Skip to Content



PDF options:  View Fullscreen   Download PDF

PDF Transcript




Sterile Solution

(Carboprost tromethamine)

Colourless, sterile, aqueous solution containing
carboprost tromethamine equivalent to carboprost
250 micrograms/ml.
The product also contains sodium chloride, benzyl
alcohol, tromethamine and water for injections.


Sterile Solution


FPO 128 10 MIL

Treatment of post-partum haemorrhage due to uterine
atony and refractory to conventional methods of treatment
with oxytocic agents and ergometrine used either alone or
in combination.
Conventional therapy should usually consist of 0.5 - 1 mg
ergometrine with up to 50 units of oxytocin infused
intravenously over periods of time from 20 minutes to
12 hours. The dosage and duration of administration
should reflect the seriousness of the clinical situation.


Sterile Solution

Dosage and administration
FPO 128 10 MIL




Sterile Solution for Injection

Carboprost tromethamine 250 mcg/ml
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 or nurse.
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Hemabate Sterile Solution is and what it is used for
2. What you need to know before you are given Hemabate
Sterile Solution
3. How you are given Hemabate Sterile Solution
4. Possible side effects
5. How to store Hemabate Sterile Solution
6. Contents of the pack and other information

1. What Hemabate Sterile Solution is
and what it is used for

Therapeutic group*
• Hemabate belongs to a group of medicines called
prostaglandins. Prostaglandins are produced naturally in
your body and are very important for a variety of activities,
including childbirth. After childbirth they make the womb
contract and to help it stay contracted, which stops heavy

Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration
whenever solution and container permit.
An initial dose of 250 micrograms (1.0 ml) of Hemabate
should be administered as a deep intramuscular injection.
If necessary, further doses of 250 micrograms may be
administered at intervals of approximately 1.5 hours. In
bleeding from the womb. Hemabate given after childbirth
increases the contraction of your womb which helps to
control bleeding after delivery.
Therapeutic indications
• Hemabate is a sterile solution for injection. It is available
in ampoules and contains 250 mcg of the active
ingredient, carboprost, per ml of solution.
• Hemabate is used to stop excessive bleeding in women
who have just given birth, when bleeding is due to the
womb failing to return to its normal size.
* A therapeutic group is one in which a drug is classified
depending on its actions and the part(s) of the body it affects.

2. What you need to know before you
are given Hemabate Sterile Solution
❖ Do not take Hemabate:

Hemabate is not suitable for all women. Your doctor
may decide to give you a different medicine if any of
these apply to you.

You should not be given Hemabate:

• if you are allergic to it or to any of the other ingredients of
the medicine, in particular benzyl alcohol which can cause
problems in some people – see Sections 4 and 6 of this
leaflet for more details.
• currently have an infection of your womb, ovaries or
fallopian tubes (this may be causing pain in your pelvis or
vaginal discharge).
• if you have any problems with your heart, lung, kidney
or liver.
• if you are pregnant.

❖ Warnings and precautions:

Talk to your doctor or nurse before you are given Hemabate

severe cases the interval between doses may be reduced
at the discretion of the attending physician, but it should
not be less than 15 minutes. The total dose of Hemabate
should not exceed 2 mg (8 doses).
Not applicable
Not applicable


1. Hemabate should not be used where the patient is
sensitive to carboprost tromethamine or any of the
2. Acute pelvic inflammatory disease.
3. Patients with known active cardiac, pulmonary, renal,
or hepatic disease.
4. Hemabate is contra-indicated in pregnancy.

