Skip to Content

EPOPROSTENOL 0.5MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): EPOPROSTENOL SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT
INFORMATION
Package
leaflet:
InformationLEAFLET
for the user

Epoprostenol 0.5 mg
0.5 mg Powder
powder and
Epoprostenol
and solvent
Solvent
for Solution
solution for infusion
for
Infusion
Epoprostenol
(as
sodium)sitaxentan, bosentan (medicines used to treat
• sildenafil,
Read all of this leaflet carefully before you start
taking this
primary
pulmonary hypertension).
medicine because it contains important information for you.
Pregnancy,
breast-feeding
Some medicines
may affect and
howfertility
Epoprostenol works or make it
Keep
this
leaflet.
You
may
need
to
read
it
again.
Read all of this leaflet carefully before you start using this
your
doctor
or
nurse
before taking
this medicine
if:
Please
talk
to
more
likely
that
you’ll
have
side
effects.
Epoprostenol
can also
If
you havebecause
any further
questions,
ask your information
doctor or nurse.
medicine,
it contains
important
for you.
­affect
howpregnant,
some other
medicines
workbeif pregnant
taken at the
same
time.

you are
think
that you may
or are
planning
• you
Keep
this
leaflet.
You may
need
to read
it again.
If
get
any
side effects
talk
to your
doctor.
This includes any
These
include:
to become
pregnant
• If you have
further
askleaflet.
your doctor or pharmacist.
possible
side any
effects
notquestions,
listed in this
• you
Medicines
used to treat high blood pressure

are breast-feeding.
• This medicine has been prescribed for you only. Do not pass
• Medicines
used to
prevent blood clots
Driving
and using
machines
What
is in
leaflet:
it on
to this
others.
It may harm them, even if their signs of illness
• Medicines used to dissolve blood clots
It
is
not
known
whether
Epoprostenol
your called‚
ability to
drive or
are
the
same
as
yours.
1. What Epoprostenol is and what it is used for
• M
 edicines to treat inflammation
oraffects
pain (also
NSAID’s)
use
machines
but
of pulmonary
hypertension
can
If youyou
getneed
any to
side
effects,
talkyou
to your
doctor or pharmacist.
• sildenafil,
sitaxentan,
bosentan
(medicines
used to treat

Digoxin
(used
to the
treatsymptoms
heart
disease).
2.•
What
know
before
use Epoprostenol
Read
all
of
this
leaflet
carefully
before
you
start
taking
this
make
you doctor
less fit to
drive.
Do notifdrive
or operate
machines
if
This includes any possible side effects not listed in this leaflet.
primary
pulmonary
hypertension).
Tell
your
or
pharmacist
you
are
taking
any
of
these.
3.medicine
How
use
Epoprostenol
because
it contains important information for you.
you are feeling unwell.
See to
section
4.
Pregnancy,and
breast-feeding
and fertility
Pregnancy
breast-feeding
4.Keep
Possible
side effects
this leaflet.
You may need to read it again.
Important information about some of the ingredients of
IfPlease
you are
or breast-feeding,
thinktaking
you may
be pregnant
or nurse before
this medicine
if:
talkpregnant
to your doctor
What
this
5.
toinstore
Epoprostenol
IfHow
youishave
anyleaflet:
further questions, ask your doctor or nurse.
Epoprostenol
or
are are
planning
to have
baby,
ask
your
or or
pharmacist
for
1. What Epoprostenol is and what it is used for
• you
pregnant,
thinka that
you
may
be doctor
pregnant
are planning
This
medicine
contains
2.43
mmol
(or
56
mg)
sodium
per
dose.
To
6.
Contents
of
the
pack
and
other
information
If
you
get
any
side
effects
talk
to
your
doctor.
This
includes
any
advice
before pregnant
taking this medicine as your symptoms could worsen
2. What you need to know before you take Epoprostenol
to become
be taken
into consideration by patients on a controlled sodium
possible
side Epoprostenol
effects not listed in this leaflet.
during
pregnancy.
3. How
to
take
• you are breast-feeding.
1. What Epoprostenol is and what it is used for
diet.
4. Possible side effects
It
is not and
known
whether
the ingredients of Epoprostenol can pass
Driving
using
machines
What istoinstore
this0.5mg
leaflet: injection contains the active substance into
Epoprostenol
5. How
Epoprostenol
breast-milk.
You should
stop breast-feeding
your child
durIt
is
not
known
whether
Epoprostenol
affects your ability
to drive
or
How to use Epoprostenol
1. What Epoprostenol
isand
andother
whatbe
it is
used
epoprostenol.
medicine
can
used
tofor
stop your blood from ing treatment with3.Epoprostenol.
6. Contents
of This
the pack
information
use
machines
but
the
symptoms
of
pulmonary
hypertension
can
clotting
kidney
dialysis.
It can
used to treat a type of Your doctor will decide on the amount of Epoprostenol that is right
2. Whatduring
you need
to know
before
youalso
usebe
Epoprostenol
Driving
andless
using
make you
fit tomachines
drive. Do not drive or operate machines if
high
blood
pressure
called 'primary
or secondary
pulmonary for
1. use
What
Epoprostenol
is and what
it is used for
3. How
to
Epoprostenol
and
howmay
longhave
you should
useon
it for.
Your
treatment
an effect
the ability to drive or use
youyou
are
feeling
unwell.
hypertension' which is present in the main blood vessels in your
machinery.
4.
Possible
side
effects
The amount
you are given
is based
on your
bodyingredients
weight
information
about
some
of the
of
Epoprostenol
contains
the active
substance
which
lungs. Epoprostenol
widens
the blood
vessels epoprostenol
in order to lower
the •Important
Don’t
usebe
machines
you’re feeling
well. on how
5. Howpressure
to
Epoprostenol
Epoprostenol
Yourdrive
doseor
may
increasedunless
or decreased
depending
belongs
tostore
a group
of medicines
blood
in
your
lungs. called prostaglandin, which stops •
Epoprostenol
contains
sodium
blood
from clotting
and widens
theinformation
blood vessels.
This
2.43
mmol (or 56 mg) sodium per dose. To
youmedicine
respond contains
to treatment
6. Contents
of the pack
and other
2. What you
to know
you use called
Epoprostenol
This
medicinal
productnot
contains
2.43
(or 56 milligram)
Epoprostenol
is need
used to
treat abefore
lung condition
‘pulmonary •
beEpoprostenol
taken
into consideration
bygiven
patients
on
a controlled
should
be
as ammol
quick
injection
insodium
to your
1.
What
Epoprostenol
is
and
what
it
is
used
for
s
­
odium
(salt)
per
dose.
To
be
taken into consideration by patients
arterial
hypertension’.
Thisif:is where the pressure is high in the
diet.
Do
not use
Epoprostenol
vein. It should always be given as a slow injection over a longer
on a controlled sodium (salt) diet.
blood
in0.5mg
the(hypersensitive)
lungs.
Epoprostenol
widens
the blood
Epoprostenol
injection
contains
the active

