EUGLUCON TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GLYBURIDE

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

A10BB01

INN (Nama Internasional):

GLIBENCLAMIDE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

GLYBURIDE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/300/500

Jenis Resep:

Prescription

Area terapi:

SULFONYLUREAS

Ringkasan produk:

Active ingredient group (AIG) number: 0108708001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1997-06-06

Karakteristik produk

_ _
_Product Monograph – EUGLUCON_
_®_
_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
PR
EUGLUCON
®
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
May 02, 2011
SUBMISSION CONTROL NO.: 138840
EUGLUCON
®
is a registered trademark used under license by Pharmascience Inc.
_ _
_Product Monograph – EUGLUCON_
_®_
_ _
_Page 2 of 30_
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..............................................................................15
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND
STABILITY..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL
INFORMATION..........................................................................21
CLINICAL
TRIALS............................