PROSTIN E2 STERILE SOLUTION 10 MG / ML - patient leaflet, side effects, dosage

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PAA077125

679

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or pharmacist.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Prostin E2 Sterile Solution is and what it is used for

• 2. What you need to know 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. Contents of the pack and other information

1. 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 is given to you as an infusion, directly into the womb. It will only be given to you in a hospital or clinic which has a specialised obstetric unit.

2. what you need to know before you are given prostin e2 sterile solution most women can be treated with prostin e2 sterile solution. 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 are allergic to dinoprostone or any other prostaglandin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin.

Your doctor or nurse will not use Prostin E2 Sterile Solution 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 have been told that you will have an obstructed 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 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.
• you have current heart, lung, kidney or liver disease.

Warnings and precautions

Talk to your doctor or nurse before they use this medicine 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
• are you 35 years or older?
• is your pregnancy over 40 weeks?
• do you have any complications related to this pregnancy?
• an increased risk of developing a generalised bleeding disorder, a condition known as post-partum disseminated coagulation.

Your doctor or nurse will ask you questions before giving you Prostin E2 Sterile Solution to make sure it is safe for you.

If you do not understand any of the questions, ask your doctor or nurse to explain.

Other medicines and Prostin E2 Sterile Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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.

Pregnancy and breast-feeding

Prostin E2 Sterile Solution will only be given to you in the late stages of pregnancy to induce labour.

Prostin E2 Sterile Solution is only used during pregnancy for the therapeutic termination of pregnancy.

Although prostaglandins are present in breast-milk, you are not expected to be breast-feeding as this medicine is used to terminate the pregnancy.

Prostin E2 Sterile Solution contains ethanol (alcohol)

Depending on the daily dose given to you this medicinal product will deliver different amounts of ethanol.

Once diluted this medicinal product contains the equivalent of 12 ml of a 3.5% vol beer, 3 ml of a 14% vol wine in the maximum daily dose. Harmful for those suffering from alcoholism.

Driving and Using Machinery

The amount of alcohol in this medicinal product may impair your ability to drive or use machines.

• 3. 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.

continued overleaf…

The following information is intended for healthcare professionals only:

Prostin ® E2 Sterile Solution 10mg/ml dinoprostone

NAME OF THE MEDICINAL PRODUCT

Prostin E2 Sterile Solution 10 mg/ml.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 10 mg dinoprostone (5 mg per ampoule).

Following dilution in accordance with instructions, each ml of the resultant solution for infusion contains 100 micrograms dinoprostone.

Excipient(s) with known effect

Each 0.5 ml ampoule contains 332 mg dehydrated alcohol (ethanol).

PHARMACEUTICAL FORM

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless, alcoholic solution free from particulate matter, for extra-amniotic administration after appropriate dilution.

CLINICAL PARTICULARS

Therapeutic indications

Oxytocic agent. Prostin E2 Sterile Solution 10 mg/ml is indicated for the therapeutic termination of pregnancy, by the extra-amniotic route.

Posology and method of administration

Posology

Adults

Directions for the Preparation of a Dilute Solution:

Withdraw 0.5 ml from the ampoule, using an aseptic technique and add to contents of the vial of diluent (50 ml) provided. Shake to ensure uniformity.

After dilution, attach the infusion bag label provided. Use dilute solution within 48 hours of preparation. Store in a refrigerator at 2–8°C.

The following is a guide to dosage:

A solution containing 100 micrograms/ per ml dinoprostone should be prepared using the diluent provided. This should be installed into the extra-ovular space via a 12–14 French gauge Foley catheter with self-retaining balloon (a fine polyethene catheter may also be used). After filling the catheter system dead space with a predetermined quantity of dilute drug solution, the initial installation should be 1 ml. Subsequent installations will vary between 1 and 2 ml (usually 2 ml) in accordance with uterine response. Two hours should usually elapse between each installation and never less than 1 hour.

The appearance of uterine hypertonus requires cessation of therapy until the state returns to normal. The situation should be re-assessed and, if necessary, the infusion can be recommenced, but at lower dosage rates, 50% of the last dose level used.

In all cases the dosage should be adapted to the patient's response. Continuous administration of the drug for more than two days is not recommended.

Elderly

Not applicable.

Paediatric population

Not applicable.

Method of administration

For extra-amniotic administration only.

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Prostin E2 Sterile Solution should not be used where the patient is sensitive to prostaglandins.

