GLYPRESSIN 1 mg Powder and Solvent for Solution for Injection

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Terlipressin acetate

Disponible desde:

Ferring Ireland Ltd

Código ATC:

H01BA; H01BA04

Designación común internacional (DCI):

Terlipressin acetate

Dosis:

1 milligram(s)

formulario farmacéutico:

Powder and solvent for solution for injection

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Vasopressin and analogues; terlipressin

Estado de Autorización:

Marketed

Fecha de autorización:

1987-04-09

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYPRESSIN 1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Terlipressin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to use it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What GLYPRESSIN is and what it is used
for
2. What you need to know before you are given GLYPRESSIN
3. How you will be given GLYPRESSIN
4. Possible side
effects
5. How to store GLYPRESSIN
6.
Content
s
of the pack and other
information
1. WHAT GLYPRESSIN IS AND WHAT IT IS USED FOR
GLYPRESSIN consists of a powder and solvent for solution for
injection. The white, freeze-
dried powder contains the active component terlipressin acetate. This
medicinal product
contains up to 1.54 mmoles of sodium per dose, therefore please tell
your doctor if you are on
a controlled sodium diet.
GLYPRESSIN IS USED IN THE TREATMENT OF BLEEDING OESOPHAGEAL VARICES.
Oesophageal varices are enlarged blood vessels that form in the
stomach or oesophagus
(gullet) as a complication of liver disease. They may burst and bleed
which is a serious and
life- threatening condition.
When injected into the bloodstream, the active ingredient,
terlipressin acetate, is broken down
to release a substance called lysine vasopressin. This acts on the
walls of the blood vessels,
causing them to narrow and restrict blood flow to the affected veins
so that bleeding is
reduced.
GLYPRESSIN IS ALSO USED AS AN EMERGENCY TREATMENT OF TYPE 1
HEPATORENAL SYNDROME
IN PATIENTS WITH LIVER CIRRHOSIS AND ASCITES.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLYPRESSIN
DO NOT USE GLYPRESSIN
- if you are
ALLERGIC
to terlipressin acetate or any of the other ingredients of this
medicine
(listed in section 6)
- if you are
PREGNANT
TAKE SPECIAL CARE

Ficha técnica

Health Products Regulatory Authority
21 March 2023
CRN00DCPK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
GLYPRESSIN 1 mg Powder and Solvent for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 1 mg terlipressin acetate.
Excipients with known effect
One vial contains 0.77 mmol (17.7 mg) sodium.
For the 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
For use in the short term management of bleeding oesophageal varices.
“Emergency treatment of type 1 hepatorenal syndrome, as defined by
IAC (International Ascites Club) criteria”.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
1) SHORT TERM MANAGEMENT OF BLEEDING OESOPHAGEAL VARICES
Adults:
Initially an i.v. injection of 2 mg terlipressin acetate is given
every 4 hours. The treatment should be maintained until bleeding
has been controlled for 24 hours, but up to a maximum of 48 hours.
After the initial dose, the dose can be adjusted to 1 mg
terlipressin acetate i.v. every 4 hours in patients with body weight <
50 kg or if adverse effects occur.
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. As an
alternative to bolus injection, terlipressin can be administered as
a continuous intravenous (IV) infusion with a starting dose of 2 mg of
terlipressin acetate/24 hours and increased to a
maximum of 12 mg of terlipressin acetate/24 hours. Administration of
terlipressin as continuous IV infusion may be associated
with lower rates of severe adverse events than with administration by
IV bolus (see section 5.1).
In 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 creati