GELOPLASMA, SOLUTION FOR INFUSION

2. What you need to know before you use Geloplasma, solution for infusion

Do not use GELOPLASMA, solution for infusion:

• if you are allergic to gelatins or any of the other components of this medicine (listed in section 6);
• if you are allergic to an allergen called galactosa-α-1,3-galactosa (alpha-Gal) or to red meat (mammal meat) and offal;
• in case of excess body fluid;
• in case of hyperkalemia (excess potassium in the blood);
• in case of high accumulation of alkaline substances (such as bicarbonate or lactate) in your blood and body fluid;
• at the end of pregnancy (during childbirth): see the section "Pregnancy, breastfeeding, and fertility".

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Geloplasma, solution for infusion.

• This solution must not be administered by intramuscular injection.

• 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 action in patients with altered hepatic function, as lactate metabolism may be altered.
• Geloplasma must not be administered at the same time as blood or its derivatives (cell concentrates, plasma, and plasma fractions), unless two separate infusion systems are used.
• You may have your blood group and other hematological tests determined if you have received up to 2 liters of gelatin fluid, but it is preferable to take the sample for these tests before perfusion of this solution.
• Due to the possibility of an allergic reaction, it is necessary to keep you under observation. If an allergic reaction occurs, the infusion should be interrupted immediately and appropriate treatment should be 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 (mammal meat) or offal.
• If you know you have tested positive for antibodies (IgE) against the alpha-Gal allergen
• The use of this solution requires clinical monitoring and laboratory testsfor:

• Blood pressure, and possibly central venous pressure (measured by a catheter in a vein that leads directly to the heart);
• Urinary elimination;
• Hematocrit (blood volume) and electrolytes (ions present in the blood)

Especially in the following situations:

• congestive heart failure;
• altered pulmonary function;
• severe kidney disease;
• edema with water/salt retention;
• circulatory overload;
• treatment with corticosteroids or their derivatives;
• important coagulation disorders.

Using Geloplasma, solution for infusion with other medicines

• It is not recommended to use other intravenous medicines at the same time as Geloplasma.
• Since this solution contains potassium, it is preferable to avoid the use of potassium and medicines that may cause an increase in potassium in your blood.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Using Geloplasma, solution for infusion with food and drinks

This is not applicable.

Pregnancy, breastfeeding, and fertility:

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are limited data on the use of Geloplasma, solution for infusion in pregnant women. Geloplasma, solution for infusion should only be used if clinically necessary. Your doctor will weigh the benefits against the potential risks to the baby.

Breastfeeding

It is unknown whether Geloplasma is excreted in breast milk. A risk to the baby cannot be excluded.

Fertility

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

Driving and using machines

This is not relevant.

Geloplasma solution for infusion contains:

This medicine contains 5 mmol of potassiumper liter. Patients with reduced kidney function or patients who are on a potassium-controlled diet should take this into account.

This medicine contains 150 mmol of sodiumper liter. Patients who are on a low-sodium diet should take this into account.

3. How to use Geloplasma, solution for infusion

Follow exactly the administration instructions of this medicine given by your doctor. Ask your doctor or pharmacist if you have any doubts.

The medicine will be administered by infusion (intravenous drip). A pump can be used to increase the infusion rate.

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

On average, the amount administered will be 500 to 1000 ml (1 or 2 bags), sometimes more.

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

If there is a blood loss of more than 1.5 liters in an adult, blood will usually be administered in addition to Geloplasma, solution for infusion.

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

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

High doses may cause your blood volume to be excessive.

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

If an overdose occurs, the infusion should be stopped immediately and a rapid-acting diuretic should be administered.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Anaphylactic shock (severe allergic reaction).

Allergic skin reactions.

If you notice these effects, inform your doctor or nurse immediately, the infusion will be stopped immediately, and the necessary treatment will be administered (see also section 2 "What you need to know before you use Geloplasma, solution for infusion" especially for allergies related to the alpha-Gal allergen, red meat, and offal).

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

• Decrease in blood pressure
• Decrease in heart rate
• Breathing difficulties
• Fever and chills

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Geloplasma, solution for infusion

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Do not freeze.

Do not store in a refrigerator.

Once opened: use immediately and discard the unused portion

Do not use this medicine if you notice:

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Geloplasma solution for infusion

The active substances are:

Modified fluid gelatin*

amount expressed as anhydrous gelatin 3,0000 g

Sodium chloride 0,5382 g

Magnesium chloride hexahydrate 0,0305 g

Potassium chloride 0,0373 g

Sodium lactate solution

amount expressed as sodium lactate 0,3360 g

per 100 ml of solution for infusion

*partially hydrolyzed and succinylated

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

Ionic formula:

Total osmolality: 295 mOsm/kg

pH: 5,8 to 7,0

Appearance of the product and pack contents

Geloplasma, solution for infusion 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 pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Manufacturer:

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

C/ Marina 16-18 6, rue du Rempart

08005 BARCELONA 27400 Louviers

SPAIN FRANCE

This medicine is authorized in the Member States of the European Economic Area under 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 šķidums infuzijām

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 last revised in October 2017.

-----------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Posology and method of administration

Posology

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

The modified fluid gelatin is administered by intravenous infusion (drip infusion). The infusion rate can be increased using a pump.

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

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

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

If there is a blood loss of more than 1.5 liters in an adult (i.e., more than 20% of the blood volume), blood should usually be administered in addition to Geloplasma, solution for infusion. The hemodynamic, hematological, and coagulation systems should be monitored.

Pediatric population

See above.

Method of administration

The solution should be administered intravenously.

Special warnings and precautions for use

Warnings

This solution must not be administered by intramuscular injection.

This gelatin fluid solution must not be infused at the same time as blood or its derivatives (cell concentrates, plasma, and plasma fractions) unless two separate infusion systems are used.

Determination of blood group, irregular antigens, and laboratory blood tests are 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 the sample for these tests before 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;
• urinary 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 should not fall below 25%; in elderly patients, it should not fall below 30%. Alterations in blood coagulation caused by the dilution of coagulation factors should be avoided.

If more than 2000 to 3000 ml of Geloplasma, solution for infusion are infused pre- and intra-surgery, it is recommended to check the post-surgery serum protein concentration, especially if there are signs of tissue edema.

Overdose

If an overdose occurs, the infusion should be stopped and a rapid-acting diuretic should be administered.

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

Special precautions for disposal and other handling

Aseptic handling of the solution must be ensured.

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

Discard any container that is damaged or from which liquid has leaked.

The residual volume of the solution remaining after infusion must not be reused under any circumstances.

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