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PROSTIN E2 STERILE SOLUTION 10MG/ML

Active substance(s): DINOPROSTONE

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date:06-Jun-17 15:04:53

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Do not use this insertformat for Trobicin

Package leaflet: Information for
the patient

1. What Prostin E2 Sterile
Solution is and what it is used
for

Prostin® E2

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
which will end the pregnancy. This is also
called termination of pregnancy or an
abortion. 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.

Sterile Solution 10 mg/ml
dinoprostone

PAA076899
695

Read all of this leaflet carefully
before you are given this medicine
because it contains important
information for you.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor, nurse or pharmacist.
If you get any side effects, talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Prostin E2 Sterile Solution is and
what it is used for
2. What you need to know 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. Contents of the pack and other
information

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. 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 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

Process structure
Black

completely, you will need another treatment,
probably an operation.
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 nurse will not use Prostin E2
Sterile Soultion to start or strengthen your
labour in certain circumstances if:
• you have had a Caesarean section or any
major surgery to your womb in the past.
• you have been told that you will have an
obstructed 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 current heart, lung, kidney or
liver disease.
Warnings and precautions
Talk to your doctor or nurse before they use
this medicine 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?
• an increased risk of developing a
generalised bleeding disorder, a condition
known as post-partum disseminated
coagulation.
Your doctor or nurse 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 nurse 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 nurse
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. 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.
Prostin E2 Sterile Solution contains
ethanol (alcohol)

Depending on the daily dose given to you
this medicinal product will deliver different
amounts of ethanol.
Once diluted this medicinal product
contains the equivalent of 36 ml of a 3.5%
vol beer, 9 ml of a 14% vol wine in the
maximum daily dose. Harmful for those
suffering from alcoholism.
Driving and Using Machinery
The amount of alcohol in this medicinal
product may impair your ability to drive or
use machines.

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,
into a vein.
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/minute. This is given for
30 minutes, after which the dose is either
kept the same or increased to
5 micrograms/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 Sterile
Solution to keep you in labour, but they
will want to make sure that the
contractions do not become too strong.

continues overleaf...

CLINICAL PARTICULARS

The following information is intended
for healthcare professionals only:

Therapeutic indications
Oxytocic agent. Prostin E2 Sterile Solution
10 mg/ml is indicated for the therapeutic
termination of pregnancy, missed abortion and
hydatidiform mole by the intravenous route.

Prostin® E2

Sterile Solution 10 mg/ml
dinoprostone

NAME OF THE MEDICINAL
PRODUCT

Prostin E2 Sterile Solution 10 mg/ml.

QUALITATIVE AND
QUANTITATIVE COMPOSITION

Each ml contains 10 mg dinoprostone
(5 mg per ampoule).
Following dilution in accordance with
instructions, each ml of the resultant
solution for infusion contains 5 micrograms
dinoprostone.
Excipient(s) with known effect
Each 0.5 ml ampoule contains 332 mg
dehydrated alcohol (ethanol).
Process Black

PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile
concentrate).
The concentrate is a clear, colourless,
alcoholic solution free from particulate
matter, for intravenous administration after
appropriate dilution.

code

PAA076899

guidelines

TSE-I134B

dimensions

330x297/37

Posology and method of
administration
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 0.5 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.

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.

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

Elderly
Not applicable.

The following is a guide to dosage:
A solution of Prostin E2 Sterile Solution 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

Method of administration
For intravenous administration only.

date

27-Jun-16 NEMA

country

ENGLAND

Paediatric population
Not applicable.

Contraindications
Hypersensitivity to the active substance(s) or to
any of the excipients listed in section 6.1.
Prostin E2 Sterile Solution 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:
• 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.
• In patients with a past history of, or
existing, pelvic inflammatory disease,
unless adequate prior treatment has been
instituted.
• 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.
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 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.
As with any oxytocic agent, Prostin E2
Sterile Solution 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). Therefore,
in these women, use of dinoprostone should
be undertaken with caution. Measures

VERSO

You should not normally be given Prostin
E2 Sterile Solution for more than two days
at a time.
If you are given more Prostin E2
Sterile Solution than you should
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, this medicine 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).

should be applied to detect as soon as
possible an evolving fibrinolysis in the
immediate post-partum phase.

