LUPIN-CELECOXIB CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CELECOXIB

Dostupno od:

LUPIN PHARMA CANADA LIMITED

ATC koda:

M01AH01

INN (International ime):

CELECOXIB

Doziranje:

100MG

Farmaceutski oblik:

CAPSULE

Sastav:

CELECOXIB 100MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500

Tip recepta:

Prescription

Područje terapije:

CYCLOOXYGENASE-2 (COX-2) INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2014-11-17

Svojstava lijeka

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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