NAPROXEN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
10-05-2019
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Werkstoffen:
NAPROXEN SODIUM
Beschikbaar vanaf:
DOMINION PHARMACAL
ATC-code:
M01AE02
INN (Algemene Internationale Benaming):
NAPROXEN
Dosering:
220MG
farmaceutische vorm:
TABLET
Samenstelling:
NAPROXEN SODIUM 220MG
Toedieningsweg:
ORAL
Eenheden in pakket:
24/100/125
Prescription-type:
OTC
Therapeutisch gebied:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0113934003; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2020-05-06
Productkenmerken
PRODUCT MONOGRAPH
NAPROXEN
Naproxen Sodium Tablets USP
220 mg
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100,
Montréal, Québec
H4P 2T4
www.pharmascience.com DATE OF REVISION:
May 10, 2019
Submission Control no.: 227094
_ _
_NAPROXEN Product Monograph _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
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
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 14
PART II: SCIENTIFIC INFORMATION
.........................................................................
15
PHARMACEUTICAL INFORMATION
............................................................................
15
CLINICAL TRIALS
..................
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