LUPIN-CELECOXIB CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CELECOXIB

Boleh didapati daripada:

LUPIN PHARMA CANADA LIMITED

Kod ATC:

M01AH01

INN (Nama Antarabangsa):

CELECOXIB

Dos:

200MG

Borang farmaseutikal:

CAPSULE

Komposisi:

CELECOXIB 200MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2014-11-17

Ciri produk

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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