Glypressin 1 mg/ 8.5 ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terlipressin acetate

Available from:

Ferring Ireland Ltd

ATC code:

H01BA; H01BA04

INN (International Name):

Terlipressin acetate

Dosage:

1mg/8.5 millilitre(s)

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Vasopressin and analogues; terlipressin

Authorization status:

Marketed

Authorization date:

2009-09-25

Patient Information leaflet

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

Summary of Product characteristics

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/ 8.5 ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
8.5 ml of injection solution contains 1mg Terlipressin Acetate (0.12
mg/ml).
Excipients with known effect
One ampoule contains 30.7 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless aqueous fluid
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 (2 x 8.5 ml) 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 (8.5 ml) 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:
An i.v. injection 3 to 4 mg (3x8.5ml to 4x8.5ml) terlipressin acetate
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
o