SANDOZ GLIMEPIRIDE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

GLIMEPIRIDE

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

A10BB12

INN (International Name):

GLIMEPIRIDE

Dosering:

1MG

Lægemiddelform:

TABLET

Sammensætning:

GLIMEPIRIDE 1MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30

Recept type:

Prescription

Terapeutisk område:

SULFONYLUREAS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2006-01-27

Produktets egenskaber

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