SOMATOSTATIN-UCB
(somatostatin)
1. 1 phial of lyophilised powder for I.V. injection:
Somatostatin. acet. hydrat. = in bas. 250 µg pro dos un.
plus 1 ampoule of solvent of 1 ml:
Natr. chlorid. 9 mg - Aqua ad iniectabil. q.s. ad ml un.
2. 1 phial of lyophilised powder for I.V. injection:
Somatostatin. acet. hydrat. = in bas. 3 mg pro dos un.
plus 1 ampoule of solvent of 1 ml:
Natr. chlorid. 9 mg - Aqua ad iniectabil. q.s. ad ml un.
3. 1 phial of lyophilised powder for I.V. injection:
Somatostatin. acet. hydrat. = in bas. 6 mg pro dos un.
plus 1 ampoule of solvent of 1 ml:
Natr. chlorid. 9 mg - Aqua ad iniectabil. q.s. ad ml un.
Somatostatin-UCBÒ 250 µg: Powder and solvent for inject able solution.
Somatostatin-UCBÒ 3 mg and Somatostatin-UCBÒ 6 mg: Powder and solvent for solution for infusion.
Somatostatin is an oligopeptide made up of 14 amino acids, which was originally isolated in the animal hypothalamus, and which has subsequently been found in epithelial cells and nerve fibres throughout the digestive system.
It is agreed that Somatostatin has a local action as a transport substance and that in this way it modulates the activity of endocrine and exocrine glands, and also the motility of the digestive tract.
Administered at pharmacological doses, Somatostatin inhibits the activity of the digestive tract. It inhibits also motility and absorption.
Somatostatin rapidly and selectively reduces the blood supply to the digestive tract, without affecting the systemic blood pressure or the heart rate. It completely inhibits gastric secretions that have an anti-haemostatic effect.
1. The treatment of pancreatic and intestinal fistulas.
2. The symptomatic treatment of hypersecretion caused by endocrine tumours of the gastro-intestinal tract.
3. Treatment of acute oesophageal haemorrhage when endoscopic sclerotherapy is not applicable, because of the intensity of the haemorrhage. The administration of Somatostatin is not recommended for more than 48 hours.
Hypersensitivity to somatostatin or to the analogues of somatostatin.
The following undesirable effects have been reported:
The hot flushes, nausea, abdominal pains, and diarrhoea observed if the substance is given by rapid injection may be avoided by injecting it slowly.
SPECIAL PRECAUTIONS FOR USE
There is a risk of sensitisation if the patient has been given somatostatin before.
Arterial haemorrhages caused by the rupture of vessels must be treated by surgery (with endoscopic checking).
The reduction of glycaemia sometimes seen at the start of the infusion may be followed after 2 to 3 hours by elevated blood sugar caused by the inhibition of the insulin secretion. For this reason, the simultaneous administration of sugar must be avoided as far as possible and the blood sugar levels must be checked regularly. Small doses of insulin may be justified.
Other gastro-intestinal hormones are also inhibited by somatostatin.
Caution is essential in diabetic patients.
As the rate of glomerular filtration, the production of urine and the blood levels of sodium may be reduced during treatment with somatostatin, regular monitoring of the renal function and the plasma electrolyte levels is recommended.
The safety of Somatostatin during pregnancy and the period of breast feeding has not been established. Therefore Somatostatin should not be used in pregnant women, during the period of lactation or in the pre- or post-natal period.
Due to the wide variety of pharmacodynamic effects caused by somatostatin on different regulatory systems, many pharmacodynamic interactions are possible.
Pharmacodynamic interactions with a possible clinical relevance have been observed with medicines that influence glucose regulation, the plasma renin levels and the blood pressure, indicating that somatostatin can modify the effects of these medicines on these variables.
The concomitant administration of any form of sugar (including glucose and fructose solutions or total parental nutrition) predisposes towards disorders of the glycaemia and requires that the blood sugar be monitored regularly.
The initial dose should be approximately 3.5 µg per kg (or one 250 µg ampoule for a person of 75 kg), made up when required in the ampoule of isotonic solvent, administered by I.V. as a slow bolus (over more than one minute).
It should be followed immediately by a continuous I.V. infusion of 3.5 µg per kg per hour (or one ampoule of 3 mg every 12 hours or one ampoule of 6 mg per 24 hours) over several days (48 hours minimum and 120 hours maximum).
In patients suffering from severe renal insufficiency (creatinine clearance ≤ 30 ml/min), the dosage must be reduced to 1.75 µg per kg per hour for a continuous IV infusion and to 1.75 µg per kg for the bolus.
Given the short half-life of 1 to 2 minutes, continuous intravenous infusion is indispensable.
SOMATOSTATINE-UCB is preferably used in an intensive care setting.
The appearance of nausea, vomiting and abdominal pains and metabolic disorders (hypoglycaemia and hyperglycaemia) have been reported following the administration of high doses of somatostatin.
Overdose treatment is symptomatic. There is no known antidote. Due to the short half life of somatostatin in the blood (2 minutes), halting the administration rapidly improves the symptoms. Regular monitoring of the glycaemia, cardiovascular parameters, the renal function and plasma electrolyte levels is recommended in the event of overdose.
STORAGE:
Somatostatin-UCBÒ 250 µg: store between 2° and 8°C
Somatostatin-UCBÒ 3 mg and Somatostatin-UCBÒ 6 mg: do not exceed 25°C.
Stability: Please refer to the date shown on the packing after the statement “Ex” (month/year). The expiry date is the first day of the month stated.
From the microbiological point of view, the somatostatin solutions should be used immediately. If they are not used immediately, the duration and conditions of storage of the reconstituted solution are the responsibility of the user. The length of time for which it can be stored should not normally exceed 24 hours between 2°C and 8°C assuming reconstitution/dilution was performed in controlled and validated aseptic conditions.
Box of 1 phial for I.V. injection of 250 µg + 1 ampoule of solvent of 1 ml.
Box of 1 phial for I.V. injection of 3 mg + 1 ampoule of solvent of 1 ml.
Box of 1 phial for I.V. injection of 6 mg + 1 ampoule of solvent of 1 ml.
UCB S.A. UCB S.A. (Pharma Division)
Allée de la Recherche, 60 Chemin du Foriest
1070 Brussels 1420 Braine-l’Alleud