AMARYL TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-01-2017
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Aktiv bestanddel:
GLIMEPIRIDE
Tilgængelig fra:
SANOFI-AVENTIS CANADA INC
ATC-kode:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosering:
2MG
Lægemiddelform:
TABLET
Sammensætning:
GLIMEPIRIDE 2MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30
Recept type:
Prescription
Terapeutisk område:
SULFONYLUREAS
Produkt oversigt:
Active ingredient group (AIG) number: 0146247002; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2018-07-31
Produktets egenskaber
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_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
AMARYL
®
glimepiride
Tablets 1, 2 and 4 mg
Manufacturer’s standard
Oral Hypoglycemic (Sulfonylurea)
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
December 29, 2016
Submission Control No.: 198596
s-a Version 5.0 dated December 23, 2016
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_Page 2 of 49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
9
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 18
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
......................................................................
23
CLINICAL TRIALS
......................................................................................................
24
DETAILED PHARMACOLOGY
...................................
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