LUPIN-CELECOXIB CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
18-11-2014

有效成分:

CELECOXIB

可用日期:

LUPIN PHARMA CANADA LIMITED

ATC代码:

M01AH01

INN(国际名称):

CELECOXIB

剂量:

100MG

药物剂型:

CAPSULE

组成:

CELECOXIB 100MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2014-11-17

产品特点

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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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_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

                                
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