PRO-GLYBURIDE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

GLYBURIDE

Предлага се от:

PRO DOC LIMITEE

АТС код:

A10BB01

INN (Международно Name):

GLIBENCLAMIDE

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

GLYBURIDE 5MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100/500

Вид предписание :

Prescription

Терапевтична област:

SULFONYLUREAS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2017-07-04

Данни за продукта

_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
PRO-GLYBURIDE
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
DATE OF REVISION:
June 6, 2013
Submission Control No.: 164951
_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 2 of 31_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARM