Prostin Vr Sterile Solution
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Prostin VR Sterile Solution
alprostadil
D Dl I RECT0
Process Black eerste vol vc blokje: 16.5mm
NOTE TO DOCTORS ON PREPARING INFUSIONS OF PROSTIN VR
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.
Read all of this leaflet carefully before you start taking this medicine
• 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.
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
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.
2. Before your baby is given Prostin VR Sterile Solution
All babies can have Prostin VR if they really need it. The doctor will carry out tests before deciding whether to give the medicine to your baby.
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.
Taking other medicines:
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
Process Black VERSO
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.
SAMPLE DILUTION AND INFUSION RATES TO PROVIDE A DOSAGE OF 0.1 MICROGRAMS/KG BODY WEIGHT/MINUTE
|
Add 1 ml ampoule (500 micrograms alprostadil) to: |
Concentration of resulting solution (micrograms/ml) |
Infusion rate (ml/min/kg) |
|
250ml |
2 |
0.05 |
|
100ml |
5 |
0.02 |
|
50ml |
10 |
0.01 |
|
25ml |
20 |
0.005 |
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 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.
PARTICULAR CARE SHOULD BE TAKEN IN CALCULATING AND PREPARING DILUTIONS OF PROSTIN VR.
Date Leaflet last revised: 02/2014
Company Ref: PR4_0
8R3718
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).
Prostin VR can be given at the same time as these medicines; no interactions with these medicines have been reported.
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 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 ProstinVR Sterile Solution. 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.
(To do this, the doctor may use the catheter through which the drug is being given, or a stethoscope or an ultrasound device). If this pressure falls significantly, the rate at which Prostin VR Sterile Solution is being given will be reduced straight away.
Your baby’s doctor or nursing staff will be able to tell you if the medicine is working properly.
4. Possible side effects
Like all medicines Prostin VR can cause side effects, although not everybody gets them.
Your baby may react to the medicine in other ways.
Starting with the most common and decreasing in frequency the reactions that he or she may develop are:
Very common side effects (likely to occur in more that 1 in 10 people)
• interrupted breathing (apnoea)
• 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)
• 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 (likelyto occur in less than 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby’s doctor.
5. How to store Prostin VR Sterile Solution
The medicine will be kept out of the reach and sight of children.
Do not use Prostin VR after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Your hospital pharmacist will store this medicine in a refrigerator.
6. Further information
What Prostin VR Sterile Solution contains
The active substance is called alprostadil. Each ampoule (small, closed glass container) contains 500 micrograms of alprostadil.
The other (inactive) ingredient is 1 ml dehydrated ethanol (alcohol).
What Prostin VR Sterile Solution looks like and contents of the pack
Prostin VR is packed in packs of 5 x 1 ml ampoules.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.
For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.
This leaflet was last revised in 02/2014
Ref: PR4 0.