TREPULMIX 1 мг/мл Инфузионный раствор

Содержание инструкции

1. Trepulmix 1 mg/ml solution for infusion, 2.5 mg/ml solution for infusion, 5 mg/ml solution for infusion, 10 mg/ml solution for infusion
   1. What is Trepulmix and what is it used for
   2. What you need to know before using Trepulmix
   3. How to use Trepulmix
   4. Possible side effects
   5. How to store Trepulmix
   6. Contents of the pack and other information

Trepulmix 1 mg/ml solution for infusion, 2.5 mg/ml solution for infusion, 5 mg/ml solution for infusion, 10 mg/ml solution for infusion

treprostinil

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Trepulmix and what is it used for

What is Trepulmix
The active ingredient of Trepulmix is treprostinil.
Treprostinil belongs to a class of medicines that act similarly to natural prostacyclins
Prostacyclins are hormone-like substances that reduce blood pressure
through relaxation and therefore dilation of blood vessels and facilitating blood flow.
Prostacyclins can also exert an influence in preventing blood coagulation.

What is Trepulmix used for
Trepulmix is indicated for the treatment of adult patients with chronic thromboembolic pulmonary hypertension
(CTEPH) who are inoperable or have persistent or recurrent disease after surgical
treatment (with WHO functional class of severity III or IV), to improve exercise capacity
and symptoms of the disease. Chronic thromboembolic pulmonary hypertension is a disease in
which the blood pressure in the blood vessels between the heart and lungs is too high, which causes shortness of
breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeat, dry cough,
chest pain and swollen ankles or legs.

How Trepulmix works
Trepulmix reduces blood pressure in the pulmonary artery, improving blood flow and
reducing the workload of the heart. Improved blood flow results in a greater supply of
oxygen to the body and a decrease in heart effort, allowing the heart itself to
function more effectively. Trepulmix improves symptoms associated with CTEPH and exercise capacity of patients with limited mobility.

2. What you need to know before using Trepulmix

Do not use Trepulmix

• if you are allergic to treprostinil or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with a disease called “pulmonary veno-occlusive disease”. This is a disease in which the blood vessels that carry blood to the lungs become swollen and blocked, causing an increase in pressure in the blood vessels between the heart and the lungs;
• if you have severe liver disease;
• if you have a heart problem, for example: a heart attack (myocardial infarction) in the last six months; serious changes in heart rate; severe coronary artery disease or unstable angina; you have been diagnosed with a heart defect, such as a heart valve defect that causes the heart to malfunction; any heart disease that is not treated or not kept under strict medical control;
• if you have a high risk of bleeding, for example, if you have active stomach ulcers, injuries, or other bleeding conditions;
• if you have had a stroke in the last 3 months or any other condition that has interrupted blood flow to the brain.

Warnings and precautions
Talk to your doctor before using Trepulmix, if:

• you suffer from any liver disease;
• you suffer from kidney disease;
• you have been told that, from a medical point of view, you are obese (Body Mass Index/BMI greater than 30 kg/m²);
• you are following a low-sodium diet.

During treatment with Trepulmix, inform your doctor:

• if your blood pressure drops (hypotension);
• if you experience a rapid increase in difficulty breathing or persistent cough (this may be related to pulmonary congestion, asthma, or other conditions), seek immediate medical attention;
• in the presence of excessive bleeding, as treprostinil may increase this risk because it prevents blood clotting. Children and adolescentsTrepulmix should not be used in children and adolescents. Other medicines and TrepulmixTell your doctor if you are taking, have recently taken, or might take any other medicine. Tell your doctor if you are taking:
• medicines used for the treatment of high blood pressure(antihypertensive drugs or other vasodilators);
• medicines used to increase the rate of urination(diuretics), including furosemide;
• medicines that stop blood clotting(anticoagulants) such as warfarin, heparin, or nitric oxide-based products;
• any non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., acetylsalicylic acid, ibuprofen);
• medicines that can increase or decrease the effects of Trepulmix (e.g., gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort or
• St. John's Wort), as the dose of Trepulmix may need to be adjusted by your doctor.

Pregnancy and breastfeeding
Trepulmix is not recommended if you are pregnant, planning a pregnancy, or suspect you are
pregnant, unless your doctor considers it necessary. The safety of this medicine for
use during pregnancy has not been established.
During treatment with Trepulmix, the use of a contraceptive is strongly recommended.
The use of Trepulmix is not recommended during breastfeeding, unless your doctor considers it
necessary. If you are prescribed Trepulmix, it is advisable to stop breastfeeding, as it is
not known whether this medicine is eliminated in breast milk.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
Trepulmix can cause a lowering of blood pressure, accompanied by dizziness and
lightheadedness. If this happens, do not drive vehicles or use machines and ask your doctor for advice.

