PROSTIN E2 STERILE SOLUTION 1 MG / ML - patient leaflet, side effects, dosage

Prostin® E2

Sterile Solution 1 mg/ml

dinoprostone

NAME OF THE MEDICINAL PRODUCT

Prostin E2 Sterile Solution 1 mg/ml.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 1 mg dinoprostone (750 micrograms per ampoule).

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

1.5 micrograms dinoprostone.

Excipient with known effect:

Prostin E2 Sterile Solution 1 mg/ml contains 600 mg anhydrous ethanol in each 0.75 ml ampoule which is equivalent to 800 mg/ml (80% w/v).

PHARMACEUTICAL FORM

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless, alcoholic solution free from particulate matter, which after appropriate dilution is intended for intravenous administration to human beings.

CLINICAL PARTICULARS

Therapeutic indications

Oxytocic agent. Prostin E2 Sterile Solution 1 mg/ml is indicated for the induction of labour by the intravenous route.

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. Dinoprostone is similar to the natural ‘E2’ type of prostaglandins which are made in your body when labour starts. It is an infusion which will be given into your blood through a vein (intravenous). 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 midwife 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 midwife to explain.

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 midwife will not use Prostin E2 Sterile Solution to start or

Posology and method of administration

Usage is restricted to qualified health care professionals and to hospitals and clinics with specialised obstetric units with facilities for continuous monitoring.

The recommended dose should not be exceeded, and the dosing interval should not be shortened as this increases the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death.

Posology

Adults

Directions for the Preparation of a Dilute Solution:

For use by IV drip (a drip set delivering 60 drops/ per ml must be used) or constant rate infusion pump. Withdraw 0.75 ml from the ampoule using an aseptic technique and add to 500 ml sterile normal saline or 5% dextrose. Shake to ensure uniformity.

After dilution attach label provided. Use dilute solution within 24 hours of preparation and store in a refrigerator at 2–8°C.

The dose of Prostin E2 Sterile Solution used, normally depends not only upon the indication, but also on patient response.

The following is a guide to dosage:

Dilute with normal saline or 5% dextrose to produce a 1.5 micrograms/ml solution. The 1.5 micrograms/ml solution is infused at 0.25 microgram­s/minute for 30 minutes and then maintained or increased. Cases of foetal death in utero may require higher doses. An initial rate of 0.5 microgram­s/minute may be used with stepwise increases, at intervals of not less than one hour.

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 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 current heart, lung, kidney or liver disease.

Warnings and precautions

Tell your doctor or midwife if you have or have had in the past any of the following

The appearance of foetal distress or 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.

If no response is seen within the first 12–24 hours of treatment, the medication should be discontinued.

Elderly

Not applicable.

Paediatric population

Not applicable.

Method of administration

For intravenous administration only.

Contraindications

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

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

Prostin E2 Sterile Solution 1 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 cephalopelvic disproportion.

• – Cases in which foetal malpresentation is present.

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.
• if you are having more than one baby
• if your water has broken

Your doctor or midwife 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 midwife 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

• – Cases where there is clinical suspicion or definite evidence of pre-existing foetal distress.

• – Cases in which there is a history of difficult labour and/or traumatic delivery.

• In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
• In patients where there is clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during this pregnancy.
• 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.

As with any oxytocic agent, the risk of uterine rupture should be considered. Concomitant medication, maternal and foetal status should be taken into consideration in order to minimise the risk of uterine hyperstimulation, uterine rupture, uterine haemorrhage, foetal and neonatal death. Continuous electronic monitoring of uterine activity and foetal heart rate should be conducted during use of dinoprostone. midwife 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.

Although prostaglandins are present in breast-milk they will not harm your baby and you may breast-feed as normal after delivery.

Prostin E2 Sterile Solution contains alcohol (ethanol)

Prostin E2 Sterile Solution contains 600 mg alcohol (ethanol) in each 0.75 ml ampoule which is equivalent to 800 mg/ml (80 % w/v). The amount of alcohol in 0.75 ml ampoule is equivalent to less than 15 ml beer or 6 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

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

Driving and Using Machinery

In view of the indication for Prostin E2 Sterile Solution, this section is not applicable.

• 3. How Prostin E2 Sterile Solution is given to you

Prostin E2 Sterile Solution will be given to you by a trained professional in a hospital or clinic where facilities for monitoring you and your baby are available. 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.

continues overleaf…

Patients who develop uterine hypertonus or hypercontractility, or in whom unusual foetal heart rate patterns develop, should be managed in a manner that addresses the welfare of the foetus and mother.

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 1 mg/ml for the induction of labour in 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.
• ruptured chorioamniotic membranes. Dinoprostone should be used with caution in patients with multiple pregnancy. In labour induction, cephalopelvic relationships should be carefully evaluated before use of Prostin E2 Sterile Solution. During use, uterine activity, foetal status and the progression of cervical dilation should be carefully monitored to detect possible evidence of undesired responses, e.g. hypertonus, sustained uterine contractions, or foetal distress.

In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state of the

PAA177955

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 1 mg of dinoprostone.

The other ingredient is ethanol

What Prostin E2 Sterile Solution looks like and contents of the pack

Each pack contains:

• one small, closed glass container (ampoule) containing 0.75 ml of a colourless, sterile solution
• one infusion bag label.