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PROSTIN E2 STERILE SOLUTION 1MG/ML

Active substance(s): DINOPROSTONE

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PHYSICIAN LEAFLET

Prostin® E2 Sterile Solution 1mg/ml
RECTO

(dinoprostone)

8R3833
200

For intravenous use only.
Presentation
This pack contains one ampoule containing 0.75 ml of
a colourless, sterile solution of 1 mg/ml dinoprostone
(prostaglandin E2) in ethanol.
Uses
Oxytocic agent. Prostin E2 Sterile Solution 1 mg/ml is
indicated for the induction of labour 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 0.75 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 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 as above 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 fetal 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.
The appearance of fetal 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.
Children and elderly patients: Not applicable.
Contra-indications, warnings etc.
Contra-indications: Prostin E2 Sterile Solution 1 mg/ml
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:
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 in which there is cephalopelvic disproportion;
Cases in which fetal malpresentation is present;
Cases in which there is clinical suspicion or definite
evidence of pre-existing fetal distress;
Cases in which there is a history of difficult labour
and/or traumatic delivery;
Grand multiparae with six or more previous term
pregnancies.
2. In patients with a past history of, or existing, pelvic
inflammatory disease, unless adequate prior
treatment has been instituted.
3. In patients where there is clinical suspicion or
definite evidence of placenta praevia or with
unexplained vaginal bleeding during this
pregnancy.
4. 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)
Immune system disorders: Hypersensitivity reactions
such as anaphylactoid reactions and anaphylactic
reactions including anaphylactic shock.
Investigations: Elevated WBC
Musculoskeletal and connective tissue disorders:
Back pain
Nervous system disorders: Transient vasovagal
symptoms (flushing, shivering, headache, dizziness)
Pregnancy, Puerperium and Perinatal conditions:
Maternal-related conditions: uterine hypertonus,
uterine rupture, abruptio placenta, pulmonary amniotic
fluid embolism, rapid cervical dilatation
Foetus-related conditions: uterine hypercontractility
with/without fetal bradycardia fetal distress/altered fetal
heart rate (FHR)

PATIENT INFORMATION LEAFLET

Prostin® E2 Sterile Solution 1mg/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
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
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. It is an
infusion 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.
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 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.

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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 six 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
• Are you 35 years or older?
• Is your pregnancy over 40 weeks?
• Do you have any complications related to this
pregnancy?
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.
3. 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

Neonatal conditions: neonatal distress, neonatal
death, stillbirths, low Apgar score

VERSO

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 1 mg/ml is only used during pregnancy, to
induce labour.
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.
In labour induction, cephalopelvic relationships should
be carefully evaluated before use of prostaglandins.
During use, uterine activity, fetal 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 fetal 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 fetus (where
applicable) should be continuously monitored
throughout labour. The possibility of uterine rupture
should be borne in mind where high-tone uterine
contractions are sustained.

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, fetal 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 fetal
distress. Because of the transient nature of
PGE2-induced myometrial hyperstimulation,
non-specific, conservative management was found to
be effective in the vast majority of cases: i.e. maternal
position change and administration of oxygen to the
mother. If conservative management is not effective,
ß-adrenergic drugs may be used as a treatment of
hyperstimulation following administration of PGE2 for
cervical ripening, in appropriate patients.
Incompatibilities: None known.
Pharmaceutical precautions
Prostin E2 Sterile Solution 1 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-2870Puurs, 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, Kent, CT13
9NJ, UK.
Product licence number
PL 00057/1028
Legal category
POM
Package quantities
Pack containing 1 x 0.75 ml ampoule of Prostin E2
Sterile Solution 1 mg/ml.
Further information
Oral Prostin E2 Tablets, Prostin E2 Vaginal Tablets and
Prostin E2 Vaginal Gel are also available for the
induction of labour.
This leaflet was last revised in 03/2014
Registered Trademark: Prostin
PR4_0

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

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).








very quick opening of the cervix
running a high temperature
backache
rash
raised white blood cell count
baby born with an Apgar score less 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).

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.
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.

4. Possible side effects
Like all medicines Prostin E2 Sterile Solution can
cause side effects, although not everybody gets them.

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 have asthma, Prostin E2 could cause you to
have an asthmatic attack by causing a narrowing of
your airways (bronchospasm). You must tell your
doctor or midwife if you suffer from asthma or if
you start having difficulty in breathing.

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.

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.

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.

Common side effects
• vomiting (being sick)
• nausea (feeling sick)
• diarrhoea
These have seldom been bad enough for the woman
to stop the treatment.

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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:
• vaso-vagal symptoms (flushing, shivering,
headache, dizziness, fainting)
• 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
• high blood pressure in the mother

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 0.75 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 03/2014
PR4_0

8R3833

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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