DOM-URSODIOL C TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
23-04-2013
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Werkstoffen:
URSODIOL
Beschikbaar vanaf:
DOMINION PHARMACAL
ATC-code:
A05AA02
INN (Algemene Internationale Benaming):
URSODEOXYCHOLIC ACID
Dosering:
500MG
farmaceutische vorm:
TABLET
Samenstelling:
URSODIOL 500MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
CHOLELITHOLYTIC AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0122789002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2006-08-10
Productkenmerken
PRODUCT MONOGRAPH
PR
DOM-URSODIOL C
Ursodiol Tablets USP
250 mg & 500 mg
CHOLESTATIC LIVER DISEASES
DOMINION PHARMACAL
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
April 23, 2013
Montreal, Quebec H4P 2T2
CONTROL NUMBER: 163339
_ _
_Dom-URSODIOL C Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................................
4
ADVERSE
REACTIONS..........................................................................................................
5
DRUG INTERACTIONS
........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
11
OVERDOSAGE
......................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 11
STORAGE AND STABILITY
................................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 13
PART II: SCIENTIFIC INFORMATION
.....................................................................................
14
PHARMACEUTICAL INFORMATION
................................................................................
14
CLINICAL TRIALS
.....................................................................................................
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