SOMATOSTATIN LYOMARK 3mg/3ml amp.

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

EIMC-EGYPT

Dosage:

3 mg/3ml

Pharmaceutical form:

injection

Units in package:

1 ampoule

Manufactured by:

LYOMARK-PHARMA GERMANY

Authorization date:

2000-09-05

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE PRODUCT
Somatostatin Lyomark 3 mg
Lyophilisate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains:
3.24-3.92 mg somatostatin acetate, equivalent to 3 mg somatostatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for solution for infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Severe, acute gastroduodenal ulcer bleeding
•
Severe, acute bleeding in acute erosive or haemorrhagic gastritis
•
Prophylaxis for postoperative pancreatic complications following
pancreatic surgery
•
Adjuvant therapy to inhibit the secretion of severe secretory
postoperative pancreatic and
upper small fistulas
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosage is recommended according to clinical experience:
3.5 µg somatostatin/kg bw/h
as a continuous infusion over the entire therapy period
_ _
_Injection of a saturation dose: _
Initially, a single saturaion dose of 3.5 µg somatostatin/kg bw (e.
g. for a 75 kg patient 250 µg
somatostatin) dissolved in 1 ml sterile, isotonic, pyrogen-free sodium
chloride solution can be
injected slowly (over 1 minute) intravenously.
_Infusion of the maintenance dose: _
For maintenance therapy, somatostatin is administered as a continuous
intravenous infusion
according to the general dosage recommendation (3.5 µg/kg bw/hour).
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Body weight
(kg)
50
60
70
80
Dose (µg/h)
170
200
250
270
In clinical practice, a largely uniform dosage of 250 µg/h has become
internationally accepted.
Therefore, 3 mg/12 hours or 2 x 3 mg/24 hours are generally
administered.
METHOD OF ADMINISTRATION
For a body weight of 70 – 75 kg and an infusion duration of 12
hours, it applies for example:
_ _
_a) Infusion with perfusor_
3 mg somatostatin lyophilisate for preparation of a solution for
injection and/or infusion are
dissolved in 36 ml sterile, pyrogen-free, isotonic sodium chloride
solution. The solution is drawn
up in a