Land: Kanada
Sprache: Englisch
Quelle: Health Canada
METFORMIN HYDROCHLORIDE
MYLAN PHARMACEUTICALS ULC
A10BA02
METFORMIN
500MG
TABLET
METFORMIN HYDROCHLORIDE 500MG
ORAL
100/500
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773001; AHFS:
CANCELLED POST MARKET
2012-10-19
_ _ _Product Monograph – -Metformin _ _Page 1 _ PRODUCT MONOGRAPH PR METFORMIN (METFORMIN HYDROCHLORIDE) TABLETS 500 AND 850 MG BP THERAPEUTIC CLASSIFICATION ORAL ANTIHYPERGLYCEMIC AGENT Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON Canada M8Z 2S6 Control#: 141657 DATE OF PREPARATION: September 28, 2010 _ _ _Product Monograph –Metformin _ _Page 2_ 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................................................................................................. 10 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION............................................................................. 13 OVERDOSAGE ............................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 15 STORAGE AND STABILITY......................................................................................... 15 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 15 PART II: SCIENTIFIC INFORMATION ............................................................................... 17 PHARMACEUTICAL INFORMATION......................................................................... 17 CLINICAL TRIALS......................................................................................................... 18 DETAILED PHARMACOLOGY. Lesen Sie das vollständige Dokument