NAPROXEN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

NAPROXEN SODIUM

Tilgjengelig fra:

PERRIGO INTERNATIONAL

ATC-kode:

M01AE02

INN (International Name):

NAPROXEN

Dosering :

220MG

Legemiddelform:

TABLET

Sammensetning:

NAPROXEN SODIUM 220MG

Administreringsrute:

ORAL

Enheter i pakken:

200

Resept typen:

OTC

Terapeutisk område:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0113934003; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-05-28

Preparatomtale

_ _
_Naproxen Sodium Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
NAPROXEN
Naproxen Sodium Tablets USP
220 mg Tablets and Caplets
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Perrigo
®
International
515 Eastern Ave.
Allegan, MI 49010
USA
Date of Preparation:
January 10, 2012
Submission Control No: 133440
_ _
_Naproxen Sodium Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
....................................................................................................