VELETRI

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

EPOPROSTENOL

Commercializzato da:

Actelion Registration Ltd

Codice ATC:

B01AC09

INN (Nome Internazionale):

EPOPROSTENOL

Dosaggio:

0.5 Milligram

Forma farmaceutica:

Pdr for Soln for Infusion

Tipo di ricetta:

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

Area terapeutica:

epoprostenol

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-09-16

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VELETRI 0.5 MG, POWDER FOR SOLUTION FOR INFUSION
VELETRI 1.5 MG, POWDER FOR SOLUTION FOR INFUSION
Epoprostenol
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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What VELETRI is and what it is used for
2.
What you need to know before you take VELETRI
3.
How to take VELETRI
4.
Possible side effects
5.
How to store VELETRI
6.
Contents of the pack and other information
1.
WHAT VELETRI IS AND WHAT IT IS USED FOR
VELETRI contains the active substance epoprostenol, which belongs to a
group of medicines called
prostaglandin, which stops blood from clotting and widens the blood
vessels.
VELETRI is used to treat a lung condition called ‘pulmonary arterial
hypertension’. This is where the
pressure is high in the blood vessels in the lungs. VELETRI widens the
blood vessels to lower the blood
pressure in the lungs.
VELETRI is used to prevent blood clotting during kidney dialysis when
heparin cannot be used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VELETRI
DO NOT USE VELETRI

IF YOU ARE ALLERGIC to VELETRI or any of the other ingredients of this
medicine (listed in section 6).

if you have HEART FAILURE.

if you start to develop a build-up of fluid in your lungs causing
breathlessness after starting this
treatment.
If you think any of these apply to you, DON’T TAKE VELETRI until you
have checked with your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using VELETRI.
VELETRI contains sodium (less than 1 mmol sodium (23 mg) per dos

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Veletri 0.5 Milligram Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg
epoprostenol
One mL of reconstituted solution contains 0.1 mg epoprostenol (as
epoprostenol sodium) (0.5 mg epoprostenol in 5 mL
of solvent).
Excipient(s) with known effect: sodium, (0.03 mg for 0.5 mg/vial)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white powder
For the pH of the diluted solution see section 4.4
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VELETRI is indicated for:
Pulmonary Arterial Hypertension
VELETRI is indicated for the treatment of pulmonary arterial
hypertension (PAH) (idiopathic or heritable PAH and
PAH associated with connective tissue diseases) in patients with WHO
Functional Class III–IV symptoms to improve
exercise capacity (see section 5.1).
Renal Dialysis
VELETRI is indicated for use in haemodialysis in emergency situations
when use of heparin carries a high risk of
causing or exacerbating bleeding or when heparin is otherwise
contraindicated (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pulmonary Arterial Hypertension
VELETRI is only indicated for continuous infusion by intravenous
route.
Treatment should only be initiated and monitored by a physician
experienced in the treatment of pulmonary arterial
hypertension.
_Short-term (acute) dose ranging:_
This procedure should be conducted in a hospital with adequate
resuscitation equipment.
A short-term dose-ranging procedure administered via either a
peripheral or central venous line is required to determine
the long-term infusion rate. The infusion is initiated at 2 ng/kg/min
and increased by increments of 2 ng/kg/min every
15 min or longer until maximum haemodynamic benefit or dose
-
limiting pharmacological effects are elicited.
If the initial infusion rate of 2 ng/kg/min is not tolerated, a lower