愛胰達10公撮小瓶注射劑

国家: 台湾

语言: 中文

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

有效成分:

INSULIN GLULISINE (HOE 901)

可用日期:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC代码:

A10AB06

药物剂型:

注射劑

组成:

INSULIN GLULISINE (HOE 901) (6820801410) eq to 100 U/mlMG

每包单位数:

小瓶

类:

菌　疫

处方类型:

限由醫師使用

厂商:

SANOFI-AVENTIS DEUTSCHLAND GMBH INDUSTRIEPARK HOECHST D-65926 FRANKFURT AM MAIN GERMANY DE

治疗领域:

insulin glulisine

疗效迹象:

糖尿病。

產品總結:

註銷日期: 2018/08/21; 註銷理由: 自請註銷; 有效日期: 2020/05/06; 英文品名: Apidra 100U/ml Solution for Injection, 10ml Vial

授权状态:

已註銷

授权日期:

2005-05-06

资料单张

1
1. NAME OF THE MEDICINAL PRODUCT
Apidra 100 Units/ml, solution for injection in a vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Each vial contains 10 ml of solution for injection, equivalent to 1000
Units.
Insulin glulisine is produced by recombinant DNA technology in
Escherichia coli.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection in a vial.
Clear, colourless, aqueous solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of adults, adolescents and children, 6 years or older with
diabetes mellitus, where treatment with insulin is required.
4.2 Posology and method of administration
The potency of this preparation is stated in units. These units are
exclusive to Apidra and are not the same as IU or the units used to
express the
potency of other insulin analogues. See section 5.1
(Pharmacodynamics).
Apidra should be given shortly (0-15 min) before or soon after meals.
Apidra should be used in regimens that include an intermediate or long
acting insulin or basal insulin analogue and can be used with oral
hypoglycaemic agents.
The dosage of Apidra should be individually adjusted.
Administration
Apidra should be given by subcutaneous injection or by continuous
subcutaneous pump infusion.
Apidra should be administered subcutaneously in the abdominal wall,
thigh or deltoid or by continuous infusion in the abdominal wall.
Injection
sites and infusion sites within an-injection area (abdomen, thigh or
deltoid) should be rotated from one injection to the next. The rate of
absorption,
and consequently the onset and duration of action, may be affected by
the injection site, exercise and other variables. Subcutaneous
injection in
the abdominal wall ensures a slightly faster absorption than other
injection sites (see section 5.2).
Care should be taken to ensure that a blood vessel has not been
entered. After injection, the site of injection should not be
massaged. Patients must
be educated t