you vessels
are allergic
to epoprostenol
or substance
anyvessels
of the
period of time 3. How to use Epoprostenol
to
lower the blood
incan
the be
lungs.
epoprostenol.
Thispressure
medicine
used
your6)blood from • There is no information
of this medicine
(listedtoinstop
section
other ingredients
on the dose of Epoprostenol in
3. How available
to take Epoprostenol
clotting
during
kidney
dialysis.
It
can
also
be
used
to
treat
a
type
of
Epoprostenol
is used
prevent
blood
clotting
during
kidney
dialysis
Your
doctororwill
decide
on 65
theyears
amount
Epoprostenol
is right

you blood
have a pressure
build
uptoofcalled
fluid in'primary
your lungs
which
causes
breathing
children
people
over
old.ofIn
general dosethat
selection
high
or
secondary
pulmonary
when
heparinThis
cannot
be
used.
Always
take
this medicine
exactly
as
your
doctor
or pharmacist
has
forfor
you
and
how
long
youshould
shouldreflect
use
it for.
problems.
may
be
especially
bad
at
night
or
when
you
are
of
an
elderly
patient
the
greater
frequency
hypertension' which is present in the main blood vessels in your told you. Check with your doctor or pharmacist if you are not sure.
lying
down

The
amount
you
are
given
is
based
on
your
body
weight
decreased
hepatic,
renal
or
cardiac
function
and
of
concomitant
lungs.
Epoprostenol
thebefore
blood vessels
in Epoprostenol
order to lower the
2. What
you needwidens
to know
you take
doctor
how much
Epoprostenol
is right for
•blood
you pressure
have heart
failure
which makes you short of breath Your
• disease
Your
dose
maydecide
be
increased
or decreased
depending
on you.
how
or will
other
drug
therapy.
in your
lungs.
amount you are given is based on your body weight and your
heart failure). It may also cause swollen feet or legs The
Do(congestive
not take Epoprostenol
you
respond
to
treatment
How
much
Epoprostenol
is
given:
type
of
illness.
Your
dose
may
be
increased
or
decreased
dependdue
to
a
build
up
of
fluid.
2.
What
you
need
to
know
before
you
use
Epoprostenol
• if you are allergic to Epoprostenol or any of the other ingredi• Epoprostenol
Kidney
dialysis should not be given as a quick injection in to your
entsare
of this
medicine
(listed
indoctor,
Section
6). or pharmacist before ing on how well you respond to treatment.
IfDo
you
notEpoprostenol
sure,
talk to
your
nurse
not
use
if:
vein.
It
should
always
be
given
as
slow
over a longer
The
usual
starting
dosebyfor
adults
is 4a nanograms
epoprostenol
Epoprostenol
is given
slow
infusion
(drip)injection
into aofvein.
• if you
have
heart failure.
you
use
Epoprostenol.
• you
are
allergic
(hypersensitive)
or any
of the for
period
of time
each kilogram
of hypertension
body weight, for each minute it is given.

if you
start
to develop
a build-up to
of epoprostenol
fluid in your lungs
causing
Pulmonary
arterial
Warnings
and precautions
ingredients
of starting
this medicine
(listed in section 6)
other
• Before
There
no information
available
on in
the
dose
Epoprostenol
in
breathlessness
after
this treatment.

your
dialysis,
may
be ofgiven
a slow
Your
first is
treatment
will beEpoprostenol
given
to you
a hospital.
This as
is b
­ ecause
Talk
tohave
your doctor
orofnurse
usingwhich
Epoprostenol
if:
you
build
fluid
inbefore
your
lungs
causes
breathing
children
orneeds
people
over
65 years
old.find
In general
your
doctorinto
monitor
you and
the bestdose
doseselection
for you.
If• you
think aany
of up
these
apply
to you,
don’t take
Epoprostenol
injection
yourtovein

you
have
a This
tendency
to
bleed
e.g.athaemophilia.
problems.
may be
especially
bad
night or when you are You
with patient
an
infusion
of Epoprostenol.
The
dose
will
bethe
inof
forwill
anstart
elderly
should
reflect
greater
frequency
until
you
have
checked
with
youreasily
doctor.
into
During
dialysis,
Epoprostenol
will bethe
slowly
injected
lying
down can affect your blood pressure and heart rate and •
creased,
untilhepatic,
your symptoms
relieved,
and and
any side
effects are
This
medicine
decreased
renal
or are
cardiac
function
of concomitant
Warnings
and precautions
blood
going
into
the
dialysis
machine
Oncedrug
the therapy.
best dose has been found, a permanent
• you you
have
which
makes
youneeds
shorttoofknow:
breath manageable.
therefore
your
doctor
or nurse
will monitor
these.
disease or other
Before
areheart
givenfailure
Epoprostenol
your
doctor
Epoprostenol
willfitted
not be
given
the end
of your
dialysis.
tube
(line) will be
into
oneafter
of your
veins.
You can
then be
heart
failure). with
It may
also cause swollen feet or legs •
• (congestive
If you
have any
problems
bleeding.
How
much
Epoprostenol
is given:
Other
medicines
and
Epoprostenol
treated using
an infusion pulmonary
pump.
due to a build up of fluid.
Primary
and secondary
hypertension
Kidney dialysis
Please
tell youratdoctor,
nurse orsite
pharmacist if you are taking, have
Skin
thetalk
injection
first start having treatment it will be given to you in
Kidneyyou
dialysis
If youdamage
are not sure,
to your doctor, nurse or pharmacist before When
Epoprostenol
into any
a vein.
It ismedicines.
important that
medi- You
recently
takenisorinjected
might use
other
Thisthe
includes
The will
usual
starting
dose
foryour
adults
is 4 nanograms
of
epoprostenol
be
given
an
infusion
ofdoctor
Epoprostenol
formake
the
duration
of
hospital.
This
is because
needs to
sure they
you
use
Epoprostenol.
cine
does
not
leak
out
of
the
vein
into
the
surrounding
tissue.
If
it
medicines you buy without a prescription, including herbal your
for
each
kilogram
of
body
weight,
for
each
minute
it
is
given.
dialysis.
monitor you and get the right dose for you.
Warnings
and
precautions
does,
the
skin
could
be
damaged.
The
symptoms
of
this
are:
medicines. This is because Epoprostenol can affect the way some At
• Before
dialysis,
Epoprostenol
may
be
given
as awhich
slow
first, Epoprostenol
youyour
will be
given
through
a tube
'line'
at Epoprostenol
home
(only for
treatment
oforPulmonary