Trepulmix contains sodium
Tell your doctor if you are on a low-sodium diet. Your doctor will take this into account.
Trepulmix 1 mg/ml solution for infusion
This medicine contains in each vial 36.8 mg of sodium (the main component of table salt), which is equivalent to 1.8% of the maximum recommended daily intake of sodium for an
adult.
Trepulmix 2.5 mg/ml solution for infusion
This medicine contains in each vial 37.3 mg of sodium (the main component of table salt), which is equivalent to 1.9% of the maximum recommended daily intake of sodium for an
adult.
Trepulmix 5 mg/ml solution for infusion
This medicine contains in each vial 39.1 mg of sodium (the main component of table salt), which is equivalent to 2.0% of the maximum recommended daily intake of sodium for an adult.
Trepulmix 10 mg/ml solution for infusion
This medicine contains in each vial 37.4 mg of sodium (the main component of table salt), which is equivalent to 1.9% of the maximum recommended daily intake of sodium for an
adult.

3. How to use Trepulmix

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
Trepulmix is administered undiluted as a continuous infusion subcutaneously (under the
skin), through a small tube (cannula) inserted into the abdomen or thigh.
Trepulmix is pumped into the tube through a portable pump.
Before leaving the hospital or clinic, your doctor will explain how to prepare Trepulmix and at what
rate the pump should deliver the treprostinil dose. You should also be given information
on the correct use of the pump or what to do in case of malfunction. You should also be
told who to contact in case of emergency.
Flushing the infusion line while it is still connected can cause accidental overdose.
Adult patients
Trepulmix is available as an infusion solution of 1 mg/ml, 2.5 mg/ml, 5 mg/ml or 10 mg/ml. The
doctor will determine the infusion rate and the dose suitable for your condition.
Elderly patients
No special dose adjustments are necessary for these patients.
Patients with hepatic or renal impairment
The doctor will determine the infusion rate and the dose suitable for your condition.
Infusion rate
The infusion rate can be reduced or increased on an individual basis only under medical
supervision.
Adjusting the infusion rate aims to establish an effective maintenance rate, capable of improving the symptoms of CTEPH and at the same time minimizing
undesirable effects.
If symptoms worsen, if you need complete rest, or if you are confined to bed or an armchair, or
if any physical activity causes you discomfort or your symptoms occur even when you are at rest, do not
increase the dose without consulting your doctor. Trepulmix may no longer be sufficient to
treat the disease and another treatment may be necessary.

If you use more Trepulmix than you should
If you accidentally take more Trepulmix than you should, you may experience nausea, vomiting,
diarrhea, low blood pressure (dizziness, mild confusion or fainting), flushed
skin and/or headache.
If any of these effects become severe, contact your doctor or hospital immediately. The
doctor may reduce or stop the infusion until the symptoms disappear. Trepulmix solution
for infusion will then be reintroduced at the dose recommended by the doctor.

If you stop using Trepulmix
Always use Trepulmix according to the instructions of your doctor or hospital specialist. Do not
stop treatment with Trepulmix unless your doctor recommends it.
Abrupt discontinuation or sudden reductions in the dose of Trepulmix can cause a recurrence
of pulmonary arterial hypertension with the possibility of rapid and serious deterioration of your
condition.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

• vasodilation
• pain around the infusion site
• reaction around the infusion site
• bleeding or bruising around the infusion site
• headache
• nausea
• diarrhoea
• jaw pain

Common (may affect up to 1 in 10 people)

• dizziness
• mild confusion or feeling faint due to low blood pressure
• skin rashes
• infection at the infusion site
• pus around the infusion site (abscess)
• muscle pain (myalgia)
• joint pain (arthralgia)
• swelling of feet, ankles, legs or fluid retention
• hot flushes
• pain in the arms and/or legs

Uncommon (may affect up to 1 in 100 people)

• swollen eyelids (eyelid edema)
• indigestion
• vomiting
• skin itching
• rash
• back pain
• decreased appetite
• fatigue

Further possible side effects observed in patients with pulmonary arterial hypertension
(PAH):

• bleeding episodes such as: nosebleeds, coughing up blood, blood in the urine, bleeding gums, blood in the stools

Other possible side effects observed in clinical practice:

• decreased number of cells (platelets) responsible for blood clotting (thrombocytopenia)
• bone pain
• skin rashes with changes in colour or formation of bumps
• infection of the tissue under the skin (cellulitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system
mentioned in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trepulmix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the vial after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
A vial of Trepulmix must be used or discarded within 30 days of first opening.
During continuous subcutaneous infusion, a single reservoir (syringe) of
undiluted Trepulmix must be used within 72 hours.
Do not use this medicine if you notice any damage to the vial, colour change or signs of
deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Trepulmix contains

• The active substance is treprostinil.

