Gelaspan solution for infusion – patient leaflet, side effects, dosage

1. What Gelaspan is and what it is used for

Gelaspan is a so-called plasma volume substitute. This means that it replaces fluid lost from your blood vessels.

Gelaspan is used to:

• Replace blood and body fluid, which have been lost following for example, an operation, an accident or a burn. It may be combined with blood transfusions, if necessary.
• Prevention of low blood pressure (hypotension) which may occur when you are receiving spinal or epidural anaesthesia or due to imminent severe blood loss in a surgical setting.
• Fill up the circulating blood volume during the use of for example heart-lung machine in combination with other fluids for infusion

2. What you need to know before you use Gelaspan

Do not use Gelaspan

• if you are allergic to gelatin or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to an allergen called “galactose-α-1,3-galactose (alpha-Gal)” or to red meat (mammal meat) and offal
• if your circulating blood volume is too large
• if you have too much water in your body
• if you have certain types of heart failure (acute congestive heart failure)
• if you have an abnormally high blood potassium level.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Gelaspan

Please inform your doctor

• if you suffer from allergic disease such as asthma. Then you may be at a greater risk of experiencing an allergic reaction

• in these cases, Gelaspan should not be given to you due to possible cross-reactions:

  • if you know you have an allergy to red meat (mammal meat) or offal
  • if you have been tested positive to antibodies (IgE) against the allergen alpha-Gal

Your doctor will take special care of your situation if you suffer from

• heart problems
• high blood pressure
• water on your lungs
• severe kidney problems

Giving large amounts of liquids through an intravenous drip may worsen your condition.

Your doctor will also exercise caution

• if you have a severe increase of sodium or chloride in your blood
• if you retain water and salt, which may be associated with tissue swelling
• if you have too much potassium in your blood or if you are taking or receiv-ing medicines that make you retain potassium
• if your blood clotting is severely impaired
• if you are elderly.

While receiving Gelaspan, your blood composition will be monitored. If neces-sary, your doctor may also give you other medications such as salts and fluids.

Children:

There is only little experience regarding the use of Gelaspan in children. The doctor will only administer this medicine to children when considered absolutely necessary.

Laboratory test results

Your doctor can take blood or urine samples before giving you Gelaspan. This is because some laboratory test results may be affected after you have received this medication and are therefore unreliable.

Other medicines and Gelaspan

Please tell your doctor or pharmacist if you are taking or using or have recent-ly taken or used any other medicines, including medicines obtained without a prescription.

In particular your doctor should know if you are taking or receiving medicines that make you retain sodium (e.g. spironolactone, triamterene, amiloride; ACE-inhibitors like captopril or enalapril, corticosteroids like cortisone or non-steroidal anti-inflammatory agents like diclofenac). Concomitant administra-tion with this medicine might lead to swelling of arms, hands, legs and feet (oedema). In addition, please inform your doctor if you are taking medications that make you lose potassium such as medicines that increase water loss.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are plan-ning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

If you are pregnant, please inform your doctor. Due to possible allergic reac-tions the use of this medicine should be avoided during pregnancy. However, your doctor may give you this medicine in emergency situations

Breast-feeding

If you are breast-feeding, please inform your doctor. There is limited informa-tion about excretion of this medicine in breast-milk. Your doctor will decide whether to discontinue breast-feeding or to discontinue this medicine taking into account the benefit of breast-feeding for the child and the benefit of ther-apy for yourself.

Fertility

There are no data on the effect of this medicine on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that it will affect fertility.

Driving and using machines

This medicinal product does not influence your ability to drive or use machines.

3. How to use Gelaspan

Your doctor only will give you Gelaspan, if they consider that other products called crystalloids are not sufficient alone.

Your doctor will adjust the dose of Gelaspan carefully in order to prevent fluid overload. This will be done especially if you have problems with your lungs or with your heart or circulation.

Dosage

Gelaspan is given intravenously, i.e. by a drip.

Adults

How much you are given and for how long will depend on how much blood or fluid you have lost and on your condition.

The doctor will carry out tests (on blood and blood pressure, for example) dur-ing treatment, and the dose of Gelaspan will be adjusted according to the patients needs. If necessary you may also receive blood or packed red blood cells

Use in children

There is only little experience of the use of this medicine in children. Your doc-tor will only administer this medicine if they consider it essential for the child’s recovery. In those cases, the clinical condition will be taken into account and therapy will be monitored especially carefully.

If you received more Gelaspan than you should

An overdose of Gelaspan may cause too high blood volume (hypervolaemia) and fluid overload that may affect your heart and lung function. You may notice headaches and difficulties breathing.

