APO-GLIMEPIRIDE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

GLIMEPIRIDE

Commercializzato da:

APOTEX INC

Codice ATC:

A10BB12

INN (Nome Internazionale):

GLIMEPIRIDE

Dosaggio:

4MG

Forma farmaceutica:

TABLET

Composizione:

GLIMEPIRIDE 4MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

SULFONYLUREAS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2007-05-16

Scheda tecnica

Page 1 of 51
PRODUCT MONOGRAPH
PR
APO-GLIMEPIRIDE
GLIMEPIRIDE TABLETS USP
1 MG, 2 MG AND 4 MG
ORAL HYPOGLYCEMIC (SULFONYLUREA)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
CANADA M9L 1T9
_ _
_ _
SUBMISSION CONTROL NO.: 219952
Page 2 of 51
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
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLINICAL TRIALS
...............................................................................................................
25
DETAILED PHARMACOLOGY
..