LUPIN-CELECOXIB CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
18-11-2014
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
CELECOXIB
Beschikbaar vanaf:
LUPIN PHARMA CANADA LIMITED
ATC-code:
M01AH01
INN (Algemene Internationale Benaming):
CELECOXIB
Dosering:
100MG
farmaceutische vorm:
CAPSULE
Samenstelling:
CELECOXIB 100MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
CYCLOOXYGENASE-2 (COX-2) INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0137043001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-11-17
Productkenmerken
_ _
_ _
_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
_ _
_ _
_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
Lees het volledige document
