देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
FENOFIBRATE
CIPHER PHARMACEUTICALS INC
C10AB05
FENOFIBRATE
100MG
CAPSULE
FENOFIBRATE 100MG
ORAL
100
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895002; AHFS:
APPROVED
2006-07-27
Page 1 of 29 PRODUCT MONOGRAPH PR FENOMAX™ (Fenofibrate Capsules) 100 MG AND 160 MG CAPSULES Professed Standard LIPID METABOLISM REGULATOR Cipher Pharmaceuticals Ltd. Suite 201 Lauriston, Collymore Rock St. Michael, Barbados IMPORTED AND DISTRIBUTED BY: Oryx Pharmaceuticals Inc., a subsidiary of Arrow Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, Ontario Canada, L5N 2B8 Date of Revision: October 18, 2006 Control Nos.: 105932 105933 105934 Page 2 of 29 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................................................................................................... 7 DRUG INTERACTIONS ................................................................................................... 8 DOSAGE AND ADMINISTRATION............................................................................. 10 OVERDOSAGE ............................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 10 STORAGE AND STABILITY......................................................................................... 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 12 PART II: SCIENTIFIC INFORMATION .............................................................................. 13 PHARMACEUTICAL INFORMATION.................. पूरा दस्तावेज़ पढ़ें