Страна: Канада
мова: англійська
Джерело: Health Canada
GLICLAZIDE
MYLAN PHARMACEUTICALS ULC
A10BB09
GLICLAZIDE
30MG
TABLET (EXTENDED-RELEASE)
GLICLAZIDE 30MG
ORAL
60/100
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0119934002; AHFS:
APPROVED
2015-03-17
_MYLAN-GLICLAZIDE MR (Gliclazide) _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYLAN-GLICLAZIDE MR Gliclazide Modified Release Tablets 30 mg Modified Release Breakable Tablets 60 mg Hypoglycemic sulfonylurea Oral antidiabetic agent Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: MAR 17, 2015 Date of Revision: MAR 08, 2024 Submission Control No. 280151 _MYLAN-GLICLAZIDE MR (Gliclazide) _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES Not Applicable. TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORISATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .......................................................................................................... 2 TABLE OF CONTENTS ............................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................... 4 1 INDICATIONS ........................................................................................................................... 4 1.1 Pediatrics (< 18 years of age) ................................................................................................ 4 1.2 Geriatrics (≥ 65 years of age) ................................................................................................ 4 2 CONTRAINDICATIONS .............................................................................................................. 4 4 DOSAGE AND ADMINISTRATION .............................................................................................. 4 4.1 Dosing Considerations .......................................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment ..................................................................... 5 4.4 Administration ........................................................... Прочитайте повний документ