Special warnings and precautions for use
Hemabate should be used by medically trained
personnel and is available only to hospitals and clinics
with specialised obstetric units where 24 hour resident
medical cover is provided. Hemabate, as with other
potent oxytocic agents, should be used only with strict
adherence to recommended dosages.
This preparation should not be used for induction of
Hemabate must not be given intravenously.
Special caution is necessary in patients with history of
asthma, hypo- or hypertension, cardiovascular, renal,
or hepatic disease, glaucoma or raised intra-ocular
pressure, anaemia, jaundice, diabetes, or epilepsy.
Benefit/risk ratio should be assessed in patients
with cardiovascular disease (risk of decreased blood
pressure up to cardiovascular collapse, bradycardia),

and in patients with a history of asthma (risk of
bronchoconstriction) and pulmonary disease (possibility
of decreased pulmonary blood flow and increased arterial
pulmonary pressure).
Very rare cases of cardiovascular collapse have been
reported following the use of prostaglandins. This should
always be considered when using Hemabate.
Decreases in maternal arterial oxygen content have
been observed in patients treated with carboprost
tromethamine. A causal relationship to carboprost
tromethamine has not been established, however,
it is recommended that patients with pre‑existing
cardio‑pulmonary problems receiving Hemabate are
monitored during treatment and given additional oxygen
if necessary.
As with any oxytocic agent, Hemabate should be used
with caution in patients with previously compromised
(scarred) uteri.
Prior treatment with, or concomitant administration
of anti-emetics and antidiarrhoeal drugs significantly
reduces the very high incidence of the gastrointestinal
side effects common to all prostaglandins. Their use
should be considered an integral part of the management
of patients.
Transient pyrexia that may be due to hypothalamic
thermoregulation has been observed after intramuscular
Hemabate. Temperature elevations exceeding 1.1 °C were
observed in approximately one-eighth of patients who
received the recommended dosage regimen but if not
complicated by endometritis, the temperature elevation
Continued overleaf...

if you currently have, or have had in the past any of the
following, as Hemabate will have to be used more carefully;
• lung disease, including asthma
• high or low blood pressure (including high blood pressure
in pregnancy)
• heart disease or anaemia (low blood count)
• kidney or liver disease (including jaundice)
• glaucoma (raised pressure in your eyes)
• diabetes or epilepsy
• a caesarean section or any other operation on your womb
In very rare cases heart and circulation failure have been
reported following the use of prostaglandins (the active
ingredient of this medicine).
It is possible that this medicine may lower the oxygen levels
in your blood. If you have previously suffered from conditions
affecting your heart and lungs your doctor will monitor you and
may give you additional oxygen as necessary.
Your doctor may give you other medicines to reduce the
side effects of being sick or having diarrhoea as these are
the common side effects of all prostaglandins (the active
ingredient of this medicine).
Raised temperature has been observed with treatment from
Hemabate. This will usually return to normal several hours
after the last injection.

❖ Pregnancy, breast-feeding and fertility:

Tell your doctor or nurse if you are taking, have recently taken
or might take any other medicines.
Treatments that strengthen contraction of the womb, including
oxytocin and ergometrine, can be affected by Hemabate.
Medical staff will watch over you very carefully if you have had
these treatments as well as Hemabate.

This product should be used only in hospitals and clinics with
specialised units for pregnancy and childbirth. Medical staff
should be available in the hospital at all times. Hemabate may
be given by a doctor or a midwife.
The staff will make sure that this medicine is used in the
right way and at the right time. You should never be given

❖ Other medicines and Hemabate:

Hemabate will only be given shortly after you have delivered
your baby and not while you are still pregnant as it could put
the embryo or foetus at risk.
It is not known if carboprost is excreted in human breast milk.
As your own body produces prostaglandins during childbirth,
Hemabate is not expected to cause any harm to your baby.
It is not known what effects Hemabate has on your fertility.
Ask your doctor or pharmacist for advice before taking any

❖ Driving and using machines:

Do not drive, use any tools or operate machinery soon after
receiving Hemabate as it may affect your ability to do so
safely. Hemabate may make you lose consciousness, feel
dizzy or drowsy.

Important information about some of the
ingredients of Hemabate

Hemabate contains less than 1 mmol sodium (23 mg) per
dose and is essentially ‘sodium free.’
Hemabate also contains benzyl alcohol which may cause
allergic reactions.

3. How you are given Hemabate Sterile

Continued overleaf..

will usually return to normal within several hours of the
last injection.
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 have received prostaglandin
E1 during prolonged treatment. There is no evidence that
short‑term administration of Hemabate can cause similar
bone effects.

