固克汎斯膜衣錠500毫克/5毫克

Country: Թայվան

language: չինարեն

source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

active_ingredient:

METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE);;GLYBURIDE (EQ TO GLIBENCLAMIDE)

MAH:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATC_code:

A10BD02

pharmaceutical_form:

膜衣錠

composition:

METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE) (6820400710) MG; GLYBURIDE (EQ TO GLIBENCLAMIDE) (6820600700) MG

units_in_package:

鋁箔盒裝

class:

製　劑

prescription_type:

須由醫師處方使用

manufactured_by:

MERCK SANTE S.A.S CENTRE DE PRODUCTION SEMOY, 2 RUE DU PRESSOIR VERT, 45400 SEMOY, FRANCE FR

therapeutic_area:

metformin and sulfonylureas

therapeutic_indication:

第二型糖尿病。

leaflet_short:

註銷日期: 2017/04/12; 註銷理由: 自請註銷; 有效日期: 2018/08/02; 英文品名: Glucovance 500mg/5mg Film-coated tablets

authorization_status:

已註銷

authorization_date:

2013-08-02

PIL

FR2579650
COMPOSITION
Glucovance 500 mg/2.5 mg:
Each file-coated tablet contains 500 mg metformin hydrochloride and
2.5 mg
of glibenclamide as active ingredients.
Glucovance 500 mg/ 5 mg:
Each file-coated tablet contains 500 mg metformin hydrochloride and 5
mg of
glibenclamide as active ingredients.
APPEARANCE
Glucovance 500 mg/2.5 mg:
Orange capsule-shaped, biconvex, film-coated tablets with “2.5”
engraved on one side.
Glucovance 500 mg/ 5 mg:
Yellow capsule-shaped, biconvex, film-coated tablets with “5”
engraved on one side.
INDICATIONS
TREATMENT OF TYPE 2 DIABETES.
Notes: Treatment of type 2 diabetic adult patients with any one of
below
situation.
1. When dietary management and exercise do not result in adequate
glycaemic
control.
2. When dietary management, exercise, and monotherapy with metformin
or
sulfonylurea do not result in adequate glycaemic control.
3. As replacement for previous combination therapy with metformin and
sulfonylurea in patients whose glycaemia is stable and well
controlled.
DOSAGE AND ADMINISTRATION
Oral.
This drug is for adults use only.
This drug should be prescribed by physicians.
General
As for all hypoglycaemic agents, the dosage should be adapted
according to the
individual metabolic response (glycaemia, HbA1c).
Initial treatment:
When dietary management and exercise do not result in adequate
glycaemic
control: The usual initial dose is 1 tablet of Glucovance 250 mg/1.25
mg daily or
drugs with same compounds and equivalent doses.
•
When treatment failed by using monotherapy with metformin or a
sulfonylurea: The usual initial dose is 1 tablet of Glucovance 500
mg/2.5 mg
daily.
•
As replacement for previous combination therapy with metformin and
glibenclamide: The recommended dose can be switched to equivalent
Glucovance dose based on previous dose being taken.
•
As replacement for previous combination therapy with metformin and
sulfonylurea: The recommended dose can be switched to 1 tablet of
Glucovance 500 mg/2.5 mg daily based on previous dose being taken.
Titration