Veletri 500microgram powder for solution for infusion vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Epoprostenol sodium

可用日期:

Janssen-Cilag Ltd

ATC代码:

B01AC09

INN（国际名称）:

Epoprostenol sodium

剂量:

500microgram

药物剂型:

Powder for solution for infusion

给药途径:

Intravenous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 02080100; GTIN: 7640111930822

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VELETRI 0.5 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 dose)
Before you are given Veletri your doctor needs

产品特点

OBJECT 1
VELETRI, 0.5MG, POWDER FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 14-Jun-2018 | Actelion
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Veletri 0.5 mg, 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 and
0.09 mg for 1.5 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
haemodyn