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PROSTIN VR STERILE SOLUTION

Active substance(s): ALPROSTADIL

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date:07-Sep-16 11:16:59

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Package leaflet: Information for the patient

Prostin® VR 500 micrograms/ml Concentrate for
solution for infusion

RECTO

alprostadil

PAA073675
315

Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor.
• If your baby gets any side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Prostin VR is and what it is used
for
2. What you need to know before your
baby is given Prostin VR
3. How to use Prostin VR
4. Possible side effects
5. How to store Prostin VR
6. Contents of the pack and other
information
1. What Prostin VR is and what it is used
for
Prostin VR contains the active substance
alprostadil. Alprostadil is a synthetic copy of a
prostaglandin chemical that occurs naturally in
your body. Prostaglandins are a complex set of
chemicals made by the body tissues. Some of
them can cause muscles, which occur in the
walls of certain blood vessels, to relax.
Prostin VR is a medicine given to new born
babies through an injection into the vein or a
catheter (fine tube) into an artery.
While a baby is in the womb, before it is born, it
does not breathe. For this reason, in a baby's
heart there is a special, small blood vessel
called the ductus arteriosus that allows blood to
pass through the heart without going through
the lungs. Once the baby is born and breathing
normally, this is no longer needed, and the
ductus arteriosus would close off.
If the baby has certain conditions affecting the
heart it may still be beneficial to keep this
channel (the ductus arteriosus) open until the
heart condition can be corrected by surgery.
This is what Prostin VR can do i.e. it relaxes the
muscles in the wall of the ductus arteriosus
while the baby still requires this. Once the baby
has had an operation to correct the heart
problem, then the ductus arteriosus will no
longer be needed and can be allowed to close.
Your baby may have one of several problems in
which it is necessary to keep the ductus
arteriosus open until an operation can take place.
Your baby's doctor will explain which problem
affects your baby.
2. What you need to know before your
baby is given Prostin VR
All babies can have Prostin VR if they really
need it. The doctor will carry out tests before
deciding whether to give this medicine to your
baby.
Do not use Prostin VR if your baby is allergic to
alprostadil (or any other prostaglandin) or any of
the other ingredients of this medicine (listed in
section 6). The symptoms of an allergic reaction
can be the following: wheezing, breathlessness,
swelling of the face, hands, itchy rash or redness
of the skin.

Warnings and precautions
There are some circumstances where special
precautions may need to be taken. These
include:
• if your baby has a tendency to bleed easily.
The doctor will be cautious when using this
medicine as it may prevent blood from
clotting properly.
• if your baby suffers from an obstruction of the
blood flow into the lungs, blood will be
flowing through the ductus arteriosus from
the main artery of the lungs. In this case,
Prostin VR can be given through a catheter
(fine tube) placed at or just above the junction
between the main artery and the ductus
arteriosus or can be given intravenously (by a
drip into a vein).
• if your baby develops interrupted breathing
(apnoea) or a slow heartbeat, this medicine
should be stopped and appropriate medical
treatment should be given. This most often
occurs in babies weighing less than 2 kg at
birth. It usually happens within the first hour
of the medicine being given. Doctors and
nurses will watch your baby carefully in case
they need to ventilate him or her (give oxygen)
until normal breathing starts again. This
medicine will only be used where there are
facilities to do this. If the baby develops a
high temperature or low blood pressure, the
drug should be given at a slower rate until
these symptoms subside.
• if your baby suffers from feeding problems.
This medicine may cause thickening of the
stomach wall, such that emptying of the
stomach contents may be difficult. This effect
has been linked with the total amount of
medicine given and the length of time it is
given for. If your baby is given this medicine
for more than 120 hours, the doctor will
watch carefully for this problem which will
cause the baby to vomit after feeds.
• if this medicine is given for a very long time
period the walls of the ductus arteriosus and
of the artery that connects the heart to the
lungs (pulmonary artery) may weaken.
• this medicine may cause abnormalities of
long bones. Your doctor will monitor your
baby’s symptoms and may decide if this
medicine needs to be withdrawn.
• if your baby has respiratory distress syndrome
(hyaline membrane disease). This medicine
must not be used in babies with this condition
therefore your baby’s doctor will ensure
correct diagnosis.
Other medicines and Prostin VR
Babies born with heart problems usually have
to be given several different medicines. These
medicines may be to:
• improve the pumping action of the heart.
These drugs act directly on the heart muscle
and belong to a group of drugs called cardiac
glycosides, e.g. digoxin.
• raise the blood pressure, e.g. dopamine or
isoproterenol.
• reduce the volume of the blood and hence
the workload on the heart. These drugs are
called diuretics or water tablets, e.g.
furosemide.

