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Gelofusine®

Succinylated gelatin solution for intravenous infusion


Consumer Medicine Information

What is in this leaflet?

This information has been provided to help you understand how this product works. If you need more information on why this product is being used or about what effects you can expect it to have please ask your doctor for more information.

More detailed technical information is included in the Product Information avaialable to the medical profession.

What is Gelofusine?

Gelofusine is an infusion solution containing 4% succinylated (or modified fluid) gelatin, sodium hydroxide and Water for Injections.

The active ingredient, succinylated gelatin is manufactured from gelatin from bovine (cows) material from the USA which is free from virus disease affecting the brain. The gelatin has been chemically modified to make its action in the body last longer.

The clear solution is sterile and is in a plastic container. Gelofusine is administered through an intravenous drip.

What is Gelofusine used for?

In the course of your treatment or operation it may be or may have become necessary to give you an intravenous infusion of fluids in order to adequately maintain your circulating blood volume. The situations in which Gelofusine is given are many and include the peri-operative period as well as trauma and burns.

For many reasons blood itself and blood components are not always the ideal choice to replace fluid losses and are only used where absolutely essential. Smaller fluid losses are nowadays replaced using "artificial" solutions called plasma substitutes or volume replacement fluids, one of which being Gelofusine.

Before using Gelofusine

Do not use this product if:

  • you have a known hypersensitivity to gelatin,
  • problems with your heart or blood clotting systems,
  • or if your circulation is overloaded
  • or if your sodium level in the blood is too high.

What precautions are necessary while using this product?

If you have problems with heart, lung function or blood clotting, special care has to be taken when this product is given to you. This is because giving large amounts of liquids through an intravenous drip can affect these organs.

As infusion of large quantities of such plasma substitutes may cause too much dilution of blood components or clotting factors, blood samples may be taken to check this. A transfusion may be given to you if blood or plasma losses cannot be replaced by the infusion of "artificial" plasma substitutes.

If your kidney function is impaired, the doctor will adjust the dosage, since this is the principal way in which Gelofusine is eliminated from the body. He will also take precautions to ensure that your fluid supply is adequate.

All plasma substitutes carry a slight risk of allergic reactions that can either be mild or severe. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.

Gelofusine should be avoided if you have a known history of drug allergy because allergic reactions can occur more frequently in this situation.

Can you use this product during pregnancy or while breast feeding?

For its usual indications, Gelofusine is not contraindicated in pregnancy. However, particular care should be taken when fluid or volume replacements are administered during or immediately after pregnancy. No information is available concerning the use of this product while breast feeding.

What may happen after using Gelofusine

As mentioned above in very rare cases allergic reactions of varying severity may occur. Symptoms of such reactions may be:

  • difficulty in swallowing or breathing,
  • localised or general redness of the skin or localised skin sensitivity reactions,
  • nausea,
  • headache,
  • drop in blood pressure

If such symptoms occur please inform your nurse or doctor immediately.

In extremely rare cases an allergic shock has been observed. Unfortunately, there is no test which can show in advance who is likely to experience such reactions, nor can their course be predicted.

It must be stressed that allergic reactions are extremely rare, but should they occur there are established methods of treating them which should be used immediately by the attending doctor.

If you think you have experienced any unusual effects during your treatment you should talk to your doctor.

Effects on ability to drive and use machines:

Treatment with Gelofusine is only given in serious conditions.

You should not drive or operate machines following treatment with Gelofusine until your doctor advises you that you are sufficiently recovered and that it is safe.

How Gelofusine is administered

Gelofusine is infused into a vein using sterile tubing and a needle. Gelofusine should only be administered to you by qualified medical staff.

Overdosage

Gelofusine overdosage may result in increased blood volume and haemodilution effects. Every effort will be made by your doctor to avoid this occurrrence in the course of treatment.

Storage conditions

Gelofusine should be stored below 25°C.

Further information

Gelofusine should only be administered by qualified healthcare professionals.

For further information about your treatment with Gelofusine, please consult your doctor.

Name and address of distributor

B. Braun Australia Pty. Ltd.
Unit 3/9 Packard Avenue
Castle Hill NSW 2154

AUST R 60644
AUST R 60645

prepared July 1998

Published by MIMS May 1999

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