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EPOPROSTENOL 0.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): EPOPROSTENOL SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Epoprostenol 0.5 mg, Powder and Solvent for solution for infusion
Epoprostenol 1.5 mg, Powder and Solvent for solution for infusion
Epoprostenol sodium
Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Epoprostenol is and what it is used for
2.
What you need to know before you take Epoprostenol
3.
How to take Epoprostenol
4.
Possible side effects
5.
How to store Epoprostenol
6.
Contents of the pack and other information
1.

WHAT EPOPROSTENOL IS AND WHAT IT IS USED FOR

Epoprostenol contains the active substance epoprostenol which belongs to a group of medicines called
prostaglandin, which stops blood from clotting and widens the blood vessels.
Epoprostenol is used to treat a lung condition called ‘pulmonary arterial hypertension’. This is where the
pressure is high in the blood vessels in the lung. Epoprostenol widens the blood vessels to lower the blood
pressure in the lungs.
Epoprostenol is used to prevent blood clotting during kidney dialysis in emergency situations when heparin
cannot be used.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPOPROSTENOL

Do not take Epoprostenol
if you are allergic to or any of the other ingredients of this medicine (listed in section 6).
if you have heart failure.
if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this
treatment.
If you think any of these apply to you, don’t take Epoprostenol until you have checked with your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Epoprostenol:
 If you have any problems with bleeding.
 If you are on a controlled sodium diet.

Skin damage at the injection site
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Epoprostenol is injected into a vein. It is important that the medicine does not leak out of the vein into the
surrounding tissue. If it does, the skin could be damaged. The symptoms of this are:
 tenderness
 burning
 stinging
 swelling
 redness
This may be followed by blistering and shedding of the skin. While you are being treated with Epoprostenol
it is important that you check the injection area.
Contact the hospital immediately for advice if the area becomes sore, painful or swollen or you notice any
blistering or shedding.
Effect of Epoprostenol on blood pressure and heart rate
Epoprostenol can cause your heart to beat faster or slower. Also your blood pressure can become too low.
While you are being treated with Epoprostenol your heart rate and blood pressure will be checked. The
symptoms of low blood pressure include dizziness and fainting.
Tell your doctor if you get these symptoms. Your dose may need to be reduced or your infusion stopped.
Other medicines and Epoprostenol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Some medicines may affect how Epoprostenol works, or make it more likely that you’ll have side effects.
Epoprostenol can also affect how some 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 called ‘NSAIDs’).
- digoxin (used to treat heart disease).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine as your symptoms could worsen during
pregnancy.
It is not known whether the ingredients of Epoprostenol can pass into breast-milk.You should stop
breastfeeding your child during treatment with Epoprostenol.
Driving and using machines
Your treatment may have an effect on the ability to drive or use machinery.
Don’t drive or use machines unless you’re feeling well.
Epoprostenol contains sodium, which should be taken into consideration by patients on a controlled
sodium diet.
3.

