Posology : מינונים

4.2     Posology and method of administration
1) Oesophageal varices bleeding
Unless otherwise prescribed, initially IV injection of 1-2 mg terlipressin acetate, equivalent to 1- 2 ampoules of Terlipressin Altan 1 mg, is slowly administered to adults. The maintenance dose is 1 mg terlipressin acetate, equivalent to 1 ampoule of Terlipressin Altan 1 mg after 4-6 hours.
The standard value of the maximum daily dose of Terlipressin Altan 1 mg is 120-150 ug/kg body weight. For an adult person of 70 kg body weight, this corresponds to a dose of 8-10 ampoules 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 Terlipressin Altan 1 mg treatment is advised.
In the other cases, Terlipressin Altan 1 mg 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.