País: Canadà
Idioma: anglès
Font: Health Canada
GLICLAZIDE
APOTEX INC
A10BB09
GLICLAZIDE
30MG
TABLET (EXTENDED-RELEASE)
GLICLAZIDE 30MG
ORAL
100
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0119934002; AHFS:
APPROVED
2008-06-04
PRODUCT MONOGRAPH Pr APO-GLICLAZIDE MR GLICLAZIDE MODIFIED-RELEASE TABLETS 30 MG MODIFIED-RELEASE BREAKABLE TABLETS 60 MG Hypoglycemic sulfonylurea - Oral antidiabetic agent APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE December 27, 2019 TORONTO ONTARIO M9L 1T9 CONTROL NO: 233440 Page 2 of 43 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 ............................................................................................................................ 8 DRUG INTERACTIONS .......................................................................................................................... 12 DOSAGE AND ADMINISTRATION ...................................................................................................... 15 OVERDOSAGE ......................................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................... 17 STORAGE AND STABILITY .................................................................................................................. 20 SPECIAL HANDLING INSTRUCTIONS ................................................................................................ 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................................... 20 PART II: SCI Llegiu el document complet