SANDOZ GLIMEPIRIDE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

GLIMEPIRIDE

Beszerezhető a:

SANDOZ CANADA INCORPORATED

ATC-kód:

A10BB12

INN (nemzetközi neve):

GLIMEPIRIDE

Adagolás:

2MG

Gyógyszerészeti forma:

TABLET

Összetétel:

GLIMEPIRIDE 2MG

Az alkalmazás módja:

ORAL

db csomag:

30

Recept típusa:

Prescription

Terápiás terület:

SULFONYLUREAS

Termék összefoglaló:

Active ingredient group (AIG) number: 0146247002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2006-01-27

Termékjellemzők

_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
..............