REMODULIN 1 мг/мл Инфузионный раствор

Содержание инструкции

1. REMODULIN 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 Remodulin and what is it used for
   2. Before using Remodulin
   3. How to use Remodulin
   4. Possible side effects
   5. How to store Remodulin
   6. Contents of the pack and other information

REMODULIN 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 could be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse (see section 4).

Contents of this leaflet:

• 1. What Remodulin is and what it is used for
• 2. Before you use Remodulin
• 3. How to use Remodulin
• 4. Possible side effects
• 5. How to store Remodulin
• 6. Contents of the pack and other information

1. What is Remodulin and what is it used for

What is Remodulin
The active substance of Remodulin is treprostinil.
Treprostinil belongs to a class of medicines that act in a similar way to natural prostacyclins.
Prostacyclins are hormone-like substances that reduce blood pressure
causing relaxation, and therefore dilation, of blood vessels and facilitating blood flow.
Prostacyclins can also prevent blood clotting.

What is Remodulin used for
Remodulin is used for the treatment of idiopathic or
hereditary pulmonary arterial hypertension (PAH) in patients who present with moderate symptoms. Pulmonary arterial hypertension is
a disease in which the pressure is too high in the blood vessels between the heart and the lungs, and
causes shortness of breath, dizziness, fatigue, fainting, palpitations or cardiac arrhythmias, dry cough,
chest pain, and swelling of the ankles or legs.
Remodulin is initially administered as a continuous subcutaneous infusion (under the skin). Some
patients may no longer be able to tolerate it due to local pain and swelling. If
necessary, your doctor will decide whether your Remodulin can be administered by continuous intravenous infusion (directly into a vein) via the insertion of a central venous catheter (catheter)
connected to an external pump or, depending on your condition, to a pump surgically implanted
under the skin of the abdomen. Your doctor will choose the best option for you.

How does Remodulin work
Remodulin reduces blood pressure in the pulmonary artery, improving blood flow and
reducing the workload on the heart. Improved blood flow results in better oxygen delivery
to the body and a decrease in strain on the heart, allowing the heart itself to function more
effectively. Remodulin improves the symptoms associated with pulmonary arterial hypertension and the ability to
move for patients with limited capacity.

2. Before using Remodulin

Do not use Remodulin

• if you are allergic (hypersensitive) to treprostinil or any of the excipients 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 vessels carrying blood to the lungs become edematous and blocked, causing an increase in pressure in the vessels between the heart and the lungs.
• in case of severe liver disease
• in case of a heart problem, for example: myocardial infarction (a heart attack) in the last six months, severe disturbances of heart rate, severe coronary artery disease or unstable angina, a heart defect has been diagnosed, such as a valve defect causing disturbance to heart function, any heart disease that is not treated or not under strict medical control
• if you have a specific risk of bleeding - for example in case of active gastric ulcer, lesions or other bleeding conditions
• if you have had a stroke in the last three months or any other condition that has interrupted blood flow to the brain.

Warnings and precautions
Before starting to take Remodulin, tell your doctor:

• if you suffer from a liver disease
• if you have been told that you are obese (BMI greater than 30 kg/m²)
• if you have a Human Immunodeficiency Virus (HIV) infection
• if you suffer from high pressure in the hepatic veins (portal hypertension)
• if you have a congenital heart defect that affects the way your heart circulation works.

During treatment with Remodulin, tell your doctor:

• if your blood pressure drops (hypotension)
• if you experience a rapid increase in difficulty breathing or persistent cough (this may be due to pulmonary congestion, asthma or other conditions), seek yourdoctor immediately.
• in case of excessive bleeding, as treprostinil may increase this risk by preventing your blood from clotting.
• if you develop a fever during intravenous administration of Remodulin or if the intravenous infusion site becomes red, swollen and/or painful to the touch, as this may be a sign of infection.

