TERLIPRESSIN ACETATE EVER PHARMA 0.2 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TERLIPRESSIN ACETATE

Available from:

PHARMALOGIC LTD

ATC code:

H01BA04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TERLIPRESSIN ACETATE 0.2 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

EVER VALINJECT GMBH, AUSTRIA

Therapeutic area:

TERLIPRESSIN

Therapeutic indications:

Bleeding oesophageal varices. Treatment of type I hepatorenal syndrome.

Authorization date:

2022-08-04

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Terlipressin Acetate EVER Pharma 0.2 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.2 mg terlipressin acetate corresponding to 0.17 mg
terlipressin.
Each vial of 5 ml solution contains terlipressin acetate 1 mg
corresponding to 0.85 mg terlipressin.
Each vial of 10 ml solution contains terlipressin acetate 2 mg
corresponding to 1.7 mg terlipressin
Excipients with known effect:
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.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with a pH of 4.0 – 5.0 and an osmolarity
of 270 – 330 mOsm/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bleeding oesophageal varices.
Treatment of type I hepatorenal syndrome
.
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 vials of 5
ml or 1 vial of 10 ml. Terlipressin 1mg, is slowly administered to
adults. The maintenance dose is 1 mg
terlipressin acetate , equivalent to 1 vial of Terlipressin 1mg after
4-6 hours. The standard value of the
maximum daily dose of Terlipressin 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 of 1 mg 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 treatment is advised.
In the other cases, Terlipressin 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.