HOW TO TAKE EPOPROSTENOL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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Your doctor will decide how much Epoprostenolis right for you. The amount you are given is based on your
body wheight, and your type of illness. Your dose may be increased or decreased depending on how well
your respond to treatment.
Epoprostenol is given by slow infusion (drip) into a vein.
Pulmonary arterial hypertension
Your first treatment will be given to you in a hospital. This is because your doctor needs to monitor you and
find the best dose for you.
You will start with an infusion of Epoprostenol. The dose will be increased, until your symptoms are
relieved, and any side effects are manageable. Once the best dose has been found, a permanent tube (line)
will be fitted into one of your veins. You can then be treated using an infusion pump.
Kidney dialysis
You will be given an infusion of Epoprostenol for the duration of your dialysis.
Using Epoprostenol at home (only for treatment of Pulmonary Arterial Hypertension)
If you are treating yourself at home, your doctor or nurse will show you how to prepare and use
Epoprostenol.
They will also advise you how to stop treatment if necessary. Stopping Epoprostenol must be done
gradually. It is very important that you follow all their instructions carefully.
Epoprostenol comes as a powder in a glass vial. Before use, the powder needs to be dissolved in the liquid
provided. The liquid does not contain a preservative. If you have any of the liquid left over, it must be
thrown away.
Looking after the injection line
If you could have been fitted with a ‘line’ into a vein it is very important to keep this area clean, otherwise
you could get an infection. Your doctor or nurse will show you how to clean your ‘line’ and the area around
it. It is very important that you follow all of their instructions carefully.
If you take more Epoprostenol than you should
Seek urgent medical attention if you think you have used or been given too much Epoprostenol 0.5 mg
and 1.5 mg powder and solvent for infusion. Symptoms of overdose may include headache, nausea,
vomiting, fast heart rate, warmth or tingling, or feeling like you might pass out (feeling faint/dizziness).
If you forget to take Epoprostenol
Do not take a double dose to make up for a forgotten dose.
If you stop taking Epoprostenol
Stopping Epoprostenol 0.5 mg and 1.5 mg powder and solvent for infusion must be done gradually. If the
treatment is stopped too quickly you may get serious side effects, including dizziness, feeling weak and
breathing difficulties. If you have problems with the infusion pump or injection line that stops, or prevents
treatment with Epoprostenol, contact your doctor, nurse or hospital immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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Tell your doctor or nurse immediately, as these may be signs of infection of the blood or low blood pressure
or serious bleeding:

You feel that your heart is beating faster, or you have chest pain or shortness of breath.

You feel dizzy or feel faint, especially on standing.

You have fevers or chills.

You have more frequent, or longer periods of bleeding.
Very common side effects
These may affect more than 1 in 10 people

headache

jaw pain

pain

being sick (vomiting)

feeling sick (nausea)

diarrhoea

redness of your face (flushing)
Common side effects
These may affect up to 1 in 10 people

infection of the blood (septicaemia)

heart beating faster

slow heart beat

low blood pressure

bleeding at various sites and bruising more easily than normal, for example from the nose or gums

stomach discomfort or pain

chest pain

joint pain

feeling anxious, feeling nervous

rash

pain at the injection site
Common side effects that may show up in blood tests

decrease in the number of blood platelets (cells that help the blood to clot)
Uncommon side effects
These may affect up to 1 in 100 people

sweating

dry mouth
Rare side effects
These may affect up to 1 in 1,000 people

Infection at the injection site
Very rare side effects
These may affect up to 1 in 10,000 people

feeling of tightness around the chest

feeling tired, weak

feeling agitated

pale skin

redness at the injection site,

overactive thyroid gland

blockage of the injection catheter
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Other side effects
Frequency cannot be estimated from the available data

enlarged or overactive spleen

build up fluid in the lungs (pulmonary oedema)

increase in sugar (glucose) in the blood.

swelling due to build-up of fluid around the stomach
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side affects you can help provide more information on the safety of this medicine.
5.

HOW TO STORE EPOPROSTENOL

Keep this medicine out of the sight and reach of children.
Do not use Epoprostenol after the expiry date which is stated on the label and carton after EXP. The expiry
date refers to the last day of that month.
Powder for solution for infusion:
Do not store above 25°C. Do not freeze. Store in the original outer carton in order to protect from light and
moisture.
Solvent for parenteral use:
Store below 25°C. Do not freeze. Store in the original outer carton in order to protect from light.
The solvent contains no preservative; consequently a vial should be used once only and then discarded.
Pulmonary Arterial Hypertension:
Once Epoprostenol powder has been dissolved, and diluted, it should ideally be used immediately. If you are
being given Epoprostenol using an infusion pump, a “cold-pouch” may be used to maintain the temperature
of the solution.
When using a “cold-pouch”, the solution can be stored in the pump for:
- a maximum of 24 hours at 2-8°C, if it has just been made up or if it was made previously and stored at
refrigerated conditions (2 to 8°C) for up to 24 hours, with a maximum total storage and in-use time of
24 hours at 2 to 8°C (refrigerated conditions and cold pouch combined).
If you are not using a ‘cold pouch’, the solution can be stored in the pump for:
- a maximum of 12 hours at 25oC, if it has just been made up.
- a maximum of 8 hours at 25oC, if it was made previously and has been stored at 2-8oC for up to 24
hours.
Renal dialysis:
Once Epoprostenol has been dissolved, and diluted, any unused solution can be stored at 25 °C and used
within 12 hours.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

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6.

