Treprostinil Tillomed 1 mg/ml solution for infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Treprostinil

Fáanlegur frá:

Tillomed Pharma GmbH

ATC númer:

B01AC21

INN (Alþjóðlegt nafn):

Treprostinil

Lyfjaform:

Solution for infusion

Lækningarsvæði:

treprostinil

Leyfisstaða:

Not marketed

Leyfisdagur:

2022-09-30

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
TREPROSTINIL TILLOMED 1 MG/ML, 2.5 MG/ML, 5 MG/ML, 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 Treprostinil Tillomed is and what it is used for
2.
What you need to know before you use Treprostinil Tillomed
3.
How to use Treprostinil Tillomed
4.
Possible side effects
5.
How to store Treprostinil Tillomed
6.
Contents of the pack and other information
1.
WHAT TREPROSTINIL TILLOMED IS AND WHAT IT IS USED FOR
WHAT TREPROSTINIL TILLOMED IS
The active ingredient of Treprostinil Tillomed 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 Treprostinil Tillomed is used to treat
Treprostinil Tillomed 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.
Treprostinil Tillomed is initially administered as a continuous
subcutaneous (under the skin)
infusion. S

Vara einkenni

Health Products Regulatory Authority
22 March 2024
CRN00DRNY
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Treprostinil Tillomed 1 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1 mg treprostinil, as treprostinil sodium.
Each 20 ml vial of solution contains 20 mg treprostinil as
Treprostinil sodium (sodium salt formed _in situ_ during manufacture
of
the finished product).
Excipients with known effect:
This medicinal product contains 74.16 mg sodium per vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear colourless to slightly yellow solution, practically free from
visible particles.
pH: 6.0 - 7.2
Osmolality: 220 - 320 mOsmol/kg
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
Treprostinil Tillomed 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 a