Other medicines and Remodulin
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
Tell your doctor if you are using:

• medicines used to treat high blood pressure(antihypertensive drugs or other vasodilators)
• medicines used to increase urineproduction (diuretics) including furosemide
• medicines that prevent blood clotting(anticoagulants) such as warfarin, heparin or products based on nitric oxide
• any non-steroidal anti-inflammatory drug (NSAIDs) (for example acetylsalicylic acid, ibuprofen)
• medicines that can increase or decrease the effect of Remodulin (for example gemfibrozil, rifampicin, trimethoprim, deferasirox, phenytoin, carbamazepine, phenobarbital, St. John's wort), as your doctor may need to adjust the dose of Remodulin.

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

Driving and operating machinery
Remodulin can cause a lowering of blood pressure with dizziness or fainting. In such
cases do not drive vehicles or use machinery and consult your doctor.

Remodulin contains sodium
This medicine contains up to 78.4 mg (3.41 mmol) of sodium (the main component of table
salt) per 20 ml, equivalent to 4% of the maximum recommended daily intake of sodium
in the diet of an adult.

3. How to use Remodulin

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor.
Remodulin is administered by continuous infusion:

• either by the subcutaneous route (under the skin) through a thin tube (catheter) inserted into the abdomen; or into the thigh.
• or intravenously through a tube (catheter) generally placed in the neck, chest or groin.

In both cases, Remodulin is pumped into the tube through a small portable pump positioned
outside the body.
Before leaving the hospital or clinic, your doctor will tell you how to prepare Remodulin and at what rate the
pump must deliver your dose of Remodulin.
Flushing the infusion cannula while it is connected may cause an accidental overdose of the
medicine.
Alternatively, Remodulin can be administered intravenously via an implantable infusion pump
for infusion which is usually surgically inserted under the skin of the abdomen. In this case, the
pump and the tube are both completely inside the body and you will need to go to hospital periodically
(e.g. every 4 weeks) to allow the internal reservoir to be refilled.
You must also be given information on the correct use of the pump and what to do in case of a
malfunction. This information will also include details of who to contact in
case of an emergency.
Remodulin is diluted only when administered for continuous intravenous infusion:

For intravenous infusion via external portable pump:the Remodulin solution should only be diluted with
sterile water for injection or with 0.9% sodium chloride solution for injection (as prescribed by your doctor).

For intravenous infusion via implantable infusion pump:you must go to hospital
periodically (e.g. every 4 weeks), as the healthcare professional must dilute the Remodulin solution with 0.9% sodium chloride solution for injection and refill the internal reservoir.
Adult patients
Remodulin is available in the form of a solution for infusion of 1 mg/ml, 2.5 mg/ml, 5 mg/ml or 10
mg/ml. Your doctor will determine the infusion rate and the dose appropriate for your condition.
Overweight patients
If you are overweight (more than 30% over your ideal body weight) your doctor will determine the initial and subsequent doses based on your ideal body weight. See also Section 2, “Warnings
and precautions”.
Elderly patients
Your doctor will determine the infusion rate and the dose appropriate for your condition.
Children and adolescents
The available data relating to the use of the medicine in children and adolescents are limited.
Dosage adjustment
The infusion rate can only be increased or decreased on an individual basis under medical
supervision.
The purpose of adjusting the infusion rate is to establish an effective maintenance rate, capable of improving the symptoms of pulmonary arterial hypertension and at the same time
minimizing any undesirable effects.
If your symptoms worsen, or if you need complete rest or if you are confined to bed or an armchair, or if any physical activity increases your discomfort or if your symptoms occur even
when you are at rest, do not increase the dosage without consulting your doctor. It is possible that Remodulin is no
longer sufficient to treat your illness and another treatment may be necessary.

How can I prevent bloodstream infections during treatment with Remodulin for
intravenous use?
As with any long-term intravenous treatment using an external infusion pump, there is a risk of bloodstream infections. Your doctor will prepare you to avoid this.

If you use more Remodulin than you should
If you accidentally take more Remodulin than you should, you may develop nausea, vomiting,
diarrhea, low blood pressure (dizziness, confusion or fainting), skin redness and/or headache.
If any of these effects become severe, you should contact your doctor or hospital immediately. The
doctor may reduce or stop the infusion until the symptoms disappear. The Remodulin infusion solution will then be restored to a level of dose recommended by the doctor.

