PROGLYCEM CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DIAZOXIDE

Dostopno od:

MERCK CANADA INC

Koda artikla:

V03AH01

INN (mednarodno ime):

DIAZOXIDE

Odmerek:

100MG

Farmacevtska oblika:

CAPSULE

Sestava:

DIAZOXIDE 100MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

DIRECT VASODILATORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-02-08

Lastnosti izdelka

_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
............................................