STILAMIN 3000 FOR INJECTION 3 mgampoule

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

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03-11-2009

Thành phần hoạt chất:

SOMATOSTATIN ACETATE EQV SOMATOSTATIN

Sẵn có từ:

MERCK PTE. LTD.

Mã ATC:

H01CB01

Liều dùng:

3 mg/ampoule

Dạng dược phẩm:

INJECTION, POWDER, FOR SOLUTION

Thành phần:

SOMATOSTATIN ACETATE EQV SOMATOSTATIN 3 mg/ampoule

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Merck Serono S.A.

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

1991-06-17

Tờ rơi thông tin

                                pp-1146   Black
page 1
STILAMIN
®
Somatostatin Serono
FOR INTRAVENOUS INFUSION ONLY
-  Adjuvant treatment in pancreatic, biliary and intestinal 
fi stulae.
-  Prophylaxis and treatment of postoperative complications 
following pancreatic surgery.
-  Adjuvant treatment in diabetic ketoacidosis.
PHARMACODYNAMIC PROPERTIES
Stilamin® is a synthetic cyclic 14 amino-acid peptide, which is 
identical in structure and action to natural somatostatin.
By i.v. 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 aff ects the absorption, motility,
splanchnic 
blood fl ow and trophic functions of the gastro-intestinal 
tract.
Physiologically, somatostatin is found mainly in the 
gastrointestinal tract and in the hypothalamus.
Somatostatin inhibits the release of gastrin, gastric acid 
and pepsin which supports its indication in the treatment 
of upper G.I., haemorrhage. Furthermore, somatostatin 
is capable of reducing remarkably splanchnic blood fl ow 
without causing
signifi cant 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 eff ective in the prophylaxis 
and treatment of postoperative complications of pancreatic 
surgery.
The positive eff ect of somatostatin in the management of 
diabetic ketoacidosis can be ascribed to its suppression 
activity of glucagon secretion.
PHARMACOKINETICS
In healthy persons the plasma level of endogenous 
somatostatin is low, generally well under 175 ng/L.
Following i.v. administration, somatostatin shows a very short 
plasma half-life which, as measured by radioimmunoassay, 
lies between 1,1 and 3 minutes in normal subjects, between 
1,2 and 4,8 minutes in subjects with liver di
                                
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Đặc tính sản phẩm

                                STILAMIN®
Somatostatin Serono
FOR INTRAVENOUS INFUSION ONLY
PRESENTATION
Ampoules of Stilamin
®
(Somatostatin Serono) contain synthetic somatostatin (as the acetate)
as a white,
freeze-dried, sterile and pyrogen-free powder.
One strength is available: 3 mg.
Each ampoule of Stilamin
®
contains:
Somatostatin
3.0 mg*
D-Mannitol (excipient)
5.0 mg
* Corresponding to 3.6 mg of somatostatin acetate.
INDICATIONS 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 in pancreatic, biliary and intestinal fistulae.
•
Prophylaxis and treatment of postoperative complications following
pancreatic surgery.
•
Adjuvant treatment in diabetic ketoacidosis.
PHARMACODYNAMIC PROPERTIES
Stilamin
®
is a synthetic cyclic 14 amino-acid peptide, which is identical in
structure and action
to natural somatostatin.
By i.v. 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 gastrointestinal
tract and in the hypothalamus.
Somatostatin inhibits the release of gastrin, gastric acid and pepsin
which supports its indication in the
treatment of upper G.I., 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 pancreatic
surgery.
The positive effect of somatostatin in the management of diabetic
ketoacidosis can be asc
                                
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