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PROSTIN E2 STERILE SOLUTION 10MG/ML

Active substance(s): DINOPROSTONE

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date:16-OCT-14 15:17:57

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

RECTO

8R3756
85

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

eerste vol vc blokje: 32.0mm

For intravenous use only.

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.

Presentation
This pack contains one ampoule containing
Children and elderly patients: Not applicable
0.5 ml of a colourless, sterile concentrate for
solution for infusion of 10 mg/ml dinoprostone Contra-indications, warnings etc.
Contra-indications: Prostin E2 Sterile Solution
(prostaglandin E2) in ethanol.
10 mg/ml should not be used where the patient
Uses
is sensitive to prostaglandins.
Oxytocic agent. Prostin E2 Sterile Solution
Prostin E2 Sterile Solution 10 mg/ml is not
10 mg/ml is indicated for therapeutic
recommended in the following circumstances:
termination of pregnancy, missed abortion and
1. For patients in whom oxytocic drugs are
hydatidiform mole, by the intravenous route.
generally contra-indicated or where
Dosage and administration
prolonged contractions of the uterus are
Directions for the Preparation of a Dilute
considered inappropriate such as:
Solution: For use by IV. drip (a drip set
Cases with a history of Caesarean section
delivering 60 drops per ml must be used) or
or major uterine surgery;
constant rate infusion pump. Withdraw 0.5 ml
Cases where there is evidence of a
from the ampoule using an aseptic technique
potential for obstructed labour.
and add to 1,000 ml of sterile normal saline or 2. In patients with a past history of, or existing,
5% dextrose. Shake to ensure uniformity.
pelvic inflammatory disease, unless
adequate prior treatment has been instituted.
After dilution, attach label provided. Use dilute
solution within 24 hours of preparation and
3. Patients with active cardiac, pulmonary,
store in a refrigerator at 2-8°C.
renal or hepatic disease.
The following is a guide to dosage:
Interactions with other medicaments and other
A solution of Prostin E2 in normal saline or 5% forms of interaction: Since it has been found
dextrose containing 5.0 micrograms per ml
that prostaglandins potentiate the effect of
oxytocin, it is not recommended that these
should be prepared in accordance with
drugs are used together. If used in sequence,
instructions given above. The initial rate of
infusion (pump, or IV. drip delivering 60 drops the patient’s uterine activity should be carefully
per ml) will be 2.5 micrograms per minute, and monitored.
this rate should be maintained for at least the
Effects on ability to drive and to use machines:
Not applicable.
first 30 minutes. If a satisfactory uterine
contractility response is produced, this rate
Other undesirable effects:
should be maintained; if not, the rate should be
Cardiac disorders: Cardiac arrest
increased to 5 micrograms per minute. If
Vascular disorders: Hypertension
satisfactory uterine activity is not produced
Gastrointestinal disorders: Diarrhoea,
after at least 4 hours at this rate of infusion, the
nausea, vomiting
rate may be increased up to 10 micrograms per
General disorders and administration site
minute, side-effects permitting, and maintained
conditions: Fever, local tissue irritation /
until abortion occurs or the treatment is
erythema (injection site), temporary
considered a failure. If significant side-effects
pyrexia, local infections
occur, the rate of infusion should be decreased
Immune system disorders:
by 50% or discontinued.
Hypersensitivity reactions such as
anaphylactoid reactions and anaphylactic
If a constant rate infusion pump is used, a
reactions including anaphylactic shock.
different concentration of solution (e.g.
15 micrograms per ml) may be required,
Investigations: Elevated WBC
dependent on the type of pump, but the dose
Musculoskeletal and connective tissue
rates (micrograms per minute) should remain
disorders: Back pain
as above.
Nervous system disorders: Transient
vasovagal symptoms (flushing, shivering,
The appearance of uterine hypertonus requires
cessation of therapy until the state returns to
headache, dizziness)
continued overleaf

