Epoprostenol Sun 1.5 mg powder for solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Epoprostenol SUN 0.5 mg powder for solution for infusion
Epoprostenol SUN 1.5 mg powder for solution for infusion
epoprostenol
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Epoprostenol SUN is and what it is used for
- What you need to know before using Epoprostenol SUN
- How to use Epoprostenol SUN
- Possible side effects
- How to store Epoprostenol SUN
- Contents of the pack and other information
1. What Epoprostenol SUN is and what it is used for
Epoprostenol SUN contains the active substance epoprostenol, which belongs to a group of medicines called prostaglandins, which prevent blood clotting and dilate blood vessels.
Epoprostenol SUN is used to treat a lung disease known as "pulmonary arterial hypertension". This occurs when the pressure in the blood vessels of the lungs is high. Epoprostenol SUN dilates the blood vessels to reduce blood pressure in the lungs.
Epoprostenol SUN is also used to prevent blood clotting during renal dialysis in emergency situations where heparin cannot be used.
2. What you need to know before using Epoprostenol SUN
Do not use Epoprostenol Sun
- if you are allergic to epoprostenol or to any of the other components of this medicine (listed in section 6)
- if you have heart failure.
- if you begin to develop fluid accumulation in the lungs causing difficulty in breathing after starting treatment.
If you think any of these situations applies to you, do not use Epoprostenol Sun until you have consulted your doctor.
Warnings and precautions
Talk to your doctor before starting Epoprostenol Sun
- if you bleed easily (e.g., from the nose).
Skin and injection site injury
Epoprostenol Sun is injected into a vein. It is important that the medicine does not leak or seep out of the vein into the surrounding tissues. If it does, it may damage the skin. Symptoms include:
- tenderness
- burning
- itching
- swelling
- redness.
This may be followed by blister formation and skin peeling. It is important that you monitor the injection site while being treated with Epoprostenol Sun.
Contact the hospital immediately if the injection site becomes painful, stings, or swells, or if you notice any blistering or skin peeling.
Effect of Epoprostenol Sun on blood pressure and heart rate
Epoprostenol Sun may increase or decrease your heart rate. Your blood pressure may also become very low. While you are being treated with Epoprostenol Sun, your heart rate and blood pressure will be monitored. Symptoms of low blood pressure include dizziness and fainting.
Tell your doctor if you experience any of these symptoms. It may be necessary to reduce your dose or stop the infusion.
Children and adolescents
The safety and efficacy of Epoprostenol Sun in children has not been established.
Using Epoprostenol Sun with other medicines
Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.
Some medicines may affect how Epoprostenol Sun works or make it more likely that you experience side effects.
Epoprostenol Sun may also affect how other medicines work if taken at the same time. These include:
- medicines used to treat high blood pressure
- medicines used to prevent blood clots
- medicines used to dissolve blood clots
- medicines used to treat inflammation or pain (also known as NSAIDs), for example ibuprofen
- digoxin (used to treat heart disorders).
Tell your doctor or nurse if you are taking any of these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether the components of Epoprostenol Sun pass into human milk. You must stop breastfeeding while being treated with Epoprostenol Sun.
Driving and using machines
This treatment may affect your ability to drive and use machines.
Do not drive or operate machinery if you do not feel well.
Epoprostenol Sun contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially "sodium-free".
The diluted solution of Epoprostenol Sun (pH 12) must not be used with administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG).
3. How to use Epoprostenol SUN
Follow exactly the instructions for administration of this medicine as given by your doctor, nurse, or pharmacist. If in doubt, consult your doctor or nurse again.
Epoprostenol SUN comes as a powder in a small glass vial. The powder must be dissolved before use.
Epoprostenol SUN must not be administered as a rapid intravenous injection. It must always be administered as an intravenous infusion (slow drip).
Your doctor will determine the appropriate amount of Epoprostenol SUN for you. The dose administered is based on your body weight and the type of disease. Your dose may be increased or decreased depending on how well you respond to treatment.
