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PROSTIN E2 STERILE SOLUTION 1MG/ML

Active substance(s): DINOPROSTONE

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date:10-Dec-15 09:59:01

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

The following is a guide to dosage:

Prostin E2 Sterile Solution 1mg/ml

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.

Text Free area

RECTO

®

(dinoprostone)

PAA068840
583

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.

For intravenous use only.

Children and elderly patients: Not applicable.

Presentation
This pack contains one ampoule containing
0.75 ml of a colourless, sterile solution of 1 mg/ml
dinoprostone (prostaglandin E2) in ethanol.

Contra-indications, warnings etc.
Contra-indications: Prostin E2 Sterile Solution
1 mg/ml should not be used where the patient is
sensitive to prostaglandins.

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

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;

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.

to make sure it is safe for you. If you do not
understand any of the questions, ask your doctor or
midwife to explain.

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

Process Black

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

code

PAA068840

guidelines

TSE-I134B

inks on file

Do not use this insertformat for Trobicin

dimensions

330x297/37

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.

date

24-Nov-15 EA

country

ENGLAND

Process structure
Black

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)

• 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.

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

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 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

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.
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.

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).
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 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.
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.

VERSO

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.

Text Free area

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.

This leaflet was last revised in 03/2014
Registered Trademark: Prostin
PR4_0

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

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

Process Black

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
• 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).

Your hospital pharmacist will store this medicine in a
refrigerator at 4 °C before use.

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.

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.

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 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.

code

guidelines

TSE-I134B

dimensions

330x297/37

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

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.
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.

PAA068840

6. Further information
What Prostin E2 Sterile Solution contain:
The active substance is called dinoprostone. It also
contains ethanol (alcohol).

date

24-Nov-15 EA

country

ENGLAND

PAA068840

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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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