GPC-METFORMIN XR TABLET (EXTENDED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

METFORMIN HYDROCHLORIDE

Prieinama:

STRIDES PHARMA CANADA INC

ATC kodas:

A10BA02

INN (Tarptautinis Pavadinimas):

METFORMIN

Dozė:

500MG

Vaisto forma:

TABLET (EXTENDED-RELEASE)

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
GPC-METFORMIN XR
Metformin Hydrochloride Extended-Release Tablets, Mfr. Std.
500 mg and 1000 mg
ORAL ANTIHYPERGLYCEMIC AGENT
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, QC
J3X 1P7 DATE OF REVISION:
December 13, 2022
CONTROL NUMBER: 269357
2
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
5
ADVERSE REACTIONS
.................................................................................................
9
DRUG INTERACTIONS
...............................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................
14
OVERDOSAGE
.............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 16
STORAGE AND STABILITY
.......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 20
PART II: SCIENTIFIC INFORMATION
PHARMACEUTICAL INFORMATION
.......................................................................
21
CLINICAL TRIALS
.......................................................................................................
22
DETAILED PHARMACOLOGY
..................................................................................
28
TOXICOLOGY
..............................................................................................................
30
REFERENCES
....................