Land: Canada
Sprog: engelsk
Kilde: Health Canada
NAPROXEN SODIUM
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
M01AE02
NAPROXEN
220MG
TABLET
NAPROXEN SODIUM 220MG
ORAL
24/50/100/120/200/300/400
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113934003; AHFS:
APPROVED
2016-01-29
_ _ _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 ............................... Læs hele dokumentet