Epoprostenol SUN is administered by slow infusion (drip) into a vein.
Pulmonary arterial hypertension
Your initial treatment will be given in a hospital. This is because your doctor needs to monitor you and identify the best dose for you.
Treatment will begin with an Epoprostenol SUN infusion. The dose will be gradually increased until your symptoms are relieved and any adverse effects are controlled. Once the optimal dose has been determined, a permanent catheter (venous access) will be placed in one of your veins. You can then be treated using an infusion pump.
Renal dialysis
You will receive an Epoprostenol SUN infusion throughout the duration of your dialysis session.
Use of Epoprostenol SUN at home (only for the treatment of pulmonary arterial hypertension)
If you are being treated at home, your doctor or nurse will teach you how to prepare and use Epoprostenol SUN. They will also instruct you on how to stop the treatment if necessary. Discontinuation of Epoprostenol SUN must be done gradually. It is very important that you carefully follow all instructions.
Epoprostenol SUN comes as a powder in a glass vial. Before use, the powder must be dissolved in a liquid. The liquid does not contain preservatives. You must discard any unused liquid.
Catheter care
If a venous access ("line") has been placed, it is very important to keep the area clean; otherwise, it could become infected. Your doctor or nurse will teach you how to clean the access site and the surrounding area. It is very important that you carefully follow all instructions. It is also very important that you carefully follow all instructions regarding changing the drug administration reservoir (cassette) of the pump and that you always use an extension set with an internal filter, as instructed by your doctor, in order to reduce the risk of infection.
If you use more Epoprostenol SUN than you should
Seek urgent medical attention if you think you have used or have been given too much Epoprostenol SUN. Symptoms of overdose may include headache, nausea, vomiting, rapid heartbeat, warmth or tingling, or feeling like you might faint (dizziness/vertigo sensation).
If you forget to use Epoprostenol SUN
Do not use a double dose to make up for missed doses.
If you stop treatment with Epoprostenol SUN
Discontinuation of Epoprostenol SUN must be done gradually. If you stop treatment too quickly, you may experience serious adverse effects, including dizziness, feeling weak, and difficulty breathing. If you have problems with the infusion pump or catheter, such as it stops or prevents Epoprostenol SUN treatment, contact your doctor, nurse, or hospital immediately.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Tell your doctor or nurse immediately if you experience any of the following signs of blood infection, low blood pressure, or serious bleeding:
- You feel your heart beating faster, or have chest pain or difficulty breathing.
- You feel dizzy or feel faint, especially when standing up.
- You have fever or chills.
- You bleed more often or for longer periods, for example from the nose.
- The injection site becomes painful, stings or swells, or you notice any blistering or peeling of the skin (see section 2).
Other possible adverse effects
Very common (affects more than 1 in 10 people)
- headache
- jaw pain
- non-specific pain
- being sick (vomiting)
- feeling unwell (nausea)
- diarrhoea
- redness of the face (facial flushing).
Common (may affect up to 1 in 10 people)
- blood infection (septicaemia)
- rapid heartbeat
- decreased heart rate
- low blood pressure
- bleeding in various locations and increased tendency to bruise, for example nose or gum bleeding
- discomfort or pain in the stomach
- chest pain
- joint pain
- feeling anxious, feeling nervous
- rash
- pain at the injection site
- decrease in the number of platelets in the blood (blood cells that help with clotting). This may be seen in blood tests.
Uncommon (may affect up to 1 in 100 people)
- sweating
- dry mouth.
Rare (may affect up to 1 in 1,000 people)
- infection at the injection site.
Very rare (may affect up to 1 in 10,000 people)
- feeling of pressure in the chest
- tiredness, weakness
- restlessness
- paleness
- redness at the injection site
- overactivity of the thyroid gland
- blockage of the intravenous catheter
Frequency not known (cannot be estimated from the available data)
- enlargement or overactivity of the spleen
- fluid accumulation in the lungs (pulmonary oedema)
- increased blood sugar (glucose)
- swelling due to fluid accumulation around the stomach
- excessive pumping of blood from the heart leading to shortness of breath, fatigue, swelling of the legs and abdomen due to fluid retention, persistent cough.