If an overdose occurred your doctor will give you any necessary treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

SUMMARY OF PRODUCT CHARACTERISTICS

B. Braun Melsungen AG · 34209 Melsungen, Germany

PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Melsungen AG · 34209 Melsungen, Germany

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Gelaspan solution for infusion

Gelaspan solution for infusion

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SPC; 8.5 PIL

The following information is intended for health-care professionals only:

Precautions for use

Gelaspan must not be infused through the same infusion line together with blood or blood products (packed cells, plasma and plasma fractions). During compensation of severe blood losses by infusions of large amounts of Gelaspan, haematocrit and electrolytes must be monitored. The haematocrit should not decrease below 25 %. In elderly or critically ill patients it should not fall below 30 %.

Likewise in those situations the dilution effect on coagulation factors should be observed, especially in patients with existing disorders of haemostasis. Because the product does not substitute lost plasma protein, it is advisable to check the plasma protein concentrations.

In severe, acute situations, Gelaspan may be infused rapidly by pressure infu-sion, 500 ml can be administered in 5 – 10 minutes, until signs of hypovolaemia are relieved.

Before rapid infusion, Gelaspan may be warmed to not more than 37°C. In cases of pressure infusion which might be necessary in vital emergencies, all

air must be removed from the container and the infusion set before the solu-tion is administered. This is to avoid the risk of air embolism that might other-wise be associated with the infusion.

Influence on laboratory tests

Laboratory blood tests (blood group or irregular antibodies) are possible after Gelaspan infusions. Nevertheless it is recommended to draw blood samples before the infusion of Gelaspan in order to avoid hampered interpretation of results.

Gelaspan may have an influence on the following clinical-chemical tests, lead-ing to falsely high values:

• erythrocyte sedimentation rate,
• specific gravity of urine,
• unspecific protein assays, e.g. the Biuret method.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

B. Braun Melsungen AG

34209 Melsungen, Germany

B. Braun Melsungen AG

34209 Melsungen

Germany

Breastfeeding

It is unknown whether Gelaspan/metabolites are excreted in human milk. Sodium and chloride are normal constituents of the human body and of food. No significant increase in the content of these electrolytes in mother’s milk is expected following the use of Gelaspan. A decision must be made whether to discontinue breast-feeding or to dis-continue/abstain from Gelespan therapy taking into account the benefit of breast feed-ing for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effect of Gelaspan on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that Gelaspan will affect fertility.

4.7 Effects on ability to drive and use machines

Gelaspan has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects

Undesirable effects are listed according to their frequencies as follows: Very common: (≥ 1/10)

Common: (≥ 1/100 to < 1/10)

Uncommon: (≥ 1/1,000 to < 1/100)

Rare: (≥ 1/10,000 to < 1/1,000)

Very rare: (< 1/10,000)

Not known: (cannot be estimated from the available data)

Summary of the safety profile

Adverse drug reactions can occur during and after the use of Gelaspan. These will usu-ally involve anaphylactic/anaphylactoid reactions of varying severity (see also sections 4.3 and 4.4, notably for hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) and allergy to red meat and offal).

Tabulated list of adverse reactions

Immune system disorders

Rare: Anaphylactic/anaphylactoid reactions up to shock (see section 4.4). Cardiac disorders

Very rare: Tachycardia

Vascular disorders

Very rare: Hypotension

General disorders and administration site conditions

Very rare: Fever, chills

Gastro intestinal disorders

Unknown: Nausea, vomiting, abdominal pain

Investigations

Unknown: Oxygen saturation decreased

Blood and lymphatic system disorders

Very common:

Decreased haematocrit and reduced concentration of plasma proteins. Common (depending on the administered dose):

Relatively large doses of Gelaspan result in dilution of coagulation factors and can therefore affect blood coagulation. Prothrombin time can be increased and activated partial thromboplastin time (aPTT) can be prolonged after administration of large doses of Gelaspan (see section 4.4).

Information on particular undesirable effects

Mild anaphylactoid reactions include:

Generalised erythema, urticaria, periorbital oedema, or angiooedema. Moderate anaphylactoid reactions include:

Dyspnoea, stridor, wheeze, nausea, vomiting, dizziness (presyncope), diaphoresis, chest or throat tightness, or abdominal pain.

Severe anaphylactoid reactions include:

Cyanosis or SaO₂ ≤ 92% at any stage, hypotension (systolic blood pressure < 90 mmHg in adults), confusion, collapse, loss of consciousness or incontinence. In the event of an anaphylactoid reaction, the infusion must be discontinued immedi-ately and the usual acute treatment given.