Tenderness
Talk
tomedicines
your doctor
or nurse
before
using Epoprostenol
if: way Using
other
work.
Also some
medicines
can affect the
injection
into your
vein
Arterial
to your
chest,
neck, groin, hands or arm.
is
put in Hypertension)

B

urning
• you have a tendency
to bleed easily
e.g.
haemophilia.
Epoprostenol
works. In particular,
check
with
your doctor, nurse or The
If• you
are treating
home,
nurse
will
show
into
the
During
dialysis,
Epoprostenol
will
be doctor
slowlyorinjected
usual
starting yourself
dose
foratadults
is your
2 nanograms
of
epoprostenol
• Stinging
This
medicine
can
affect
your
blood
pressure
and heart rate and you
howgoing
to prepare
and
use
Epoprostenol.
They itwill
also advise
pharmacist
if
you
are
taking
any
of
the
following:
intoofthe
dialysis
machine
• Swelling
forblood
each
kilogram
body
weight,
for each minute
is given.
you how to stop treatment if necessary. Stopping Epoprostenol
therefore
your
doctorororaspirin
nurse will
monitor these.

heparin,
warfarin
(medicines
to prevent blood clots)

Redness.
Epoprostenol
will increased
not be
after
end
your
dialysis.

This
dose
is gradually.
then
every
15the
minutes
the
best
must
be
done
It isgiven
very
important
thatofuntil
you
follow
alldose
their
Other
medicines
andby
Epoprostenol

doxazocin
(medicines
used to treat
bloodof
pressure)
This
may
be followed
blistering
andhigh
shedding
the skin. While instructions
is foundand
for
you. The best
dose willhypertension
relieve your symptoms but
Primary
secondary
pulmonary
carefully.
Please
tell
your
doctor,
nurse
or
pharmacist
if
you
are
taking,
have
you
are
being
treated
with
Epoprostenol
it
is
important
that
you
• glyceryl trinitrate or other nitrate medicines (used to treat Epoprostenol
causeyou
the first
fewest
possible
side
effects.
When
start
having
treatment
it will vial.
be given
youthe
in
comes
as
a powder
in a glass
Beforetouse,
check
thetaken
injection
area. use any other medicines. This includes
recently
or might
angina)
Once
theneeds
correct
dose
hasyour
beenin
found,
a permanent
tube
orliquid
line
powder
be dissolved
the liquid
provided.
The
hospital.
This
istobecause
doctor
needs
to make
sure
they
Contact
theyou
hospital
for
advice
the
area
becomes
medicines
buy immediately
without pain
a prescription,
including
herbal will
does
contain
a preservative.
If for
youyou.
have any of the liquid left

ibuprofen
(anti-inflammatory
killers
alsoif called
NSAIDs)
benot
fitted.
monitor
you
and get
the right dose
sore, painfulThis
or swollen
or you
notice any blistering
or shedding.
is because
Epoprostenol
can affect
some •
over,
it must
bewill
thrown
•medicines.
digoxin (medicines
used
to treat heart
failurethe
orway
irregular
doctor
then away.
continue
to give
you this
dose
through
a
AtYour
first,
you will
be
given
Epoprostenol
through
a tube
or 'line'
which
other
medicines
work. Also
somepressure
medicines
can
affect
the way Looking
Effect
of Epoprostenol
on blood
and
heart
rate
yourthe
chest,
neck,line
groin, hands or arm.
is pump
put in to
heartbeats)
after
injection
Epoprostenol works.
can cause
your heart
to beat
or slower.
Also
In particular,
check
withfaster
your doctor,
nurse
or IfThe
youusual
havestarting
been fitted
with
‘line’ into
vein it is very
important to
dose
foraadults
is 2 ananograms
of epoprostenol
your
blood ifpressure
can become
toofollowing:
low. While you are being keep
pharmacist
you are taking
any of the
thiskilogram
area clean,
otherwise
you
could
get anitinfection.
for
each
of
body
weight,
for
each
minute
is
given. Your
treated
withwarfarin
Epoprostenol
your (medicines
heart rate and
blood pressure
will doctor or nurse will show you how to clean your ‘line’ and
the area
• heparin,
or aspirin
to prevent
blood clots)
• This dose
thenimportant
increased
every
minutes
the
best dose
be checked.The
The symptoms
of information
low blood pressure
include dizzifollowing
is pressure)
intended
for medical
healthcare
professionals
around
it.or
It isis
very
that
you15follow
all only:
ofuntil
their
instructions

