Geloplasma

Leaflet attached to the packaging: information for the user

GELOPLASMA, solution for infusion

Composite productcontaining
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What is Geloplasma and what is it used for

Geloplasma is a solution for intravenous infusion. It contains gelatin, which belongs to a group of medicines known as plasma volume expanders. Plasma volume expanders work by increasing the volume of fluid in the bloodstream, which helps to stabilize blood circulation and blood pressure.

This medicine is used in emergency medical care to rapidly replenish blood volume in the following situations:

• bleeding (hemorrhage), dehydration, increased vascular permeability (capillary leak syndrome), burns;
• vascular shock (vasodilation) of traumatic, surgical, infectious, or toxic origin.

The medicine is also used to treat low blood pressure (hypotension) caused by medications that lower blood pressure through vasodilation, especially during anesthesia.

2. Important information before using Geloplasma

When not to use Geloplasma:

• if the patient is allergic to gelatin or any other component of the medicine (listed in section 6);
• if the patient is allergic to a substance called galactose-alpha-1,3-galactose (alpha-Gal) or to red meat (mammalian meat) and offal;
• if the patient has fluid overload;
• if the patient has hyperkalemia (elevated potassium levels in the blood);
• if the patient has significant accumulation of alkaline substances (e.g., lactate, bicarbonate) in the blood and body fluids;
• in pregnant women at the end of pregnancy (during labor): see section "Pregnancy, breastfeeding, and fertility".

Warnings and precautions

Before starting treatment with Geloplasma, you should discuss it with your doctor, pharmacist, or nurse.

• The solution must not be administered by intramuscular injection.
• The solution may cause accumulation of alkaline substances in the blood, as it contains lactate ions.
• The solution may not have an alkalizing effect in patients with impaired liver function, as lactate metabolism may be impaired.
• Geloplasma must not be administered together with blood or blood products (red blood cells, plasma, and plasma components); two separate infusion sets must be used.
• Blood grouping and any laboratory blood tests can be performed in patients who have received up to 2 liters of gelatin solution, but it is recommended to take a blood sample for these tests before infusing this solution.
• Due to the possibility of an allergic reaction, it is necessary to closely monitor the patient's condition. If an allergic reaction occurs, the infusion should be stopped immediately and appropriate treatment should be administered.
• Due to the possibility of cross-reactions, Geloplasma should not be administered in the following cases: if the patient is allergic to red meat (mammalian meat) or offal; if the patient has tested positive for the presence of antibodies (IgE) against the alpha-Gal allergen.
• During administration of the solution, the patient's condition should be clinically and laboratory monitored:
• blood pressure and, if possible, central venous pressure (measured using a catheter placed in a vein that leads directly to the heart);
• urine output;
• hematocrit (blood volume) and electrolytes (ions present in the blood). This is especially important if the patient has:
• congestive heart failure (a condition in which the heart cannot supply enough blood to other organs);
• respiratory failure;
• severe renal impairment;
• edema with fluid and/or salt retention;
• overload of the circulatory system with fluids (intravascular fluid overload);
• corticosteroid therapy or their derivatives;
• coagulation disorders.

Geloplasma and other medicines

• It is not recommended to use other intravenously administered medicines with Geloplasma at the same time.
• Since the solution contains potassium ions, it is recommended to avoid administering products containing potassium and medicines that may increase potassium levels in the blood.

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Geloplasma with food and drink

This is not applicable.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

There is limited or no data on the use of Geloplasma in pregnant women. Therefore, Geloplasma should only be used when clinically justified. The doctor will assess the benefit-risk ratio for the fetus.

Breastfeeding

It is not known whether Geloplasma passes into breast milk. A risk to the child cannot be excluded.

Fertility

There is no data on the effect of Geloplasma on human fertility or animal fertility.

Driving and using machines

Geloplasma has a negligible influence on the ability to drive and use machines.

Geloplasma contains potassium and sodium

This medicine contains 5 mmol of potassiumper liter. This should be taken into account in patients with reduced kidney function or those controlling their potassium intake.

This medicine contains 150 mmol of sodiumper liter. This should be taken into account in patients controlling their sodium intake.

3. How to use Geloplasma

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

The patient will receive the medicine by infusion (intravenous drip). The infusion rate can be increased using a pump.

The volume and rate of infusion of the solution depend on the patient's needs.

The average administered volume is 500 to 1000 ml (1 to 2 bags), in some cases more.

As a general rule, 500 ml (1 bag) should be administered to adult patients and children over 25 kg, with a rate depending on the patient's condition.

In case of blood loss or fluid loss of more than 1.5 liters in an adult patient, blood and Geloplasma should usually be administered.

During treatment, blood pressure, blood parameters, and coagulation should be monitored.

Using a higher dose of Geloplasma than recommended

Higher doses of the medicine may lead to circulatory overload.

Increased pressure in the pulmonary circulation can lead to fluid leakage into the extravascular space and may cause pulmonary edema (shortness of breath).

If an overdose occurs, the doctor will immediately stop the infusion and administer a rapidly acting diuretic.

In case of any further doubts related to the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

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

Rare (less than 1 in 1000 patients):

• anaphylactic shock (severe allergic reaction);
• allergic skin reaction. If the above side effects occur, you should immediately inform your doctor or nurse, and the infusion will be stopped and appropriate treatment will be administered (see section "Important information before using Geloplasma", in particular regarding allergy to the alpha-Gal allergen, red meat, and offal).

