Prostin E2 Sterile Solution 10mg/Ml
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date:25-Nov-15 13:37:51
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Prostin® E2 Sterile Solution 10mg/ml (dinoProstone) | |
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PHYSICIAN LEAFLET Prostin® E2
Sterile Solution 10 mg/ml
(dinoprostone)
For intravenous use only.
Presentation
This pack contains one ampoule containing 0.5 ml of a colourless, sterile concentrate for solution for infusion of 10 mg/ml dinoprostone (prostaglandin E2) in ethanol. Uses
Oxytocic agent. Prostin E2 Sterile Solution 10 mg/ml is indicated for therapeutic termination of pregnancy, missed abortion and hydatidiform mole, by the intravenous route.
Dosage and administration
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 0.5 ml from the ampoule using an aseptic technique and add to 1,000 ml of 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 following is a guide to dosage:
A solution of Prostin E2 in normal saline or 5% dextrose containing 5.0 micrograms per ml should be prepared in accordance with instructions given above. The initial rate of infusion (pump, or IV. drip delivering 60 drops per ml) will be 2.5 micrograms per minute, and this rate should be maintained for at least the first 30 minutes. If a satisfactory uterine contractility response is produced, this rate should be maintained; if not, the rate should be increased to 5 micrograms per minute. If satisfactory uterine activity is not produced after at least 4 hours at this rate of infusion, the rate may be increased up to 10 micrograms per minute, side-effects permitting, and maintained until abortion occurs or the treatment is considered a failure. If significant side-effects occur, the rate of infusion should be decreased by 50% or discontinued.
If a constant rate infusion pump is used, a different concentration of solution (e.g. 15 micrograms per ml) may be required, dependent on the type of pump, but the dose rates (micrograms per minute) should remain as above.
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.
Children and elderly patients: Not applicable Contra-indications, warnings etc.
Contra-indications: Prostin E2 Sterile Solution 10 mg/ml 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:
1. 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.
2. In patients with a past history of, or existing, pelvic inflammatory disease, unless adequate prior treatment has been instituted.
3. Patients with active cardiac, pulmonary, renal or hepatic disease.
Interactions with other medicaments and other forms of interaction: Since it has been found that prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patient's uterine activity should be carefully monitored.
Effects on ability to drive and to use machines: Not applicable.
Other undesirable effects:
Cardiac disorders: Cardiac arrest Vascular disorders: Hypertension Gastrointestinal disorders: Diarrhoea, nausea, vomiting
General disorders and administration site conditions:
Fever, local tissue irritation / erythema (injection site), temporary pyrexia, local infections Immune system disorders:
Hypersensitivity reactions such as anaphylactoid reactions and anaphylactic reactions including anaphylactic shock. continued over-leaf
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PATIENT INFORMATION LEAFLET
Prostin® E2 Sterile Solution 10mg/ml
dinoprostone
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
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 will only be given to you in a hospital or clinic.
You could need this treatment for different reasons:
• if your baby has died in your womb;
• if it is required to end your pregnancy for health reasons;
• if you have an abnormal growth of the placenta called a ‘hydatidiform mole’.
2. 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
• 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 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
• Are you 35 years or older?
• Is your pregnancy over 40 weeks?
• Do you have any complications related to this pregnancy?
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.
Prostin E2 Sterile Solution is only used during pregnancy for therapeutic termination of pregnancy, missed abortion and hydatidiform mole.
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.
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 a salt (saline) or sugar (dextrose) solution and given by an intravenous drip.
Medical staff will adjust the dose to suit you. It depends on why you need the treatment and how you react to it. The mixture is made up to contain 5 micrograms /ml of Prostin E2 Sterile Solution and the drip is set to deliver 2.5 micrograms per minute. This is given for 30 minutes,
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PAA068837 |
TSE-I134A |
196x297/37 |
25-nov-15 EA |
ENGLAND |
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Investigations: Elevated WBC Musculoskeletal and connective tissue disorders: Back pain
Nervous system disorders: Transient vasovagal symptoms (flushing, shivering, headache, dizziness) Pregnancy and puerperium conditions Maternal-related conditions: uterine hypertonus, uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm
Blood and lymphatic system disorders: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labour was induced by pharmacological means, either with dinoprostone or oxytocin. The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labours).
