施他寧

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)

资料单张 资料单张 (PIL)
16-06-2021
公众评估报告 公众评估报告 (PAR)
26-03-2020

有效成分:

SOMATOSTATIN (ACETATE)

可用日期:

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代码:

H01CB01

药物剂型:

凍晶注射劑

组成:

SOMATOSTATIN (ACETATE) (6828091210) MG

每包单位数:

安瓿;;盒裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

Alfasigma S.P.A. Via Enrico Fermi, 1 65020 Alanno-Pescara-Italy IT

治疗领域:

somatostatin

疗效迹象:

食道靜脈曲張引起的嚴重急性出血。胃潰瘍、十二指腸潰瘍、出血性胃炎引起的嚴重急性出血。胰臟手術後胰臟併發症之預防。胰臟、膽及腸道廔管之輔助治療。

產品總結:

有效日期: 2026/08/16; 英文品名: STILAMIN 3MG

授权日期:

1996-08-16

资料单张

                                PAGE 1
PRESENTATION
Ampoules of Stilamin (Somatostatin) contain synthetic
somatostatin (as the acetate) as a white, freeze-dried, sterile
and pyrogen-free powder.
Two strengths are available: 250µg and 3mg.
Each ampoule of Stilamin contains:
Somatostatin
250µg or 3.0mg
D-Mannitol (excipient) 5.0mg
*
Corresponding to 300µg and 3.6mg of somatostatin
acetate respectively.
Each ampoule of the strength 250µg is accompanied by
a solvent ampoule containing 1ml of isotonic, sterile and
pyrogen-free Sodium Chloride injection solution.
INDICATION AND USE
Stilamin is indicated for:
•
Severe acute haemorrhage from oesophageal varices.
•
Severe acute haemorrhage from gastric or duodenal
ulcers, or accompanying acute erosive or haemorrhagic
gastritis.
•
Adjuvant treatment of pancreatic, biliary and intestinal
fistulae.
•
Prophylaxis and treatment of postoperative
complications following pancreatic surgery.
PHARMACODYNAMIC PROPERTIES
Stilamin is a synthetic cyclic 14 amino-acid peptide, which
is identical in structure and action to natural somatostatin.
By intravenous infusion in humans, somatostatin causes
inhibition of growth hormone, thyroid stimulating hormone,
insulin and glucagon secretion as well as inhibition of
gastric acid secretion. It also affects the absorption,
motility, splanchnic blood flow and trophic functions of
the gastro-intestinal tract.
Physiologically, somatostatin is found mainly in the
gastro-intestinal tract and in the hypothalamus.
Somatostatin inhibits the release of gastrin, gastric acid,
and pepsin which supports its indication in the treatment
of upper gastro-intestinal haemorrhage. Furthermore,
somatostatin is capable of reducing remarkably splanchnic
blood flow without causing significant variations in the
systemic arterial pressure, which proves to be valuable for
the management of oesophageal variceal haemorrhage.
Somatostatin reduces both pancreatic endocrine and
exocrine secretion which makes it effective in the
prophylaxis and treatment of postoperative complications
of pancrea
                                
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