Undesirable effects
Hemabate can cause serious breathing difficulties as well
as asthma and wheezing.
Less frequent, but potentially more serious, adverse
effects are elevated blood pressure, dyspnoea and
pulmonary oedema. Other less serious adverse effects
noted include chills, headache, diaphoresis, dizziness and
injection site erythmea and pain.
Adverse drug reactions reported during clinical trials and
post marketing experience are presented below.
Very common conditions may affect more than 1 in
10 patients.
These include:
Diarrhoea*, nausea*, vomiting*, body temperature
Common conditions may affect up to 1 in 10 patients.
These include:
Headache*, flushing, hot flush, chills, cough, uterine
haemorrhage, retained placenta or membranes,
Uncommon conditions may affect up to 1 in
100 patients.
Hemabate while you are pregnant, only after the birth. It must
never be given by injection into a vein.
• Hemabate is given by injection deep into a muscle.
• The first dose is usually 1 ml of solution (250 micro­grams
of carboprost). Your doctor may give you more doses of
1 ml if you need them. You should not have doses more
often than once every 15 minutes. Usually you would have
them less often, about once in one-and-a-half hours.
• You should not be given more than 8 doses (2 mg of
carboprost) altogether.
Hemabate is not indicated for use in children.

If you are given more Hemabate than you should be
If you get very bad sickness and diarrhoea, your doctor may
delay the next injection of Hemabate, or may not give you
any more doses. Your doctor will treat the symptoms that the
Hemabate has caused.

If you continue to bleed

If you continue to bleed heavily after being given Hemabate
you may be given other medicines to help control the bleeding.
Your doctor or midwife will be watching you closely to help
them decide whether Hemabate is working for you.

4. Possible Side Effects

Like all medicines, Hemabate can cause side effects although
not everybody gets them.
• Effects on your respiratory system and immune
system: Hemabate can very occasionally cause serious
breathing difficulties as well as asthma and wheezing. If
you have any difficulty breathing after receiving Hemabate
tell your doctor or midwife immediately.
• The benzyl alcohol in Hemabate solution can cause
an allergic reaction in some people. If you suffer from

11608103.indd 2

9/13/13 3:04 PM

These include:
Septic shock, urinary tract infection, sleep disorder,
syncope vasovagal, dizziness*, dystonia, paraesthesia,
somnolence, dysgeusia, vision blurred, eye pain, vertigo,
tinnitus, tachycardia, hypertension, asthma, respiratory
distress, dyspnoea, hyperventilation*, wheezing, hiccups,
haematemesis, upper abdominal pain, dry mouth,
hyperhidrosis, torticollis, back pain, myalgia, uterine
rupture, uterine cervical laceration, pelvic pain*, breast
tenderness, lethargy, chest discomfort, injection site pain.
Not known. This means that there is not enough or no
data to determine the frequency of the condition:
Thyrotoxic crisis†, anxiety †, nervousness, syncope†,
palpitations, bronchospasm, pharyngeal oedema†,
choking sensation†, epistaxis†, dry throat, upper
respiratory tract infection†, retching, rash†, muscle
spasms, blepharospasm, uterine disorder, chest pain†,
asthenia†, excessive thirst †, hypersensitivity reactions†
(e.g. anaphylactic reaction, anaphylactic shock,
anaphylactoid reaction, angioedema).
* Events reported for both intramuscular and
intra‑amniotic routes of administration are marked with
an asterisk. All other events were reported only for the
intramuscular route.
† Identified from post-marketing experience.

