RATIO-GLIMEPIRIDE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
06-11-2014
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Aktiv bestanddel:
GLIMEPIRIDE
Tilgængelig fra:
TEVA CANADA LIMITED
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:
2017-04-04
Produktets egenskaber
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_Page 1 of 49_
PRODUCT MONOGRAPH PR
RATIO-GLIMEPIRIDE
glimepiride
Tablets 1, 2 and 4 mg
Teva Standard
Oral Hypoglycemic (Sulfonylurea)
TEVA CANADA LIMITED
30 NOVOPHARM COURT
TORONTO, ONTARIO
CANADA, M1B 2K9
DATE OF REVISION:
NOVEMBER 6, 2014
Submission Control No.: 178528
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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
................................................................................................
8
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
.................................................................................
29
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