Tresuvi 5 mg/ml solution for infusion

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

TREPROSTINIL SODIUM

Beschikbaar vanaf:

Orpha-Devel Handels und Vertriebs GmbH Wintergasse 85/1B, A-3002 Purkersdorf, Austria

ATC-code:

B01AC21

INN (Algemene Internationale Benaming):

TREPROSTINIL SODIUM 5 mg/ml

farmaceutische vorm:

SOLUTION FOR INFUSION

Samenstelling:

TREPROSTINIL SODIUM 5 mg/ml

Prescription-type:

POM

Therapeutisch gebied:

ANTITHROMBOTIC AGENTS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2020-12-14

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRESUVI 1 MG/ML SOLUTION FOR INFUSION
TRESUVI 2.5 MG/ML SOLUTION FOR INFUSION
TRESUVI 5 MG/ML SOLUTION FOR INFUSION
TRESUVI 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 Tresuvi is and what it is used for
2.
What you need to know before you use Tresuvi
3.
How to use Tresuvi
4.
Possible side effects
5.
How to store Tresuvi
6.
Contents of the pack and other information
1.
WHAT TRESUVI IS AND WHAT IT IS USED FOR
WHAT TRESUVI IS
The active ingredient of Tresuvi 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 TRESUVI IS USED FOR
Tresuvi 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.
Tresuvi is initially administered as a continuous subcutaneous (under
the skin) infusion. Some
patients may become unable to tolerate this because of

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tresuvi 5 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 5 mg treprostinil, as treprostinil sodium.
Each 10 ml vial of solution contains 50 mg treprostinil as
treprostinil sodium.
Excipients with known effect: sodium: 39.1 mg (1.70 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
Tresuvi 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.
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Dose adjustments
The infusion rate should be increased under medical supervision in
increments of 1.25 ng/kg/min per
week for the first four weeks of treatment and then