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GELOFUSINE ECOBAG

Active substance(s): CHLORIDE ION / SODIUM ION / SUCCINYLATED MODIFIED FLUID GELATIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelofusine Ecobag
Succinylated (modified fluid) gelatin, Sodium Chloride
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others.
- 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.

In this leaflet:
1. What Gelofusine Ecobag is and what it is used for
2. Before you use Gelofusine Ecobag
3. How to use Gelofusine Ecobag
4. Possible side effects
5. How to store Gelofusine Ecobag
6. Further information

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 obtained without a prescription.

1. WHAT GELOFUSINE ECOBAG IS AND
WHAT IT IS USED FOR
Pregnancy and breast-feeding

2. BEFORE YOU USE GELOFUSINE ECOBAG
Do not use Gelofusine Ecobag
• if you are allergic (hypersensitive) to gelatin or any of
the other ingredients of Gelofusine Ecobag.

Take special care with Gelofusine Ecobag
• if you have problems with your heart or your kidneys.
Please inform your doctor accordingly. Giving large
amounts of liquids through an intravenous drip may
affect these organs.
All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very

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Ask your doctor or pharmacist for advice before taking
any medicine.
Your doctor will give you Gelofusine Ecobag only if he
thinks it is essential for you.

Driving and using machines
Gelofusine Ecobag 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.

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

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

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An overdose of Gelofusine Ecobag may give rise to circulatory overload and electrolyte imbalance.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gelofusine Ecobag can cause side
effects, although not everybody gets them.
As mentioned above, in rare cases (i.e. in 1 - 10 of 10,000
treated patients) mild skin reactions (hives, nettle rash)
may occur.
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.
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.
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.

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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GELOFUSINE ECOBAG
Keep out of the reach and sight of children.
Do not use Gelofusine Ecobag 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.
Do not store above 25 °C.

• leaking of the container.
Previously opened or partly used Gelofusine Ecobag
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.

6. FURTHER INFORMATION
What Gelofusine Ecobag contains
- The active substances are succinylated (modified fluid)
gelatin and sodium chloride
1000 ml of the solution contain:
Succinylated (modified fluid) gelatin
40.0 g
Sodium
154 mmol/l
Chloride
120 mmol/l
- The other ingredients are water for injections and sodium hydroxide for pH adjustment.

What Gelofusine Ecobag looks like and contents
of the pack
Gelofusine Ecobag 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 is available in non-PVC plastic bags of 100, 250, 500
and 1000 ml.

Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany
Postal address
B. Braun Melsungen AG
34209 Melsungen, Germany

Manufacturer
B. Braun Medical AG
Route de Sorge 9
1023 Crissier, Switzerland

This leaflet was last approved in July 2014.

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Schwarz
148x210 mm
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Lätus: 500
Großbritannien
Font size 8

B. Braun Melsungen AG
34209 Melsungen
Germany

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If you use more Gelofusine Ecobag than you Do not use Gelofusine Ecobag if you notice
• cloudiness or discoloration of the solution
should

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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