Ország: Kanada
Nyelv: angol
Forrás: Health Canada
DIAZOXIDE
MERCK CANADA INC
V03AH01
DIAZOXIDE
100MG
CAPSULE
DIAZOXIDE 100MG
ORAL
100
Prescription
DIRECT VASODILATORS
Active ingredient group (AIG) number: 0108984003; AHFS:
APPROVED
2011-02-08
_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 ............................................ Olvassa el a teljes dokumentumot