Label: Information for the Patient

GELOPLASMA, Infusion Solution

Read this label carefully before starting to use the medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What is Geloplasma, Infusion Solution, and for what it is used

2. What you need to know before starting to use Geloplasma, Infusion Solution

3. How to use Geloplasma, Infusion Solution

4. Possible adverse effects

5. Storage of Geloplasma, Infusion Solution

6. Contents of the container and additional information

Geloplasma is an intravenous perfusion solution. It contains gelatin, which belongs to the group of medications known as plasma volume expanders. Plasma volume expanders increase the fluid in your bloodstream, which helps to maintain your blood flow, and therefore your blood pressure, stable.

This medication is an emergency treatment in case of a decrease in blood volume in the following situations:

• Bleeding(bleeding), dehydration, capillary extravasation(increase in microvascular permeability), burns;
• Severe vasodilation (widening of blood vessels) of traumatic, surgical, septic, or toxic origin.

It is also used in the treatment of decreased blood volume associated with hypotension (low blood pressure) in the context of severe vasodilation related to the effects of hypotensive drugs, mainly during anesthesia.

Do not use GELOPLASMA, perfusion solution:

• 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 calledgalactosa-α-1,3-galactosa(alpha-Gal)or to red meat (mammalian meat) and offal;
• in case of excess body fluid;
• in case of hyperkalemia(excess potassium in the blood);
• in case of a high accumulation of alkaline substances (e.g., bicarbonate or lactate) in your blood and body fluid;
• at the end of pregnancy (during delivery/childbirth): see the section “Pregnancy, lactation and fertility”.

Warnings and precautions

Consult your doctor, pharmacist or nurse before using Geloplasma, perfusion solution.

• This solution should not be administered intramuscularly.

• This solution may cause accumulation of alkaline substances in your blood due to the presence of lactate ions.
• This solution may not produce its alkalizing effect in patients with altered liver function, as lactate metabolism may be altered.
• Geloplasma should not be administered at the same time as blood orits derivatives (cell concentrates, plasma and plasma fractions), unless separate perfusion systems are used.
• You may be determined to have a blood group and undergo other hematological tests if you have received up to 2 liters of gelatin fluid, but it is preferable to take the sample for these testsbeforethe perfusion of this solution.
• Due to the possibility of an allergic reaction, you must be kept under observation. In case of an allergic reaction, the perfusion must be stopped immediately and appropriate treatment administered.
• • In the following cases, Geloplasma should not be administered due to the risk of cross-reactions:
  • • If you know you are allergic to red meat (mammalian meat) or offal.
• If you know you have tested positive for IgE antibodies against the alpha-Gal allergen
• The use of this solutionrequires clinical monitoring and laboratory tests of:

-blood pressure, and possibly central venous pressure (measured through a catheter in a vein leading directly to the heart);

• urine elimination;
• hematocrit (blood volume) and electrolytes (ions present in the blood);

Especially in the following situations:

• congestive heart failure(condition in which the heart cannot pump enough blood to the rest of the body);
• altered pulmonary function;
• severe kidney disease;
• edema with water/salt retention;
• circulatory overload(excess intravascular fluid);
• treatment with corticosteroids or their derivatives;
• important coagulation disorders.

Use of Geloplasma, perfusion solution with other medications

• Do not use other intravenous medications at the same time as Gelosplasma.
• As this solution contains potassium, it is preferable to avoid the use of potassium and medications that may cause an increase in potassium in the blood.

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Use of Geloplasma, perfusion solution with food and drinks

Not applicable.

Pregnancy, lactation and fertility:

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There are no data or limited data on the use of Geloplasma, perfusion solution in pregnant women. Geloplasma, perfusion solution should only be administered if it is clinically necessary. Your doctor will weigh the benefits against the potential risks for the baby.

Lactation

The excretion of Geloplasma in breast milk is unknown. It cannot be ruled out that there is a risk to the baby.

Fertility

There are no data on the effects of Geloplasma, perfusion solution on human or animal fertility.

Driving and operating machinery

Not relevant.

Geloplasma perfusion solution contains:

This medication contains5 mmol of potassiumper liter. Patients with reduced kidney function or those following a potassium-controlled diet should take this into account.

This medication contains150 mmol of sodiumper liter. Patients following a low-sodium diet should take this into account.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The medication will be administered through infusion (intravenous drip). A pump may be used to increase the infusion rate.

The infusion rate, along with the volume infused, will depend on your specific needs.

On average, the amount you will be administered will be500 to1000 ml (1 or 2 bags), sometimes more.

As a general rule, in adults and children with a weight of over 25 kg, 500 ml (1 bag) will be administered at an appropriate infusion rate.

If there is a blood loss greater than 1.5 liters in an adult, blood will generally be administered in addition to Geloplasma, infusion solution.

During treatment, you may undergo tests to ensure that your blood pressure, blood parameters, and coagulation are under control.

If you use more Geloplasma, infusion solution than you should:

High doses may cause excessive blood volume.

An increase in pulmonary circulation pressure may lead to fluid leakage into the extravascular space and may cause fluid accumulation in the lungs (difficulty breathing symptoms).

If a overdose occurs, infusion should be stopped immediately and a rapid-acting diuretic (medication that increases urine output from your body).

If you have any further questions about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare (may affect up to 1 in 1000 people):

Anaphylactic shock (severe allergic reaction).

Skin allergic reactions.

