Gelaspan

Leaflet attached to the packaging: information for the user

Gelaspan solution for infusion

Please read carefully the contents of the leaflet before taking the medicine, as it contains information

important for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gelaspan and what is it used for
• 2. Important information before using Gelaspan
• 3. How to use Gelaspan
• 4. Possible side effects
• 5. How to store Gelaspan
• 6. Contents of the packaging and other information

1. What is Gelaspan and what is it used for

Gelaspan is a so-called plasma substitute. This means that it replaces the fluid that has been lost from the bloodstream. Gelaspan is used to:

• Replace blood and body fluid lost due to, for example, surgical procedures, accidents, or burns. If necessary, this medicine can be administered in combination with blood transfusion.
• Prevent low blood pressure (hypotension), which may occur in the case of spinal or epidural anesthesia, or as a result of significant blood loss during surgery.
• Supplement the circulating blood volume during therapy using, for example, a heart-lung machine in combination with other infusion fluids.

2. Important information before using Gelaspan solution for infusion

When not to use Gelaspan solution for infusion:

• if the patient is allergic to gelatin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy to the allergen called galactose-alpha-1,3-galactose (alpha-gal) or red meat (mammalian meat) and offal;
• in the case of too much circulating blood volume;
• in the case of too much water in the body;
• if the patient has certain types of heart failure (acute congestive heart failure);
• in the case of excessively high potassium levels in the blood.

Warnings and precautions:

Before starting to use Gelaspan, the patient should discuss it with their doctor, pharmacist, or nurse. The patient should inform their doctor in the following cases:

• if the patient has an allergic disease, such as asthma. In such cases, the patient may be at greater risk of an allergic reaction.
• Due to the possibility of cross-reactions, Gelaspan should not be administered to the patient in the following cases:
• if the patient knows they are allergic to red meat (mammalian meat) or offal;
• if the patient has undergone testing for antibodies (IgE) against the alpha-gal allergen and the test result was positive.

Special caution should be exercised if the patient has:

• heart disease;
• high blood pressure;
• fluid in the lungs;
• severe kidney disorders. Administration of too much fluid through intravenous infusion may worsen the patient's condition.

The attending physician will exercise special caution:

• in the case of significant increases in sodium or chloride levels in the blood;
• in the case of water and salt retention, which may be associated with tissue swelling;
• in the case of elevated potassium levels in the blood or if the patient is taking or receiving medications that cause potassium retention;
• in the case of severe blood coagulation disorders;
• in the case of elderly patients.

During the use of Gelaspan, the patient's blood components should be monitored. If necessary, the doctor may also administer other medications, such as electrolytes and fluids, to the patient.

Children

There is only limited experience with the use of Gelaspan in children. The attending physician will decide to use this medicine only if it is necessary. In such cases, the overall condition of the child and the treatment should be monitored with special caution.

Effect on laboratory test results

The doctor may take blood or urine samples before administering Gelaspan to the patient. This is because some laboratory test results may be disturbed after administering Gelaspan and therefore may be unreliable.

Gelaspan and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. In particular, the patient should inform their doctor about any medications they are taking that may cause sodium retention (e.g., spironolactone, triamterene, amiloride, ACE inhibitors such as captopril or enalapril, corticosteroids such as cortisone, or non-steroidal anti-inflammatory drugs such as diclofenac). Concomitant use of these medications with Gelaspan may lead to swelling of the hands, feet, and face. Additionally, the patient should inform their doctor if they are taking medications that lead to potassium loss, such as diuretics.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. PregnancyIf the patient is pregnant, they should inform their doctor. Due to possible allergic reactions, this medicine should be avoided during pregnancy. However, the doctor may administer this medicine in emergency situations. BreastfeedingIf the patient is breastfeeding, they should inform their doctor. There is only limited data available on the penetration of this medicine into breast milk. The doctor will decide whether to discontinue breastfeeding or stop this medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the patient. FertilityThere is no data available on the effect of this medicine on human or animal fertility. However, due to the composition of the medicine, any effect on fertility is considered unlikely.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

3. How to use Gelaspan solution for infusion

The doctor will administer Gelaspan to the patient only if they consider that the use of other medicines, called crystalloids, is not sufficient. The doctor will carefully adjust the dose of Gelaspan to prevent fluid overload, especially in cases of lung, heart, or circulatory problems.

Dosage

Gelaspan is administered intravenously, i.e., by infusion. Adults:The dose and duration of treatment depend on the amount of blood or fluid lost and the patient's condition. During treatment, the doctor will perform tests (e.g., blood and blood pressure tests), and the dose of Gelaspan will be adjusted according to the patient's needs. If necessary, the patient may also be administered blood or red blood cell concentrate. Children:There is only limited experience with the use of this medicine in children. The attending physician will decide to use this medicine only if it is necessary. In such cases, the overall condition of the child and the treatment should be monitored with special caution.

