LUPIN-CELECOXIB CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
18-11-2014

有効成分:

CELECOXIB

から入手可能:

LUPIN PHARMA CANADA LIMITED

ATCコード:

M01AH01

INN(国際名):

CELECOXIB

投薬量:

200MG

医薬品形態:

CAPSULE

構図:

CELECOXIB 200MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0137043002; AHFS:

認証ステータス:

APPROVED

承認日:

2014-11-17

製品の特徴

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_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
_ _
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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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