Leaflet: information for the user

Gelaspan 40 mg/ml infusion solution

Contents of the pack and additional information

Gelaspan is one of the so-called plasma volume substitutes. This means that it replaces the lost fluid from the blood vessels.

Gelaspan is used for:

• To replace blood and bodily fluids that have been lost after, for example, an operation, an accident, or a burn. It can be combined with blood transfusions if necessary.
• To prevent low blood pressure (hypotension) that can occur when receiving spinal or epidural anesthesia or due to severe and imminent blood loss in a surgical setting.

To fill the circulating blood volume during the use of, for example, an extracorporeal circulation system with other perfusion liquids.

Do not use Gelaspan

• If you are allergic to gelatin or any of the other components of this medication (listed in section 6)
• If you are allergic to an allergen called “galactosa-α-1,3-galactosa (alfa-Gal)” or red meat (mammalian meat) and by-products
• If your circulating blood volume is too high
• If you have too much water in your body
• If you have certain types of heart failure (acute congestive heart failure)
• If you have an abnormally high level of potassium in your blood.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to use Gelaspan.

Inform your doctor

• If you have an allergic disease such as asthma, as you may be at greater risk of experiencing an allergic reaction
• In these cases, Gelaspan should not be administered to you due to possible cross-reactions:

• If you know you are allergic to red meat (mammalian meat) or by-products
• If you have tested positive for antibodies (IgE) against the alfa-Gal allergen

Your doctor will take special care with your situation if you suffer from

• Heart problems
• High blood pressure
• Water in your lungs
• Severe kidney problems.

Administering large amounts of fluids through an intravenous drip may worsen your condition.

Your doctor will also act with caution

• If you have a severe increase in sodium or chloride in your blood
• If you retain water and salt, which may be associated with inflammation of the tissues.
• If you have too much potassium in your blood or if you are taking or receiving medications that cause potassium retention
• If your blood coagulation is severely affected
• If you are an elderly person

While you are receiving Gelaspan, your blood composition will be monitored. If necessary, your doctor may administer other medications such as salts and fluids.

Children:

There is limited experience with the use of Gelaspan in children. Your doctor will only administer this medication to children when they deem it absolutely necessary.

Laboratory test results

Your doctor may take blood or urine samples from you before administering Gelaspan. This is because some laboratory test results may be affected after receiving this medication and are therefore unreliable.

Other medications and Gelaspan

Inform your doctor or pharmacist if you are taking or using or have taken or used recently any other medication, including those purchased without a prescription.

In particular, your doctor should be aware if you are taking or receiving medications that cause you to retain sodium (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 medication may cause swelling of the arms, hands, legs, and feet (edema). Additionally, inform your doctor if you are taking medications that cause you to lose potassium such as medications that increase water loss.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking any other medication.

Pregnancy

If you are pregnant, inform your doctor. Due to the possibility of allergic reactions, use of this medication should be avoided during pregnancy. However, your doctor may administer this medication in emergency situations.

Breastfeeding

If you are breastfeeding, inform your doctor. There is limited information available on the excretion of this medication in breast milk. Your doctor will decide whetherit is necessary to interrupt breastfeeding or interrupt treatment with this medication after considering the benefit of breastfeeding for the child and the benefit of treatment for you.

Fertility

No data are available on the effect ofthis medication on human or animal fertility. However, due to the nature of its components, it is considered unlikely to affect fertility.

Driving and operating machinery

The medication does not affect your ability to drive or operate machinery.

Your doctor will only administer Gelaspan if they consider that other products called crystalloids are not sufficient on their own.

Your doctor will carefully adjust the dose of Gelaspan to prevent fluid overload. This will be done especially if you have problems with your lungs, heart, or circulation.

Dosage

Gelaspan is administered intravenously, i.e., drop by drop.

Adults

The amount of volume administered and the duration will depend on the amount of blood or fluid you have lost and your condition.

Your doctor will perform tests (e.g., blood pressure and blood) during treatment and adjust the dose of Gelaspan according to your needs. If necessary, you may also receive blood or hematocrit concentrates.

Use in children

There is limited experience with the use of this medication in children. Your doctor will only administer this medication if they consider it essential for the child's recovery. In these cases, the clinical condition will be taken into account and the treatment will be closely monitored.

If you have received more Gelaspan than you should

A Gelaspan overdose can cause excessive blood volume (hypervolemia) and fluid overload that can affect the heart and pulmonary function.

If an overdose occurs, your doctor will administer the necessary treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Gelaspan may cause side effects, although not everyone will experience them.

