Posology : מינונים

4.2      Posology and method of administration

1.Oesophageal varices bleeding
Unless otherwise prescribed, initially IV injection of 1-2mg terlipressin acetate, equivalent to 1-2 vials of Glypressin 1mg, is slowly administered to adults. The maintenance dose is 1 mg terlipressin acetate , equivalent to 1 vial of Glypressin 1mg after 4-6 hours. The standard value of the maximum daily dose of Glypressin is 120-150 ug/kg body weight. For an adult person of 70 kg body weight, this corresponds to a dose of 8- 10 vials per day, to be administered in 4-hour intervals.

2) In type 1 hepatorenal syndrome:
3 to 4 mg every 24 hours as 3 or 4 administrations.
In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of Glypressin treatment is advised.
In the other cases, Glypressin treatment is to be pursued until the obtaining either of a serum creatinine less than 130 µmol/litre or of a drop of at least 30 % in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome.
The standard average duration of treatment is 10 days.

Special Populations
Elderly patients
There is no data available regarding dosage recommendation in the elderly.
Paediatric population
There is no data available regarding dosage recommendation in the paediatric population.
Type 1 hepatorenal syndrome
Renal impairment
Terlipressin should be avoided in patients with advanced renal dysfunction, i.e., baseline serum creatinine ≥ 442µmol/L (5.0 mg/dL), unless the benefit is judged to outweigh the risks (see section 4.4).
Hepatic impairment
Terlipressin should be avoided in patients with severe liver disease defined as Acute-on-Chronic Liver Failure (ACLF) grade 3 and/or a Model for End-stage Liver Disease (MELD) score ≥39, unless the benefit is judged to outweigh the risks (see section 4.4).

Method of Administration
IV injection