Embesin 40 I.U./2 ml concentrate for solution for infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Argipressin

Tersedia dari:

Orpha-Devel Handels und Vertriebs GmbH

Kode ATC:

H01BA; H01BA01

INN (Nama Internasional):

Argipressin

Dosis:

40 IU/2 millilitre(s)

Bentuk farmasi:

Concentrate for solution for infusion

Jenis Resep:

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

Area terapi:

Vasopressin and analogues; vasopressin

Status otorisasi:

Marketed

Tanggal Otorisasi:

2018-03-23

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMBESIN 40 IU/2 ML CONCENTRATE FOR SOLUTION FOR INFUSION
Argipressin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Embesin is and what it is used for
2.
What do you need to know before you use Embesin
3.
How to use Embesin
4.
Possible side effects
5.
How to store Embesin
6.
Contents of the pack and other information
1.
WHAT EMBESIN IS AND WHAT IT IS USED FOR
Embesin is an artificially produced active substance equivalent to the
natural hormone vasopressin. It
regulates the water balance of the body and reduces the urinary
excretion. Embesin is used in states of
septic shock after unsuccessful use of other adequate methods to
obtain target blood pressure values set
by treating physicians.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU USE EMBESIN DO NOT USE EMBESIN
-
if you are hypersensitive to argipressin or any of the other
excipients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Special precautions for use of Embesin is mandatory,
-
if it is used for increasing the blood pressure in cases of shock
following the use of other methods.
The administration must be carried out under close control of vital
parameters.
-
if it is used in patients with cardiovascular diseases.
-
if it is administered in patients with epilepsy, migraine, asthma,
heart failure, or with a disease in
which a rapid increase of extracellular water represents a risk.
-
if the patient suffers from chronic nephritis.
CHILDREN AND ADOLESCENTS
The use of Embesin in this indi

Karakteristik produk

Health Products Regulatory Authority
01 February 2024
CRN00DQG3
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Embesin 40 I.U./2 ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule with 2 ml concentrate for solution for infusion contains
argipressin acetate corresponding to 40 I.U. argipressin
(equating 133 microgram).
1 ml concentrate for solution for infusion contains argipressin
acetate corresponding to 20 I.U. argipressin (equating 66.5
microgram).
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion. The solution is clear,
colourless and free from visible particles with a pH between 2.5 -
4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Embesin is indicated for the treatment of catecholamine refractory
hypotension following septic shock in patients older than 18
years. A catecholamine refractory hypotension is present if the mean
arterial blood pressure cannot be stabilised to target
despite adequate volume substitution and application of catecholamines
(see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
The therapy with argipressin in patients with catecholamine refractory
hypotension is preferably started within the first six
hours after the onset of septic shock, or within 3 hours of onset in
patients on high doses of catecholamines (see section 5.1).
Argipressin should be administered by continuous intravenous infusion
of 0.01 I.U. per minute using a perfusor / motor pump.
Dependent on the clinical response, the dose may be increased every 15
– 20 minutes up to 0.03 I.U. per minute. For intensive
care patients, the usual target blood pressure is 65 – 75 mmHg.
Argipressin should only be used in addition to conventional
vasopressor therapy with catecholamines. Doses above 0.03 I.U. per
minute should only be applied as emergency treatment, as
this may cause gut and skin necrosis and increase the risk for cardiac
arrest (see section 4.4). The treatment duration should be
chosen acco