PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
HEMABATE STERILE SOLUTION FOR INJECTION
Carboprost tromethamine 250mcg/ml
In this leaflet:
- 1. What Hemabate Sterile Solution is and what it is used for
- 2. Before you are given Hemabate Sterile Solution
- 3. How you are given Hemabate Sterile Solution
- 4. Possible side effects
- 5. Storing Hemabate Sterile Solution
- 6. Further information
What Hemabate Sterile Solution is and what it is used for
- Hemabate is a sterile solution for injection. It is available in ampoules and contains 250mcg 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.
- 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 bleeding from the womb. Hemabate given after childbirth increases the contraction of your womb which helps to control bleeding after delivery.
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:
- have ever had an allergic reaction to Hemabate 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).
Take special care with Hemabate:
Tell your doctor if you currently have, or have had in the past any of the following, as Hemabate will have to be used more carefully;
- glaucoma (raised pressure in your eyes)
- high or low blood pressure (including high blood pressure in pregnancy)
- heart disease or anaemia (low blood count)
- lung disease, including asthma
- kidney or liver disease (including jaundice)
- diabetes or epilepsy
- a caesarean section or any other operation on your womb
Taking 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.
Tell your midwife or doctor if you are taking any other medicines.
Pregnancy and Breastfeeding:
Hemabate will only be given shortly after you have delivered your baby and not while you are still pregnant.
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.
Driving and using machinery:
It is unlikely that you will be well enough to drive or operate machinery soon after receiving Hemabate. Make sure you are fully recovered before driving or doing any activity where you need to concentrate.
Important information about some of the ingredients of Hemabate
Hemabate contains less than 1 mmol sodium (23mg) per dose and is essentially ‘sodium free.’
Hemabate also contains benzyl alcohol which may cause allergic reactions.
How you are given Hemabate Sterile Solution
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 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
What if I am given too much Hemabate?
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
What if I 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.
Possible Side Effects
All medicines can cause side effects.
The following side effects occur occasionally after Hemabate treatment and can be serious, so it is important to bring these to the attention of medical staff straight away:
- 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 wheezing together with any itching or swelling of the face or tongue tell your doctor or midwife immediately.
Other side effects seen with Hemabate include:
- Effects on your heart and circulation: Hemabate may temporarily raise blood pressure and sometimes this can be dangerous if it gets very high. It can also suddenly lower blood pressure making you faint. Your doctor or midwife will be monitoring your blood pressure closely to look for signs of this. Some people treated with carboprost may develop low oxygen levels in their blood. It is still unclear whether this is caused by treatment with carboprost. If you develop low oxygen levels, it might make you feel dizzy. Your doctor can give you extra oxygen if this happens to you.
- Effects on your stomach and intestines: The most common side effects with Hemabate are nausea (feeling sick), vomiting and diarrhoea. If these side effects are very bad, your doctor may give you other medicines to stop you being sick and to reduce the diarrhoea. They may also reduce or delay the next dose (also see ‘How you are given Hemabate’, above).
- Effects on your metabolism Hemabate can cause you to experience changes in body temperature. You may feel hot, flushed and sweaty, or chilled and shivery. These effects usually wear off quickly after treatment.
- Effects on skin: Hemabate can sometimes cause pain and redness around where you had your injection.
Most effects are mild and short-lived and will wear off quickly after treatment. If you feel very unwell or have any other unusual effects not listed above, tell your doctor at once.
Storing Hemabate Sterile Solution
Hemabate should not be used after the expiry date printed on the box and on the ampoule. Your pharmacist will check this before the injection is given.
Ampoules should be stored in a refrigerator between 2 – 8 °C. Your pharmacist will check the ampoules are still clear and colourless before use. As with all medicines they will be kept out of the sight and reach of children. .
Further Information
What Hemabate contains
The active substance in each ampoule is 250mcg of carboprost..
The other ingredients are sodium chloride (sodium content approximately 4.0mg/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 present.
What Hemabate looks like and contents of the pack
Hemabate is a colourless solution available in glass ampoules containing 1ml of solution. Hemabate comes in packs of two or ten ampoules.
Marketing Authorisation Holder:
Manufacturer:
Hemabate is made by
Company contact address:
For further information on your medicine contact Medical Information at the following address:
Leaflet last updated: June 2008
Ref: HM_003
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