Use of a higher than recommended dose of Gelaspan

Overdose of Gelaspan may lead to excessive blood volume (hypervolemia) and fluid overload, which can disrupt heart and lung function. In the event of an overdose, headaches and breathing difficulties may occur. In the case of an overdose, the attending physician will initiate appropriate treatment. In case of doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The use of plasma substitutes is associated with a low risk of allergic reactions, which in most cases are mild or moderate, but in very rare cases can be severe. Such reactions occur more frequently in patients with known allergic diseases, such as asthma. Therefore, healthcare professionals will carefully monitor the patient's condition, especially at the beginning of the infusion.

The following side effects may be serious. If the following side effects occur, the patient should immediately inform their doctor:

Rare (occurring in more than 1 in 1000 people):

• allergic reactions (anaphylactic/anaphylactoid), including difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, chest tightness or throat, abdominal pain, swelling of the neck and face. In the event of an allergic reaction, the infusion should be stopped immediately and appropriate treatment initiated (see also section 2 "Important information before using Gelaspan", especially information on allergies caused by the alpha-gal allergen, red meat, and offal).

Other side effects include:

Very common (occurring in more than 1 in 10 people):

• decrease in red blood cell and protein levels in the blood

Common (occurring in 1 to 10 in 100 people)

• blood coagulation disorders and increased bleeding may occur

Rare (occurring in more than 1 in 10,000 people):

• rapid heartbeat
• low blood pressure
• fever, chills

Frequency not known (cannot be estimated from the available data)

• malaise, abdominal pain.
• decrease in oxygen levels in the blood, which may cause dizziness.

Additional information on side effects in children

There is no data available on differences in side effects in children.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gelaspan solution for infusion

The medicine should be stored in a place inaccessible and invisible to children. Do not use Gelaspan after the expiry date stated on the packaging and cardboard box after: EXP. The expiry date refers to the last day of the month stated. Do not store above 25°C. Do not freeze. Do not use Gelaspan if:

• the solution is cloudy or has changed color;
• the container is leaky.

Once opened or partially used, the packaging of Gelaspan should be discarded. Partially used containers or bags should not be reconnected to the infusion device/set.

6. Contents of the packaging and other information

What Gelaspan contains

Active substances: 1,000 ml of solution contains: Gelatin (in the form of modified liquid gelatin) 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 hexahydrate 0.20 g Electrolyte concentrations Sodium 151 mmol/l Chloride 103 mmol/l Potassium 4 mmol/l Calcium 1 mmol/l Magnesium 1 mmol/l Acetate 24 mmol/l Other ingredients of the medicine are: water for injections, diluted hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Gelaspan looks like and contents of the packaging

Gelaspan is a solution for infusion administered intravenously, directly into a vein. It is a clear, colorless or slightly yellowish, sterile solution. Gelaspan is supplied:

• in low-density polyethylene containers, type Ecoflac plus, with a capacity of 500 ml, available in collective packaging of 10 x 500 ml;
• in plastic bags, type Ecobag, closed with a halogenated butyl rubber stopper, with a capacity of 500 ml, available in collective packaging of 20 x 500 ml.

Not all types of packaging may be available.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1

34212 Melsungen, Germany Postal address:34209 Melsungen Telephone: +49-5661-71-0 Fax: +49-5661-4567

Manufacturer responsible for batch release in the United Kingdom:

• B. Braun Medical Limited Brookdale Road Thorncliffe Park Estate Chapeltown Sheffield S35 2PW United Kingdom

Manufacturer responsible for batch release in Spain and Portugal

• B. Braun Medical S.A. Carretera de Terrassa, 121 08191 Rubi (Barcelona) Spain

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 09-2023

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Information intended for healthcare professionals only:
Warnings related to use
Gelaspan should not be administered together with transfused blood or blood products (platelet concentrate, plasma, or plasma fraction) through the same infusion set.
During the supplementation of significant blood losses through infusions of large volumes of Gelaspan, the hematocrit and electrolytes should be monitored. Hematocrit values should not fall below 25%. In elderly patients or critically ill patients, hematocrit values should not fall below 30%. In such cases, the dilution effect and coagulation factors should be monitored, especially in patients with hemostasis disorders.
Since this medicine does not replace lost plasma proteins, it is recommended to monitor plasma protein levels.
In severe, acute situations, Gelaspan may be rapidly administered by pressure infusion. 500 ml of the medicine may be administered within 5-10 minutes until the symptoms of hypovolemia subside.
Before starting rapid infusion, Gelaspan can be warmed to a temperature not exceeding 37°C.
In the case of pressure infusion, which may be necessary in life-saving situations, all air should be removed from the container and infusion set before administration. This is to eliminate the risk of air embolism.
Effect on laboratory test results:
After completing the infusion of Gelaspan, laboratory blood tests (blood group or non-typical antibodies) can be performed. However, it is recommended to take blood samples before starting the infusion of Gelaspan to avoid difficulties in interpreting the results.
Gelaspan may interfere with the results of the following clinical-chemical tests, giving falsely elevated values:

• erythrocyte sedimentation rate;
• urine specific gravity;
• non-specific plasma protein levels, e.g., by the biuret method.

Incompatibilities
Since there are no compatibility studies, this medicine should not be mixed with other medicines.