Land: Canada
Språk: engelsk
Kilde: Health Canada
METFORMIN HYDROCHLORIDE
ANGITA PHARMA INC.
A10BA02
METFORMIN
500MG
TABLET
METFORMIN HYDROCHLORIDE 500MG
ORAL
15G/50G
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773001; AHFS:
APPROVED
2019-12-02
Page 1 of 40 Product Monograph of AG-Metformin PRODUCT MONOGRAPH Pr AG-METFORMIN MetforminHydrochloride Tablets, USP 500 mg, 850mg Oral Antihyperglycemic Agent Submission Control No.: 232222 J4B 5H3 Boucherville , Qu e bec 1310 rue Nobel Angita Pharma Inc. November 2 8 ,2019 Date of Revision : Page 2 of 40 Product Monograph of AG-Metformin Table of Contents PART I: HEALTH PROFESSIONAL IN FORMATION ......................................................... 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 PAR T II: SCIENTIFIC INFORMATION....................................................................................23 PHARMACEUTICAL INFORMATION ................................................................................. 23 CLINICAL TRIALS ............................... Les hele dokumentet