Post-marketing surveillance:
Use in pregnancy and lactation: Prostin E2 Sterile Solution 10 mg/ml is only used during pregnancy for therapeutic termination of pregnancy. There has been some evidence in animals of a low order of teratogenic activity, therefore, if abortion does not occur or is suspected to be incomplete as a result of prostaglandin therapy, (as in spontaneous abortion, where the process is sometimes incomplete), the appropriate treatment for complete evacuation of the pregnant uterus should be instituted in all instances.
Prostaglandins are excreted in breast milk. This is not expected to be a hazard given the circumstances in which the product is used.
Other special warnings and precautions:
Warnings: This product is available only 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, as there have been reports of a possible association between this route of administration and cardiac arrest in severely ill patients.
Precautions: Caution should be exercised in the administration of prostaglandins to patients with:
(i) asthma or a history of asthma;
(ii) epilepsy or a history of epilepsy;
(iii) glaucoma or raised intra-ocular pressure;
(iv) compromised cardiovascular, hepatic, or renal function;
(v) hypertension.
As with any oxytocic agent, prostaglandins 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 Undesirable Effects). 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.
Overdosage (symptoms, emergency procedures, antidotes): Overdosage may be expressed by uterine hypercontractility and uterine hypertonus. During use, uterine activity and the progression of cervical dilation should be carefully
monitored to detect possible evidence of undesired responses, e.g. hypertonus or sustained uterine contractions. Because of the transient nature of PGE2-induced myometrial hyperstimulation, non-specific, conservative management should be used (rate of infusion should be decreased or discontinued, maternal position change and administration of oxygen). If conservative management is not effective, a tocolytic agent may be used in appropriate patients as a treatment of hyperstimulation following administration of PGE2 or appropriate measures should be considered.
Incompatibilities: None known.
Pharmaceutical precautions
Prostin E2 Sterile Solution 10 mg/ml has a shelf-life of 24 months when stored under refrigeration at 4°C.
It should be diluted before use only with the diluents stated. Diluted solutions should be used within 24 hours and stored in a refrigerator at 2-8°C. Manufacturer
The product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium and distributed in the United Kingdom by Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK. Marketing Authorisation Holder Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK. Further information
Oral Prostin E2 Tablets, Prostin E2 Vaginal Tablets and Prostin E2 Vaginal Gel are also available for the induction of labour.
Product authorisation number
PL 00057/1027
Date of preparation or last review
12/2014
® Prostin is a Registered Trademark PR4_0
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after which the dose is either kept the same or increased to 5 micrograms per minute, depending on how you respond. It could then be increased again after a further four hours if necessary. The doctor or nurse will want to give you enough Prostin E2 to keep you in labour, but they 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 a Caesarean section or some other obstetric procedure.
You should not normally be given Prostin E2 Sterile Solution for more than two days at a time.
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 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 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 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 / 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 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:
• 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
• raised white blood cell count
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.
A higher risk of a 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 and who have pregnancy- related complications.
You might have reddening and irritation in the area around the needle for two to five hours after the needle has been removed.
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.
5. 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.
6. 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 0.5 ml of Prostin E2 Sterile Solution. Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK Manufacturer:
Pfizer Manufacturing Belgium NV Rijksweg 12 B-2870 Puurs Belgium
For further information on this medicine, please contact Pfizer Medical Information on:
01304 616161.
This leaflet was last revised in 12/2014 PR4_0
JAA06883/
|
code |
guidelines |
dimensions |
date |
country |
1 | |
|
PAA068837 |
TSE-I134A |
196x297/37 |
25-nov-15 EA |
ENGLAND |