SANDOZ GLIMEPIRIDE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

GLIMEPIRIDE

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

A10BB12

INN (Medzinárodný Name):

GLIMEPIRIDE

Dávkovanie:

4MG

Forma lieku:

TABLET

Zloženie:

GLIMEPIRIDE 4MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

SULFONYLUREAS

Prehľad produktov:

Active ingredient group (AIG) number: 0146247003; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2006-01-27

Súhrn charakteristických

_Sandoz Glimepiride _
_ Page 1 of 48 _
PRODUCT MONOGRAPH
PR
SANDOZ GLIMEPIRIDE
Glimepiride Tablets
1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Sandoz Canada Inc.
Date of Revision:
110 rue de Lauzon
February 4, 2021
Boucherville,
Quebec
J4B 1E6
Submission
Control No: 243337
_Sandoz Glimepiride _
_ Page 2 of 48 _
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
....................................................................................................
8
DRUG
INTERACTIONS...................................................................................................
11
DOSAGE AND
ADMINISTRATION................................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 16
STORAGE AND
STABILITY...........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 20
PART II: SCIENTIFIC INFORMATION
..........................................................................
22
PHARMACEUTICAL
INFORMATION............................................................................
22
CLINICAL TRIALS
..........................................................................................................
23
DETAILED PHARMACOLOGY
..............