doxazocin
(medicines
used
to
treat
high
blood
is found for you. The best dose will relieve your symptoms but
ness and fainting.
carefully.
• glyceryl
trinitrate
orget
other
medicines
(used
to need
treat Calculation
cause the fewest
possible
effects.
Tell
your doctor
if you
thesenitrate
symptoms.
Your dose
may
Reconstitution
and
dilution:
of infusion
rate:sidethan
If you take more
Epoprostenol
you should
to angina)
be reduced
your infusion
Once
the
correct
dose
has
been
found,
a following
permanent
tubeororbeen
line
Seek
urgent
medical
attention
if
you
you have formula:
used
Particular
care or
should
be takenstopped.
in the preparation of the infusion The
infusion rate may be calculated
bythink
the
• ibuprofen
(anti-inflammatory
pain killers
also calledgiven
NSAIDs)
will betoo
fitted.
Other
and
Epoprostenol
much Epoprostenol. Symptoms of overdose may include
and
in medicines
calculating
the rate
of infusion.
The procedure
below given
• digoxin
(medicines
used iftoyou
treat
heart failure
or irregular
Tell
yourbe
doctor
or followed.
pharmacist
are taking,
have recently
taken headache,
• Your doctor
will then
continue
give
youwarmth
this
dose
through
nausea,
vomiting,
fast to
heart
rate,
or tingling,
dosage
(ng/kg/min)
x bodyweight
(kg)ora
should
closely
or heartbeats)
might take any other medicines.
feeling
you
might pass
Infusion
rate
(ml/min)
= out (feeling faint/dizziness).
pumplike
concentration of solution (ng/ml)
Renal dialysis
Reconstitution:
=
Infusion rate (ml/hr)
Infusion rate (ml/min) x 60
The
following
information
is reconstitution.
intended for
for medical
medical or
or healthcare
healthcare professionals
professionals only:
only:
1.Use only the
Glycine
Buffer Diluent
provided for
The
following
information
is
intended
2.Withdraw approximately 10 ml of the Glycine Buffer Diluent into Infusion rate formulae – examples
Calculation
Reconstitution
and dilution:
dilution:
rate:
used
ininfusion
renal
dialysis
0.5 mg may be
a sterile syringe,
inject the contents of the syringe into the vial When
Reconstitution
and
The
filter
unitof
must
be used
onceEpoprostenol
only and then discarded.
Particular
care
be taken inepoprostenol
the preparation
the infusion
as the
concentrated
solution
or in diluted
form (b).
The infusion
rate
may
be diluted
calculated
by the(a)
following
formula:
containing
0.5should
mg freeze-dried
andofshake
gently administered
When
reconstituted
and
as
directed
above,
epoprostenol
and
in the
calculating
of infusion. The procedure given below a.
infusion
havesolution
a pH of
and will retain
until
powder the
hasrate
dissolved.
Using solutions
concentrated
i.e.approximately
10,000 ng/ml 10
epoprostenol.
should
closely followed.
90 % of their initial potency for
approximately
at 25 °C.
dosage
(ng/kg/min)12x hours
bodyweight
(kg)
should be
be
followed.
3.Draw
upclosely
the and
resulting
epoprostenol
solution
into must
the syringe,
Infusion rate (ml/min)
= = 10,000 ng/ml epoprostenol
Reconstitution
dilution
of Epoprostenol
0.5 mg
be car- Concentration
of
solution
CALCULATION
OF
INFUSION
RATE:
re-inject
it
into
the
remaining
volume
of
the
Glycine
Buffer
Diluent
concentration
of
solution
(ng/ml)
ried
outdialysis
using sterile techniques, immediately prior to clinical use.
Renal
The infusion rate may be calculated by the following formula:
solution and mix
Reconstitution
timethoroughly.
should be below 30 seconds.
Dosage
Bodyweight
Reconstitution:
=
Infusion rate (ml/hr)
Infusion rate (ml/min) x 60
After
reconstitution
Epoprostenol
is
a
colourless
solution,
practi(ng/kg/min)
(kilograms)
This
solution
is
now
referred
to
as
the
concentrated
solution
and
dosage
(ng/kg/min) x bodyweight (kg)
1.Usefree
only
the
Glycine Buffer Diluent provided for reconstitution.
Infusion rate (ml/min) =
cally
of
particles.
contains
10,000
nanograms per ml epoprostenol. Only this Infusion
30
40– examples
50concentration
60
70 of 80
90(ng/ml)
100
rate formulae
solution
2.Withdraw
approximately
10
ml
of
the
Glycine
Buffer
Diluent
into
Renal dialysissolution is suitable for further dilution prior to use.
concentrated
When
used 0.18
in renal
dialysis
Epoprostenol
0.5 0.54
mg may
be
1
0.24
0.30
0.36
0.42
0.48
0.60
a
sterile
syringe,
inject
the
contents
of
the
syringe
into
the
vial
Infusion rate (ml/hr) =
Infusion rate (ml/min) x 60
Reconstitution:
When
0.5 mg0.5
epoprostenol
powder
is reconstituted
with
50gently
ml of
administered
as
the
concentrated
solution
(a)
or
in
diluted
form
(b).
containing
mg
freeze-dried
epoprostenol
and
shake
2
0.36 0.48 0.60 0.72 0.84 0.96 1.08 1.20
1.  Use
only the
Glycine
Buffer the
Diluent
for has
reconstitution.
the
Glycine
Buffer
finalprovided
injection
a pH of
rate
formulae –solution
examples
the powder
hasDiluent,
dissolved.
2. until
Withdraw
approximately
10 ml of the Glycine Buffer Diluent into Infusion
a. Using
concentrated
i.e.
10,000
ng/ml
3 used
0.54
0.72 0.90
1.08
1.26
1.44epoprostenol.
1.62
1.80
approximately
10.5
and
a
sodium
ion
content
of
approximately
56
mg.
When
in
renal dialysis
Epoprostenol
0.5 mg
may
be adminisa sterile
inject epoprostenol
the contents of
the syringe
intosyringe,
the vial
3.Draw
up syringe,
the resulting
solution
into the
Concentration
of
solution
=
10,000
ng/ml
epoprostenol
tered
as
the
concentrated
solution
(a)
or
in
diluted
4
0.72 0.96 1.20 l.44 1.68 1.92 form
2.16(b).2.40
containing
0.5 mg
freeze-dried
epoprostenol
and
shake
gently
Dilution:
re-inject it into the remaining volume of the Glycine Buffer Diluent
Using
solution
i.e.1.80
10,000
ng/ml
epoprostenol.
until
the powderusing
has dissolved.
Forsolution
administration
a pump capable of delivering small volume a. Dosage
5 concentrated
0.90 1.20
1.50Bodyweight
2.10
2.40
2.70 3.00
and
thoroughly.
3. 
Draw up
themix
resulting
epoprostenol
solution intosolution
the syringe,
constant
infusions,
suitable
aliquots
of
concentrated
may
Concentration
of
solution
=
10,000
ng/ml
epoprostenol
(ng/kg/min)
(kilograms)
This
solution
is now
referred tovolume
as theofconcentrated
solution
and
re-inject
it into
the remaining
the Glycine Buffer
Diluent
Flow rates in ml/hr
be
diluted 10,000
with
physiological
solution
andsterile
mixnanograms
thoroughly.
