LUPIN-CELECOXIB CAPSULE
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
18-11-2014
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Aktívna zložka:
CELECOXIB
Dostupné z:
LUPIN PHARMA CANADA LIMITED
ATC kód:
M01AH01
INN (Medzinárodný Name):
CELECOXIB
Dávkovanie:
100MG
Forma lieku:
CAPSULE
Zloženie:
CELECOXIB 100MG
Spôsob podávania:
ORAL
Počet v balení:
100/500
Typ predpisu:
Prescription
Terapeutické oblasti:
CYCLOOXYGENASE-2 (COX-2) INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0137043001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2014-11-17
Súhrn charakteristických
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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
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