CO GLIMEPIRIDE TABLET
Riik: Kanada
keel: inglise
Allikas: Health Canada
Toote omadused
(SPC)
23-12-2005
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Toimeaine:
GLIMEPIRIDE
Saadav alates:
COBALT PHARMACEUTICALS COMPANY
ATC kood:
A10BB12
INN (Rahvusvaheline Nimetus):
GLIMEPIRIDE
Annus:
1MG
Ravimvorm:
TABLET
Koostis:
GLIMEPIRIDE 1MG
Manustamisviis:
ORAL
Ühikuid pakis:
30
Retsepti tüüp:
Prescription
Terapeutiline ala:
SULFONYLUREAS
Toote kokkuvõte:
Active ingredient group (AIG) number: 0146247001; AHFS:
Volitamisolek:
CANCELLED POST MARKET
Loa andmise kuupäev:
2012-08-02
Toote omadused
Page 1 of 43
PRODUCT MONOGRAPH
PR
_CO GLIMEPIRIDE_
glimepiride
Tablets 1, 2, 3, and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario L5N 2B8
Date of Preparation:
December 22, 2005
Submission Control No: 092544
Page 2 of 43
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................3
SUMMARY PRODUCT
INFORMATION....................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................4
ADVERSE
REACTIONS................................................................................................7
DRUG
INTERACTIONS................................................................................................9
DOSAGE AND ADMINISTRATION
..........................................................................11
OVERDOSAGE
............................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY.........................................................14
STORAGE AND STABILITY
......................................................................................17
DOSAGE FORMS, COMPOSITION AND
PACKAGING..........................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL
INFORMATION......................................................................18
CLINICAL
TRIALS......................................................................................................19
DETAILED PHARMACOLOGY
.................................................................................25
TOXICOLOGY
.................................
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