Trepulmix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Treprostinil sodium

Available from:

SciPharm Sàrl

ATC code:

B01AC21

INN (International Name):

treprostinil

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Hypertension, Pulmonary

Therapeutic indications:

Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2020-04-03

Patient Information leaflet

31
B.
PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
TREPULMIX 1 MG/ML SOLUTION FOR INFUSION
TREPULMIX 2.5 MG/ML SOLUTION FOR INFUSION
TREPULMIX 5 MG/ML SOLUTION FOR INFUSION
TREPULMIX 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 Trepulmix is and what it is used for
2.
What you need to know before you use Trepulmix
3.
How to use Trepulmix
4.
Possible side effects
5.
How to store Trepulmix
6.
Contents of the pack and other information
1.
WHAT TREPULMIX IS AND WHAT IT IS USED FOR
WHAT TREPULMIX IS
The active ingredient of Trepulmix 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 TREPULMIX IS USED TO TREAT
Trepulmix is used for the treatment of adult patients with inoperable
chronic thromboembolic
pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after
surgical treatment (severity
classified WHO Functional Class (FC) III or IV), to improve exercise
capacity and symptoms of the
disease. Chronic thromboembolic pulmonary 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 abnor

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trepulmix 1 mg/ml solution for infusion
Trepulmix 2.5 mg/ml solution for infusion
Trepulmix 5 mg/ml solution for infusion
Trepulmix 10 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trepulmix 1 mg/ml solution for infusion:
One ml of solution contains 1 mg treprostinil (as sodium salt).
Each 10 ml vial of solution contains 10 mg treprostinil (as sodium
salt).
_Excipients with known effect _
Each 10 ml vial contains 36.8 mg (1.60 mmol) sodium.
Trepulmix 2.5 mg/ml solution for infusion:
One ml of solution contains 2.5 mg treprostinil (as sodium salt).
Each 10 ml vial of solution contains 25 mg treprostinil (as sodium
salt).
_Excipients with known effect _
Each 10 ml vial contains 37.3 mg (1.62 mmol) sodium.
Trepulmix 5 mg/ml solution for infusion:
One ml of solution contains 5 mg treprostinil (as sodium salt).
Each 10 ml vial of solution contains 50 mg treprostinil (as sodium
salt).
_Excipients with known effect _
Each 10 ml vial contains 39.1 mg (1.70 mmol) sodium.
Trepulmix 10 mg/ml solution for infusion:
One ml of solution contains 10 mg treprostinil (as sodium salt).
Each 10 ml vial of solution contains 100 mg treprostinil (as sodium
salt).
_Excipients with known effect _
Each 10 ml vial contains 37.4 mg (1.63 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear colourless to slightly yellow solution, free from visible
particles with a pH of 6.0 – 7.2 and an
osmolality between 253 and 284 mOsm/kg.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trepulmix is indicated for the treatment of adult patients with WHO
Functional Class (FC) III or IV
and:
-
inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or
-
persistent or recurrent CTEPH after surgical treatment to improve
exercise capacity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Trepulmix should be initiated and monitored only by
clinicians experienced in the