Treposuvi 1 mg/ml solution for infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Treprostinil

Dostupné s:

Orpha-Devel Handels und Vertriebs GmbH

ATC kód:

B01AC21

INN (Mezinárodní Name):

Treprostinil

Dávkování:

1 milligram(s)/millilitre

Léková forma:

Solution for infusion

Terapeutické oblasti:

treprostinil

Datum autorizace:

2021-05-07

Informace pro uživatele

1
AT/H/1058/001-004/DC, PL
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREPOSUVI 1 MG/ML SOLUTION FOR INFUSION
TREPOSUVI 2.5 MG/ML SOLUTION FOR INFUSION
TREPOSUVI 5 MG/ML SOLUTION FOR INFUSION
TREPOSUVI 10 MG/ML SOLUTION FOR INFUSION
treprostinil
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.
-
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 Treposuvi is and what it is used for
2.
What you need to know before you use Treposuvi
3.
How to use Treposuvi
4.
Possible side effects
5.
How to store Treposuvi
6.
Contents of the pack and other information
1.
WHAT TREPOSUVI IS AND WHAT IT IS USED FOR
WHAT TREPOSUVI IS
The active ingredient of Treposuvi is treprostinil.
Treprostinil belongs to a group of medicines which work in a similar
way to the naturally occurring
prostacyclins. Prostacyclins are hormone-like substances which reduce
blood pressure by relaxing blood
vessels, causing them to widen, which allows the blood to flow more
easily. Prostacyclins can also have an
influence in preventing blood from clotting.
WHAT TREPOSUVI IS USED FOR
Treposuvi is used to treat idiopathic or heritable pulmonary arterial
hypertension (PAH) in patients with
moderate severity of the symptoms. Pulmonary arterial hypertension is
a condition where your blood
pressure is too high in the blood vessels between the heart and the
lungs causing shortness of breath,
dizziness, tiredness, fainting, palpitations or abnormal heartbeat,
dry cough, chest pain and swollen ankles
or legs.
Treposuvi is initially administered as a continuous subcutaneous
(under the skin) infusion. Some patients
may

Charakteristika produktu

Health Products Regulatory Authority
09 February 2023
CRN00CZSV
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Treposuvi 1 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg treprostinil, as treprostinil sodium.
Each 10 ml vial of solution contains 10 mg treprostinil as
treprostinil sodium.
Excipients with known effect: sodium: 36.8 mg (1.6 mmol) per 10 ml
vial
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion:
Clear colourless to slightly yellow, isotonic solution, free from
visible particles, with pH value between 6.0 and 7.2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of idiopathic or heritable pulmonary arterial hypertension
(PAH) to improve exercise tolerance and symptoms of the
disease in patients classified as New York Heart Association (NYHA)
functional class III.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treposuvi is administered by continuous subcutaneous or intravenous
infusion. Due to the risks associated with chronic
indwelling central venous catheters, including serious blood stream
infections, subcutaneous infusion (undiluted) is the
preferred mode of administration and continuous intravenous infusion
should be reserved for patients stabilised with
treprostinil subcutaneous infusion and who become intolerant of the
subcutaneous route, and in whom these risks are
considered acceptable.
The treatment should be initiated and monitored only by clinicians
experienced in the treatment of pulmonary hypertension.
ADULTS
Treatment initiation for patients new to prostacyclin therapy
Treatment should be initiated under close medical supervision in a
medical setting able to provide intensive care.
The recommended initial infusion rate is 1.25 ng/kg/min. If this
initial dose is poorly tolerated, the infusion rate should be
reduced to 0.625 ng/kg/min.
Dose adjustments
The infusion rate should be increased under medical supervision in
increments of 1.25 ng/kg/min per we