The following information is intended for healthcare professionals only:

Prostin® VR 500 micrograms/ml Concentrate for
solution for infusion

alprostadil

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For further information, refer to the Summary of Product Characteristics (SPC).
Posology and method of administration
For administration by intravenous drip or constant rate infusion pump.
In infants with lesions restricting pulmonary blood flow (blood is flowing through the ductus arteriosus
from the aorta to the pulmonary artery), Prostin VR may be administered by continuous infusion
through an umbilical artery catheter placed at or just above the junction of the descending aorta and
the ductus arteriosus, or intravenously. Adverse effects have occurred with both routes of
administration, but the types of reactions are different. A higher incidence of flushing has been
associated with intra-arterial than with intravenous administration.
The infusion is generally initiated at a rate of 0.05-0.1 micrograms/kg/min. The most experience has
been with 0.1 micrograms/kg/min. After a therapeutic response (an increase in p02 in neonates with
restricted pulmonary blood flow or an increase in systemic blood flow pressure and blood pH in
neonates with restricted systemic blood flow) has been obtained, the infusion rate should be reduced
to the lowest possible dosage that will maintain the desired response.
Dilution instructions
To prepare infusion solutions, dilute 1 ml of Prostin VR with sterile 0.9% sodium chloride intravenous
infusion or sterile 5% dextrose intravenous infusion.
If undiluted Prostin VR comes in direct contact with a plastic container, plasticisers are leached from the
side walls. The solution may turn hazy and the appearance of the container may change. Should this
occur, the solution should be discarded and the plastic container should be replaced. This appears to
be a concentration-dependent phenomenon. To minimise the possibility of haze formulation, Prostin VR
should be added directly to the intravenous infusion solution, avoiding contact with the walls of plastic
containers. Dilute to volumes appropriate for the delivery system available. Prepare fresh infusion
solutions every 24 hours. Discard any solution more than 24 hours old.
Sample dilution and infusion rates to provide a dosage of 0.1 micrograms/kg body weight/minute:
Add 1 ml ampoule
Concentration of resulting
Infusion rate (ml/min/kg)
(500 micrograms alprostadil)
solution (micrograms/ml)
to:
250 ml
2
0.05
100 ml
5
0.02
50 ml
10
0.01
25 ml
20
0.005

