Gelofusine®

Succinylated gelatin solution 4% for intravenous infusion


Consumer Medicine Information

1. What is in this leaflet

This leaflet contains some common questions about Gelofusine.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risk of you taking this medicine against the benefits they expect it will have for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

2. What is Gelofusine used for

Gelofusine is a plasma volume substitute. This means, it replaces fluid lost from the circulation.

Gelofusine is used to replace blood and body fluid, which have been lost as a result of, for example, an operation, an accident or a burn. It can be used instead of, or as well as, a blood transfusion.

It may also be used for filling up the circulating blood volume during use of the heart-lung machine or artificial kidney.

3. Before you are given Gelofusine

When you must not be given Gelofusine

DO NOT USE GELOFUSINE:

  • if you are allergic (hypersensitive) to gelatin or any of the other ingredients of Gelofusine
  • if your circulating blood volume is too large
  • if you have excess fluid in your body
  • if you are at markedly increased risk of bleeding because your blood clotting is severely impaired.

TAKE SPECIAL CARE WITH GELOFUSINE

Please inform your doctor:

  • if you have problems with your heart or your kidneys because giving large amounts of liquids through an intravenous drip may affect these organs
  • if you are suffering from allergic diseases such as asthma, because you may be at a greater risk to experience an allergic reaction.
    All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very few cases also become severe. Such reactions are assumed to be more frequent in patients with known allergic conditions such as asthma. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.

TAKING OR USING OTHER MEDICINES

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

PREGNANCY AND BREAST-FEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding, please inform your doctor. Although you may be given Gelofusine during pregnancy and while breast-feeding, the possible risks and benefits should be considered carefully.

DRIVING AND USING MACHINES

Not relevant. Gelofusine is normally given to immobile patients in a controlled setting (e.g. emergency treatment, acute treatment in a hospital or a day therapy unit) and this excludes the likelihood of driving and using machines.

4. How to use Gelofusine

Gelofusine is given intravenously, i.e. by a drip.

How much you are given and for how long will depend on how much blood or fluid you have lost and on your condition.

For children, the doctor will determine the dose especially carefully. A child will receive this medicine only if the doctor considers it essential for his/her recovery.

The doctor will carry out tests (on your blood and blood pressure, for example) during your treatment, and the dose of Gelofusine will be adjusted according to your needs.

IF YOU USE MORE GELOFUSINE THAN YOU SHOULD

An overdose of Gelofusine may give rise to circulatory overload and to alterations of your blood salt (electrolyte) levels.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

5. Possible Side Effects

Like all medicines, Gelofusine can cause side effects