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EPOPROSTENOL SODIUM 1.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): EPOPROSTENOL SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Epoprostenol Sodium 0.5 mg Powder and
Solvent for Solution for Infusion
Epoprostenol Sodium 1.5 mg Powder and
Solvent 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. You may need to read it again.
• If you have any further questions, ask your doctor or 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 or 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 use
Epoprostenol
3. How to use Epoprostenol
4. Possible side effects
5. How to store Epoprostenol
6. Contents of the pack and other information

1

These include:
• medicines used to treat high blood pressure
• medicines used to prevent blood clots
• medicines used to dissolve blood clots
• medicines to treat inflammation or pain (also
called ‘NSAIDs’)
• digoxin (used to treat heart disease).

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.

Tell your doctor or pharmacist if you are taking
any of these.

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 lungs.
Epoprostenol widens the blood vessels to lower the
blood pressure in the lungs.

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.

Epoprostenol is used to prevent blood clotting during
kidney dialysis when heparin cannot be used.

2

It is not known whether the ingredients of
Epoprostenol can pass into breast-milk. You
should stop breast-feeding your child during
treatment with Epoprostenol.

What you need to know before you
use 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.

Do not use Epoprostenol
• if you are allergic to epoprostenol 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.

Epoprostenol contains sodium
Epoprostenol Sodium 0.5 mg Powder and Solvent
for Solution for Infusion contains 2.4 mmol (or 54.7 mg)
sodium per vial. To be taken into consideration by
patients on a controlled sodium diet.

If you think any of these apply to you, don’t take
Epoprostenol until you have checked with your doctor.

Epoprostenol Sodium 1.5 mg Powder and Solvent
for Solution for Infusion contains 2.4 mmol (or 54.8 mg)
sodium per vial. To be taken into consideration by
patients on a controlled sodium diet.

Warnings and precautions
Before you are given Epoprostenol your doctor
needs to know:
• if you have any problems with bleeding.

3

Skin damage at the injection site
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.

How to use 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.

Your doctor will decide how much Epoprostenol is
right for you. The amount you are given is based on
your body weight, and your type of illness. Your
dose may be increased or decreased depending on
how well you respond to treatment.

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.

Epoprostenol is given by slow infusion (drip) into a vein.

Contact the hospital immediately for advice if the
area becomes sore, painful or swollen or you notice
any blistering or shedding.

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.

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.

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.

Other medicines and Epoprostenol
Tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.

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.

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.

Continued on the next page >>

The following information is intended for medical or healthcare professionals only
7. INFORMATION FOR HEALTHCARE PROFESSIONALS

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

1. Use only the solvent provided for reconstitution

2. Withdraw approximately 10mL 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
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 54.7 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 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 from the following formula:

Infusion rate = dosage (nanogram/kg/min) x bodyweight (kg)
(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 infusions, suitable aliquots of
concentrated solution may be diluted with sterile sodium chloride 0.9% w/v solution.

Pulmonary arterial hypertension

There are four packs available for use in the treatment of pulmonary arterial hypertension, as follows:
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.
One 0.5 mg powder vial.
One 1.5 mg powder vial.
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.

draft: 44030376, 44030375
laetus code: 0000
mat.no.: 00000000

Only vials of the same amount as that included in the initial starter pack may be used to increase the final
concentration of solution.
Continued on the next page >>
SZ00000LT000

Artwork Proof Box
Ref: V005 - SPC and PIL update in line with the QRD template
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Date prepared:
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Colours:
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Dimensions: 130 x 540 mm

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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 via the
Yellow Card Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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 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.

5

If you use more Epoprostenol than you should
Seek urgent medical attention if you think you
have used or been given too much Epoprostenol.
Symptoms of overdose may include headache,
nausea, vomiting, fast heart rate, warmth or tingling,
or feeling like you might pass out (feeling faint/dizziness).

Keep this medicine out of the sight and reach of
children.

Powder for solution for infusion: Keep the vial in the
outer carton in order to protect from light.

Solvent: Do not freeze.

If you forget to use Epoprostenol
Do not take a double dose to make up for a
forgotten dose.

Do not use this medicine 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.

If you stop using Epoprostenol
Stopping Epoprostenol 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.

