NOVO-GLIMEPIRIDE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
23-11-2005
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Aktiva substanser:
GLIMEPIRIDE
Tillgänglig från:
NOVOPHARM LIMITED
ATC-kod:
A10BB12
INN (International namn):
GLIMEPIRIDE
Dos:
1MG
Läkemedelsform:
TABLET
Sammansättning:
GLIMEPIRIDE 1MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
SULFONYLUREAS
Produktsammanfattning:
Active ingredient group (AIG) number: 0146247001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2015-10-26
Produktens egenskaper
PRODUCT MONOGRAPH
Pr
NOVO-GLIMEPIRIDE
(glimepiride)
Tablets 1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 091409
Date of Preparation:
November 22, 2005
2
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..............................................................................
12
OVERDOSAGE
................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND
STABILITY..........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION..........................................................................
19
CLINICAL
TRIALS..........................................................................................................
19
DETAILED
PHARMACOLOGY.....................................................................................
24
TOXICOLOGY
...
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