MOTRIMAX 12 HOUR TABLETS
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
03-02-2016
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Werkstoffen:
NAPROXEN SODIUM
Beschikbaar vanaf:
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
ATC-code:
M01AE02
INN (Algemene Internationale Benaming):
NAPROXEN
Dosering:
220MG
farmaceutische vorm:
TABLET
Samenstelling:
NAPROXEN SODIUM 220MG
Toedieningsweg:
ORAL
Eenheden in pakket:
24/50/100/120/200/300/400
Prescription-type:
OTC
Therapeutisch gebied:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0113934003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2016-01-29
Productkenmerken
_ _
_MotriMAX 12 HOUR™ Tablets Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
MOTRIMAX 12 HOUR™ TABLETS
Naproxen Sodium Tablets USP
220 mg Tablets and Caplets
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
88 McNabb St.
Markham, Ontario
L3R 5L2
Date of Preparation:
January 28, 2016
Control No: 191125
_ _
_MotriMAX 12 HOUR™ Tablets Product Monograph _
_Page 2 of 32_
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
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
...............................
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