PATIENT INFORMATION LEAFLET

Prostin® E2 Sterile Solution 10mg/ml
dinoprostone

Read all of this leaflet carefully before • you have an infection of your womb, ovaries
or tubes (pelvic inflammatory disease)
you are given this medicine.
unless you are receiving treatment for these,
Keep this leaflet. You may need to read it again.
or if you have ever had such an infection in
If you have any further questions, ask your
the past
doctor or nurse.
If any of the side effects gets serious, or if you • you have been told that you will have an
obstructed labour
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
Take special care with Prostin E2
Sterile Solution:
In this leaflet:
1. What Prostin E2 Sterile Solution is and what Tell your doctor or nurse if you have or have
had in the past any of the following conditions
it is used for
2. Before you are given Prostin E2 Sterile Solution as they may want to monitor you more closely.
3. How Prostin E2 Sterile Solution is given to you • heart, lung, kidney or liver disease
• glaucoma (raised pressure in the eye)
4. Possible side effects
• epilepsy
5. How to store Prostin E2 Sterile Solution
• suffered from asthma
6. Further information
• hypertension (high blood pressure) at any
1. What Prostin E2 Sterile Solution is
time, including during this or any previous
and what it is used for
pregnancy
Prostin E2 Sterile Solution contains the
• been told you had abnormally strong
prostaglandin dinoprostone and is used to
contractions of your womb during a previous
“induce” labour. This means that the medicine
labour
will help your uterus (womb) to start
• scarring of your womb from a previous
contracting and you will go into labour.
operation
Dinoprostone is similar to the natural ‘E2’, type
of prostaglandins which are made in your body • Are you 35 years or older?
when labour starts. It will only be given to you • Is your pregnancy over 40 weeks?
• Do you have any complications related to
in a hospital or clinic.
this pregnancy?
You could need this treatment for different
Your doctor or nurse will ask you questions
reasons:
before giving you Prostin E2 to make sure it is
• if your baby has died in your womb;
safe for you.
• if it is required to end your pregnancy for
If you do not understand any of the questions,
ask your doctor or nurse to explain.

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.

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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 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

code

8R3756

guidelines

TSE-I001F

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.

dimensions

105x520/20.5

date

13-MAR-14 CDH

country

ENGLAND

VERSO

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.

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
Use caution in handling this product to prevent The product is manufactured by Pfizer
contact with skin. Wash hands thoroughly with Manufacturing Belgium NV, Rijksweg 12,
soap and water after administration.
B-2870 Puurs, Belgium and distributed in the
It is advised that Prostin E2 Sterile Solution
United Kingdom by Pfizer Limited, Ramsgate
should not be administered by the
Road, Sandwich, Kent, CT13 9NJ, UK.
intramyometrial route, as there have been
Marketing Authorisation Holder
reports of a possible association between this
Pfizer Limited, Ramsgate Road, Sandwich,
route of administration and cardiac arrest in
CT13 9NJ, UK.
severely ill patients.
Precautions: Caution should be exercised in the Further information
administration of prostaglandins to patients with: Oral Prostin E2 Tablets, Prostin E2 Vaginal
Tablets and Prostin E2 Vaginal Gel are also
(i) asthma or a history of asthma;
available for the induction of labour.
(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.

Product authorisation number
PL 00057/1027

Date of preparation or last review
12/2014
® Prostin is a Registered Trademark
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
complications during pregnancy and those with
a gestational age over 40 weeks have been
shown to have an increased risk of post-partum
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, 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.

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.

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

5. How to store Prostin E2 Sterile
Solution

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.

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.

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
Medical staff will be keeping a very close eye
on you during your treatment. They should be • high blood pressure in the mother
able to act quickly if you have side-effects or if • very quick opening of the cervix
your womb reacts too strongly to the dose you • running a high temperature
are given. You might just need a lower dose, or • backache
you might need a Caesarean section or some • rash
other obstetric procedure.
• raised white blood cell count
You should not normally be given Prostin E2 In some women the number of white blood
Sterile Solution for more than two days at a
cells rises during treatment. This will not
time.
cause you any symptoms, but your doctor or
Tell your doctor or nurse if you think you have nurse may mention this if you have a blood
sample taken.
been given too much Prostin E2 Sterile
Solution. Symptoms of this would be
A higher risk of a generalised bleeding
excessive contractions of your womb (very
disorder following delivery (post-partum
strong, frequent and painful contractions) or
disseminated intravascular coagulation-DIC)
severe side-effects, such as feeling and being has been described in women who are aged
sick. If you have such symptoms, the rate at
35 and above, whose pregnancies are more
which Prostin E2 Sterile Solution is being
than 40 weeks and who have pregnancygiven should be reduced, or the treatment
related complications.
should be stopped. If you have a massive
You might have reddening and irritation in the
overdose, so that the muscles of your womb
become very tense and over-active or ruptures, area around the needle for two to five hours
after the needle has been removed.
you might need another obstetric procedure.
Your doctor or nurse will do internal checks to If you think you may be having any of the
make sure that your cervix is opening enough. above side effects, or you are worried about
They will also check your contractions to make anything unusual happening during your
labour, please tell your doctor or nurse.
sure that they are not too strong.

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 ).

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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

The medicine will be kept out of the reach and
sight of children.

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

8R3756

code

8R3756

guidelines

TSE-I001F

dimensions

105x520/20.5

date

13-MAR-14 CDH

country

ENGLAND

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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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