contains
per saline.
ml epoprostenol. Only this
30
40
50 Bodyweight
60
70
80
90 100
Dosage
ItThis
may
be
diluted
with
physiological
saline
(0.9
%),
provided
a
ratio
b.
Using
concentrated
solution,
diluted:
concentrated
solution
is suitable
forthe
further
dilution prior
to use.
solution is
now referred
to as
concentrated
solution
and
(ng/kg/min)
(kilograms)
1
0.18
0.24
0.30
0.36
0.42
0.48
0.54
0.60
of
6
volumes
of
saline
to
1
volume
of
concentrated
solution
is
not
contains
nanograms powder
per  ml epoprostenol.
consolution + 40 ml physiological saline (0.9 %).
When 0.510,000
mg epoprostenol
is reconstitutedOnly
withthis
50 ml
of 10 ml concentrated
30 0.48
40 0.60
50 0.72
60 0.84
70 0.96
80 1.08
90 1.20
100
2
0.36
exceeded;
e.g.
50
ml
of
concentrated
solution
further
diluted
with
centrated
solution
is
suitable
for
further
dilution
prior
to
use.
the Glycine Buffer Diluent, the final injection has a pH of To give a final total volume of 50 ml.
a
maximum
of
300
ml
saline.
When
0.5 mg
epoprostenol
powder
is
reconstituted
with
50 ml
of
0.18
0.24
0.30
0.36
0.42
0.48
0.54
0.60
1
3
0.54 0.72= 2,000
0.90 nanograms/ml
1.08 1.26 1.44
1.62 1.80
approximately 10.5 and a sodium ion content of approximately 56 mg. Resultant
concentration
epoprostenol.
the Glycine
Buffer
Diluent, the
final
has a pH
of approxiOther
common
intravenous
fluids
areinjection
unsatisfactory
for the
dilution
0.36 0.48
0.60
0.72
0.84 1.92
0.96 2.16
1.08 1.20
2
4
0.72
0.96
1.20
l.44
1.68
Dilution:10.5 and a sodium ion content of approximately 56 mg.
mately
of solution = 2,000 ng/ml epoprostenol 2.40
of the concentrated solution as the required pH is not attained. Concentration0.54
0.72
0.90
1.08
1.26
1.44
1.62 3.00
1.80
3
For administration using a pump capable of delivering small volume
5
0.90 1.20 1.50 1.80 2.10 2.40 2.70
Dilution:
Epoprostenol
solutions are less stable at low pH.
Dosage
For
administration
a pump
capable
of delivering
small may
volconstant
infusions, using
suitable
aliquots
of concentrated
solution
0.72 0.96 1.20Bodyweight
1.44 1.68 1.92 2.16 2.40
4
Prior
to using
the
concentrated
solution,
the diluted solution
form, a
Flow rates in ml/hr
ume
constant
suitable aliquots
concentrated
(ng/kg/min)
(kilograms)
be diluted
withinfusions,
sterile
physiological
saline.ofor
0.90 1.20 1.50 1.80 2.10 2.40 2.70 3.00
5
filtration
step is needed.
To filter,
draw the saline.
reconstituted product into
may be diluted
with sterile
physiological
It
may
be
diluted
with
physiological
saline
(0.9
%),
provided
a
ratio
b.
Using
concentrated
solution,
diluted:
30
40
50
60
70
80
90 100
It may
dilutedand
withthen
physiological
saline
(0.9 %),
provided a
Flow rates in ml/hr
a
largebe
syringe
attach the
sterile
filter provided
toratio
the
of 66 volumes
volumes of
of saline
saline to
to 11 volume
volume of
of concentrated
concentrated solution
solution is
is not
not b.
of
1
0.90
1.20
1.50
1.80
2.10
2.40
2.70
3.00%).
Using
concentrated
solution,
diluted:
10
ml
concentrated
solution
+
40
ml
physiological
saline
(0.9
syringe.
50 ml of concentrated solution further diluted with 10 ml concentrated solution + 40 ml physiological saline (0.9 %).
exceeded; e.g. 50 ml
To give
a final 1.80
total volume
of 50 ml.
2
2.40
3.00
3.60
4.20
4.80
5.40
6.00
Dispense
the
concentrated
solution
directly
into
the
chosen
infusion
a maximum of 300 ml
300 ml saline.
To
give a final
total volume
of 50 ml.
solution
using
firm
but
not
excessive
pressure;
the
typical
time
Resultant
concentration
=
2,000
nanograms/ml
epoprostenol.
3
2.70
3.60
4.50
5.40
6.30
7.20
8.10
9.00
Other
Other common
common intravenous
intravenous fluids
fluids are
are unsatisfactory
unsatisfactory for
for the
the dilution
dilution Resultant concentration = 2,000 nanograms/ml epoprostenol.
taken
for
filtration of 50
ml of concentrated
solution
is not
70 seconds.
of
the
concentrated
solution
as
the
required
pH
is
attained.
Concentration
of
solution
=
2,000
ng/ml
epoprostenol
4
3.60
4.80
6.00
7.20
8.40
9.60
10.80
12.00
of the concentrated solution as the required pH is not attained. Concentration of solution = 2,000 ng/ml epoprostenol
Mix
well.
Epoprostenol
solutions are less stable at low pH.
Epoprostenol solutions are less stable at low pH.
5
4.50 6.00 7.50Bodyweight
9.00 10.50 12.00 13.50 15.00
Dosage
Priorfilter
to using
concentrated
solution,
or the
diluted
form, a filtration
The
unit the
must
be used once
only and
then
discarded.
Dosage
Bodyweight
Prioristoneeded.
using the
concentrated
solution, or product
the diluted
form,
a
(ng/kg/min)
(kilograms)
step
To
filter,
draw
the
reconstituted
into
a
large
When
reconstituted
and diluted
as directed
above, epoprostenol
(ng/kg/min)
(kilograms) Flow rates in ml/hr
filtration
stepthen
is needed.
draw
theprovided
reconstituted
syringe
and
attach To
thefilter,
sterile
filter
to theproduct
syringe.into
30
40
50
60
70
infusion
solutions
have
a
pH
of
approximately
10
and
will
retain
30
40
50
60
70 80
80 90
90 100
100
a large syringe
and then attach
thedirectly
sterile into
filter the
provided
the
Dispense
the concentrated
solution
chosentoinfu90%
of their initial
12 hours
25 °C.time
11
0.90
1.20 1.50
1.50 1.80
sion
solution
usingpotency
firm but for
notapproximately
excessive pressure;
the at
typical
syringe.
0.90 1.20
1.80 2.10
2.10 2.40
2.40 2.70
2.70 3.00
3.00
taken
for filtration
of 50 ml of
concentrated
solution
is 70 seconds.
22
1.80
2.40 3.00
3.00 3.60
6.00
Dispense
the concentrated
solution
directly into
the chosen
infusion
KPAC3L481-2
1.80 2.40
3.60 4.20
4.20 4.80
4.80 5.40
5.40
6.00
Mix well.
solution using firm but not excessive pressure; the typical time
3
2.70 3.60 4.50 5.40 6.30 7.20 8.10 9.00
taken for filtration of 50 ml of concentrated solution is 70 seconds.
4
3.60 4.80 6.00 7.20 8.40 9.60 10.80KPAC3L481-3
12.00
Mix well.
Epoprostenol_UK_101934LF3_KPAC3L481-2.indd 1
03.10.14
5
4.50 6.00 7.50 9.00 10.50 12.00 13.50 15.00
The filter unit must be used once only and then discarded.
When reconstituted and diluted as directed
above, epoprostenol
Flow rates in 01.04.16
ml/hr
32070898_Epoprostenol_05mg_UK_KPAC3L481-3.indd
1
Date
of Approval:
infusion solutions have a pH of approximately 10
and
will retain