CONTENT OF THE PACK AND OTHER INFORMATION

What Epoprostenol contains
The active substance is epoprostenol sodium. Epoprostenol injection comes in different strenghts.
Each vial contains either:
0.5 mg Epoprostenol 0.5 mg and 1.5 mg powder and solvent for infusion sodium.
1.5 mg Epoprostenol 0.5 mg and 1.5 mg powder and solvent for infusion sodium .
The other ingredients are Mannitol, Glycine, Sodium Chloride, Sodium Hydroxide and Water.
What Epoprostenol looks like and contents of the pack
Injection:
Epoprostenol is a solution for injection made up of powder and solution. The powder is white and the
solution is clear and colourless.

There are two packs of Epoprostenol available for use in the treatment of pulmonary arterial hypertension,
the contents of each pack include:

One 0.5 mg powder vial and one or two solvent vials and a filter unit.

One 1.5 mg powder vial and one or two solvent vials and a filter unit.
Not all pack sizes are available in all markets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Beacon Pharmaceuticals Limited, 85 High Street, Tunbridge Wells , Kent, TN1 1YG, UK
Manufacturer:
DEPO-PACK S.N.C. DI DEL DEO SILVIO E C., VIA MORANDI 28, 21047 - SARONNO (VA) – Italy
PIERREL S.p.A.,Strada statale Appia, 46/48, 81043 Capua (CE), Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherland: Epoprostenol 0.5 mg and 1.5 mg powder and solvent for infusion 0,5 mg en 1,5 mg,

poeder en oplosmiddel voor oplossing voor infusie
The United Kingdom: Epoprostenol 0.5 mg and 1.5 mg powder and solvent for infusion
0.5 mg and 1.5 mg powder and solvent for solution for infusion
Italy: Epoprostenolo PH&T 0,5 mg e 1.5 mg, polvere e solvente per soluzione per infusione
This leaflet was last last revised in May 2016

The following information is intended for healthcare professionals only:

7.

INFORMATION FOR HEALTHCARE PROFESSIONALS

Renal Dialysis
There is only one pack available for use in renal dialysis:
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One 0.5 mg powder vial and one solvent vial

Reconstitution
1. Use only the solvent provided for reconstitution.
2. Withdraw approximately 10 ml of the solvent into a sterile syringe, inject it into the vial containing
0.5 mg freeze-dried Epoprostenol powder and shake gently until the powder has dissolved.
3. Draw up the resulting Epoprostenol solution into the syringe, re-inject it into the remaining volume
of the solvent and mix thoroughly.
This solution is now referred to as the concentrated solution and contains 10,000 nanogram per ml
Epoprostenol. Only this concentrated solution is suitable for further dilution prior to use. When 0.5 mg of
Epoprostenol powder is reconstituted with 50 ml of the solvent, the final injection has a pH of approximately
10.5 and a sodium ion content of approximately 56 mg.
Dilution:
The concentrated solution is normally further diluted before use. It may be diluted with sodium chloride
0.9% w/v solution, provided a ratio of 6 volumes of sodium chloride 0.9% w/v solution to 1 volume of
concentrated solution is not exceeded e.g. 50 ml of concentrated solution further diluted with a maximum of
300 ml sodium chloride 0.9% w/v solution. Other common intravenous fluids are unsatisfactory for the
dilution of the concentrated solution as the required pH is not attained. Epoprostenol solutions are less stable
at low pH.
To dilute the concentrated solution, draw it up into a larger syringe and then attach the sterile filter provided
to the syringe.
Dispense the concentrated solution directly into the chosen infusion solution using firm but not excessive
pressure; the typical time taken for the filtration of 50 ml of concentrated solution is 70 seconds. Mix well.
The filter unit must be used once only and then discarded.
When reconstituted and diluted as directed above, Epoprostenol infusion solutions have a pH of
approximately 10 and will retain 90% of their initial potency for approximately 12 hours at 25°C.