If you notice these effects, immediately inform your doctor or nurse, the infusion will be stopped immediately and the necessary treatment will be administered (see also section 2 “What you need to know before using Geloplasma, infusion solution” especially for allergies related to the galactosa-α-1,3-galactosa(α-Gal),red meat and charcuterie).

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

- Decreased blood pressure

- Decreased heart rate

- Respiratory difficulties

- Fever and chills

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not freeze.

Do not store in the refrigerator.

Once opened: use immediately and discard the unused portion

Do not use this medication if you observe that:

• the packaging is damaged,
• the solution is not transparent,
• the liquid has leaked from the bag.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medications that you no longer need. This will help protect the environment.

Composition of Geloplasma solution for perfusion

The active principles are:

Modified fluid gelatin*

expressed as anhydrous gelatin3,0000 g

Sodium chloride0,5382 g

Magnesium chloride hexahydrate0,0305 g

Potassium chloride0,0373 g

Solution of (S)-sodium lactate

expressed as sodium lactate0,3360 g

per 100 ml of perfusion solution

*partially hydrolyzed and succinylated

The other components are:sodium hydroxide, succinic anhydride as succinic acid, hydrochloric acid, concentrated and water for injectable preparations.

Ionic formula:

Total osmolality: 295 mOsm/kg

pH:5,8 to7,0

Appearance of the product and contents of the package

Geloplasma, perfusion solution is presented in PVC bags (boxes of 1 and 15 bags) or freeflex (polyolefins) of 500 ml with overbag (box with 20 bags).

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:Responsible for manufacturing:

Fresenius Kabi España, S.A.U.Fresenius Kabi France

C/ Marina 16-186, rue du Rempart

08005 BARCELONA27400 Louviers

SPAINFRANCE

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria: GELOPLASMA Infusionslösung

Czech Republic: Geloplasma, infuzní roztok

Estonia: Geloplasma, infusioonilahus

Finland: GELOPLASMA infuusioneste, liuos

France: PLASMION, solution pour perfusion

Germany: Geloplasma Infusionslösung

Hungary: Geloplasma oldatos infúzió

Ireland: GELOPLASMA, solution for infusion

Italy: Infuplas soluzione per infusione

Latvia: Geloplasma škidums infuzijam

Lithuania: GELOPLASMA infuzinis tirpalas

Norway: Geloplasma infusjonsvæske, oppløsning

Poland: GELOPLASMA

Portugal: Geloplasma, Solução para perfusão

Romania: Geloplasma 3 g/100 ml solutie perfuzabila

Slovakia: GELOPLASMA, infúzny roztok

Slovenia: Geloplasma raztopina za infundiranje

Spain: Geloplasma, solución para perfusión

United Kingdom: GELOPLASMA solution for infusion

This leaflet was revised inOctober 2017.

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This information is intended solely for medical professionals or healthcare professionals:

Dosage and method of administration

Dosage

The volume of the dose and the rate of perfusion depend on the patient's condition, circumstances, and response to vascular substitution.

Modified fluid gelatin is administered by intravenous perfusion (infusion in drip). The rate of perfusion can be increased using a pump.

The dose and rate of perfusion depend on the patient's needs and the volume of blood to be replaced and the patient's hemodynamic status.

On average, the dose administered is 500 to 1000 ml (1 or 2 bags), sometimes more.

As a general rule, in adults and children weighing more than 25 kg, 500 ml (1 bag) is administered at an appropriate rate depending on the patient's condition. The rate of perfusion can be increased in case of severe hemorrhage.

If there is a blood/fluid loss greater than1.5 litersin an adult (i.e., greater than 20% of the blood volume) normally blood should be administered in addition to Geloplasma, perfusion solution. The patient's hemodynamic, hematological, and coagulation systems should be monitored.

Pediatric population

See above.

Administration form

The solution must be administered by intravenous route.

Warnings and special precautions for use

Warnings

This solution must not be administered by intramuscular injection.

This gelatin fluid solution must not be perfused at the same time as blood or its derivatives (cell concentrates, plasma, and plasma fractions) but using two separate perfusion systems.

Determination of blood group, irregular antigens, and laboratory blood tests may be possible in patients who have received up to 2 liters of gelatin fluid, although interpretation may be hindered by hemodilution and it is preferable to take samples for these testsbeforethe perfusion of the gelatin fluid.

Precautions

The use of this solution requires clinical and laboratory monitoring of the patient's condition:

• blood pressure, and possibly central venous pressure;
• urine elimination;
• hematocrit and electrolytes.

Especially in the following situations:

• congestive heart failure;
• altered pulmonary function
• severely altered renal function;
• edema with water/salt retention;
• circulatory overload;
• treatment with corticosteroids and their derivatives;
• important coagulation disorders.

The hematocrit must not fall below 25%; in elderly patients it must not fall below 30%. The coagulation of the blood must be avoided due to the dilution of the coagulation factors.

If more than2000 to3000 ml of Geloplasma, perfusion solution are perfused pre- and intra-circumcision, it is recommended to control the post-circumcision serum protein concentration, especially if there are signs of tissue edema.

Overdose

If overdose occurs, stop the perfusion and administer a rapid-acting diuretic.

In case of overdose, the patient should be treated symptomatically and electrolytes should be monitored.

Special precautions for elimination and other manipulations

Ensure proper aseptic handling of the solution

Check that the package is intact and that the solution is transparent before use.

Dispose of any damaged package or solution that has leaked.

The residual volume of the unused solution must not be reused under any circumstances.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.