Prostin VR Sterile Solution for Injection
Alprostadil
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
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’) stay open until the heart condition can be corrected by surgery,. This is what Prostin VR can do ie. 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.
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.
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 opening from the stomach. 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 as 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 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 frusemide;
- 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.
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 Prostin VR 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.
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:
- a high temperature for a short time period (transient pyrexia);
- a heart beat that is slower than normal (bradycardia);
- fits (seizures);
- 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.
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.
A test has shown that Prostin VR does not cause changes in the cells of the body that can cause cancer (mutations).
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.
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.
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 1ml 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:
Manufacturer:
For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.
This leaflet was last updated in July 2008.
Ref: PR 2_1
No comments:
Post a Comment