AMARYL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GLIMEPIRIDE

Disponibil de la:

SANOFI-AVENTIS CANADA INC

Codul ATC:

A10BB12

INN (nume internaţional):

GLIMEPIRIDE

Dozare:

1MG

Forma farmaceutică:

TABLET

Compoziție:

GLIMEPIRIDE 1MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SULFONYLUREAS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-07-31

Caracteristicilor produsului

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