Glypressin 1mg powder and solvent for solution for injection vials

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Terlipressin acetate

Предлага се от:

Ferring Pharmaceuticals Ltd

АТС код:

H01BA04

INN (Международно Name):

Terlipressin acetate

дозиране:

1mg

Лекарствена форма:

Powder and solvent for solution for injection

Начин на приложение:

Intravenous

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06050200; GTIN: 05015919401812

Листовка

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 the arteries of the heart become hardened,
narrow or blocked leading to an insufficient blood supply to
the heart muscle)
•
if you have atherosclerosis (a disease of the arteries in which
fat

Данни за продукта

OBJECT 1
GLYPRESSIN POWDER & SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 12-Sep-2017 | 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, freeze-dried 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
Posology
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.
Paediatric population:
There is no relevant use of Glypressin in paediatric population.
Method of administration
Intravenous injection use
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 products and other forms of
interaction
The hypotensive effect of non-selective beta-b