TERLIPRESSIN ACETATE

v. injection of 2 mg Terlipressin Acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.

Paediatric population:

There is no relevant use of Terlipressin Acetate in paediatric population. Method of administration Intravenous injection use

Summary of safety profile The most frequently reported undesirable effects in clinical trials are abdominal pain, nausea, diarrhoea, pallor, vomiting and bradycardia. 4 for further information Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Monitoring during treatment During treatment regular monitoring of blood pressure, ECG or heart rate, oxygen saturation, serum levels of sodium and potassium, as well as fluid balance are required. Particular care is required in the management of patients with cardiovascular or pulmonary disease since terlipressin may induce ischaemia and pulmonary vascular congestion.

Caution should also be exercised in treating patients with hypertension. v. Septic shock In patients with septic shock with a low cardiac output Terlipressin Acetate should not be used. 8). Patients with diabetes mellitus and obesity seem to have a greater tendency to this reaction.

Therefore, caution should be exercised when administering terlipressin in these patients. 8). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) or medications with concomitant effect on QT prolongation.

5).

Children and the elderly:

Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups. There is no data available regarding dosage recommendation in these special patient categories. 8% respectively of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Contraindicated in pregnancy. 1).