If you stop taking Remodulin
Always use Remodulin according to your doctor's or hospital specialist's instructions. Do not stop
using Remodulin unless your doctor tells you to.
Abrupt discontinuation or sudden reductions in the dose of Remodulin may cause a recurrence
of pulmonary arterial hypertension with the possibility of a sudden and serious deterioration in your
condition.
If you have any doubts about using this product, please consult your doctor.

4. Possible side effects

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

• dilation of blood vessels with redness of the skin
• pain or sensitivity at the infusion site
• discoloration of the skin or bruising at the infusion site
• headaches
• skin rashes
• nausea
• diarrhea
• jaw pain

Common side effects (more than 1 in 100 people)

• dizziness
• vomiting
• mental confusion or fainting due to low blood pressure
• itching or redness of the skin
• swelling of feet, ankles or legs or fluid retention
• bleeding episodes such as nosebleeds, coughing up blood, blood in the urine, bleeding gums, blood in the stool
• joint pain
• muscle pain
• pain in the legs and/or arms

Other possible side effects with unknown frequency (frequency cannot be estimated based on available data)

• infection at the infusion site
• abscess at the infusion site
• decrease in blood cells responsible for coagulation (platelets) (thrombocytopenia)
• bleeding at the infusion site
• bone pain
• skin rash with skin discoloration or papule formation
• infection of the tissue under the skin (cellulitis)
• due to the heart pumping too much blood, shortness of breath, fatigue, swelling of the legs and abdomen due to fluid accumulation, persistent cough occur

Further side effects associated with the intravenous route of administration

• inflammation of the vein (thrombophlebitis)
• bacterial infection of the bloodstream (bacteremia)* (see section 3)
• septicemia (severe bacterial blood infection)

* potentially life-threatening or fatal cases of bacterial bloodstream infections have been reported

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at ”www.aifa.gov.it/content/segnalazioni-reazioni-avverse ”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Remodulin

Keep Remodulin out of the reach and sight of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the vial. The expiry date
refers to the last day of the month.
Do not use Remodulin if you notice any damage to the vial, alteration of the product's colour or other
visible signs of deterioration.
A vial of Remodulin must be used or discarded within 30 days of first opening.
During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Remodulin must
be used within 72 hours.
During continuous intravenous infusion via external portable pumps, a single reservoir (syringe) of
diluted Remodulin must be used within 24 hours.
During continuous intravenous infusion via implantable infusion pumps, the solution of
diluted Remodulin inserted into the pump reservoir must be used within a maximum of 35 days.
The healthcare professional at the hospital will inform you of the duration of the interval before the next
reservoir refill.
Any remaining diluted solution must be discarded.
For instructions for use, refer to paragraph 3 “How to use Remodulin”.
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 Remodulin contains
The active ingredient is treprostinil sodium 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml.
The excipients of Remodulin are:
Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol and water for
injections.

Description of the appearance of Remodulin and contents of the pack
Remodulin is a transparent solution, from colorless to slightly yellow, available in a vial of
20 ml of transparent glass sealed with a rubber stopper and a color-coded crimp cap:

• Remodulin 1 mg/ml solution for infusion is equipped with a rubber crimp cap of yellow color.
• Remodulin, 2.5 mg/ml solution for infusion is equipped with a rubber crimp cap of blue color.
• Remodulin, 5 mg/ml solution for infusion is equipped with a rubber crimp cap of green color.
• Remodulin, 10 mg/ml solution for infusion is equipped with a rubber crimp cap of red color. Each box contains one vial.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Ferrer Internacional, S.A
Gran Vía Carlos III, 94

• 08028 - Barcelona Spain

Distributor for sales: Dompé farmaceutici S.p.A – Via San Martino, 12 – 20122 Milan

Manufacturer and responsible for batch release:
McGregor Cory Limited
Middleton Close,
Banbury, Oxfordshire, OX16 4RS – UNITED KINGDOM
Ferrer Internacional, S.A.
Joan Buscallà, 1-9

• 08173 - Sant Cugat del Vallès (Barcelona) SPAIN