Patient leaflet - Gelofusine Ecobag
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 following for example, an operation, an accident or a burn. It may be combined with blood trans-fusions if necessary.
- Prevent low blood pressure (hypotension) which may occur when you are receiving spinal or epidural anaesthesia or due to imminent severe blood loss in a surgical setting.
- Fill up the circulating blood volume during the use of for example heart-lung machine in combination with other fluids for infusion.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GELOFU-SINE ECOBAG
Do not use Gelofusine Ecobag
- if you are allergic to gelatin or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to an allergen called “galactose-α-1,3-galactose (alpha-Gal) or to red meat (mammal meat) and offal
- if your circulating blood volume is too large
- if you have excess fluid in your body
- if you have certain types of heart failure (acute congestive heart failure)
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Gelofusine Ecobag
Please inform your doctor
- if you suffer from allergic diseases such as asthma. Then you may be at a greater risk of experiencing an allergic reaction.
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
Your doctor will take special care about your situation if you suffer from:
- heart problems
- high blood pressure
- water on your lungs
severe kidney problems
Giving large amounts of liquids through an intravenous drip may worsen your condition.
Your doctor will also exercise caution
- if you have a severe increase of sodium or chloride in your blood
- if you retain water and salt, which may be associated with tissue swelling
- if your blood clotting is severely impaired
- if you are elderly
While receiving Gelofusine, your blood composition will be monitored. If nec-essary, your doctor may also give you other medications such as salts and flu-ids.
Children
There is only little experience regarding the use of Gelofusine in children. The doctor will only administer this medicine to children when considered absolutely necessary.
Laboratory test results
Your doctor can take blood or urine samples before giving you Gelofusine. This is because some laboratory test results may be affected after you have received this medication and are therefore unreliable.
Other medicines and Gelofusine
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular your doctor should know if you are taking or receiving medicines that make you retain sodium (e.g. spironolactone, triamterene, amiloride; ACE-inhibitors like captopril or enalapril, corticosteroids like cortisone or non-steroidal anti-inflammatory agents like diclofenac). Concomitant administra-tion with this medicine might lead to swelling of arms, hands, legs and feet (oedema).
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are plan-ning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, please inform your doctor. Due to possible allergic reac-tions the use of this medicine should be avoided during pregnancy. However, your doctor may give you this medicine in emergency situations.
Breast-feeding
If you are breast-feeding, please inform your doctor. There is limited informa-tion about excretion of this medicine in breast-milk, but based on its chemi-cal characteristics, it is unlikely that it passes over into breast-milk. Your doc-tor will decide whether to discontinue breast-feeding or to discontinue this medicine, taking into account the benefit of breast-feeding for the child and the benefit of therapy for yourself.
Fertility
There are no data on the effect of this medicine on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that it will affect fertility.
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany
Gelofusine Ecobag
Succinylated (modified fluid) gelatin, Sodium Chloride
B|BRAUN
Schwarz
210x297 mm
0340/NP34032/1023
Lätus: 500
Großbritannien
Projekt18_Layout 1 30.10.23 12:27 Seite 1
0340/NP34032/1023
B. Braun Melsungen AG
34209 Melsungen
Germany
Driving and using machines
This medicinal product does not influence your ability to drive or use machines.
3. HOW TO USE GELOFUSINE ECOBAG
Your doctor only will give you Gelofusine if they consider that other products called crystalloids are not sufficient alone.
Your doctor will adjust the dose of Gelofusine carefully in order to prevent fluid overload. This will be done especially if you have problems with your lungs or with your heart or circulation.
Dosage
Gelofusine is given intravenously, i.e. by a drip.
Adults
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 exam-ple) during your treatment, and the dose of Gelofusine will be adjusted according to your needs. If necessary you may also receive blood or packed red blood cells.
Use in children
There is only little experience of the use of this medicine in children. Your doc-tor will only administer this medicine if they consider it essential for the child’s recovery. In those cases, the clinical condition will be taken into account and therapy will be monitored especially carefully.
If you use more Gelofusine Ecobag than you should
An overdose of Gelofusine may cause too high blood volume (hypervolaemia) and fluid overload that may affect your heart and lung function. You may notice headaches and difficulties breathing
If an overdose occurs your doctor will give you any necessary treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not every-body gets them.
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 reac-tions are assumed to be more frequent in patients with known allergic condi-tions such as asthma. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.
The following side effects may be serious. If any of the following side effects occur consult a doctor immediately:
Rare (may affect up to 1 in 1 000 people):
- allergic (anaphylactic/anphylactoid) reactions, including e.g. difficulty breathing, wheeze, nausea, vomiting, dizziness, sweating, chest or throat tightness, stomach ache, swelling of neck and face
If an allergic reaction occurs, your infusion will be stopped immediately and you will be given any necessary treatment (see also section 2 “What you need to know before you use Gelofusine, notably for allergies involving the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat and offal).
Other side effects include:
Very common (may affect up to 1 in 10 people):
- a decrease of red blood cells and proteins in your blood
Common (may affect up to 1 in 100 people):
- your blood may not clot as well as before and you may notice more bleeding
Very rare (may affect up to 1 in 10,000 people):
- quickening of heartbeat
- low blood pressure
- fever, chills.
Unknown (frequency cannot be estimated from the available data):
- feeling sick, being sick, stomach pain
a decrease of oxygen in your blood which may make you feel dizzy
Additional side effects in children
There are no data relating a difference in side effects in children.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safe-ty of this medicine.
5. HOW TO STORE GELOFUSINE ECOBAG
Keep out of the sight and reach 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 mea-sures 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 intra-venous 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
Manufacturer responsible for batch release
B. Braun Melsungen AG
Am Schwerzelshof 1
34212 Melsungen
Germany
B. Braun Medical Limited
Brookdale Road
Thorncliffe Park Estate
Chapeltown
Sheffield
S35 2PW
United Kingdom
This leaflet was last approved in November 2023
B|BRAUN
Schwarz
210x297 mm
0340/NP34032/1023
Lätus: 500
Großbritannien
Projekt18_Layout 1 30.10.23 12:27 Seite 2