Projekt16_Layout 1 23.07.14 11:03 Seite 1

-

“ PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelofusine Ecobag

Succinylated (modified fluid) gelatin, Sodium Chloride

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

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

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.

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 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.

Pregnancy and breast-feeding

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.

BlBRAUN

llllllll

Schwarz 148x210 mm 340/NP34032/0714 Latus: 500 GroRbritannien Font size 8

-

MINI

340/NP34032/0714

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.

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.

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

-    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.

B. Braun Melsungen AG

34209 Melsungen Germany

llllllil

Schwarz 148x210 mm 340/NP34032/0714 Latus: 500 GroRbritannien Font size 8