APO-GLIMEPIRIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GLIMEPIRIDE

Mevcut itibaren:

APOTEX INC

ATC kodu:

A10BB12

INN (International Adı):

GLIMEPIRIDE

Doz:

4MG

Farmasötik formu:

TABLET

Kompozisyon:

GLIMEPIRIDE 4MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

SULFONYLUREAS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2007-05-16

Ürün özellikleri

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
..