Prostin E2 Sterile Solution 10 mg/ml is not recommended in the following circumstances:

• For patients in whom oxytocic drugs are generally contra-indicated or where prolonged contractions of the uterus are considered inappropriate such as:

• – Cases with a history of Caesarean section or major uterine surgery.

• – Cases where there is evidence of a potential for obstructed labour.

• In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
• In patients with cervicitis or vaginal infections.
• Patients with active cardiac, pulmonary, renal or hepatic disease.

Special warnings and precautions for use

This product is only available to hospitals and clinics with specialised obstetric units and should only be used where 24-hour resident medical cover is provided.

Use caution in handling this product to prevent contact with skin. Wash hands thoroughly with soap and water after administration.

It is advised that Prostin E2 Sterile Solution should not be administered by the intramyometrial route since there have been reports of a possible association between this route of administration and cardiac arrest in severely ill patients.

Caution should be exercised in the administration of Prostin E2 Sterile Solution to patients with:

• asthma or a history of asthma
• epilepsy or a history of epilepsy
• glaucoma or raised intra-ocular pressure
• compromised cardiovascular, hepatic, or renal function
• hypertension.

As with any oxytocic agent, Prostin E2 Sterile Solution should be used with caution in patients with compromised (scarred) uteri.

Animal studies lasting several weeks at high doses have shown that prostaglandins of the E and F series can induce proliferation of bone. Such effects have also been noted in newborn infants who received prostaglandin E1 during prolonged treatment. There is no evidence that short-term administration of prostaglandin E2 can cause similar bone effects.

Women aged 35 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labour induction (see section 4.8). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase.

Ethanol (alcohol)

Depending on the daily dose administered this medicinal product will deliver varying amounts of ethanol.

This product contains 84.16% v/v ethanol (alcohol).

Once diluted with the appropriate diluent this medicinal product contains 0.84% v/v ethanol (alcohol) i.e. up to 332 mg per maximum daily dose (instillation rate of 2 ml/hour per 24 hrs), equivalent to 12 ml of a 3.5% vol beer, 3 ml of a 14% vol wine per maximum daily dose. Harmful for those

The doctor or nurse will keep a very close eye on you during your treatment to make sure that the contractions do not become too strong, as this could cause your uterus to tear. 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.

If you are given more Prostin E2 Sterile Solution than you should

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, or ruptures you might need another obstetric procedure.

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.

4. possible side effects

Like all medicines, this medicine 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 by causing a narrowing of your airways (bronchospasm). You must tell your doctor or nurse if you suffer from asthma or if you start having difficulty in breathing.

Rare: may affect up to 1 in 1,000 people

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/anap­hylactic reactions, including anaphylactic shock (serious allergic reactions which can include skin rash, itching, wheezing, shortness of breath, swollen face, lips, hands, fingers, neck and throat, sudden drop in blood pressure, abdominal pain and collapse).

If you get any of these symptoms please tell your doctor or nurse straight away.

Common: may affect up to 1 in 10 people

• Vomiting (being sick)
• Nausea (feeling sick)
• Diarrhoea.

Not known: frequency cannot be estimated from the available data

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 Sterile Solution. This includes:

• Vaso-vagal symptoms (flushing, shivering, headache, dizziness, fainting)
• Detached placenta
• 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
• High blood pressure in the mother
• Very quick opening of the cervix
• Running a high temperature
• Backache
• Rash.

Talk to your doctor or nurse about this if you want to know more, as they will be able to give you the information that you need.

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.

You might have reddening and irritation in the area around the needle for two to five hours after the needle has been removed.

A higher riskofa generalised bleeding disorder following delivery (post-partum disseminated intravascular coagulation-DIC) has been described in women who:

• are aged 35 and above.
• whose pregnancies are more than 40 weeks.
• who have pregnancy-related complications.

Reporting of side effects

If you get any side effects or you are worried about anything unusual happening during your labour, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store prostin e2 sterile solution

Keep this medicine out of the sight and reach of children.

Prostin E2 Sterile Solution will not be given to you after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

The hospital pharmacist will store this medicine in a refrigerator at 2–8°C before use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Prostin E2 Sterile Solution contains:

The active substance is dinoprostone. Each 1 ml of solution contains 10 mg of dinoprostone.

The other ingredient is ethanol (alcohol) (see section 2 Prostin E2 Sterile Solution contains ethanol (alcohol) ).

The liquid (diluent) supplied separately to dilute 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 small, closed glass container (ampoule) containing 0.5 ml ofa colourless, sterile solution
• one small glass bottle (vial) containing 50 ml ofa colourless liquid (diluent)
• one infusion bag label.