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PROSTIN E2 STERILE SOLUTION 10MG/ML

Active substance(s): DINOPROSTONE

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date:25-Nov-15 13:37:51

Do not use this insertformat for Trobicin

Prostin® E2 Sterile Solution 10mg/ml

Text Free area

RECTO

(dinoprostone)

After dilution, attach label provided. Use dilute solution
within 24 hours of preparation and store in a refrigerator at
2-8°C.
PAA068837
585

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.

PHYSICIAN LEAFLET
Prostin® E2
Sterile Solution 10 mg/ml
(dinoprostone)

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.

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.

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.

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.

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.

PATIENT INFORMATION LEAFLET

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

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.

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

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’.
Process Black

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.

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.

code

PAA068837

guidelines

TSE-I134A

dimensions

196x297/37

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?

date

25-nov-15 EA

country

ENGLAND

inks on file

Process structure
Black

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 overleaf
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,

VERSO

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.

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.

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

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.

Process Black

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

code

PAA068837

guidelines

TSE-I134A

dimensions

196x297/37

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.

date

25-nov-15 EA

country

ENGLAND

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.

Text Free area

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).

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

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

PAA068837

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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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