Paediatric population

There are no data relating to a special pattern or incidence of adverse reactions in pae-diatric patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms

Overdose of Gelaspan may cause hypervolaemia and circulatory overload with a signif-icant fall in haematocrit and plasma proteins, accompanied by an electrolyte and acid base imbalance. This may be associated with consecutive impairment of heart and lung function (pulmonary oedema). Symptoms of circulatory overload are e.g. headache, dys-pnoea, and jugular vein congestion.

Treatment

In case circulatory overload appears the infusion must be stopped and a rapid-acting diuretic should be given. If an overdose occurs, the patient should be treated sympto-matically and electrolytes should be monitored with monitoring of electrolytes. 5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmaco-therapeutic group

Blood substitutes and plasma protein fractions

ATC code: B05A A06, gelatine agents.

Mechanisms of action

Gelaspan is a 40 mg/ml solution of succinylated gelatine (also known as modified fluid gelatine) with an average molecular weight of 26, 500 Dalton (weight average) in a plasma–adapted, balanced isotonic electrolyte solution. The negative charges introduced into the molecule by succinylation cause an expansion of the molecule. The molecular volume is therefore higher than that of unsuccinylated gelatin of the same molecular weight.

In healthy volunteers, the measured initial volume effect of modified fluid gelatine was found to be between 80 and 100% of the infused volume with a volume effect over 4 – 5 hours.

The colloid-osmotic pressure of the solution determines its initial volume effect. The duration of the effect depends on the clearance of the colloid mainly by renal excretion. Since the volume effect of Gelaspan is equivalent to the administered amount of solu-tion, Gelaspan is a plasma substitute, not a plasma expander. The solution also restores the extravascular compartment, and does not disturb the electrolyte balance of the extracellular space.

Gelaspan contributes in the restoration of electrolyte balance and the correction of aci-dosis. Gelaspan is lactate free and can be used in patients with liver diseases. As a pre-cursor of bicarbonate the solution contains acetate which is metabolisable in all organs and muscles.

Pharmacodynamic effect:

Gelaspan substitutes intra- and extravascular volume deficits caused by losses of blood, plasma and interstitial fluid. Thus the mean arterial pressure, the left-ventricular end-diastolic pressure, the cardiac stroke volume, the cardiac index, the oxygen supply, the microcirculation and the diuresis are increased without dehydrating the extravascular space.

Paediatric population

No studies have been performed in the paediatric population with Gelaspan. Therefore, the efficacy and safety of Gelaspan in the paediatric population cannot be assessed. 5.2 Pharmacokinetic properties

Distribution

After infusion, Gelaspan is rapidly distributed in the intravascular compartment. Biotransformation/elimination

Most of the infused modified fluid gelatine is excreted via the kidneys. Only a minor amount is excreted in faeces and not more than about 1 % is metabolised. The smaller molecules are excreted directly by glomerular filtration while the larger molecules are first degraded proteolytically and secondly are excreted via kidneys. Pharmacokinetics in special clinical situations

The plasma half-life of modified fluid gelatine may be prolonged in patients on haemodialysis (GFR < 0.5 ml/min), however no accumulation of gelatine is observed. Gelaspan minimizes the risks of dilutional acidosis and rebound alkalosis as observed with lactate containing solutions infused to patients with liver diseases. Gelaspan con-tains acetate and is lactate free. It therefore can also be indicated in hypovolaemic patients with liver disease.

5.3 Preclinical safety data

No additional concerns identified.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium hydroxide (for pH adjustment),

Hydrochloric acid, diluted (for pH-adjustment),

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

• Unopened

Polyethylene containers “Ecoflac plus”: 2 years

Plastic bags “Ecobag” (non-PVC): 2 years

• After first opening the container

The infusion should commence immediately after connecting the container to the giv-ing set.

• After admixture of an additive

Not applicable (see section 6.2)

6.4 Special precautions for storage

Do not store above 25 °C. Do not freeze.

6.5 Nature and contents of container

Gelaspan is supplied in:

• Bottles of low-density polyethylene “Ecoflac plus”, contents: 500 ml available in packs of 10 × 500 ml

• Plastic bags “Ecobag” (non-PVC), sealed with halogenbutyl rubber stoppers contents: 500 ml

  available in packs of 20 × 500 ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

The product is supplied in containers for single use only. Unused contents of an opened container must be discarded.

Only to be used if solution is clear and free of precipitate and the container undamaged. Use immediately after connecting container to the giving set.

