Gelaspan

Patient Information Leaflet

Gelaspan infusion solution
Please read all of this leaflet carefully before receiving this medicine, as it contains important
information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Gelaspan is and what it is used for

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

• To replace blood and body fluid lost, for example, during surgery, trauma, or burns. If necessary, this medicine may be given together with blood transfusion.
• To prevent low blood pressure (hypotension) that may occur during spinal or epidural anaesthesia, or due to significant blood loss during surgery.
• To restore circulating blood volume during therapy involving, for example, cardiopulmonary bypass, in combination with other infusion fluids.

2. Important information before receiving Gelaspan
When not to use Gelaspan infusion solution:

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

Warnings and precautions:
Before starting treatment with Gelaspan, please discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if:

• you have an allergic condition such as asthma. In this case, you may be at higher risk of an allergic reaction.
• Due to the possibility of cross-reactions, Gelaspan should not be administered in the following cases:
  • if you know you are allergic to red meat (mammalian meat) or offal;
  • if you have been tested for antibodies (IgE) against the alpha-gal allergen and the test result was positive.

Special caution is required if you have:

• heart disease;
• high blood pressure;
• fluid in the lungs;
• severe kidney problems. Administering too large a volume of intravenous fluids may worsen your condition.

Your doctor will exercise particular caution:

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

During treatment with Gelaspan, blood parameters will be monitored. If necessary, your doctor may also administer other medications such as electrolytes and fluids.
Children
There is limited experience with the use of Gelaspan in children. Your doctor will decide whether to use this medicine only if it is considered necessary.
Effect on laboratory test results
Your doctor may take blood or urine samples before administering Gelaspan. This is because some laboratory test results may be altered after administration of Gelaspan and therefore unreliable.
Gelaspan with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In particular, inform your doctor about any medicines you 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). Concurrent use with Gelaspan may lead to swelling of the hands, arms, feet, and legs. Additionally, inform your doctor if you are taking medications that lead to potassium loss, such as diuretics increasing water excretion.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before receiving this medicine.
Pregnancy
If you are pregnant, inform your doctor. Due to the risk of allergic reactions, use of this medicine during pregnancy should be avoided. However, your doctor may administer this medicine in emergency situations.
Breastfeeding
If you are breastfeeding, inform your doctor. Data on passage of this medicine into breast milk are limited. Your doctor will decide whether to discontinue breastfeeding or discontinue the medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.
Effect on fertility
There are no data on the effect of this medicine on fertility in humans or animals. 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 operate machinery.
3. How to use Gelaspan infusion solution
Your doctor will administer Gelaspan only if other medicines called crystalloids are considered insufficient.
Your doctor will carefully adjust the dose of Gelaspan to prevent fluid overload, especially if you have problems with the lungs, heart, or circulation.
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 your clinical condition. During treatment, your doctor will perform tests (e.g. blood tests and blood pressure measurements), and the dose of Gelaspan will be adjusted accordingly. If necessary, blood or red blood cell concentrate may also be administered.
Children:
There is limited experience with the use of this medicine in children. Your doctor will decide whether to use this medicine only if it is considered necessary. In such cases, the child's overall condition should be taken into account, and treatment should be closely monitored with special caution.
Use of more than the recommended dose of Gelaspan
Overdose of Gelaspan may lead to excessive blood volume (hypervolemia) and fluid overload, which may impair heart and lung function.
In case of overdose, headache and breathing difficulties may occur.
In the event of overdose, your doctor will initiate appropriate treatment.
If you have any doubts regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The use of plasma substitutes carries a small risk of allergic reactions, which in most cases are mild or moderate, but in very rare cases may be severe. Such reactions occur more frequently in patients with known allergic conditions, such as asthma. Therefore, healthcare professionals will closely monitor the patient's condition, especially at the beginning of the infusion.

The adverse reactions listed below may be serious. If any of the following adverse reactions occur, inform a doctor immediately:
Rare (occur in more than 1 in 1,000 people):

• allergic reactions (anaphylactic/anaphylactoid), including difficulty breathing, wheezing, nausea, vomiting, dizziness, sweating, chest or throat tightness, abdominal pain, swelling of the neck and face. If an allergic reaction occurs, the infusion must be stopped immediately and appropriate treatment initiated (see also section 2 "Important information before using Gelaspan", especially information regarding allergies caused by an allergen called galactose-α-1,3-galactose (alpha-gal), red meat and offal).

Other adverse reactions include:
Very common (occur in more than 1 in 10 people):

• reduction in the number of red blood cells and blood protein

Common (occur in 1 to 10 in 100 people):

• disturbances in blood coagulation and increased bleeding may occur

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

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

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

• malaise, abdominal pain
• decreased oxygen concentration in the blood, which may cause dizziness

Additional information on adverse reactions in children
There are no data available regarding differences in adverse reactions in children.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gelaspan infusion solution
Keep the medicine out of the reach and sight of children.
Do not use Gelaspan after the expiry date stated on the packaging label and cardboard box after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze.
Do not use Gelaspan if:

• the solution is cloudy or has changed colour;
• the container is leaking.

Any previously opened or partially emptied Gelaspan container must be discarded. Partially emptied containers or bags must not be reconnected to an infusion device/set.

6. Contents of the package and other information

What Gelaspan contains
Active substances:
1,000 ml of solution contains:
Gelatine (as modified fluid gelatine) 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:
Water for injections, hydrochloric acid (dilute) (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Gelaspan looks like and contents of the pack
Gelaspan is an infusion solution administered intravenously via drip.
It is a clear, colourless or slightly yellowish, sterile solution.

Gelaspan is supplied:

• in low-density polyethylene containers of the type Ecoflac plus, with a capacity of 500 ml, available in multi-packs of 10 x 500 ml;
• in plastic bags of the type Ecobag closed with a halobutyl rubber stopper, with a capacity of 500 ml, available in multi-packs of 20 x 500 ml.

Not all pack types may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for healthcare professionals:

Warnings regarding use
Gelaspan must not be administered simultaneously with transfused blood or blood products (platelet concentrate,
plasma, or plasma fraction) using the same infusion set.
During significant blood loss replacement with large-volume infusions of Gelaspan, hematocrit and electrolyte levels should be monitored. Hematocrit values should not fall below 25%.
In elderly individuals or critically ill patients, hematocrit values should not fall below 30%.
In such cases, the hemodilution effect and coagulation factors should be monitored, especially in patients with coagulation disorders.
Since this medicinal product does not replace lost plasma proteins, monitoring of plasma protein concentration is recommended.
In severe, acute situations, Gelaspan may be rapidly administered by pressure infusion. 500 mL of the medicinal product may be infused within 5–10 minutes until symptoms of hypovolemia resolve.
Prior to initiating rapid infusion, Gelaspan may be warmed to a temperature not exceeding 37°C.
In case of pressure infusion, which may be necessary in life-threatening situations, all air must be removed from the container and infusion set before administration to eliminate the risk of air embolism.
Effect on laboratory test results:
After completion of Gelaspan infusion, blood tests (blood group or atypical antibodies) can be performed. However, blood samples should preferably be collected before starting Gelaspan infusion to avoid difficulties in interpreting test results.
Gelaspan may interfere with the results of the following clinical chemistry tests, leading to falsely elevated values:

• red blood cell sedimentation rate test;
• urine specific gravity;
• concentration of nonspecific plasma proteins, e.g., by the biuret method.

Incompatibilities
Due to lack of compatibility studies, this medicinal product must not be mixed with other medicinal products.