ACH-METFORMIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

METFORMIN HYDROCHLORIDE

Prieinama:

ACCORD HEALTHCARE INC

ATC kodas:

A10BA02

INN (Tarptautinis Pavadinimas):

METFORMIN

Dozė:

500MG

Vaisto forma:

TABLET

Sudėtis:

METFORMIN HYDROCHLORIDE 500MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/500

Recepto tipas:

Prescription

Gydymo sritis:

BIGUANIDES

Produkto santrauka:

Active ingredient group (AIG) number: 0101773001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2021-03-01

Prekės savybės

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
........................................................................................