Trepulmix 1 mg/ml solution for infusion
Each ml of solution contains 1 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 10 mg of treprostinil (as sodium salt).
Trepulmix 2.5 mg/ml solution for infusion
Each ml of solution contains 2.5 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 25 mg of treprostinil (as sodium salt).
Trepulmix 5 mg/ml solution for infusion
Each ml of solution contains 5 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 50 mg of treprostinil (as sodium salt).
Trepulmix 10 mg/ml solution for infusion
Each ml of solution contains 10 mg of treprostinil (as sodium salt).
Each 10 ml vial of solution contains 100 mg of treprostinil (as sodium salt).

• The other ingredients are: Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol and water for injections. See section 2 “Trepulmix contains sodium”.

Description of the appearance of Trepulmix and contents of the pack
Trepulmix is a transparent solution, from colourless to yellowish, available in a 10 ml vial
of transparent glass sealed with a coloured rubber stopper and a closing cap:
Trepulmix 1 mg/ml solution for infusion
Trepulmix 1 mg/ml solution for infusion with a yellow rubber closing cap.
Trepulmix 2.5 mg/ml solution for infusion
Trepulmix 2.5 mg/ml solution for infusion with a blue rubber closing cap.
Trepulmix 5 mg/ml solution for infusion
Trepulmix 5 mg/ml solution for infusion with a green rubber closing cap.
Trepulmix 10 mg/ml solution for infusion
Trepulmix 10 mg/ml solution for infusion with a red rubber closing cap.
Each box contains one vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SciPharm Sàrl
7, Fausermillen
L-6689 Mertert
Luxembourg

Manufacturer
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
AOP Orphan Pharmaceuticals GmbH (Austria)
Tél/Tel: +43 1 5037244

Lietuva
AOP Orphan Pharmaceuticals GmbH (Austrija)
Tel: + 43 1 5037244

България
AOP Orphan Pharmaceuticals GmbH (Австрия)
Teл.: + 43 1 5037244

Luxembourg/Luxemburg
AOP Orphan Pharmaceuticals GmbH (Austria)
Tél/Tel: + 43 1 5037244

Magyarország
AOP Orphan Pharmaceuticals GmbH (Ausztria)
Tel.: + 43 1 5037244

Danmark
AOP Orphan Pharmaceuticals GmbH (Østrig)
Tlf: + 43 1 5037244

Česká republika
AOP Orphan Pharmaceuticals GmbH (Rakousko)
Tel: + 43 1 5037244

Malta
AOP Orphan Pharmaceuticals GmbH (L-Awstrija)
Tel: + 43 1 5037244

Deutschland
AOP Orphan Pharmaceuticals Germany GmbH
Tel: + 49 89 99 740 7600

Nederland
AOP Orphan Pharmaceuticals GmbH (Oostenrijk)
Tel: + 43 1 5037244

Eesti
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel: + 43 1 5037244

Norge
AOP Orphan Pharmaceuticals GmbH (Østerrike)
Tlf: + 43 1 5037244

Ελλάδα
AOP Orphan Pharmaceuticals GmbH (Αυστρία)
Τηλ: + 43 1 5037244

Österreich
AOP Orphan Pharmaceuticals GmbH
Tel: + 43 1 5037244

España
AOP Orphan Pharmaceuticals Iberia S.L.
Tel: +34 91 395 40 84

Polska
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel.: + 43 1 5037244

France
AOP Orphan Pharmaceuticals GmbH (Autriche)
Tél: + 43 1 5037244

Portugal
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel: + 43 1 5037244

Hrvatska
AOP Orphan Pharmaceuticals GmbH (Austrija)
Tel: + 43 1 5037244

România
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel: + 43 1 5037244

Ireland
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel: + 43 1 5037244

Slovenija
AOP Orphan Pharmaceuticals GmbH (Avstrija)
Tel: + 43 1 5037244

Ísland
AOP Orphan Pharmaceuticals GmbH (Austurríki)
Sími: + 43 1 5037244

Slovenská republika
AOP Orphan Pharmaceuticals GmbH (Rakúsko)
Tel: + 43 1 5037244

Italia
AOP Orphan Pharmaceuticals GmbH (Austria)
Tel: + 43 1 5037244

Suomi/Finland
AOP Orphan Pharmaceuticals GmbH (Itävalta)
Puh/Tel: + 43 1 5037244

Κύπρος
AOP Orphan Pharmaceuticals GmbH (Αυστρία)
Τηλ: + 43 1 5037244

Sverige
AOP Orphan Pharmaceuticals GmbH (Österrike)
Tel: + 43 1 5037244

Latvija
AOP Orphan Pharmaceuticals GmbH (Austrija)
Tel: + 43 1 5037244
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/. Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.