瑪爾胰１．０錠

البلد: تايوان

اللغة: الصينية

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

العنصر النشط:

GLIMEPIRIDE

متاح من:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC رمز:

A10BB12

الشكل الصيدلاني:

錠劑

تركيب:

GLIMEPIRIDE (6820601200) 1MG

الوحدات في الحزمة:

鋁箔盒裝;;玻璃瓶裝

الفئة:

製　劑

نوع الوصفة الطبية :

須由醫師處方使用

المصنعة من قبل:

SANOFI S.P.A. STRADA STATALE 17 KM 22,67019 SCOPPITO (AQ), ITALY IT

المجال العلاجي:

glimepiride

الخصائص العلاجية:

非胰島素依賴型（第２型）糖尿病。

ملخص المنتج:

註銷日期: 2018/08/21; 註銷理由: 自請註銷; 有效日期: 2019/11/08; 英文品名: AMARYL 1.0 TABLETS

الوضع إذن:

已註銷

تاريخ الترخيص:

1999-11-08

نشرة المعلومات

1
1.
NAME OF THE MEDICINAL PRODUCT
Amaryl 1mg, tablet
Amaryl 2mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1, or 2 mg glimepiride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
The tablets are oblong and scored on both sides. Amaryl 1 mg is pink
and
Amaryl 2 mg is green.
Tablets are for oral administration. The tablets can be divided into
two equal
doses along the score line.
Amaryl tablets must be swallowed without chewing with sufficient
amounts of
liquid.
3.1 Special populations
Children
Data are insufficient to recommend pediatric use of glimepiride
Renal impairment
There is limited information available on the use of Amaryl in renal
insufficiency.
Patients
with
impaired
renal
function
may
be
more
sensitive
to
the
glucose-lowering effect of Amaryl.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Amaryl is indicated for the treatment of type 2 diabetes mellitus,
when diet,
physical exercise and weight reduction alone are not adequate.
4.2 Posology and method of administration
The basis for successful treatment of diabetes is a good diet, regular
physical
activity, as well as routine checks of blood and urine. Tablets or
insulin cannot
compensate if the patient does not keep to the recommended diet.
Dosage
is
determined
by
the
results
of
blood
and
urinary
glucose
determinations.
The starting dose is 1 mg glimepiride per day. If good control is
achieved this
dosage should be used for maintenance therapy.
If control is
unsatisfactory the dosage should be increased, based on
the
glycaemic control, in a stepwise manner with an interval of about 1 to
2 weeks
between each step, to 2, 3 or 4 mg glimepiride per day. A dosage of
more than 4
mg glimepiride per day gives better results only in exceptional cases.
The
maximum recommended dose is 8 mg glimepiride per day.
In
patients
not
adequately
controlled
with
the
maximum
daily
dose
of
metformin, concomitant glimepiride therapy can be initiated.
While maintaining the metformin dose, the glimepiride therapy is
started with a
low