Very rare (less than 1 in 10,000 patients):

• tetanic hypocalcemia;
• bradycardia (slow heart rate);
• breathing difficulties;
• fever, chills.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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

e-mail: ndl@urpl.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Geloplasma

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Do not freeze.

Do not store in a refrigerator.

After opening: use immediately, any unused solution should be discarded.

Do not use this medicine if:

• the packaging is damaged;
• the solution is not clear;
• part of the liquid has been withdrawn.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Geloplasma contains

• The active substances of the medicine are: modified liquid gelatin* in an 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 (S)-lactate, solution in an amount expressed as sodium (S)-lactate 0.3360 g per 100 ml of infusion solution

* partially hydrolyzed and succinylated

• The other ingredients are: sodium hydroxide, anhydrous succinic acid (in the form of succinic acid), hydrochloric acid, water for injections.

Ion content:

Sodium: 150 mmol/l

Potassium: 5 mmol/l

Magnesium: 1.5 mmol/l

Chloride: 100 mmol/l

Lactate: 30 mmol/l

Total osmolality: 295 mOsm/kg

pH: 5.8 to 7.0

What Geloplasma looks like and contents of the packaging

Geloplasma is available in a flexible PVC bag or a freeflex(polyolefin) bag with a capacity of 500 ml, in an outer bag.

Available pack sizes: 15 flexible PVC bags of 500 ml, in outer bags, or 20 freeflex(polyolefin) bags of 500 ml, in outer bags.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134

02-305 Warsaw

Manufacturer

Fresenius Kabi France

6 rue du Rempart 27400 Louviers

France

To obtain more detailed information, you should contact the marketing authorization holder:

Fresenius Kabi Polska Sp. z o.o.

Al. Jerozolimskie 134

02-305 Warsaw

tel.: +48 22 345 67 89

This medicinal product 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

Spain:

Geloplasma, solución para perfusión

Ireland:

GELOPLASMA, solution for infusion

Lithuania:

GELOPLASMA infuzinis tirpalas

Latvia:

Geloplasma šķīdums infūzijām

Germany:

Geloplasma Infusionslösung

Norway:

Geloplasma infusjonsvæske, oppløsning

Poland:

GELOPLASMA

Portugal:

Geloplasma, Solução para perfusão

Romania:

Geloplasma 3 g/100 ml soluție perfuzabilă

Slovakia:

GELOPLASMA, infúzny roztok

Slovenia:

Geloplasma raztopina za infundiranje

Hungary:

Geloplasma oldatos infúzió

United Kingdom:

GELOPLASMA, solution for infusion

Italy:

Infuplas soluzione per infusione

Date of last revision of the leaflet:09.01.2018

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Information intended for healthcare professionals only:

Dosage and administration

Dosage

The volume and rate of administration of the solution depend on the patient's condition, circumstances, and response to volume replacement.

Modified liquid gelatin should be administered by intravenous infusion. The infusion rate can be increased using a pump.

The dose and infusion rate depend on the patient's needs, the volume of blood replaced, and the patient's hemodynamic performance.

The average administered dose is 500 to 1000 ml (1 to 2 bags), in some cases more.

As a general rule, 500 ml (1 bag) should be administered to adult patients and children over 25 kg, with a rate depending on the patient's condition. The infusion rate can be increased if there is severe bleeding.

In case of blood loss and/or fluid loss of more than 1.5 liters in an adult patient (i.e., more than 20% of blood volume), blood and Geloplasma should usually be administered. Hemodynamic parameters, blood tests, and coagulation should be monitored.

Children and adolescents

See above.

Administration

Intravenous administration.

Special warnings and precautions for use

Warnings

This medicine must not be administered by intramuscular injection.

The gelatin solution must not be administered together with blood or blood products (red blood cells, plasma, and plasma components), but two separate infusion sets must be used.

Blood grouping and any laboratory blood tests can be performed in patients who have received up to 2 liters of gelatin solution. However, due to the effect of hemodilution on test results, it is recommended to take a blood sample for these tests before infusing the gelatin solution.

Precautions

During administration of this solution, the patient's condition should be clinically and laboratory monitored:

• blood pressure and, if possible, central venous pressure;
• urine output;
• hematocrit and electrolytes.

This is especially important if the patient has:

• congestive heart failure;
• respiratory failure;
• severe renal impairment;
• edema with fluid and/or salt retention;
• overload of the circulatory system with fluids;
• corticosteroid therapy or their derivatives;
• coagulation disorders.

Hematocrit should not decrease below 25%; in elderly patients, below 30%.

Disorders of coagulation caused by dilution of coagulation factors should be avoided.

If more than 2000 to 3000 ml of Geloplasma is administered before or during surgery, it is recommended to check the plasma protein concentration after surgery, especially if there are symptoms of tissue edema.

Overdose

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

In case of overdose, symptomatic treatment should be administered and electrolyte levels should be monitored.

Special precautions for disposal and preparation of the medicinal product

The solution should be used in accordance with aseptic principles.

Before use, you should check if the packaging is intact and the solution is clear.

Any damaged packaging or solution from which part of the liquid has been withdrawn should be discarded.

Under no circumstances should the remaining solution be reused after infusion.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.