All plasma substitutes carry a slight risk of allergic reactions, which are usually mild or moderate, but in very rare cases can be severe. It is assumed that these reactions are more common in patients with known allergic disorders, 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 any of the following side effects occur, consult a doctor immediately:

Rare (may affect up to 1 in 1,000 people):

Allergic reactions (anaphylactic/anaphylactoid) that include, for example, difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, chest or throat tightness, stomach pain, swelling of the neck and face.

If an allergic reaction occurs, the infusion will be stopped immediately and the necessary treatment will be administered (see also section 2 "What you need to know before starting to use Gelaspan", especially for allergies involving the allergens called galactosa-α-1,3-galactosa (alfa-Gal), red meat, and by-products).

Other side effects include:

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

• Decreased red blood cells and blood proteins

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

• It is possible that your blood will not clot as well as before and that you will notice that you bleed more easily

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

• Increased heart rate
• Low blood pressure
• Fever, chills

Unknown frequency (cannot be estimated from available data):

• Nausea, vomiting, stomach pain
• Decreased oxygen in the blood that may make you feel dizzy

Other side effects in children

No data are available regarding a difference in side effects in children.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use. www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use Gelaspan after the expiration date that appears on the label and on the box. The expiration date is the last day of the month indicated.

Do not store above 25 °C. Do not freeze.

Do not use Gelaspan if you observe:

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

Gelaspan previously opened or partially used must be discarded. Do not attempt to reseal partially used containers or bags.

Composition of Gelaspan

Active Principles:

1,000 ml of solution contains:

Succinylated gelatin (modified fluid) 40.0 g

Sodium chloride 5.55 g

Sodium acetate trihydrate 3.27 g

Potassium chloride 0.30 g

Calcium chloride dihydrate 0.15 g

Magnesium chloride hexahydrate0.20 g

Electrolyte Concentration

Sodium 151 mmol/l

Chloride 103 mmol/l

Potassium4 mmol/l

Calcium 1 mmol/l

Magnesium 1 mmol/l

Acetate 24 mmol/l

The other components are:

Water for injection, diluted hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the container

Gelaspan is a solution for infusion administered by intravenous drip (drip in a vein).

It is a sterile, transparent and colourless or slightly yellowish solution.

Gelaspan is presented in:

• Polyethylene low-density bottles “Ecoflac plus”, containing 500 ml available in packs of 10 x 500 ml
• Plastic bags “Ecobag” (without PVC), sealed with rubber stoppers, containing 500 ml available in packs of 20 x 500 ml.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization, responsible for manufacturing and local representative

Holder and responsible for manufacturing

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Postal address

34209 Melsungen, Germany

Telephone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer responsible for batch release in UK

B. Braun Medical Limited

Brookdale Road

Thorncliffe Park Estate

Chapeltown

Sheffield

S35 2PW

United Kingdom

Manufacturer responsible for batch release in ES and PT

B. Braun Medical S.A.

Carretera de Terrassa, 121

08191 Rubí (Barcelona)

Spain

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder

B. Braun Medical, SA

Ctra. Terrassa, 121

08191 Rubí (Spain)

This medicinal product has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:April 2023

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Precautions for use

Gelaspan should not be infused through the same infusion route as blood, blood components or haemoderivatives (haematite concentrates, plasma and plasma fractions).

During the compensation of severe blood loss by infusion of large quantities of Gelaspan, the haematocrit and electrolytes should be monitored. The haematocrit should not decrease below 25%. In elderly or severely ill patients, it should not be less than 30%.

Similarly, the effect of dilution of coagulation factors in these situations should be observed, especially in patients with existing haemostasis disorders.

Since the product does not replace plasma protein losses, it is recommended to control plasma protein concentrations.

In acute severe situations, Gelaspan can be infused rapidly by pressure infusion (500ml can be administered in 5‑10minutes) until the signs of hypovolemia are alleviated.

Before a rapid infusion, Gelaspan can be warmed to no more than 37°C.

In the case of pressure infusion, which may be necessary in emergency vital situations, all air should be eliminated from the container and the infusion equipment before administering the solution to avoid the risk of gas embolism, which could otherwise be associated with the infusion.

Influence on laboratory tests

Blood tests (blood group and irregular antigens) are possible after Gelaspan infusions. However, it is recommended to take blood samples before Gelaspan infusion to avoid any doubt in the interpretation of the results.

Gelaspan may influence the following chemical-clinical tests, resulting in falsely elevated values:

• erythrocyte sedimentation rate
• specific gravity of urine
• non-specific protein tests, for example, the Biuret method.

Incompatibilities

Without compatibility studies, this medicinal product should not be mixed with other medicinal products.