LUPIN-CELECOXIB CAPSULE

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

CELECOXIB

มีจำหน่ายจาก:

LUPIN PHARMA CANADA LIMITED

รหัส ATC:

M01AH01

INN (ชื่อสากล):

CELECOXIB

ปริมาณ:

100MG

แบบฟอร์มเภสัชกรรม:

CAPSULE

องค์ประกอบ:

CELECOXIB 100MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

100/500

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

สรุปสินค้า:

Active ingredient group (AIG) number: 0137043001; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2014-11-17

สรุปลักษณะสินค้า

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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
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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