Process Black

Ethanol (alcohol)
Depending on the daily dose administered
this medicinal product will deliver varying
amounts of ethanol.
This product contains 84.16% v/v ethanol
(alcohol).
Once diluted with appropriate diluent this
medicinal product contains 0.04% v/v
ethanol (alcohol) i.e. up to 996 mg per
maximum daily dose (infusion rate of
10 microgram/min per 24 hrs), equivalent
to 36 ml of a 3.5% vol beer, 9 ml of a 14%
vol wine per maximum daily dose. Harmful
for those suffering from alcoholism. It
should also be taken into account when
considering using this medicine in children
and high-risk groups such as patients with
liver disease or epilepsy. The amount of
alcohol in this medicinal product may alter
the effects of other medicines.
Interaction with other medicinal
products 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.

code

PAA076899

guidelines

TSE-I134B

dimensions

330x297/37

You must tell your doctor or nurse if
you suffer from asthma or if you start
having difficulty in breathing.
Rare: may affect up to 1 in
1,000 people
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 nurse
straight away.
Common: may affect up to 1 in
10 people
• Vomiting (being sick)
• Nausea (feeling sick)
• Diarrhoea.
Not known: frequency cannot be
estimated from the available data
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 Sterile Solution. This
includes:
• 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

Fertility, pregnancy and lactation
Pregnancy
Prostin E2 Sterile Solution 10 mg/ml is only
used during pregnancy for therapeutic
termination of pregnancy, missed abortion
and hydatidiform mole. 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.
Breast-feeding
Prostaglandins are excreted in breast milk.
This is not expected to be a hazard given the
circumstances in which the product is used.
Effects on ability to drive and use
machines
The amount of ethanol (alcohol) in this
medicinal product may impair the patient’s
ability to drive or use machines.
Undesirable effects
Cardiac disorders: Cardiac arrest
Vascular disorders: Hypertension
Gastrointestinal disorders: Diarrhoea,
nausea, vomiting
General disorders and administration site
conditions: Fever, local tissue irritation /

date

27-Jun-16 NEMA

country

ENGLAND







High blood pressure in the mother
Very quick opening of the cervix
Running a high temperature
Backache
Rash.

Talk to your doctor or nurse about this if you
want to know more, as they will be able to
give you the information that you need.
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.
You might have reddening and irritation in
the area around the needle for two to five
hours after the needle has been removed.
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.
• who have pregnancy-related
complications.
Reporting of side effects

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.

For any information on this medicine,
please contact Pfizer Medical
Information on: 01304 616161.
This leaflet was last revised in
05/2017.
Ref: PR 5_2

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 10 mg of
dinoprostone.
The other ingredient is ethanol (alcohol) (see
section 2 Prostin E2 Sterile Solution
contains ethanol (alcohol)).

If you get any side effects, or you are
worried about anything unusual happening
during your labour, talk to your doctor, nurse
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

What Prostin E2 Sterile Solution looks
like and contents of the pack
Each pack contains:
• one small, closed glass container
(ampoule) containing 0.5 ml of a
colourless, sterile solution
• one infusion bag label.

erythema (injection site), temporary pyrexia,
local infections
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 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 (see section 4.4).
The frequency of this adverse event, however,
appears to be rare (<1 per 1,000 labours).

product. Healthcare professionals are asked
to report any suspected adverse reactions
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of
the benefit/risk balance of the medicinal

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium

Text Free area

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.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK

Overdose
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
prostaglandin E2 (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.

PHARMACEUTICAL PARTICULARS
List of excipients
Dehydrated alcohol (ethanol).
Incompatibilities
Not applicable.
Shelf life
2 years.

Special precautions for storage
Store in a refrigerator at 2-8°C.
Once diluted, the diluted solution should
be stored in a refrigerator at 2-8°C and
used within 24 hours.
Nature and contents of container
Ph. Eur. Type I glass ampoule, containing
0.5 ml sterile solution, packed in a carton.
Special precautions for disposal and
other handling
Use caution in handling this product to
prevent contact with skin. Wash hands
thoroughly with soap and water after
administration.
Any unused medicinal product or waste
material should be disposed of in
accordance with local requirements.

MARKETING AUTHORISATION
HOLDER

Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, UK

MARKETING AUTHORISATION
NUMBER(S)
PL 00057/1027

This leaflet was last revised in
05/2017.
Ref: PR 5_2
PAA076899

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