ACH-METFORMIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
23-02-2021
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Aktiv bestanddel:
METFORMIN HYDROCHLORIDE
Tilgængelig fra:
ACCORD HEALTHCARE INC
ATC-kode:
A10BA02
INN (International Name):
METFORMIN
Dosering:
500MG
Lægemiddelform:
TABLET
Sammensætning:
METFORMIN HYDROCHLORIDE 500MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500
Recept type:
Prescription
Terapeutisk område:
BIGUANIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0101773001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2021-03-01
Produktets egenskaber
PRODUCT MONOGRAPH
PR
ACH-METFORMIN
Metformin Hydrochloride Tablets, Mfr Std
500 mg and 850 mg tablets
Oral Antihyperglycemic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
DATE OF REVISION:
FEBRUARY 23, 2021
SUBMISSION CONTROL NO.: 244440
_Page 2 of 37_
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
CLINICAL TRIALS
........................................................................................
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