DOM-URSODIOL C TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
23-04-2013
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
URSODIOL
Fáanlegur frá:
DOMINION PHARMACAL
ATC númer:
A05AA02
INN (Alþjóðlegt nafn):
URSODEOXYCHOLIC ACID
Skammtar:
250MG
Lyfjaform:
TABLET
Samsetning:
URSODIOL 250MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
CHOLELITHOLYTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0122789001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2006-08-10
Vara einkenni
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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