NAPROXEN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-01-2012
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Aktiv bestanddel:
NAPROXEN SODIUM
Tilgængelig fra:
PERRIGO INTERNATIONAL
ATC-kode:
M01AE02
INN (International Name):
NAPROXEN
Dosering:
220MG
Lægemiddelform:
TABLET
Sammensætning:
NAPROXEN SODIUM 220MG
Indgivelsesvej:
ORAL
Enheder i pakken:
200
Recept type:
OTC
Terapeutisk område:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0113934003; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2021-05-28
Produktets egenskaber
_ _
_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
....................................................................................................
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