Prostin E2 Sterile Solution 10 mg/ml
Dinoprostone
Pharmacia Logo
Read all of this leaflet carefully before you are given this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
- 1. What Prostin E2 Sterile Solution is and what it is used for
- 2. Before you are given Prostin E2 Sterile Solution
- 3. How Prostin E2 Sterile Solution is given to you
- 4. Possible side effects
- 5. How to store Prostin E2 Sterile Solution
- 6. Further information
What Prostin E2 Sterile Solution is and what it is used for
Prostin E2 Sterile Solution contains the prostaglandin dinoprostone and is used to “induce” labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour which will end the pregnancy. This is also called termination of pregnancy or an abortion. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. It will only be given to you in a hospital or clinic. It is given to you as an infusion, directly into the womb.
Before you are given Prostin E2 Sterile Solution
Most women can be treated with Prostin E2. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or nurse will ask you questions before giving you Prostin E2 to make sure it is safe for you. If you do not understand any of the questions, ask your doctor or nurse to explain.
If you are having a pregnancy termination (abortion), it is very important for it to be complete. This is because prostaglandins given at this stage in pregnancy may cause abnormalities in the foetus. If your doctor thinks that the abortion has not worked completely, you will need another treatment, probably an operation.
Do not use Prostin E2 Sterile Solution:
- If you have had an allergic reaction (e.g. wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin) to dinoprostone or any other prostaglandin or any of the other ingredients in the infusion, which are listed in Section 6 below.
- If you have current heart, lung, kidney or liver disease
Your doctor or nurse will not use Prostin E2 to start or strengthen your labour in certain circumstances if:
- you have had a Caesarean section or any major surgery to your womb in the past
- you had any abnormal contractions of your womb that were too strong or went on for too long during a previous labour
- you have an infection of your womb, ovaries or tubes (pelvic inflammatory disease) unless you are receiving treatment for these, or if you have ever had such an infection in the past
- you have been told that you will have an obstructed labour
Take special care with Prostin E2 Sterile Solution:
Tell your doctor or nurse if you have or have had in the past any of the following conditions as they may want to monitor you more closely.
- heart, lung, kidney or liver disease
- glaucoma (raised pressure in the eye)
- epilepsy
- suffered from asthma
- hypertension (high blood pressure) at any time, including during this or any previous pregnancy
- been told you had abnormally strong contractions of your womb during a previous labour
- scarring of your womb from a previous operation
Your doctor or nurse will ask you questions before giving you Prostin E2 to make sure it is safe for you.
If you do not understand any of the questions, ask your doctor or nurse to explain.
Taking other medicines:
Prostin E2 Sterile Solution can make you more sensitive to another medicine called oxytocin which is used to strengthen contractions. Medical staff will normally try not to use this medicine at the same time as Prostin E2 Sterile Solution. If used with this medicine in sequence, your doctor or nurse will watch over the womb contractions very carefully.
Your doctor may give you antibiotics before you start this prostaglandin treatment.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
Prostin E2 will only be given to you in the late stages of pregnancy to induce labour.
Although prostaglandins are present in breast milk, you are not expected to be breast-feeding as this medicine is used to terminate the pregnancy.
Driving and using machinery
No effect on your ability to drive or use machinery is expected after being given Prostin E2.
How Prostin E2 Sterile Solution is given to you
This product can only be used in hospitals and clinics with specialised units for pregnancy and childbirth (obstetric units). Medical staff will be available at all times.
Prostin E2 Sterile Solution is diluted before use with the 50 ml of diluent supplied, to make a solution containing 100 micrograms/ml. The 100 micrograms/ml solution is instilled (placed drop by drop) into the womb, using a fine tube that is passed up into the womb through your vagina and cervix (neck of the womb). Medical staff will adjust the dose to suit you. At first 1 ml of solution is given. Then depending on how your womb responds, another 1 ml or 2 ml may be given at two-hourly intervals. The doctor or nurse will want to make sure that the contractions do not become too strong.
Medical staff will be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects or if your womb reacts too strongly to the dose you are given. You might just need a lower dose, or you might need some other obstetric procedure.
You should not normally be given Prostin E2 Sterile Solution for more than two days at a time.
Your doctor or nurse will do internal checks to make sure that your cervix is opening enough. They will also check your contractions to make sure that they are not too strong.
If you are given too much Prostin E2 Sterile Solution
Tell your doctor or nurse if you think you have been given too much Prostin E2 Sterile Solution. Symptoms of this would be excessive contractions of your womb (very strong, frequent and painful contractions) or severe side-effects, such as feeling and being sick. If you have such symptoms, the rate at which Prostin E2 Sterile Solution is being given should be reduced, or the treatment should be stopped. If you have a massive overdose, so that the muscles of your womb become very tense and over-active, you might need another obstetric procedure.
Possible side effects
Like all medicines Prostin E2 Sterile Solution can cause side effects, although not everybody gets them.
If you have asthma, Prostin E2 Sterile Solution could cause you to have an asthmatic attack. You must tell your doctor or nurse if you suffer from asthma or if you start having difficulty in breathing.
Rare side effects
Rare but serious side effects which can sometimes happen include the following:
- tearing or bursting of the wall of your womb (uterine rupture)
- heart attack
- allergic reactions (symptoms may include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin). If you get any of these symptoms please tell your doctor or midwife straight away.
Common side effects
- vomiting (being sick),
- nausea (feeling sick)
- diarrhoea
These have seldom been bad enough for the woman to stop the treatment.
Other side effects
As prostaglandins make the body go into labour in the same way as it would happen naturally, anything that can happen in a natural labour can also happen if you have been given Prostin E2. Talk to your nurse or doctor about this if you want to know more, as they will be able to give you the information that you need.
These include:
- sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by a blood clot in the lungs. This could cause chest pain and shortness of breath.
- abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby
- abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby
- high blood pressure in the mother
- very quick opening of the cervix
- running a high temperature
- backache
- rash
- heart attack
In some women the number of white blood cells rises during treatment. This will not cause you any symptoms, but your doctor or nurse may mention this if you have a blood sample taken.
If you are still running a temperature after the Prostin E2 Sterile Solution has been stopped, the doctor or nurse will want to make sure that this is not caused by an infection. You may be given antibiotics to treat any infection.
If you have very long and strong contractions, the wall of the uterus could tear. (This can happen in natural labour too). This is one reason for close monitoring during treatment.
There may be a link between Prostin E2 Sterile Solution and cardiac arrest (stopping of the heart) in women who were already severely ill and who were given Prostin E2 Sterile Solution by injection into the muscle of the womb. This method of injections is not recommended.
If you think you may be having any of the above side effects, or you are worried about anything unusual happening during your labour, please tell your doctor or nurse.
How to store Prostin E2 Sterile Solution
The medicine will be kept out of the reach and sight of children.
Prostin E2 Sterile Solution will not be given to you after the expiry date which is stated on the packs. The expiry date refers to the last day of that month.
Your hospital pharmacist will store this medicine in a refrigerator at 4 °C before use.
Further information
What Prostin E2 Sterile Solution contain:
The active substance is called dinoprostone. It also contains ethanol (alcohol).
The liquid (diluent) supplied separately to dilute the Prostin E2 Sterile Solution stops the growth of bacteria, and contains sodium chloride (salt), benzyl alcohol and water.
What Prostin E2 Sterile Solution looks like and contents of the pack
Each pack contains:
- one 0.5 ml ampoule (small, closed glass container) of Prostin E2 Sterile Solution;
- one 50 ml vial (small glass bottle) of diluent.
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 1_1
No comments:
Post a Comment