Suite 100
Mississauga, ON L5N 2V8
Date of Preparation: 14 March 2016
2
TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................6
SUMMARY PRODUCT INFORMATION
............................................................................
6
INDICATIONS AND CLINICAL USE
..................................................................................
6
CONTRAINDICATIONS
........................................................................................................
7
WARNINGS AND PRECAUTIONS
......................................................................................
8
GENERAL
...................................................................................................................................
9
CARDIOVASCULAR
......................................................................................................................
9
ENDOCRINE AND METABOLISM
................................................................................................
10
GASTROINTESTINAL (GI)
...........................................................................................................
10
GENITOURINARY
......................................................................................................................
11
HEMATOLOGIC
.........................................................................................................................
12
HEPATIC/BILIARY/PANCREATIC
.................................................................................................
13
HYPERSENSITIVITY REACTIONS
............................................................................