Glypressin Injection

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Terlipressin Acetate

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

H01BA04

INN (International Name):

Terlipressin Acetate

Dosage:

1mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Injection

Units in package:

Packs, each with one vial of powder and one ampoule of 5ml solvent

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Ferring GmbH

Therapeutic indications:

It is indicated in the treatment of bleeding oesophageal varices

Authorization status:

Authorised

Authorization date:

2001-07-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYPRESSIN  INJECTION
Terlipressin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- If any of the side effects gets serious, or if you notice any
side
effects not listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What GLYPRESSIN  Injection is and what it is used for
2.
Before you use GLYPRESSIN Injection
3.
How GLYPRESSIN Injection is administered
4.
Possible side effects
5.
How to store GLYPRESSIN Injection
6.
Further information
1. WHAT GLYPRESSIN INJECTION IS AND WHAT IT 
    IS USED FOR
Glypressin Injection consists of a powder and solvent for solution
for injection. The white, freeze-dried powder contains terlipressin
acetate.
Glypressin Injection is used in the treatment of bleeding
oesophageal varices.
Bleeding oesophageal varices are enlarged blood vessels that
form in the stomach or oesophagus as a complication of liver
disease. They may burst and bleed and this 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 the blood flow to the affected
veins so that bleeding is reduced.
2. BEFORE YOU USE GLYPRESSIN INJECTION
GLYPRESSIN INJECTION SHOULD NOT BE USED:
•
if you are pregnant
•
if you are allergic to any of the ingredients listed.
PLEASE CONSULT YOUR DOCTOR BEFORE GLYPRESSIN INJECTION IS 
ADMINISTERED TO YOU:
•
if you have hypertension (high blood pressure)
•  
if you have a heart condition (such as an irregular heart beat)
•
if you have heart disease e.g. coronary insufficiency (a 
condition in which 

Summary of Product characteristics

Glypressin Powder & Solvent for Solution for Injection
Summary of Product Characteristics Updated 06­Jul­2015 | Ferring Pharmaceuticals Ltd
1. Name of the medicinal product
Glypressin® Injection
2. Qualitative and quantitative composition
Each vial contains 1mg Terlipressin Acetate
For excipients, see 6.1
3. Pharmaceutical form
Powder and solvent for solution for injection
Vial contains white, freeze­dried powder.
Ampoule contains solvent.
4. Clinical particulars
4.1 Therapeutic indications
Glypressin
®
 is indicated in the treatment of bleeding oesophageal varices.
4.2 Posology and method of administration
In acute variceal bleeding:
Adults:
Initially an i.v. injection of 2 mg Glypressin 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 i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.
4.3 Contraindications
Contraindicated in pregnancy.
Hypersensitivity to terlipressin acetate or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Blood pressure, heart rate and fluid balance should be monitored during treatment.
To avoid local necrosis at the injection site, the injection must be given i.v.
Caution should be exercised in treating patients with hypertension or recognised heart disease.
In patients with septic shock with a low cardiac output Glypressin should not be used.
Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as
experience is limited in these groups.
There is no data available regarding dosage recommendation in these special patient categories.
4.5 Interaction with other medicinal