PATIENT INFORMATION LEAFLET

Epoprostenol 0.5 mg powder and solvent
for solution for infusion

&

&

10:05
11:14

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 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

Do not use this medicine after the expiry date which is stated on
the label. The expiry date refers to the last day of that month.
Powder for solution for infusion:
Keep the vial in the outer carton in order to protect from light.
Keep the vial tightly closed in order to protect from moisture.
Store below 25 °C
Solvent:
Keep the vial in the outer carton in order to protect from light.
Store below 25 °C
Shelf-life after reconstitution:
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 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:
• for up to 12 hours at 25 °C, if it has just been made up
• for a maximum of 8 hours if it was made previously and has been
• sildenafil,
sitaxentan, bosentan (medicines used to treat
stored at 2 – 8 °C.
primary
pulmonary hypertension).
Renal
Dialysis:
Pregnancy,
breast-feeding
and
fertility and diluted, any unused
Once
Epoprostenol
has been
dissolved
solution
cantobe
stored
at 25 °C
andbefore
used within
hours.
your
doctor
or nurse
taking12
this
medicine if:
Please talk
Do
notare
throw
away think
any medicines
viabe
wastewater
household
• you
pregnant,
that you may
pregnant ororare
planning
waste.
Ask your
pharmacist how to throw away medicines you no
to become
pregnant
longer
use.breast-feeding.
These measures will help to protect the environment.
• you are
Driving and using machines
6. Contents
ofEpoprostenol
the pack andaffects
other your
information
It is not known
whether
ability to drive or
use machines
but the
symptoms of pulmonary hypertension can
What
Epoprostenol
contains
make you less fit to drive. Do not drive or operate machines if
Powder for solution for infusion
you are feeling unwell.
• The active substance is Epoprostenol (as Sodium).
Important
information
about some
of the ingredients
of

1 vial contains
0.531 milligrams
Epoprostenol
Sodium, correEpoprostenol
sponding to 0.5 milligrams Epoprostenol.
This
medicine
contains 2.43

The
other ingredients
are: mmol (or 56 mg) sodium per dose. To
bePtaken
by patients
on a controlled
sodium

owderinto
for consideration
solution for infusion:
Mannitol,
Glycine, Sodium
diet.
Chloride, Sodium Hydroxide (for pH adjustment)
• Solvent: Glycine, Sodium Chloride, Sodium Hydroxide (for pH
3. How
to use Epoprostenol
adjustment), Water
for Injection

PATIENT INFORMATION LEAFLET

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
or pharmacist
nurseyou
about
any
other this
side
Read
all ofdoctor
this leaflet
carefully or
before
start
taking
effects,
including
those
not listed important
in this leaflet.
medicine
because
it contains
information for you.
Other
side
include:
Keeppossible
this leaflet.
Youeffects
may need
to read it again.
Very
common
side
effects
If you
have any
further
questions, ask your doctor or nurse.
These
affect
more
thantalk
1 into10
people:
If youmay
get any
side
effects
your
doctor. This includes any
• Headache
possible side effects not listed in this leaflet.
• Jaw pain

Painis in this leaflet:
What

eing Epoprostenol
sick (vomiting)is and what it is used for
1. B
What
• Feeling sick (nausea)
2.
What
you
• Diarrhoea need to know before you use Epoprostenol
3. R
How
to use
Epoprostenol

edness
of your
face (flushing)
4. Possibleside
sideeffects
effects
Common
These
affectEpoprostenol
up to 1 in 10 people:
5. Howmay
to store

nfection ofofthe
(septicaemia)
6. IContents
theblood
pack and
other information
• Heart beating faster
1. What
• Slow heart
beatEpoprostenol is and what it is used for

Low blood pressure
Epoprostenol
0.5mg injection contains the active substance

Bleeding at various
sites and
easily
than
normal,
epoprostenol.
This medicine
canbruising
be usedmore
to stop
your
blood
from
for
example
from
thedialysis.
nose orItgums
clotting during kidney
can also be used to treat a type of
• Stomach discomfort or pain
high blood pressure called 'primary or secondary pulmonary
• Chest pain
hypertension'

Joint pain which is present in the main blood vessels in your
lungs.
Epoprostenol
widens
the blood vessels in order to lower the

Feeling
anxious, feeling
nervous
blood

Rashpressure in your lungs.
• P2.
ainWhat
at theyou
injection
need site
to know before you use Epoprostenol
Common side effects that may show up in blood tests
Dodecrease
not use Epoprostenol

in the number if:
of blood platelets (cells that help the
• you
aretoallergic
(hypersensitive) to epoprostenol or any of the
blood
clot)
ingredients
of
this
medicine
(listed in section 6)
other
Uncommon side effects
• you have
a buildup
uptoof1fluid
in your
lungs which causes breathing
These
may affect
in 100
people:
• problems.
Sweating This may be especially bad at night or when you are
down
• lying
Dry mouth
• you have heart failure which makes you short of breath
Rare side effects
(congestive heart failure). It may also cause swollen feet or legs
These may affect up to 1 in 1,000 people:
to a build
of fluid.site
• due
Infection
at theup
injection
If you are not sure, talk to your doctor, nurse or pharmacist before
Very rare side effects
you use
Epoprostenol.
These
may
affect up to 1 in 10,000 people:
Warnings
and
precautions

Feeling of
tightness
around the chest

Feeling
tired,
weakor nurse before using Epoprostenol if:
Talk
to your
doctor

Feeling
• you
haveagitated
a tendency to bleed easily e.g. haemophilia.
• Pale skin
This
medicine
caninjection
affect your
• Redness at the
site blood pressure and heart rate and
therefore
yourthyroid
doctorgland
or nurse will monitor these.

Overactive

Blockage
of the and
injection
catheter
Other
medicines
Epoprostenol
Pleaseside
tell your
doctor, nurse or pharmacist if you are taking, have
Other
effects
taken how
or might
any are
other
medicines. This includes
Itrecently
is not known
manyuse
people
affected:

Build up ofyou
fluidbuy
in the
lungs (pulmonary
oedema)
medicines
without
a prescription,
including herbal

Increase in
sugar
(glucose)
in the bloodcan affect the way some
medicines.
This
is because
Epoprostenol
Reporting
of sidework.
effects
other medicines
Also some medicines can affect the way
IfEpoprostenol
you get any works.
side effects,
talk to check
your doctor
or pharmacist.
This
In particular,
with your
doctor, nurse
or
includes
anyif possible
side effects
in this leaflet. You can
pharmacist
you are taking
any ofnot
thelisted
following:
also report side effects directly via the Yellow Card Scheme.
• heparin,
warfarin or aspirin (medicines to prevent blood clots)
Website:
www.mhra.gov.uk/yellowcard
• doxazocin
(medicines
used
to help
treatprovide
high blood
pressure)
By
reporting side
effects you
can
more
information on
• glyceryl
or other nitrate medicines (used to treat
the
safety oftrinitrate
this medicine.
angina)
5. How to store
Epoprostenol
• ibuprofen (anti-inflammatory
pain
killers also called NSAIDs)

digoxin
(medicines
used
to
treat
heart of
failure
or irregular
Keep this medicine out of the sight and reach
children.
heartbeats)