code

PAA073675

guidelines

TSE-I012F

dimensions

148x520/35

date

06-apr-16 EA

country

ENGLAND

VERSO

• fight infections (antibiotics), e.g. penicillin or
gentamicin.
Prostin VR can be given at the same time as
these medicines as no interactions with these
medicines have been reported.
Prostin VR contains ethanol
This medicinal product contains ethanol. Your
doctor will take this into account when deciding
to give this medicine to your baby.
3. How to use Prostin VR
This medicine must only be given by a doctor in
a hospital or in a place where intensive care
facilities are immediately available if needed.
This medicine can be given by an intravenous
drip or through an artery by way of a tube
(catheter).
The small volume (1 ml) of medicine must be
diluted with larger volumes of a special salt or
sugar solution. The amount of solution used will
depend on how the medicine is to be given.
Different babies need different amounts of
Prostin VR. Your doctor will give the smallest
amount needed for the shortest length of time
to give a good result. The doctor will have
carefully worked out the risks of giving the
medicine over a long period in a very ill baby,
against the possible benefits that the baby will
get from the treatment or the risks of reducing
or stopping Prostin VR treatment early.
As soon as tests show that the baby is
responding, the rate will be reduced to the
lowest possible dose that will maintain the
response. (If your baby has an obstruction to
the flow of blood to the lungs, the doctor will be
looking for an increase in the amount of oxygen
in the blood; if your baby has an obstruction in
the flow of blood to the rest of the body, the
doctor will be looking for an increase in the
blood pressure and a fall in the acidity of the
blood).
As soon as the baby starts to have the
medicine, the pressure of the blood in the
arteries will be checked at regular intervals. As
Prostin VR relaxes muscles in other blood
vessels this may cause a lowering of the baby's
blood pressure. In order to do this, the doctor
may use the catheter through which the drug is
being given, or a stethoscope or an ultrasound
device. If pressure falls significantly, the rate at
which Prostin VR is being given will be reduced
straight away.
If you have any further questions on the use of
this medicine, as your baby’s doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Starting with the most common and decreasing
in frequency, the reactions that he or she may
develop are:
Very common side effects (may affect
more than 1 in 10 people)
• interrupted breathing (apnoea)
• a high temperature for a short time period
(transient pyrexia).
Common side effects (may affect up to 1 in
10 people)
• fits (seizures)
• a heartbeat that is slower than normal
(bradycardia)
• low blood pressure
• a heartbeat that is faster than normal
(tachycardia)
• diarrhoea
• flushing of the skin. This happens more often
when the medicine is given by catheter into
an artery and is usually relieved by
repositioning the tip of the catheter.
Uncommon side effects (may affect up to
1 in 100 people)
• narrowing of the stomach outlet (gastric
obstruction)
• irregular thickening of the stomach lining
(gastric mucosal hypertrophy)

• growth of new bone upon bone (exostosis)
• blood vessels prone to leaking (vascular
fragility).
The following have occurred in babies given
Prostin VR. It is possible that they are adverse
reactions to the drug, but may not have been
caused by it:
• infection
• stopping of the heart
• clotting and bleeding throughout the
circulation (disseminated intravascular
coagulation)
• low levels of potassium in the blood, which if
not corrected can cause muscle weakness
and an abnormal heart rhythm
• swelling caused by too much fluid in the
body.
Reporting of side effects
If your baby gets any side effects, talk to your
doctor 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 Prostin VR
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 after EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Diluted solutions should be used within
24 hours.
6. Contents of the pack and other
information
What Prostin VR contains
The active substance is alprostadil. Each
ampoule contains 500 micrograms of
alprostadil.
The other ingredient is ethanol.
What Prostin VR looks like and contents of
the pack
Prostin VR is a clear, colourless, sterile
concentrate for solution for infusion contained
in 1 ml glass ampoules.
Prostin VR is available in multipacks of 5 x 1 ml
ampoules.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK
Manufacturer:
Pfizer Manufacturing Belgium NV/SA
Rijksweg 12
Puurs
B-2870
Belgium
For further information on this medicine, please
contact Pfizer Medical Information on:
01304 616161.
This leaflet was last revised in 09/2016.
Ref: PR 6_1

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Example:
To provide 0.1 micrograms/kg/min to a 2.8 kg neonate, using a concentration of 5 micrograms/ml:
Infusion Rate = 0.02 ml/min/kg x 2.8 kg = 0.056 ml/min or 3.36 ml/hr
Change the dosage from 0.1 micrograms/kg/min to 0.05 micrograms/kg/min by reducing the pump
rate to half of the original rate.
The diluted solution should contain no more than 20 micrograms/ml alprostadil.
PARTICULAR CARE SHOULD BE TAKEN IN CALCULATING AND PREPARING DILUTIONS OF
PROSTIN VR.

PAA073675

code

PAA073675

guidelines

TSE-I012F

dimensions

148x520/35

date

06-apr-16 EA

country

ENGLAND

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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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