Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
METFORMIN HYDROCHLORIDE
STRIDES PHARMA CANADA INC
A10BA02
METFORMIN
1000MG
TABLET (EXTENDED-RELEASE)
METFORMIN HYDROCHLORIDE 1000MG
ORAL
100/500
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773003; AHFS:
APPROVED
2021-03-01
PRODUCT MONOGRAPH PR GPC-METFORMIN XR Metformin Hydrochloride Extended-Release Tablets, Mfr. Std. 500 mg and 1000 mg ORAL ANTIHYPERGLYCEMIC AGENT Strides Pharma Canada Inc. 1565, Boul. Lionel-Boulet Varennes, QC J3X 1P7 DATE OF REVISION: December 13, 2022 CONTROL NUMBER: 269357 2 TABLE OF CONTENTS PART 1: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ..................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS ............................................................................... 5 ADVERSE REACTIONS ................................................................................................. 9 DRUG INTERACTIONS ............................................................................................... 12 DOSAGE AND ADMINISTRATION ........................................................................... 14 OVERDOSAGE ............................................................................................................. 16 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 16 STORAGE AND STABILITY ....................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 20 PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION ....................................................................... 21 CLINICAL TRIALS ....................................................................................................... 22 DETAILED PHARMACOLOGY .................................................................................. 28 TOXICOLOGY .............................................................................................................. 30 REFERENCES .................... Perskaitykite visą dokumentą