Leaflet SOMATOSTATINA ROMPHARM 3mg powder for solution for infusion

Indicated for: gastrointestinal bleeding; endocrine disorders

Route of administration: infusion

Substance: somatostatin (somatostatin analogue)

ATC: H01CB01 (Systemic hormonal preparations, excluding sex hormones and insulins | Hypothalamic hormones | Somatostatin and analogues)

Precautions:
Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Somatostatin is a medicine similar to a natural hormone made by the body and is mainly used in hospital for serious digestive conditions. It may be given for acute bleeding from the stomach, duodenum or oesophageal varices, for intestinal or pancreatic fistulas, and sometimes to reduce excessive secretions from certain digestive endocrine tumours.

It works by slowing the release of several hormones and digestive fluids and by reducing blood flow in the digestive area. This can help control bleeding or decrease the amount of fluid draining from a fistula. It does not replace endoscopy, surgery, transfusion or other emergency measures when those are needed.

Somatostatin is usually given into a vein, often as a slow injection followed by a continuous infusion. Blood pressure, pulse, blood glucose and signs of ongoing bleeding are monitored closely. The dose and duration are decided by the doctor according to the reason for treatment, body weight, test results and clinical response.

Possible side effects include nausea, flushing, dizziness, abdominal cramps, changes in blood sugar or changes in heart rhythm. Tell the medical team immediately if you develop chest pain, fainting, breathing difficulty, continuing bleeding, black stools or sudden worsening abdominal pain.

General data about SOMATOSTATINA ROMPHARM 3mg

  • Substance: somatostatin
  • Date of latest medicines list: 01-06-2026
  • Product code: W71848001
  • Concentration: 3mg
  • Pharmaceutical form: powder for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ROMPHARM COMPANY S.R.L. - ROMANIA
  • Holder: ROMPHARM COMPANY S.R.L. - ROMANIA
  • Number: 16549/2026/01
  • Shelf life: 3 years-after packing for marketing;after the first opening of the bottle-it is used immediately