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FLOLAN 0.5MG INJECTION

Active substance(s): EPOPROSTENOL SODIUM

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2
10000000134982
GSK-ITA-Parma-ITPAR
United Kingdom-GBR

10000000134982

Package leaflet: Information for the user

Flolan® 0.5 mg
powder and solvent
for solution for infusion
Flolan® 1.5 mg
powder and solvent
for solution for infusion
epoprostenol

Flolan
N/A
D10070LEA

N/A
N/A
1
K

0

0

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 Flolan is and what it is used for
2. What you need to know before you
use Flolan
3. How to use Flolan
4. Possible side effects
5. How to store Flolan
6. Contents of the pack and other
information

1. What Flolan is and what it is
used for
What Flolan is
Flolan contains the active substance
epoprostenol which belongs to a group
of medicines called prostaglandin, which
stops blood from clotting and widens
the blood vessels.
What Flolan is used for
• Flolan 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. Flolan widens
the blood vessels to lower the blood
pressure in the lungs.
• Flolan 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 use Flolan

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 9.5pt
Horizontal Scale: 100%
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Microtext:No

Do not use Flolan
• if you are allergic to Flolan 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 use Flolan until you have checked
with your doctor.

Skin damage at the injection site
Flolan 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 Flolan 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 Flolan on blood pressure and
heart rate
Flolan can cause your heart to beat faster
or slower. Also your blood pressure can
become too low. While you are being
treated with Flolan 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 Flolan
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 Flolan
works, or make it more likely that you’ll
have side effects. Flolan 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 to treat inflammation or pain
(also called ‘NSAIDs’)
• digoxin (used to treat heart disease).
Tell your doctor or pharmacist if you are
taking any of these.
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
using this medicine as your symptoms
could worsen during pregnancy.
It is not known whether the ingredients
of Flolan can pass into breast-milk. You
should stop breast-feeding your child
during treatment with Flolan.
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.
Flolan contains Sodium
This medicinal product contains sodium.
To be taken into consideration by
patients on a controlled sodium diet.

Warnings and precautions
Talk to your doctor before using Flolan:
• if you have any problems
with bleeding.
• if you are on a controlled
sodium diet.

3. How to use Flolan
Always use 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
Flolan 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.
Flolan 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 Flolan.
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 Flolan
for the duration of your dialysis.
Using Flolan 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 Flolan. They will also
advise you how to stop treatment if
necessary. Stopping Flolan must be done
gradually. It is very important that you
follow all their instructions carefully.
Flolan 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.
If you use more Flolan than you should
Seek urgent medical attention if you
think you have used or been given too
much Flolan. 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 use Flolan
Do not take a double dose to make up
for a forgotten dose.
If you stop using Flolan
Stopping Flolan 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 Flolan, 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.

The following information is intended for medical or healthcare professionals only:

Flolan® 0.5 mg powder and solvent for solution for infusion
Flolan® 1.5 mg powder and solvent for solution for infusion
epoprostenol

DOSAGE AND ADMINISTRATION INFORMATION ONLY
Please refer to the Summary of Product Characteristics for complete prescribing information
INFORMATION FOR HEALTHCARE PROFESSIONALS
Pulmonary arterial hypertension
There are six packs available for use in the treatment of pulmonary arterial hypertension, as follows:
• One 0.5 mg powder vial and one solvent vial and a filter unit.
• One 0.5 mg powder vial and two solvent vials and a filter unit.
• One 1.5 mg powder vial and one solvent vial and a filter unit.
• One 1.5 mg powder vial and 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 Flolan 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 Flolan.
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 Flolan powder and shake gently until the powder has dissolved.
3. Draw up the resulting Flolan 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 Flolan (for the 1.5 mg strength). Only these concentrated solutions are suitable for further
dilution prior to use. When 0.5 mg Flolan powder is reconstituted with 50 mL of the solvent, the final injection has a pH
of approximately 12 and a sodium ion content of approximately 73 mg.
Dilution:
Flolan 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 Flolan.
Sodium chloride 0.9% w/v solution must not be used when Flolan 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 of pulmonary arterial hypertension are as follows:
• 5,000 nanogram/mL – One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 10,000 nanogram/mL – Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 15,000 nanogram/mL – One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 30,000 nanogram/mL – Two vials containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.

