Prostin E2 Sterile Solution 1 mg/ml
Dinoprostone
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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 midwife.
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 midwife.
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. It is an injfusion which will be given into your blood through a vein (intravenous). 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.
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 midwife 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 midwife to explain.
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 midwife 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
- you have been told that your baby is too big for your pelvis, is lying awkwardly or may be physically stressed
- your baby is not lying with his or her head down
- there has been or there is suspected foetal distress (your baby is short of oxygen).
- you had a difficult labour or traumatic delivery in a previous pregnancy
- you have already had five or more full-term pregnancies
- 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 have or might have placenta praevia (where the placenta lies across the entrance to the womb, rather than being high up and out of the way during birth). This causes bleeding from the vagina during pregnancy and may require that your baby is delivered by Caesarean section.
- during your pregnancy you have had bleeding from the vagina or spotting at any time during months four to nine (second and third trimester) of your pregnancy
- you have any infection or irritation in your cervix (the neck of the womb) or in your vagina, for example you might notice an unusual discharge or an unpleasant smell.
Take special care with Prostin E2 Sterile Solution:
Tell your doctor or midwife 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 midwife 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 midwife 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 midwife 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 they will not harm your baby and you may breast-feed as normal after delivery.
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
Prostin E2 Sterile Solution is given by an intravenous drip, into a vein. It is always diluted before use with a saline (salt) or dextrose (sugar) solution. Your doctor or midwife will adjust the dose to suit you.
The mixture is made up to contain 1.5 micrograms per ml of Prostin E2 Sterile Solution and the drip is set to deliver 0.25 micrograms per minute (a microgram is a millionth of a gram – a very small unit of measurement) for 30 minutes. This dose is then either kept the same or increased. (If the baby has died (a 'still birth'), a higher dose may be needed so the drip may be set to deliver 0.5 micrograms per minute and this may be adjusted hourly).
Your doctor or midwife will be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects. If your baby becomes distressed or the muscles of your womb become very tense (uterine hypertonus), or your contractions become very strong and painful your doctor or midwife will stop your treatment temporarily. When the muscles of your womb have relaxed and your baby is not distressed any more your doctor or midwife may start your treatment again with half the last dose used. If your doctor or midwife stops your treatment temporarily and your condition does not return to normal then he or she may deliver your baby by Caesarean section.
If labour does not start within the first 12 to 24 hours of your being given prostaglandin E2, your doctor or midwife will stop treatment.
Your doctor or midwife 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) and your baby (to make sure he or she does not get distressed).
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 could cause you to have an asthmatic attack. You must tell your doctor or midwife 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 midwife 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.
- placenta becoming detached
- stillbirth or death of the newborn baby
- abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby
- itching and rash of the vaginal area
- stillbirth or death of the newborn 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
- baby born with an Apgar score than seven. (The Apgar score, which is measured on a scale of one to ten, is used to describe the baby’s condition at birth. A low Apgar score means that the baby’s heart or lungs are not working properly).
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.
You might have reddening and irritation in the area around the needle for two to five hours after the needle has been removed.
Studies have shown proliferation (thickening) of bone in new-born infants who have been treated with prostaglandins for a long time. There is no evidence that this occurs following short-term treatment with Prostin E2 Sterile Solution.
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 midwife.
How to store Prostin E2 Sterile Solution
The medicine will be kept out of the reach and sight of children.
Prostin E2 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).
What Prostin E2 Sterile Solution looks like and contents of the pack
Prostin E2 Sterile Solution is available in a pack that contains a small, closed glass container (ampoule) containing 0.75 ml of Prostin E2 Sterile Solution.
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
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