Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Cardiac, pulmonary and vascular disease
During treatment regular monitoring and control of blood pressure, ECG, heart rate, serum levels of sodium and potassium, as well as fluid balance are required.
Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure.

Injection site reaction: To avoid local necrosis at the injection site, the injection must be administered intravenously.

Septic shock
In patients with septic shock with a low cardiac output terlipressin should not be used.

Torsade de pointes
During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including “Torsade de pointes” have been reported (see section 4.8). 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. Therefore, extreme caution should be exercised in the use of terlipressin in patients with a history of QT interval prolongation, electrolyte abnormalities, or concomitant medications that can prolong the QT interval (see section 4.5).

Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy.

Paediatric population and elderly patients: 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.

Excipients
This medicinal product contains 0.8 mmol (18.4 mg) sodium per 5 ml dose and 1.6 mmol (36.8 mg) sodium per 10 ml dose. To be taken into consideration by patients on a controlled sodium diet.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.