Calculation of infusion rate:
The infusion rate may be calculated by the following formula:
dosage (nanogram/kg/min) x bodyweight (kg)
Infusion rate (ml/min) =
concentration of solution (nanogram/ml)
Infusion rate (ml/h) = Infusion rate (ml/min) x 60
For administration using a pump capable of delivering small volume constant infusion, suitable aliquots of
concentrate solution may be diluted with sterile sodium chloride 0.9% w/v solution.
Pulmonary arterial hypertension
The following packs are available for use in the treatment of pulmonary arterial hypertension:



One 0.5 mg powder vial and one or two solvent vials and a filter unit.
One 1.5 mg powder vial and one or two solvent vials and a filter unit.
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Not all pack sizes are available in all markets.

Initially a pack containing solvent must be used. During chronic therapy with Epoprostenol the final
concentration of solution may be increased by the addition of a further 0.5 mg or 1.5 mg vial of freeze-dried
Epoprostenol.
Only vials of the same amount as that included in the initial starter pack may be used to increase the final
concentration of solution.
Reconstitution:
1. Use only the solvent provided for reconstitution.
2. Withdraw approximately 10ml of the solvent into a sterile syringe, inject the contents of the syringe
into the vial containing Epoprostenol powder and shake gently until the powder has dissolved.
3. Draw up the resulting Epoprostenol solution into the syringe, re-inject it into the remaining volume
of the solvent and mix thoroughly.
This solution is now referred to as the concentrated solution and contains either 10,000 (for the 0.5 mg
strength) or 30,000 nanogram per ml Epoprostenol (for the 1.5 mg strength). Only this concentrated solution
is suitable for further dilution prior to use. When 0.5 mg of Epoprostenol powder is reconstituted with 50 ml
of the solvent, the final injection has a pH of approximately 10.5 and a sodium ion content of approximately
56 mg.
Dilution:
Epoprostenol may be used either as concentrated solution or in a diluted form in the treatment of pulmonary
arterial hypertension. Only the solvent provided may be used for the further dilution of reconstituted
Epoprostenol. Sodium chloride 0.9% w/v solution must not be used when Epoprostenol is to be used for the
treatment of pulmonary arterial hypertension.

To dilute the concentrated solution, draw it up into a larger syringe and then attach the sterile filter provided
to the syringe.
Dispense the concentrated solution directly into the solvent using firm but not excessive pressure; the
typical time taken for filtration of the 50 ml of concentrated solution is 70 seconds. Mix well.
The filter must be used once only and then discarded.
Concentrations commonly used in the treatment of pulmonary arterial hypertension are as follows:

5,000 nanogram/ml – one vial containing 0.5 mg Epoprostenol reconstituted and diluted to a total
volume of 100 ml in solvent.

10,000 nanogram /ml – two vials containing 0.5 mg Epoprostenol reconstituted and diluted to a total
volume of 100 ml in solvent

15,000 nanogram /ml – one vial containing 1.5 mg Epoprostenol reconstituted and diluted to a total
volume of 100 ml in solvent
.
Calculation of infusion rate:
The infusion rate may be calculated from the following formula:
Infusion rate (ml/min) =

dosage (nanogram/kg/min) x bodyweight (kg)
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concentration of solution (nanogram/ml)

Infusion rate (ml/h) = Infusion rate (ml/min) x 60
Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term
administration of Epoprostenol.
Special precautions for storage:
Store below 25°C.
Do not freeze.
Keep container in the original outer carton in order to protect from light and moisture.
Any cold pouch used must be capable of maintaining the temperature of the reconstituted solution.
Store between 2 and 8 °C for the full administration period.
Reconstitution and dilution should be carried out immediately prior to use.
The solvent contains no preservative; consequently, a vial should be used once only and then discarded.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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