PROGLYCEM CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DIAZOXIDE

Доступно од:

MERCK CANADA INC

АТЦ код:

V03AH01

INN (Међународно име):

DIAZOXIDE

Дозирање:

100MG

Фармацеутски облик:

CAPSULE

Састав:

DIAZOXIDE 100MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

DIRECT VASODILATORS

Резиме производа:

Active ingredient group (AIG) number: 0108984003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2011-02-08

Карактеристике производа

_PROGLYCEM (diazoxide)_
_ _
_Page 1 of 20 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PROGLYCEM®
Diazoxide
Capsules, 100 mg, Oral
Merck Standard
Hyperglycemic Agent
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
MAR 23, 1981
Date of Revision:
AUG 21, 2023
Submission Control Number: 271481
_PROGLYCEM (diazoxide)_
_ _
_Page 2 of 20_
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS
08/2023
8 ADVERSE REACTIONS, 8.5 Post-market Adverse Reactions
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
............................................