Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
METFORMIN HYDROCHLORIDE
SANOFI-AVENTIS CANADA INC
A10BA02
METFORMIN
500MG
TABLET
METFORMIN HYDROCHLORIDE 500MG
ORAL
100/500
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773001; AHFS:
APPROVED
2006-05-12
_ _ _ _ _Page 1 of 39_ PRODUCT MONOGRAPH Pr GLUCOPHAGE ® Metformin Hydrochloride Tablets Manufacturer’s standard 500 mg, 850 mg Oral Antihyperglycemic Agent ® Registered trade mark of Merck Santé. Used under licence sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval (Québec) H7V 0A3 Date of revision : March 2, 2018 Submission Control No.: 211582 _ _ _ _ _Page 2 of 39_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION................................................................................ 3 INDICATIONS AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 15 DOSAGE AND ADMINISTRATION ..................................................................................... 18 OVERDOSAGE........................................................................................................................ 20 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 21 STORAGE AND STABILITY ................................................................................................. 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 22 PART II: SCIENTIFIC INFORMATION ............................................................................... 23 PHARMACEUTICAL INFORMATION ................................................................................. 23 CLINICAL TRIALS .. Přečtěte si celý dokument