Page 1 of 2

2
10000000134982
GSK-ITA-Parma-ITPAR
United Kingdom-GBR
Flolan
N/A
D10070LEA

N/A
N/A
1
K

0

0

4. Possible side effects
Like all medicines, this medicine
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.
Talk to your doctor or pharmacist
or nurse about any other side
effects, including those not listed
in this leaflet.
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

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 9.5pt
Horizontal Scale: 100%
Smallest text size: 8.0pt

Other side effects
It is not known how many people
are affected:
• enlarged or overactive spleen
• build up of fluid in the lungs
(pulmonary oedema)
• increase in sugar (glucose) in the blood
• swelling due to build up of fluid
around the stomach

Microtext:No

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 effects you can help
provide more information on the safety
of this medicine.

5. How to store Flolan
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 label.
Do not store above 25°C.
Store Flolan in a dry place.
Store in the original outer carton, to
protect from light.
Do not freeze.
Pulmonary arterial hypertension
Once Flolan powder has been dissolved,
and diluted, it should ideally be used
immediately.
Freshly prepared Flolan solution or
Flolan solution stored for a maximum
of 8 days at refrigerated conditions
(2 to 8oC), can be stored in the
medication cassette and used within a
maximum time of:
• 72 hours at up to 25°C or
• 48 hours at up to 30ºC or
• 24 hours at up to 35 ºC or
• 12 hours at up to 40 ºC

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited,
.
Stockley Park West, Uxbridge,
. .
Middlesex UB11 1BT
Manufacturer: GlaxoSmithKline
Manufacturing S.p.A.,
San Polo di Torrile, Parma, Italy
Other formats
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name Flolan 0.5 mg and
1.5 mg injection
Reference number 10949/0310 and
PL 10949/0312
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in 01/2016.
Flolan is a registered trade mark of the
GSK group of companies.
© 2016 GSK group of companies.
All rights reserved.

Renal Dialysis
Once Flolan has been dissolved and
diluted, any unused solution can be
stored at 25oC and used within 12 hours.

6. Contents of the pack and
other information
What Flolan contains
The active substance is epoprostenol
sodium. Flolan Injection comes in
different strengths.
Each vial contains either:
• 0.5 mg epoprostenol sodium or
• 1.5 mg epoprostenol sodium.
The other ingredients are Mannitol,
Glycine, Sodium Chloride, Sodium
Hydroxide and Water.
What Flolan looks like and contents of
the pack
Injection:
Flolan is a solution for injection made
up of powder and solution. The powder
is white or off-white and the solution is
clear and colourless.
There are six packs of Flolan available
for use in the treatment of pulmonary
arterial hypertension, the contents of
each pack include:
• One 0.5 mg powder vial and one
solvent vial and a filter unit.
• One 0.5 mg powder vial and two
solvent vials and a filter unit.
• One 1.5 mg powder vial and one
solvent vial and a filter unit.
• One 1.5 mg powder vial and two
solvent vials and a filter unit.
• One 0.5 mg powder vial.
• One 1.5 mg powder vial.
There is only one pack of Flolan
available for use in renal dialysis,
the contents of each pack include:
• One 0.5 mg powder vial and one
solvent vial and a filter unit.
Not all pack sizes are available in all
markets.

Calculation of infusion rate:
The infusion rate may be calculated from the following formula:
dosage (nanogram/kg/min) x bodyweight (kg)
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 Flolan.
Special precautions for storage
Don’t store above 25°C.
Keep container in the outer carton to protect from light.
Keep dry.
Do not freeze.
Ideally reconstitution and dilution should be carried out immediately prior to use. For additional details of stability following
reconstitution, see section 5 (‘How to store Flolan’).
The solvent contains no preservative; consequently a vial should be used once only and then discarded.
Renal Dialysis
There is only one pack available for use in renal dialysis:
• One 0.5 mg powder vial and one solvent vial and a filter unit
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 Flolan
powder and shake gently until the powder has dissolved
3. Draw up the resulting Flolan 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 Flolan. Only this concentrated
solution is suitable for further dilution prior to use. When 0.5 mg Flolan powder is reconstituted with 50 mL of the solvent, the final
injection has a pH of approximately 12 and a sodium ion content of approximately 73 mg.
Dilution:
The concentrated solution is normally further diluted immediately prior to use. It may be diluted with sodium chloride
0.9% w/v (saline) solution, in a ratio of 2.3 volumes of saline to 1 volume of concentrated solution, e.g. 50 mL of
concentrated solution further diluted with 117 mL of saline.
Other common intravenous fluids are unsatisfactory for the dilution of the concentrated solution as the required pH is
not attained. Flolan 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, Flolan infusion solutions 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
(mL/min)

=

dosage (nanogram/kg/min) x bodyweight (kg)
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.
This leaflet was last revised in 01/2016.
Flolan is a registered trade mark of the GSK group of companies.
10000000134982
©2016 GSK group of companies. All rights reserved.
Infusion rate
(mL/min)

=

Page 2 of 2

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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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