国家: 加拿大
语言: 英文
来源: Health Canada
CELECOXIB
LUPIN PHARMA CANADA LIMITED
M01AH01
CELECOXIB
200MG
CAPSULE
CELECOXIB 200MG
ORAL
100/500
Prescription
CYCLOOXYGENASE-2 (COX-2) INHIBITORS
Active ingredient group (AIG) number: 0137043002; AHFS:
APPROVED
2014-11-17
_ _ _ _ _1 of 53 _ PRODUCT MONOGRAPH PR LUPIN-CELECOXIB (celecoxib) Capsules, 100 mg and 200 mg Non-steroidal anti-inflammatory drug (NSAID) Lupin Pharma Canada Limited DATE OF PREPARATION: 1155, René-Lévesque West Blvd., Suite 2500 25 July 2014 Montreal QC, H3B 2K4 SUBMISSION CONTROL NO: 154401, 175860 _ _ _ _ _2 of 53 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION.....................................................................3 INDICATIONS AND CLINICAL USE...........................................................................3 CONTRAINDICATIONS ................................................................................................4 WARNINGS AND PRECAUTIONS...............................................................................5 ADVERSE REACTIONS................................................................................................14 DRUG INTERACTIONS................................................................................................22 DOSAGE AND ADMINISTRATION...........................................................................25 OVERDOSAGE...............................................................................................................27 ACTION AND CLINICAL PHARMACOLOGY........................................................27 STORAGE AND STABILITY.......................................................................................29 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................30 PART II: SCIENTIFIC INFORMATION ...............................................................................31 PHARMACEUTICAL INFORMATION.....................................................................31 CLINICAL TRIALS.......................................................................................................32 DETAILED PHARMACOLOGY.................................................................................40 阅读完整的文件