NAPROXEN CAPSULES 200 MG

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

NAPROXEN (NAPROXEN, NAPROXEN SODIUM)

Verfügbar ab:

CATALENT ONTARIO LIMITED

ATC-Code:

M01AE02

INN (Internationale Bezeichnung):

NAPROXEN

Dosierung:

200MG

Darreichungsform:

CAPSULE

Zusammensetzung:

NAPROXEN (NAPROXEN, NAPROXEN SODIUM) 200MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

2/16/30/60/90/120/240

Verschreibungstyp:

OTC

Therapiebereich:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0109634009; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2016-10-04

Fachinformation

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_Page 1 of 38_
PRODUCT MONOGRAPH
NAPROXEN CAPSULES 200 MG
Naproxen Capsules 200 mg (as free acid and sodium salt)
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Catalent Ontario Limited
Windsor, Ontario
Canada, N9C 3R5
Date of Revision:
March 29, 2021
Submission Control No: 245549
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_Page 2 of 38_
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
...........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
11
STORAGE AND STABILITY
.....................................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 13
PART II: SCIENTIFIC INFORMATION
...........................................................................................
14
PHARMA