Pays: Canada
Langue: anglais
Source: Health Canada
NAPROXEN SODIUM
PERRIGO INTERNATIONAL
M01AE02
NAPROXEN
220MG
TABLET
NAPROXEN SODIUM 220MG
ORAL
24/50/100/120/200/300 FOR BOTH TABS & CAPL./400(CAPLETS ONLY)
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113934003; AHFS:
CANCELLED PRE MARKET
2021-07-22
_ _ _NX 12 Hour (naproxen sodium) Product Monograph _ _Page 1 of 32_ PRODUCT MONOGRAPH NX 12 HOUR 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 17, 2012 Submission Control No: 133444 _ _ _NX 12 Hour (naproxen sodium) 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 ........................................................................ Lire le document complet