Reporting of adverse effects
If you get any adverse effects, talk to your doctor, pharmacist or nurse, including any possible adverse effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Epoprostenol SUN
Keep this medicine out of the sight and reach of children.
Do not use Epoprostenol SUN after the expiry date stated on the label of the vial and the carton following EXP. The expiry date refers to the last day of the month indicated.
Do not freeze.
Store the vial in the outer carton to protect it from light.
The reconstituted solution must be diluted to the final concentration within the first hour after reconstitution (see Information for healthcare professionals).
For storage conditions after reconstitution and dilution of the medicinal product, see Information for healthcare professionals.
Do not use this medicine if you notice the presence of particles in the reconstituted solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Epoprostenol Sun
Epoprostenol SUN 0.5 mg, powder for solution for infusion:
- The active substance is epoprostenol (as epoprostenol sodium). Each vial contains 0.531 mg of epoprostenol sodium equivalent to 0.5 mg of epoprostenol. One ml of reconstituted solution contains 0.1 mg of epoprostenol (as epoprostenol sodium).
Epoprostenol SUN 1.5 mg, powder for solution for infusion:
- The active substance is epoprostenol (as epoprostenol sodium). Each vial contains 1.593 mg of epoprostenol sodium equivalent to 1.5 mg of epoprostenol. One ml of reconstituted solution contains 0.3 mg of epoprostenol (as epoprostenol sodium).
The other components are glycine, sucrose and sodium hydroxide (to adjust pH).
Appearance of Epoprostenol Sun and contents of the pack
White or almost white powder in a clear glass vial with a rubber stopper and an aluminium screw cap.
Each pack contains one vial with 0.5 mg of powder.
Each pack contains one vial with 1.5 mg of powder.
Only certain pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Local Representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
Tel: +34 93 342 78 90
This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:
Germany Epoprostenol SUN
France Epoprostenol SUN
Italy Epoprostenolo SUN
Netherlands Epoprostenol SUN
Spain Epoprostenol SUN
United Kingdom (Northern Ireland) Epoprostenol
Date of the latest review of this summary: October 2023
This information is intended for healthcare professionals only:
Renal dialysis
One pack is available for use in the treatment of renal dialysis:
- One vial containing 0.5 mg of powder.
Reconstitution:
Withdraw approximately 5 ml of sterile water or 0.9% sodium chloride injection solvent using a sterile syringe, inject it into the vial containing Epoprostenol SUN, and gently shake until the powder is completely dissolved. The reconstituted solution must be inspected before proceeding with dilution. Use must be avoided if particles or discoloration are observed. Disposal of unused reconstituted solution must be carried out in accordance with local regulations.
Dilution:
The reconstituted solution must be diluted to the final concentration within the first hour after reconstitution. Subsequent dilution must be performed using the same solvent used for reconstitution of the sterile lyophilised powder.
When Epoprostenol SUN lyophilisate is reconstituted with sterile water for injection or 0.9% sodium chloride injection solvent, the final injection solution has a pH between 11.5 and 12.
Infusion rate calculation:
The infusion rate can be calculated using the following formula:
Infusion rate (ml/min) = Dose (ng/kg/min) × body weight (kg)
Concentration of solution (ng/ml)
Infusion rate (ml/h) = Infusion rate (ml/min) × 60
Pulmonary arterial hypertension
Two packs are available for use in the treatment of pulmonary arterial hypertension:
- One vial containing 0.5 mg of powder.
- One vial containing 1.5 mg of powder.
Reconstitution:
Withdraw approximately 5 ml of sterile water or 0.9% sodium chloride injection solvent using a sterile syringe, inject it into the vial containing Epoprostenol SUN, and gently shake until the powder is completely dissolved. The reconstituted solution must be inspected before proceeding with dilution. Use must be prohibited if particles or discoloration are present. Disposal of unused reconstituted solution must be carried out in accordance with local regulations.