Treatment of overdosage must be symptomatic at this
time, as clinical studies with prostaglandin antagonists
have not progressed to the point where recommendations
may be made.
If evidence of excessive side‑effects appears, the
wheezing together with any itching or swelling of the face
or tongue tell your doctor or midwife immediately.
The following side effects are listed by frequency.
Very common conditions may affect more than 1 in
10 patients.
These include: diarrhoea, nausea, vomiting, increased body
Common conditions may affect up to 1 in 10 patients.
These include: headache, flushing, hot flush, chills, coughing,
bleeding from the uterus, retained placenta or membranes,
and inflammation of the uterus.
Uncommon conditions may affect up to 1 in 100 patients.
These include: septic shock, urinary tract infection, irregular
sleep patterns or general feeling of drowsiness, dizziness,
muscle contractions affecting your posture and positioning of
the head, general muscle pain, pins and needles, abnormal
taste, increased levels of sweating, chest discomfort, severe
shortness of breath, asthma and general breathing difficulties
such as rapid breathing or wheezing, general pain especially
in regions such as the upper abdomen, back and pelvis,
tenderness of the breasts, blurred vision, eye pain, dry mouth,
hiccups, vertigo, ringing in the ears, increased heart rate,
high blood pressure, vomiting blood, uterine rupture, uterine
cervical laceration, fluid retention, general feeling of being
unwell and injection site pain.

Side effects with unknown frequency

These include: a rare but severe form of hyperthyroidism,
anxiety, nervousness, fainting, temporary loss of
consciousness caused by a fall in blood pressure, palpitations,
muscle spasm in the walls of the bronchioles, swelling of
the throat, choking sensation, nose bleeds, dry throat,
infection affecting the nose sinuses and throat, retching,

frequency of administration should be decreased or
administration discontinued.

How to store Hemabate
The ampoules must be stored in a refrigerator at 2 – 8°C.
The vial must be stored in a refrigerator at 0 – 6°C.

Legal category

Manufacturer’s name and address
Pfizer Service Company BVBA, 10 Hoge Wei,
1930 Zaventem, Belgium.

Date of Revision of the text
Ref: HM 7_5

Package quantities
Pack containing 10 x 1 ml ampoules of Hemabate Sterile
Solution 250 micrograms/ml.

Further information
Carboprost tromethamine stimulates the myometrium
of the gravid uterus to contract in a manner that is
similar to that observed in the term uterus during labour.
Whether or not this action results from a direct effect of
carboprost tromethamine on the myometrium has not
been determined with certainty at this time.
When Hemabate is given post‑partum, the resulting
myometrial contractions provide haemostasis at the site
of placentation and hence prevent further blood loss.

Product licence number
PL 00057/1000

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

rash, muscle spasms, uncontrolled abnormal contraction or
twitch of the eyelid, uterine disorder, chest pain, abnormal
physical weakness or lack of energy, excessive thirst and
hypersensitivity reactions (e.g. anaphylactic reaction,
anaphylactic shock, anaphylactoid reaction, angioedema).
Most effects are mild and short-lived and will wear off
quickly after treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Hemabate Sterile

Keep this medicine out of the sight and reach of children.
Do not use Hemabate after the expiry date which is stated on
the carton and on the ampoule after EXP. Your pharmacist will
check this before the injection is given. The expiry date refers
to the last day of the month.
The vial must be stored in a refrigerator at 0 – 6°C.
Ampoules must be stored in a refrigerator between 2 – 8°C.
Your pharmacist will check the ampoules are still clear and
colourless before use.
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

6. Contents of the pack and other
What Hemabate contains

The active substance in each ampoule is 250 mcg of
The other ingredients are sodium chloride (sodium content
approximately 4.0 mg/ml), water for injections, tromethamine
and a preservative, benzyl alcohol (8.1 – 10.4 mg/ml). Small
amounts of hydrochloric acid and sodium hydroxide, (used to
regulate the acidity or alkalinity of the solution) may also be

What Hemabate looks like and contents of the pack
Hemabate is a colourless solution available in glass ampoules
containing 1 ml of solution. Hemabate comes in packs of two
or ten ampoules.

Marketing Authorisation Holder and Manufacturer:

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ
Pfizer Service Company BVBA, 10 Hoge Wei, 1930 Zaventem,
For more information about this medicine, please contact
the local representative of the local Marketing Authorisation
Medical Information, Pfizer Limited, Walton Oaks,
Dorking Road, Tadworth, Surrey, KT20 7NS, UK
Telephone 01304 616161
This leaflet was last revised in 09/2013
Ref: HM 7_5

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.