País: Canadá
Língua: inglês
Origem: Health Canada
METFORMIN HYDROCHLORIDE
BIOMED PHARMA
A10BA02
METFORMIN
850MG
TABLET
METFORMIN HYDROCHLORIDE 850MG
ORAL
100
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773002; AHFS:
CANCELLED PRE MARKET
2022-07-19
_Bio-METFORMIN _ _Page 1 of 28 _ PRODUCT MONOGRAPH PR BIO-METFORMIN Metformin Hydrochloride, Mfr. Std. 500 mg and 850 mg tablets ORAL ANTIHYPERGLYCEMIC AGENT BIOMED PHARMA DATE OF PREPARATION: 100-5950, Ch. de la Côte de Liesse December 9, 2015 Mont-Royal Qc, H4T 1E2 CONTROL NO: 189023 _Bio-METFORMIN_ _Page 2 of 28 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................................. 3 CONTRAINDICATIONS .................................................................................................................. 3 WARNINGS AND PRECAUTIONS ................................................................................................. 4 ADVERSE REACTIONS ................................................................................................................... 9 DRUG INTERACTIONS ................................................................................................................. 10 DOSAGE AND ADMINISTRATION .............................................................................................. 12 OVERDOSAGE ............................................................................................................................... 12 ACTION AND CLINICAL PHARMACOLOGY ............................................................................ 13 STORAGE AND STABILITY ......................................................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................ 13 PART II: SCIENTIFIC INFORMATION ............................................................................... 14 PHARMACEUTICAL INFORMATION................................................................................. Leia o documento completo