Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
METFORMIN HYDROCHLORIDE
BAUSCH HEALTH, CANADA INC.
A10BA02
METFORMIN
1000MG
TABLET (EXTENDED-RELEASE)
METFORMIN HYDROCHLORIDE 1000MG
ORAL
30/90/500/1000
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773003; AHFS:
APPROVED
2020-12-22
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR GLUMETZA ® Metformin Hydrochloride Extended- Release Tablets, Mfr. Std. 500 mg and 1000 mg PR GLUMETZA ® (SB) Metformin Hydrochloride Extended- Release Tablets, Mfr. Std. 1000 mg ORAL ANTIHYPERGLYCEMIC AGENT BAUSCH HEALTH, CANADA INC. DATE OF INITIAL AUTHORIZATION: 2150 St-Elzear Blvd. West November 03, 2015 Laval, Quebec H7L 4A8 DATE OF REVISION: February 14, 2023 Submission Control number: 264310 _Pr_ _GLUMETZA_ _®_ _ and GLUMETZA_ _®_ _ (SB) Product Monograph _ _Page 2 of 37 _ RECENT MAJOR LABEL CHANGES N/A TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS.......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics ........................................................................................................... 4 1.2 Geriatrics............................................................................................................ 4 2 CONTRAINDICATIONS............................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................... 5 4 DOSAGE AND ADMINISTRATION.............................................................................. 5 4.1 Dosing Considerations ........................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment..................................................... 6 4.4 Administration..................................................................................................... 7 4.5 Missed Dose .......................................................................... Aqra d-dokument sħiħ