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FLOLAN 0.5MG INJECTION

Active substance: EPOPROSTENOL SODIUM

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10000000107880

3

Package leaflet: Information for the user

10000000107880
GSK-ITA-Parma-ITPAR
United Kingdom-GBR
Flolan

Flolan® 0.5 mg
Powder and Solvent
for Solution for Infusion
Flolan® 1.5 mg
Powder and Solvent
for Solution for Infusion
epoprostenol

1

K

D00055LEA

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
- eep this leaflet. You may need to
K
read it again.
- f you have any further questions, ask
I
your doctor or pharmacist or nurse.
- his medicine has been prescribed for
T
you only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
- f you get any side effects , talk to
I
your doctor or pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
1 What Flolan is and what it is used for
2 hat you need to know before you
W
take Flolan
3 How to take Flolan
4 Possible side effects
5 How to store Flolan
6 ontents of the pack and other
C
information

1 What Flolan is and what it is
used for
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.

FRONT PAGE
TYPE SIZE: 8/9.5
HORIZONTAL SCALE: 100%

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 when heparin
cannot be used.

2 What you need to know before
you take Flolan

Page 1 of 2

Do not take Flolan
• f you are allergic to Flolan or any of
i
the other ingredients of this medicine
(listed in section 6).
• f you have heart failure.
i
• f you start to develop a build-up
i
of fluid in your lungs causing
breathlessness after starting this
treatment.
If you think any of these apply to you,
don’t take Flolan until you have checked
with your doctor.
Warnings and precautions
Before you are given Flolan your doctor
needs to know:
• f you have any problems with
i
bleeding.
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:
• enderness
t
.
• urning
b
. .
• tinging
s
• welling
s
• edness.
r
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:
• edicines used to treat high blood
m
pressure
• edicines used to prevent blood
m
clots
• edicines used to dissolve blood
m
clots
• edicines to treat inflammation or
m
pain (also called ‘NSAIDs’)
• igoxin (used to treat heart disease).
d
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
taking 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 breastfeeding 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.

3 How to take Flolan
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
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 take 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 take Flolan
Do not take a double dose to make up
for a forgotten dose.
If you stop taking 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.

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:
• ou feel that your heart is beating
Y
faster, or you have chest pain or
shortness of breath.
• ou feel dizzy or feel faint, especially
Y
on standing.
• ou have fevers or chills.
Y
• ou have more frequent, or longer
Y
periods of bleeding.

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
Renal Dialysis
There is only one pack available for use in renal dialysis:
• ne 0.5 mg powder vial and one solvent vial
O
Reconstitution:
1. se only the solvent provided for reconstitution
U
2. ithdraw 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
W
until the powder has dissolved
3. raw up the resulting Flolan solution into the syringe, re-inject it into the remaining volume of the solvent and mix thoroughly.
D
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 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. 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 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:
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.
Infusion rate
(mL/min)

=

3
10000000107880
GSK-ITA-Parma-ITPAR
United Kingdom-GBR
Flolan
1

K

D00055LEA

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:
• eadache
h
• aw pain
j
• ain
p
• eing sick (vomiting)
b
• eeling sick (nausea)
f
• iarrhoea
d
• edness of your face (flushing)
r
Common side effects
These may affect up to 1 in 10 people:
• nfection of the blood (septicaemia)
i
• eart beating faster
h
• low heart beat
s
• ow blood pressure
l
• leeding at various sites and bruising
b
more easily than normal, for example
from the nose or gums
• tomach discomfort or pain
s
• hest pain
c
• oint pain
j
• eeling anxious, feeling nervous
f
• ash
r
• ain at the injection site
p
Common side effects that may show up
in blood tests
• ecrease in the number of blood
d
platelets (cells that help the blood to
clot)
Uncommon side effects
These may affect up to 1 in 100 people:
• weating
s
• ry mouth
d
Rare side effects
These may affect up to 1 in 1,000 people:
• nfection at the injection site
i
Very rare side effects
These may affect up to 1 in 10,000 people:
• eeling of tightness around the chest
f
• eeling tired, weak
f
• eeling agitated
f
• ale skin
p
• edness at the injection site
r
• veractive thyroid gland
o
• lockage of the injection catheter
b

BACK PAGE
TYPE SIZE: 8/9.5
HORIZONTAL SCALE: 100%

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

5 How to store Flolan

Page 2 of 2

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. If you are being given
Flolan 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 up to
24 hours at 2-8°C if necessary. The
cold pouch must be regularly changed
throughout the day, to maintain the
temperature of the solution.

If you are not using a ‘cold pouch’, the
solution can be stored in the pump:
• or up to 12 hours at 25°C, if it has
f
just been made up
• or a maximum of 8 hours if it was
f
made previously and has been stored
at 2-8°C.

.
. .

Renal Dialysis
Once Flolan has been dissolved and
diluted, any unused solution can be
stored at 25°C 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:
• .5 mg epoprostenol sodium
0
• .5 mg epoprostenol sodium.
1
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 four packs of Flolan available
for use in the treatment of pulmonary
arterial hypertension, the contents of
each pack include:
• ne 0.5 mg powder vial and one or
O
two solvent vials and a filter unit.
• ne 1.5 mg powder vial and one or
O
two solvent vials and a filter unit.
• ne 0.5 mg powder vial.
O
• ne 1.5 mg powder vial.
O
Not all pack sizes are available in all
markets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK, 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

P
L 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 10/2012.
Flolan is a registered trademark of the
GlaxoSmithKline group of companies
© 2012 GlaxoSmithKline group of
companies

Pulmonary arterial hypertension
There are four packs available for use in the treatment of pulmonary arterial hypertension, as follows:
• ne 0.5 mg powder vial and one or two solvent vials and a filter unit.
O
• ne 1.5 mg powder vial and one or two solvent vials and a filter unit.
O
• ne 0.5 mg powder vial.
O
• ne 1.5 mg powder vial.
O
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. se only the solvent provided for reconstitution.
U
2. ithdraw approximately 10mL of the solvent into a sterile syringe, inject the contents of the syringe into the vial containing Flolan powder and shake
W
gently until the powder has dissolved.
3. raw up the resulting Flolan solution into the syringe, re-inject it into the remaining volume of the solvent and mix thoroughly.
D
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 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 10.5 and a sodium ion content of approximately 56 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:
• ,000 nanogram/mL – One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
5
• 0,000 nanogram/mL – Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
1
• 5,000 nanogram/mL – One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
1
Calculation of infusion rate:
The infusion rate may be calculated from 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
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.
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.
This leaflet was last revised in 10/2012.
.
Flolan is a registered trademark of the GlaxoSmithKline group of companies
. .
© 2012 GlaxoSmithKline group of companies

10000000107880

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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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