Dilution:
The reconstituted solution must be diluted to the final concentration within the first hour after reconstitution. Subsequent dilution must be performed using the same solvent used for reconstitution of the sterile lyophilised powder. When administered chronically, Epoprostenol SUN must be prepared in a suitable drug administration reservoir compatible with the infusion pump.
When Epoprostenol SUN lyophilisate is reconstituted with sterile water for injection or 0.9% sodium chloride injection solvent, the final injection solution has a pH between 11.5 and 12.
Compatible ambulatory infusion pumps for administration of Epoprostenol SUN include:
- CADD-Legacy 1
- CADD-Legacy PLUS
Manufactured by Smiths Medical.
Compatible pump accessories for administration of Epoprostenol SUN include:
- Disposable medication cassettes CADD 50 mL; 100 mL from Smiths Medical.
- Extension set with internal 0.2 micron filter (CADD extension set with male Luer, 0.2 micron air-eliminating filter, clamp and integral anti-siphon valve with male Luer) from Smiths Medical.
Only extension sets with internal 0.22 micron filters must be used between the infusion pump and the catheter. It is recommended to use filters with a hydrophilic polyethersulfone membrane. The extension set and internal filter must be changed at least every 48 hours.
The diluted solution of Epoprostenol SUN (pH 12) must not be used with administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG).
The vial containing 0.5 mg of epoprostenol must be used for the preparation of solutions with concentrations below 15,000 ng/mL.
Table 1 shows examples of preparation of common concentrations of Epoprostenol SUN solutions. Each vial is for single use only.
Table 1: Common concentrations: examples of reconstitution and dilution
Final concentration (ng/ml) | Instructions: |
3,000 ng/ml | Dissolve the contents of one 0.5 mg vial in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw 3 ml of the vial contents and add sufficient volume of the same solvent to obtain a total of 100 ml. |
5,000 ng/ml | Dissolve the contents of one 0.5 mg vial in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw the entire contents of the vial and add sufficient volume of the same solvent to obtain a total of 100 ml. |
10,000 ng/ml | Dissolve the contents of two 0.5 mg vials, each in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw the entire contents of the vials and add sufficient volume of the same solvent to obtain a total of 100 ml. |
15,000 ng/ml* | Dissolve the contents of one 1.5 mg vial in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw the entire contents of the vial and add sufficient volume of the same solvent to obtain a total of 100 ml. |
30,000 ng/ml* | Dissolve the contents of two 1.5 mg vials, each in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw the entire contents of the vials and add sufficient volume of the same solvent to obtain a total of 100 ml. |
30,000 ng/ml* | Dissolve the contents of one 1.5 mg vial in 5 ml of sterile water for injection or 0.9% sodium chloride for injection. Withdraw the entire contents of the vial and add sufficient volume of the same solvent to obtain a total of 50 ml. |
|
Epoprostenol SUN, diluted to the final concentration in the drug administration reservoir according to the instructions, can be administered immediately at room temperature (25°C) or stored for up to 8 days between 2 and 8°C under the conditions of use described in
Table 2.
Table 2: Maximum duration of administration (hours) at room temperature (25°C) of fully diluted solutions stored in the drug administration reservoir.
Final concentration range | Immediate administration* | If stored for up to 8 days between 2 and 8°C* |
≥ 3,000 ng/mL and <15,000 ng/mL | 48 hours | 24 hours |
≥ 15,000 ng/mL | 48 hours | 48 hours |
Do not expose the fully diluted solution to direct sunlight.
Special storage precautions
Do not freeze.
The reconstituted solution must be diluted to the final concentration within the first hour after reconstitution.
Reconstitution and dilution must be performed immediately before use.
Freshly prepared diluted solutions of epoprostenol for the treatment of pulmonary arterial hypertension may be administered immediately at 25°C or stored in the drug delivery reservoir protected from light for up to 8 days between 2 and 8°C, under the conditions of use described in Table 2.