Epoprostenol 0.5 mg powder and solvent
for solution for infusion

When
1 vial with
0.5 mgon
epoprostenol
of
Your doctor
will decide
the amountisofreconstituted
Epoprostenolwith
that50 ml
is right
sterile
thelong
resultant
concentration
for youbuffer,
and how
you should
use it for. is 10,000 nanograms
per ml.
• The amount you are given is based on your body weight
Solvent
• Your dose may be increased or decreased depending on how
Each vial of solvent contains 50 ml of a sterile glycine buffer soluyou
respond approximately
to treatment 55 milligram sodium.
tion
containing
• Epoprostenol
should
notlike
be given
as a quickofinjection
in to your
What
Epoprostenol
looks
and contents
the pack
vein. It should always be given as a slow injection over a longer
Epoprostenol is a white lyophilised powder cake packed in clear
period
timegrey lyo stopper and aluminium caps with blue flipglass
vialsofwith
• There
is no
information
the dosesolution
of Epoprostenol
in
off
inserts.
The
solvent isavailable
a clear, on
colourless
packed in
children
people over 65 years old. In general dose selection
clear
glass or
vials.
After
Epoprostenol
is a colourless
solution,
practiof
for reconstitution
an elderly patient
should reflect
the greater
frequency
cally
free of particles.
decreased
hepatic, renal or cardiac function and of concomitant
Each
packor
unit
contains
disease
other
drug therapy.

onemuch
vial Epoprostenol
mg, containing a white freeze-dried
How
Epoprostenol0.5 
is given:
powder cake packed in a 15 ml clear glass vial Type I with grey
Kidney
dialysis
lyo stopper and aluminium caps with blue flip-off inserts.
The
usual
dose forbuffer
adults
is 4 nanograms
epoprostenol

one
50 mlstarting
sterile Glycine
solution,
pH 10.5 in of
a clear
glass vial
foroeach
kilogram
of body
for aseptic
each minute
it is given.

ne single
unit sterile
filterweight,
device for
preparation
of infusion
solutionyour dialysis, Epoprostenol may be given as a slow
• Before
injection into
your vein Holder and Manufacturer
Marketing
Authorisation
Marketing
Authorisation
Holder will be slowly injected into the
• During dialysis,
Epoprostenol
Mercury
Ltd., Capital
House, 85 King William Street,
blood Pharmaceuticals
going into the dialysis
machine
London
EC4N 7BL,
• Epoprostenol
will UK
not be given after the end of your dialysis.
Manufacturer
Primary and secondary pulmonary hypertension
Karmed HandelsgesmbH, Arsenal, Objekt 3, Top 15, A-1030 Vienna
When you first start having treatment it will be given to you in
This
medicinal
authorised
in the Member
of
hospital.
This isproduct
becauseisyour
doctor needs
to make States
sure they
the
EEA you
under
names:
monitor
andthe
getfollowing
the right dose
for you.
UK:
poprostenol
0.5 mg Powder
and Solvent
Solution
At first, you Ewill
be given Epoprostenol
through
a tube orfor
'line'
which
Infusion
your
chest, neck, groin, hands or arm.
is put in to for
Denmark:
Epoprostenol
“Campuspharma”
500 mikrogram
pulver
The usual starting
dose for
adults is 2 nanograms
of epoprostenol
og solvens til infusionsvæske, opløsning
for each kilogram of body weight, for each minute it is given.
Norway: Epoprostenol Campuspharma 0,5 mg pulver og væske
• This dosetilisinfusjonsvæske,
then increased every
15 minutes until the best dose
oppløsning
is found for
you. The best
dose will relieve
your
symptoms
but
Sweden: 
Epoprostenol
CampusPharma
0,5 mg
Pulver
och vätska
cause thetillfewest
possible side
effects.
infusionsvätska,
lösning
Germany:
Epoprostenol
Rotexmedica
0,5amg
Pulver und
LösungsOnce the correct
dose has
been found,
permanent
tube
or line
mittel zur Herstellung einer Infusionslösung
will be fitted.
• Your
doctor
willlast
then
continue
to give2016
you this dose through a
This
leaflet
was
revised
in March
pump

&

The following information is intended for medical
professionals
Dispense or
the healthcare
concentrated solution
directly intoonly:
the pump cassette

2.70 3.60 4.50 5.40 6.30 7.20 8.10 9.00
3
Reconstitution
and dilution:
3.60
4.80 6.00 7.20 8.40 9.60 10.80 12.00
4
Particular
should
be taken
the preparation
the infusion
6.00
7.50 in
9.00
10.50 12.00 of13.50
15.00
5 care4.50
and in calculating the rate of infusion. The procedure given below
Flow rates in ml/hr
should be closely followed.
Primary and secondary Pulmonary Hypertension
The
following
Renal
dialysispack unit is available for use in the treatment of primary
pulmonary hypertension:
Reconstitution:
One vial containing sterile freeze-dried epoprostenol sodium
1.Use onlyto
the0.5 mg
Glycine
Buffer Diluent
provided
forone
reconstitution.
equivalent
epoprostenol
supplied
with
50 ml vial of
sterile
Glycine
Buffer Diluent
2.Withdraw
approximately
10solution.
ml of the Glycine Buffer Diluent into
Initially
a pack
unit containing
diluent buffer
be used.
During
a sterile
syringe,
inject the contents
of themust
syringe
into the
vial
chronic
epoprostenol
therapy theepoprostenol
final concentration
of solution
containing
0.5 mg freeze-dried
and shake
gently
may be increased by the addition of a further 0.5 mg or 1.5 mg vial
until the powder has dissolved.
of freeze dried epoprostenol.
3.Draw
upofthe
epoprostenol
solutionininto
the syringe,
Only
vials
theresulting
same amount
as that included
the initial
starter
re-inject
it into
theto
remaining
the Glycine Buffer
Diluent
pack
may be
used
increasevolume
the finalofconcentration
of solution.
solution and mix thoroughly.
Reconstitution:
solutionbe
is carried
now referred
to as thetoconcentrated
solution
This should
out according
the instructions
givenand
for
renal
dialysis.
Where
a pack containing
0.5 mg epoprostenol
is
contains
10,000
nanograms
per ml epoprostenol.
Only this
­rconcentrated
econstituted with
50 ml
sterile diluent
the resultant
concentration
solution
is suitable
for further
dilution prior
to use.
is 10,000 nanograms per ml.
When 0.5 mg epoprostenol powder is reconstituted with 50 ml of
Dilution:
the Glycine Buffer Diluent, the final injection has a pH of
Epoprostenol 0.5 mg may be used either as concentrated solution
approximately
10.5 and
a sodium
ion content
of approximately
56 mg.
or
in a diluted form
for the
treatment
of PPH/SPH.
Only the Glycine

