AMARYL TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

GLIMEPIRIDE

Dostupno od:

SANOFI-AVENTIS CANADA INC

ATC koda:

A10BB12

INN (International ime):

GLIMEPIRIDE

Doziranje:

1MG

Farmaceutski oblik:

TABLET

Sastav:

GLIMEPIRIDE 1MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

SULFONYLUREAS

Proizvod sažetak:

Active ingredient group (AIG) number: 0146247001; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2018-07-31

Svojstava lijeka

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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
...................................