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Active substance(s): ALPROSTADIL

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Toegelaten insertformaten voor Genotropin Mixer: max I012/J ---- Toegelaten insertformaten voor Genotropin Pen: max I012/H

Prostin VR Sterile Solution



eerste vol vc blokje: 16.5mm

For further information, consult the Data Sheet.
Dosage and 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 to 0.1 micrograms alprostadil per kilogram of body weight
per minute. 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.
Continued overleaf...


Prostin VR
Sterile Solution

Read all of this leaflet carefully before you start taking this
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

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In this leaflet
1. What Prostin VR Sterile Solution is and what it is used for
2. Before your baby is given Prostin VR Sterile Solution
3. How Prostin VR Sterile Solution is given to your baby
4. Possible side effects
5. How to store Prostin VR Sterile Solution
6. Further information

Do not use Prostin VR
Prostin VR should not be given to your baby if your baby is allergic to
alprostadil or any other prostaglandin or any of the other ingredients in
this medicinal product listed in Section 6 of this leaflet. The symptoms
of an allergic reaction can be the following: wheezing, breathlessness,
swelling of the face, hands, itchy rash or redness of the skin.
Take special care with Prostin VR
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
heart beat, 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.

1. What Prostin VR Sterile Solution is and what it is used for
Prostin VR Sterile Solution 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 open the ductus arteriosus until an operation can take place.
Your baby’s doctor will explain which problem affects your baby.
Prostin VR Sterile Solution contains a medicine called ’alprostadil’
which is a synthetic copy of a natural prostaglandin chemical which
occurs in your body. Prostaglandins are a group of 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.
Taking other medicines:

2. Before your baby is given Prostin VR Sterile Solution
Babies born with heart problems usually have to be given several
All babies can have Prostin VR if they really need it. The doctor will carry different medicines. These medicines may be to:
out tests before deciding whether to give the medicine to your baby.
• improve the pumping action of the heart. These drugs act directly


Dilution Instructions:
To prepare infusion solutions, dilute 1 ml of Prostin VR Sterile Solution with Sterile 0.9% Sodium Chloride
Intravenous Infusion or sterile 5% Dextrose Intravenous Infusion. If undiluted Prostin VR Sterile Solution
comes in direct contact with a plastic container, plasticizers are leached from the sidewalls. 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 minimize the possibility of haze formulation, Prostin VR Sterile Solution 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.
Add 1 ml ampoule (500
micrograms alprostadil) to:

Concentration of resulting
solution (micrograms/ml)

Infusion rate (ml/min/kg)













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 per kilogram of body weight per minute to 0.05 micrograms per
kilogram of body weight per minute by reducing the pump rate to one-half the original rate.
Date Leaflet last revised: 02/2014
Company Ref: PR4_0

on the heart muscle and belong to a group of drugs called ’cardiac
glycosides’; an example is 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; an example
is furosemide
• fight infections (antibiotics, such as penicillin or gentamicin).

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Prostin VR can be given at the same time as these medicines; no
interactions with these medicines have been reported.

• a heart beat that is slower than normal (bradycardia)
• low blood pressure
• a heart beat that is faster than normal (tachycardia)
• diarrhoea
• flushing of the skin may occur. 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 (likely to occur in less than 1 in 100 people)
• narrowing of the stomach outlet (gastric obstruction)
• irregular thickening of the stomach lining (gastric mucosal
3. How Prostin VR Sterile Solution is given to your baby
This medicine must only be given by a doctor in a hospital or in a place
• growth of new bone upon bone (exostosis)
where intensive care facilities are immediately available if needed.
• blood vessels prone to leaking (vascular fragility).
This medicine can be given by an intravenous drip or through an
artery by way of a tube (catheter).
The following have occurred in babies given Prostin VR. It is
The small volume (1 ml) of medicine must be diluted with larger
possible that they are adverse reactions to the drug, but may not have
volumes of a special salt or sugar solution. The amount of solution
been caused by it:
used will depend on how the medicine is to be given.
• infection
Different babies need different amounts of ProstinVR Sterile Solution.
• stopping of the heart
Your doctor will give the smallest amount needed for the shortest length
• clotting and bleeding throughout the circulation (disseminated
of time to give a good result. The doctor will have carefully worked out
intravascular coagulation)
the risks of giving the medicine over a long period in a very ill baby,
• low levels of potassium in the blood, which if not corrected can
against the possible benefits that the baby will get from the treatment or
cause muscle weakness and an abnormal heart rhythm
the risks of reducing or stopping Prostin VR treatment early.
• swelling caused by too much fluid in the body.
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 any of the side effects gets serious, or if you notice any side effects
(If your baby has an obstruction to the flow of blood to the lungs, the not listed in this leaflet, please tell your baby’s doctor.
doctor will be looking for an increase in the amount of oxygen in the
5. How to store Prostin VR Sterile Solution
blood; if your baby has an obstruction in the flow of blood to the rest
The medicine will be kept out of the reach and sight of children.
of the body, the doctor will be looking for an increase in the blood
Do not use Prostin VR after the expiry date which is stated on the
pressure and a fall in the acidity of the blood).
label. The expiry date refers to the last day of that month.
As soon as the baby starts to have the medicine, the pressure of the
Your hospital pharmacist will store this medicine in a refrigerator.
blood in the arteries will be checked at regular intervals. As Prostin
VR relaxes muscles in other blood vessels this may cause a lowering 6. Further information
of the baby’s blood pressure.
What Prostin VR Sterile Solution contains
(To do this, the doctor may use the catheter through which the drug The active substance is called alprostadil. Each ampoule (small,
is being given, or a stethoscope or an ultrasound device). If this
closed glass container) contains 500 micrograms of alprostadil.
pressure falls significantly, the rate at which Prostin VR Sterile
The other (inactive) ingredient is 1 ml dehydrated ethanol (alcohol).
Solution is being given will be reduced straight away.
What Prostin VR Sterile Solution looks like and contents of
Your baby’s doctor or nursing staff will be able to tell you if the
the pack
medicine is working properly.
Prostin VR is packed in packs of 5 x 1 ml ampoules.
4. Possible side effects
Marketing Authorisation Holder
Like all medicines Prostin VR can cause side effects, although not
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
everybody gets them.
Your baby may react to the medicine in other ways.
Starting with the most common and decreasing in frequency the
Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs,
reactions that he or she may develop are:
Very common side effects (likely to occur in more that 1 in 10 people)
For further information on this medicine, please contact Pfizer
• interrupted breathing (apnoea)
Medical Information on: 01304 616161.
• a high temperature for a short time period (transient pyrexia)
Common side effects (likely to occur in less than 1 in 10 people)
• fits (seizures)

This leaflet was last revised in 02/2014
Ref: PR4_0.


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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.