MG-2 TABLETS 500/2

Quốc gia: Tanzania

Ngôn ngữ: Tiếng Anh

Nguồn: Tanzania Medicinces & Medical Devices Authority

Thành phần hoạt chất:

Metformin , Glimepiride

Sẵn có từ:

RESONANT PHARMACEUTICALS PVT. LTD., INDIA

Mã ATC:

Combinations of oral blood glucose lowering drugs

INN (Tên quốc tế):

Metformin and Glimepiride

Liều dùng:

500/2

Dạng dược phẩm:

Tablets

Sản xuất bởi:

East African (India) Overseas Limited, INDIA

Tóm tắt sản phẩm:

Physical description: Light yellow coloured, elongated, biconvex uncoated tablets scored one side; Local technical representative: Heko Pharmacy Limited (7718)

Tình trạng ủy quyền:

Registered/Compliant

Ngày ủy quyền:

2021-08-20

Đặc tính sản phẩm

Effective date: 03/10/2022
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR MG-2 (METFORMINHYDROCHLORIDE 500 MG
AND GLIMEPIRIDE 2MG) TABLETS
VERSION NUMBER 01
3
RD JANUARY, 2023
TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA
ROAD, P. O. BOX
1253, DODOMA – TANZANIA, TELEPHONE: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], Website:
WWW.TMDA.GO.TZ
Toll free: 0800110084
Effective date: 03/10/2022
1
1.
INTRODUCTION
MG-2 is a generic medicine of
AMARYL (Glimepiride Tablets 2 mg) of Sanofi-Aventis U.S.
LLC Bridgewater, NJ 08807 and GLUCOPHAGE (Metformin Hydrochloride 500
mg Tablets) of
Bristol-Myers
Squibb
Company
Princeton,
NJ
USA.
MG-2 is an antidiabetic medicine
belonging to A10B B12 (Blood glucose lowering drugs, excl. insulins:
Sulfonamides,
urea derivatives) group.
Glimepiride is an orally active hypoglycaemic substance belonging to
the sulphonylurea
group. Glimepiride acts mainly by stimulating insulin release from
pancreatic beta cells.
As with other sulfonylureas this effect is based on an increase of
responsiveness of the
pancreatic beta cells to the physiological glucose stimulus. In
addition, glimepiride
seems
to
have
pronounced
extrapancreatic
effects
also
postulated
for
other
sulfonylureas. Sulfonylureas regulate insulin secretion by closing the
ATP-sensitive
potassium channel in the beta cell membrane. Closing the potassium
channel induces
depolarisation of the beta cell and results -by opening of calcium
channels - in an
increased influx of calcium into the cell. This leads to insulin
release through exocytosis.
Glimepiride binds with a high exchange rate to a beta cell membrane
protein which is
associated with the ATP-sensitive potassium channel but which is
different from the
usual sulfonylureas binding site.
Metformin is a biguanide with antihyperglycaemic effects, lowering
both basal and
postprandial plasma glucose. It does not stimulate insuli