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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
B. Braun Melsungen AG · 34209 Melsungen, Germany

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:

Pregnancy and breast-feeding

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

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.

1. WHAT GELOFUSINE ECOBAG IS AND WHAT IT IS USED
FOR

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.

Gelofusine Ecobag is a so-called plasma volume substitute. This means, it 3. HOW TO USE GELOFUSINE ECOBAG
replaces fluid lost from the circulation.
Gelofusine Ecobag is given intravenously, i.e. by a drip.
Gelofusine Ecobag is used to replace blood and body fluid, which have
How much you are given and for how long will depend on how much
been lost as a result of, for example, an operation, an accident or a burn.
blood or fluid you have lost and on your condition.
It can be used instead of, or as well as, a blood transfusion.
The doctor will carry out tests (on your blood and blood pressure, for
example) during your treatment, and the dose of Gelofusine Ecobag will
2. BEFORE YOU USE GELOFUSINE ECOBAG
be adjusted according to your needs.

Do not use Gelofusine Ecobag
• if you are allergic (hypersensitive) to gelatin or any of the other ingredients of Gelofusine Ecobag.
• if you are allergic to an allergen called “galactose-α-1,3-galactose
(alpha-Gal) or to red meat (mammal meat) and offal

If you use more Gelofusine Ecobag than you should
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.

Take special care with Gelofusine Ecobag

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 (see also section 2 “What
you need to know before you use Gelofusine, notably for allergies involvTaking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently ing the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat
and offal).
taken any other medicines obtained without a prescription.

B|BRAUN
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Lätus: 500
Großbritannien
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• 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.
- In these cases, Gelofusine should not be given to you due to possible
cross-reactions:
· if you know you have an allergy to red meat (mammal meat) or offal
· if you have been tested positive to antibodies (IgE) against the allergen
alpha-Gal
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.

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If any of the side effects become serious, or if you notice any side effects What Gelofusine Ecobag looks like and contents of the pack
not listed in this leaflet, please tell your doctor or pharmacist.
Gelofusine Ecobag is a solution for infusion administered through an
intravenous drip (a drip into a vein).
Reporting of side effects
It is a clear colourless or slightly yellowish sterile solution.
If you get any side effects, talk to your doctor, pharmacist or nurse. This
It is available in non-PVC plastic bags of 100, 250, 500 and 1000 ml.
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at: Marketing Authorisation Holder
www.mhra.gov.uk/yellowcard
B. Braun Melsungen AG
By reporting side effects you can help provide more information on the Carl-Braun-Str. 1
34212 Melsungen, Germany
safety of this medicine.
Postal address
B. Braun Melsungen AG
5. HOW TO STORE GELOFUSINE ECOBAG
34209 Melsungen, Germany
Keep out of the reach and sight of children.
Do not use Gelofusine Ecobag after the expiry date which is stated on the Manufacturer
label and the outer carton. The expiry date refers to the last day of that B. Braun Medical AG
Route de Sorge 9
month.
1023 Crissier, Switzerland
Do not store above 25 °C.

This leaflet was last approved in October 2017.
Do not use Gelofusine Ecobag if you notice
• cloudiness or discoloration of the solution
• 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

B|BRAUN

Schwarz
210x297 mm
340/NP34032/0118
Lätus: 500
Großbritannien
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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- 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.

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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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