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

7 MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Postal address

34209 Melsungen

8 MARKETING AUTHORISATION NUMBER(S)

PL 03551/0120

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/06/2011

10 DATE OF REVISION OF THE TEXT

May 2021

All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very few cases also become severe. Such reactions are assumed to be more frequent in patients with known allergic conditions such as asthma. For that reason you will be under close observation by a health professional, especially at the beginning of the infusion.

The following side effects may be serious. If any of the following side effects occur, consult a doctor immediately:

Rare (may affect up to 1 in 1 000 people:

allergic (anaphylactic/anaphylactoid) reactions, including e.g. difficulty breath-ing, wheeze, nausea, vomiting, dizziness, sweating, chest or throat tightness, stomach ache, swelling of neck and face.

If an allergic reaction occurs your infusion will be stopped immediately and you will be given any necessary treatment (see also section 2 “What you need to know before you use Gelaspan”, notably for allergies involving the allergen called galactose-α-1,3-galactose (alpha-Gal), red meat and offal).

Other side effects include:

Very common (may affect up to 1 in 10 people):

• a decrease of red blood cells and proteins in your blood

Common (may affect up to 1 in 100 people):

• your blood may not clot as well as before and you may notice more bleeding

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

• quickening of the heartbeat
• low blood pressure
• fever, chills

Unknown (frequency cannot be estimated from the available data):

• feeling sick, being sick, stomach pain
• a decrease of oxygen in your blood which may make you feel dizzy

Additional side effects in children

There are no data relating a difference in side effects in children

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By report-ing side effects you can help provide more information on the safety of this medicine.

5. How to store Gelaspan

Keep out of the reach and sight of children.

Do not use Gelaspan after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month. Do not store above 25 °C. Do not freeze.

Do not use Gelaspan if you notice:

• cloudiness or discolouration of the solution
• leaking of the container.

Previously opened or partly used Gelaspan should be thrown away. Partially used bottles or bags should not be reconnected.

6. Contents of the pack and other information

What Gelaspan contains

Active substances:

1000 ml of the solution contain:

Succinylated (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

The other ingredients are:

Water for injections, hydrochloric acid, diluted (for pH-adjustment) and sodium hydroxide (for pH adjustment).

What Gelaspan looks like and contents of the pack

Gelaspan is a solution for infusion administered through an intravenous drip (a drip into a vein).

It is a clear colourless or slightly yellowish sterile solution.

Gelaspan is supplied in:

• Bottles of low-density polyethylene “Ecoflac plus”, contents: 500 ml available in packs of 10 × 500 ml
• Plastic bags “Ecobag” (non-PVC), sealed with rubber stoppers, contents: 500 ml available in packs of 20 × 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Postal address

34209 Melsungen

Phone: +49-5661-71-0

Fax: +49-5661-4567

Manufacturer responsible for batch release UK

B. Braun Medical Limited

Brookdale Road

Thorncliffe Park Estate

Chapeltown

Sheffield

S35 2PW

United Kingdom

Manufacturer responsible for batch release ES & PT

B. Braun Medical S.A.

Carretera de Terrassa, 121

08191 Rubi (Barcelona)

Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (GB and NI) under the following names:

Austria Gelofusin Iso 40mg/ml Infusionslösung Belgium Isogelo oplossing voor infusie, solution pour perfu-sion, Infusionslösung

Bulgaria Gelofusine Balance 4% solution for Infusion Czech Republic Gelaspan 4%

Germany Gelafundin ISO 40mg/ml Infusionslösung Denmark Gelaspan

Estonia Gelaspan infusioonilahus 4%

Greece Gelaspan solution for Infusion 4% Spain Gelaspan 40mg/ml solución para perfusión France Gelaspan, solution pour perfusion Hungary Gelaspan 4% oldatos infúzió

Ireland Gelaspan Solution for Infusion

Italy Gelaspan

Lithuania Gelaspan 4% infuzinis tirpalas

Luxembourg Gelafundin ISO 40mg/ml Infusionslösung Latvia Gelaspan 4% Solution for Infusion Malta Gelaspan 4% Solution for Infusion Norway Gelaspan

Netherlands Gelaspan, oplossing voor infusie Portugal Gelaspan

Poland Gelaspan

Romania Gelaspan 40 mg/ml solutie perfuzabila Sweden Gelaspan

Slovenia Gelaspan 40 mg/ml raztopina za infundiranje Slovakia Gelaspan 4%

United Kingdom (GB and NI) Gelaspan solution for infusion

This leaflet was last revised in July 2024

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B|BRAUN

Schwarz

210x700 mm

0343/12632950/0724

Lätus: 2892

Großbritannien

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