GLYPRESSIN

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

TERLIPRESSIN ACETATE

Dostopno od:

FERRING PHARMACEUTICALS LTD

Koda artikla:

H01BA04

Farmacevtska oblika:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sestava:

TERLIPRESSIN ACETATE 1 MG/VIAL

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

FERRING GmbH ,GERMANY

Terapevtska skupina:

TERLIPRESSIN

Terapevtsko območje:

TERLIPRESSIN

Terapevtske indikacije:

Bleeding oesophageal varices. Treatment of type I hepatorenal syndrome.

Datum dovoljenje:

2020-11-30

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glypressin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains terlipressin acetate 1 mg.
Excipient: Each 5 ml vial of solvent contains 17.7 mg sodium.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White, sterile powder.
Clear, colourless solvent.
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 1-2 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
2
Terlipressin should be avoided in patients with advanced renal
dysfunction, i.e., baseline serum creatinine ≥
442µmol/L (5.0 mg/dL), unless th