Buffer
Diluent provided may be used for the further dilution of
Dilution:
­rFor
econstituted
Epoprostenol
0.5 mg.
Physiological
saline
must
not
administration
using a pump
capable
of delivering
small
volume
be
used when
Epoprostenol
0.5 mg isoftoconcentrated
be used for the
treatment
constant
infusions,
suitable aliquots
solution
may
of primary pulmonary hypertension.
be diluted with sterile physiological saline.
Concentrations commonly used in the treatment of primary or secIt may be
diluted with
physiological
(0.9 %), provided a ratio
ondary
pulmonary
hypertension
aresaline
as follows:
of 165,000
volumes
of saline
to 1ofvolume
of epoprostenol
concentrated or
solution
is not
− 
ng/ml
– 3  vials
0.5  mg
one vial
of
exceeded;
e.g. 50 ml ofreconstituted
concentratedand
solution
further
diluted
with
1.5 mg epoprostenol
diluted
to a total
volume
of 100 ml in
Buffer Diluent.
a maximum
of the
300Glycine
ml saline.
− 
10,000
ng/ml intravenous
– two vials containing
0.5 mg epoprostenol
reconOther
common
fluids are unsatisfactory
for the dilution
stituted and diluted to a total volume of 100  ml in the Glycine
of Buffer
the concentrated
solution as the required pH is not attained.
Diluent.
Epoprostenol
are lessconcentration
stable at low pH.
The
maximumsolutions
recommended
for administration in
Prior to pulmonary
using the concentrated
or the diluted form, a
primary
hypertension issolution,
60,000 ng/ml.
filtration step is0.5 mg
needed.
To filter,
draw
the reconstituted
product
into
Epoprostenol
must
not be
administered
with other
parenteral
solutions
or and
medications
when
used
for primary
or secondary
a large
syringe
then attach
the
sterile
filter provided
to the
pulmonary
syringe. hypertension.
To
dilute the
draw it into
up into
larger infusion
syringe
Dispense
theconcentrated
concentrated solution,
solution directly
the achosen
and then attach the sterile filter provided to the syringe.
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
32070898_Epoprostenol_05mg_UK_KPAC3L481-3.indd
2
infusion solutions have a pH of approximately 10 and will retain

using firm but not excessive pressure; the typical time taken for
Calculation
of infusion
rate:
filtration
of 50 ml
of concentrated
solution is 70 seconds.

Remove
the filter
from be
thecalculated
syringe and
up the additional
The infusion
rate may
by draw
the following
formula: volume of the Glycine Buffer Diluent required to achieve the desired
dilution.
dosage (ng/kg/min) x bodyweight (kg)
Infusion
rate (ml/min)
=
Refit
the filter
to the syringe
and dispense the additional buffer
concentration
of solution
through this into the concentrated
Epoprostenol
0.5 mg(ng/ml)
solution in
the
cassette.
=
Infusion
rate (ml/hr)
Infusion rate (ml/min) x 60
Mix well.
The
filter
unit
must
be
used
for
the
Infusion rate formulae – examples dilution of one pack only and
then discarded.
When used in renal dialysis Epoprostenol 0.5 mg may be
The ambulatory pump used to administer Epoprostenol 0.5  mg
administered
the concentrated
solution
or intodiluted
(b).
should
(1) be as
small
and lightweight,
(2) be(a)
able
adjust form
infusion
rates
in ng/kg/min
increments,
occlusion,
end of infusion,
a. Using
concentrated
solution (3)
i.e.have
10,000
ng/ml epoprostenol.
and low battery alarms, (4) be accurate to ± 6 % of the proConcentration
ofbe
solution
10,000 ng/ml
grammed
rate (5)
positive=pressure
driven epoprostenol
(continuous or pulsatile) with intervals between pulses not exceeding 3 minutes at infuDosage
Bodyweight
sion rates used to deliver Epoprostenol 0.5 mg, and (6) include a
(ng/kg/min)
(kilograms)
cold
pouch system. The reservoir
should be made of polyvinyl
chloride, polypropylene,
glass. 60
30
40 or 50
70
80
90 100
Protect infusion bags from light during infusion.
1
0.18 0.24 0.30 0.36 0.42 0.48 0.54 0.60
CALCULATION OF INFUSION RATE:
2
0.36may
0.48
0.60 0.72from
0.84
0.96 1.08
The infusion
rate
be calculated
the formula
given1.20
above
for renal
3 dialysis.
0.54 0.72 0.90 1.08 1.26 1.44 1.62 1.80
An example of a concentration commonly used in primary or sec4 pulmonary
0.72 hypertension
0.96 1.20 isl.44
1.68
1.92 2.16 2.40
ondary
shown
below.
5 rates for
0.90a concentration
1.20 1.50 1.80
2.10nanograms/ml:
2.40 2.70 3.00
Infusion
of 15,000
Concentration of solution = 15,000 ng/ml epoprostenol
Flow rates in ml/hr
Bodyweight
b. Dosage
Using concentrated solution, diluted:
(ng/kg/min)
(kilograms)
10 ml concentrated solution + 40 ml physiological saline (0.9 %).
30
40
50
60
70
80
90
100
To give a final total volume of 50 ml.
1.0
1.1
1.3
1.4
1.6
4
Resultant concentration = 2,000 nanograms/ml epoprostenol.
1.0
1.2
1.4
1.7
1.9
2.2
6
Concentration of solution = 2,000 ng/ml epoprostenol 2.4
8
Dosage
10
(ng/kg/min)
12
14

1
16
2
3
4
5

1.0

1.3

1.2

1.6

1.4

1.9

30
0.90
1.9
1.80
2.70
3.60
4.50
1.7

40
1.20
2.6
2.40
3.60
4.80
6.00
2.2

1.6
1.9
2.2
Bodyweight
2.0
2.4
2.8
(kilograms)
2.4
2.9
3.4

50
1.50
3.2
3.00
4.50
6.00
7.50
2.8

60
1.80
3.8
3.60
5.40
7.20
9.00
3.4

70
3.9
2.10
4.5
4.20
6.30
8.40
10.50

2.6

2.9

3.2

3.2

3.6

4.0

3.8

4.3

4.8

80
90 100
4.5
5.0
5.6
2.40 2.70 3.00
5.1
5.8
6.4
4.80 5.40 6.00
Flow rates in ml/hr
7.20 8.10 9.00
9.60 10.80KPAC3L481-3
12.00
12.00 13.50 15.00
Flow rates in 01.04.16
ml/hr

11:14

Expand view ⇕

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.

Hide