Gelofusine

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelofusine, solution for infusion

succinylated gelatin (modified fluid gelatin)
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Gelofusine is and what it is used for
2. What you need to know before you use Gelofusine
3. How to use Gelofusine
4. Possible side effects
5. How to store Gelofusine
6. Contents of the pack and other information

1. What Gelofusine is and what it is used for

Gelofusine is a so-called plasma volume substitute. This means that it replaces fluids
lost from the circulatory system.
Gelofusine is used for:

• replacing blood and body fluids that have been lost, for example, due to surgery, an accident, or a burn. If necessary, it can be used in combination with a blood transfusion;
• preventing low blood pressure (hypotension) that may occur during spinal or epidural anaesthesia, or in anticipation of significant blood loss during surgery;
• restoring circulating blood volume, for example, when using a heart-lung machine, in combination with other infusion fluids.

2. What you need to know before using Gelofusine

Do not use Gelofusine

• if you are allergic to gelatin or to any of the 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 (mammalian meat) and offal;
• if the volume of circulating blood is too high;
• if you have excess fluid in the body;
• if you suffer from certain types of heart failure (acute congestive heart failure).

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Gelofusine
Talk to your doctor

• if you suffer from an allergic condition such as asthma. In this case, the risk of an allergic reaction may be higher.
• In these cases, Gelofusine must not be administered to you due to possible cross-reactions:
• if you know you are allergic to red meat (mammalian meat) or offal
• if you have tested positive for antibodies (IgE) directed against the alpha-Gal allergen. Your doctor will pay particular attention to your condition if you have:
• heart problems,
• high blood pressure,
• fluid in the lungs,
• severe kidney problems. The administration of large amounts of fluid via intravenous infusion may worsen your condition.

Your doctor will also exercise caution:

• if you have a severe increase in sodium or chloride levels in the blood;
• if you have fluid and salt retention, which may be associated with tissue swelling;
• if blood coagulation is severely impaired;
• if you are elderly.

During administration of Gelofusine, the composition of your blood will be monitored. If necessary, your doctor may also give you other medications such as electrolytes and fluids.
Children
Experience with the use of Gelofusine in children is very limited. Your doctor will administer this medicine to a child only if absolutely necessary.
Laboratory test results
Your doctor may require blood or urine samples before administering Gelofusine, as some laboratory test results may be affected by taking this medicine and thus become unreliable.
Other medicines and Gelofusine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
In particular, your doctor should know if you are taking other medicines that may cause sodium retention (for example, spironolactone, triamterene, amiloride; ACE inhibitors such as captopril or enalapril; corticosteroids such as cortisone or non-steroidal anti-inflammatory drugs such as diclofenac). Concomitant administration with this medicine may cause swelling of the arms, hands, legs, and feet (edema).
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, inform your doctor. Due to possible allergic reactions, use of this medicine should be avoided during pregnancy. However, your doctor may administer this medicine in emergency situations.
Breastfeeding
If you are breastfeeding, inform your doctor. Information regarding excretion of this medicine in breast milk is limited, but based on its chemical characteristics, it is unlikely to pass into breast milk. Your doctor will decide whether to discontinue breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.
Fertility
There are no data on the effect of this medicine on animal or human fertility. However, due to the nature of its constituents, it is considered unlikely to affect fertility.
Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

3. How to use Gelofusine

Your doctor will give you Gelofusine only if they consider that other products called crystalloids are not sufficient on their own.
Your doctor will carefully adjust the dose of Gelofusine to prevent fluid overload, especially if you have lung, heart, or circulatory problems.
Dosage
Gelofusine is administered intravenously, i.e. by infusion.
Adults
The amount and duration of administration depend on how much blood or fluids have been lost and on your general condition.
Your doctor will perform tests (such as blood tests and blood pressure measurements) during treatment, and the dose of Gelofusine will be adjusted according to need. If necessary, blood or concentrated red blood cells may also be administered.
Use in children
There are insufficient data on the use of this medicine in children. The doctor will administer this medicine only if they consider it essential for the child's recovery. In such cases, the child's clinical condition will be taken into account and the therapy will be monitored with special caution.
If you use more Gelofusine than you should
An overdose of Gelofusine may lead to an excessively high blood volume (hypervolemia) and fluid overload, which may affect cardiac and pulmonary function.
You may experience headache and breathing difficulties.
In case of overdose, your doctor will administer any necessary treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
All plasma substitutes carry a slight risk of allergic reactions, which are mostly mild or moderate, but in very rare cases may become severe. Such reactions are thought to occur more frequently in patients suffering from allergic conditions such as asthma. For this reason, you will be closely monitored by a healthcare professional, especially at the beginning of the infusion.
The following side effects can be serious. If you experience any of the following side effects,
consult your doctor immediately.
Rare (may affect up to 1 in 1,000 people):

• allergic reactions (anaphylactic/anaphylactoid), including for example difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, tightness in the chest or throat, stomach pain, swelling of the neck and face. If an allergic reaction occurs, the infusion must be stopped immediately and you will be given any necessary treatment (see also section 2 “What you need to know before using Gelofusine”, particularly regarding allergies related to the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat, and offal).

Other side effects:
Very common (may affect up to 1 in 10 people):

• reduction in red blood cells and blood proteins.

Common (may affect up to 1 in 100 people):

• blood may not clot as well as before, and you may notice increased bleeding.

Very rare (may affect up to 1 in 10,000 people):

• increased heart rate
• low blood pressure
• fever and chills

Not known (frequency cannot be estimated from the available data):

• nausea, vomiting, stomach ache;
• reduced oxygen in the blood, which may cause dizziness.

Additional side effects in children
There are no data supporting different side effects in children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gelofusine

Keep Gelofusine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the container label and on the
outer packaging after the wording “EXP.”. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not freeze.
Do not use this medicinal product if you notice:

• cloudiness or discoloration of the solution;
• leakage of liquid from the container.

Gelofusine that has been previously opened or partially used must be discarded. Partially used
containers must not be reconnected.
The product should be used immediately after opening.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gelofusine contains
The active substances are succinylated gelatin (modified fluid) and sodium chloride.
1,000 ml of solution contain:
Succinylated gelatin (modified fluid) 40.0 g
Sodium chloride 7.0 g
Electrolyte concentrations:
Sodium 154 mmol
Chloride 120 mmol
The other ingredients are water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Physicochemical characteristics
pH 7.4 ± 0.3
Osmolarity 274 mOsm/l

Description of the appearance of Gelofusine and pack contents
Gelofusine is an infusion solution administered via an intravenous drip (into a vein).
It is a sterile, clear, colourless or slightly yellowish solution.
It is marketed in:

• polyethylene bottles (Ecoflac) of 500 ml, available in packs of 10;
• polypropylene bags (Ecobag) of 250 ml and 500 ml, available in packs of 20;
• polypropylene bags (Ecobag) of 1,000 ml, available in packs of 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Postal address
B. Braun Melsungen
34209 Melsungen
Germany

This medicinal product is authorised in the European Economic Area countries under the following names: