Succinylated gelatin solution 4% for intravenous infusion
Consumer Medicine Information
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.
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.
DO NOT USE GELOFUSINE:
Please inform your doctor:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
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.
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.
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.
Like all medicines, Gelofusine can cause side effects, although not everybody gets them.
As mentioned above, in rare cases (i.e. in 1 to 10 treated patients in 10,000) mild skin reactions (hives, nettle rash) may occur.
In very rare cases (i.e. in less than 1 treated patient in 10,000) an allergic shock has been observed.
It must be stressed that allergic reactions are extremely rare, but should they occur there are established methods of treating them, which would be used immediately by the attending doctor.
Uncommon side effects (affecting 1 to 10 treated patients in a 1,000) include:
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Gelofusine after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use Gelofusine if you notice:
Previously opened or partly used Gelofusine should be thrown away. Partially used bags should not be reconnected.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Gelofusine is a solution for infusion administered through an intravenous drip (a drip into a vein).
It is a clear colourless or slightly yellowish sterile solution.
It comes in:
The active substances are succinylated (modified fluid) gelatin and sodium chloride.
1000 ml of the solution contain:
The other ingredients are water for injections and sodium hydroxide for pH adjustment.
Australian Registration Numbers:
500 mL bottles (Ecoflac plus) ARTG 60644
1000 mL bottles (Ecoflac plus) ARTG 60645
500 mL plastic bags (Ecobag) ARTG 78102
1000 mL plastic bags (Ecobag) ARTG 78103
B. Braun Australia Pty Ltd
17 Lexington Drive
Bella Vista NSW 2156
Toll Free Number: 1800 251 705
This leaflet was updated in January 2010.
Published by MIMS November 2014