The reconstituted solution should not be used if
particles are present. Glycine buffer diluent contains
no preservative, consequently a vial should be used
once only and then discarded.

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.

6

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist or nurse.

4

How to store Epoprostenol

Possible side effects

Contents of the pack and other
information

What Epoprostenol contains
Epoprostenol Sodium 0.5 mg Powder and
Solvent for Solution for Infusion
• The active substance is epoprostenol (as
epoprostenol sodium). Each vial contains
epoprostenol sodium equivalent to 0.5 mg
epoprostenol.

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

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.

One ml of reconstituted concentrate solution
contains epoprostenol (as epoprostenol sodium)
10,000 nanogrammes.

Epoprostenol Sodium 1.5 mg Powder and
Solvent for Solution for Infusion
• The active substance is epoprostenol (as
epoprostenol sodium). Each vial contains
epoprostenol sodium equivalent to 1.5 mg
epoprostenol.

Talk to your doctor or pharmacist or nurse about any
other side effects, including those not listed in this
leaflet.

One ml of reconstituted concentrate solution
contains epoprostenol (as epoprostenol sodium)
30,000 nanogrammes.

Very common side effects (may affect more than
1 in 10 people):
• headache
• redness of your face
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• jaw pain
• pain

• The other ingredients are: Mannitol, Glycine,
Sodium Chloride, Sodium Hydroxide (only for pH
adjustment).

The solvent for Epoprostenol is composed of
sodium chloride, glycine, sodium hydroxide (only for
pH adjustment) and water for injection.

Common side effects (may affect up to 1 in 10
people):
• infection of the blood (septicaemia)
• bleeding at various sites and bruising more
easily than normal, for example from the nose or
gums
• feeling anxious, feeling nervous
• heart beating faster
• slow heart beat
• stomach discomfort or pain
• rash
• joint pain
• pain at the injection site
• chest pain
• low blood pressure

What Epoprostenol looks like and contents of
the pack
Powder for solution for infusion: 15 ml colourless
glass type I vials closed with rubber stopper and
aluminium/propylene cap
Solvent: 55 ml colourless glass type I vials closed
with rubber stopper and aluminium/propylene cap.

Pack sizes:
• 1, 2, 3, 4, 5, 6 or 10 packs containing 1 vial with
powder for solution for infusion, 1 vial with
solvent and 1 filter;
• 1, 2, 3, 4, 5, 6 or 10 packs containing 1 vial with
powder for solution for infusion, 2 vials with
solvent and 1 filter.

Common side effects that may show up in blood
tests
• decrease in the number of blood platelets (cells
that help the blood to clot)

The powder needs to be reconstituted and diluted
before infusion.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Uncommon side effects (may affect up to 1 in
100 people):
• dry mouth
• sweating

Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia,

Rare side effects (may affect up to 1 in 1,000
people):
• infection at the injection site

This leaflet was last revised in 03/2015.
Other sources of information

Very rare side effects (may affect up to 1 in
10,000 people):
• feeling agitated
• pale skin
• redness at the injection site
• feeling tired, weak
• feeling of tightness around the chest
• overactive thyroid gland
• blockage of the injection catheter

Other side effects
It is not known how many people are affected:
• build up of fluid in the lungs (pulmonary oedema)
• increase in sugar (glucose) in the blood

SZ07701LT03A

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 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 54.8 mg.
Dilution:

Epoprostenol may be used either as concentrated solution or in a diluted form for 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 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 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 = dosage (nanogram/kg/min) x bodyweight (kg)
(mL/min)
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
Don’t store above 25ºC.

Keep container in the outer carton to protect from light.

Keep dry.

Do not freeze.

Any cold pouch used must be capable of maintaining the temperature of the reconstituted solution.
Store between 2 and 8ºC 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.

draft: 44030376, 44030375
laetus code: 0000
mat.no.: 00000000

00000000
SZ00000LT000

Artwork Proof Box
Ref: V005 - SPC and PIL update in line with the QRD template
Proof no.
003.0

Date prepared:
19/03/2015

Colours:
Black
Dimensions: 130 x 540 mm

Font size:
6.5pt
Fonts:
Helvetica

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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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