Pharmacy Guide

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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Gelaspan solution for infusion

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Succinylated gelatin, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Succinylated gelatin, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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 take it

e 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 1

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 receiving 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 necessary, 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 recently 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 administration 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 planning 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 reactions 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 information 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 therapy for yourself.

2

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 to take it

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) during 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 doctor 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. 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: 3

Rare (may affect up to 1 in 1,000 people): allergic (anaphylactic/anaphylactoid) reactions, including e.g. difficulty breathing, 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 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 reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

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.

4

6.

Contents of the pack and other information

What Gelaspan contains Active substances: 1000 ml of the solution contain: Succinylated (modified fluid) gelatine Sodium chloride Sodium acetate trihydrate Potassium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate

40.0 g 5.55 g 3.27 g 0.30 g 0.15 g 0.20 g

Electrolyte concentrations Sodium Chloride Potassium Calcium Magnesium Acetate

151 mmol/l 103 mmol/l 4 mmol/l 1 mmol/l 1 mmol/l 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

5

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 perfusion, 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. 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). 6

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 infusion, 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 solution is administered. This is to avoid the risk of air embolism that might otherwise 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, leading 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.

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Frequently asked questions about Gelaspan solution for infusion

How do I take Gelaspan solution for infusion?

Gelaspan solution for infusion comes as infusion. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Gelaspan solution for infusion?

The active substance in Gelaspan solution for infusion is succinylated gelatin, sodium chloride, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Gelaspan solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Gelaspan solution for infusion without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

  • Source: electronic medicines compendium (emc), Datapharm
  • Active substance: succinylated gelatin, sodium chloride, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Calcium chloride dihydrate (39 medicines), Potassium chloride (66 medicines), Sodium chloride (98 medicines), Succinylated gelatin, sodium chloride, sodium acetate trihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Gelaspan is a colloidal plasma volume substitute in an isotonic, fully balanced electrolyte solution for:

● Treatment of relative or absolute hypovolaemia and shock

• Prophylaxis of hypotension

- caused by relative hypovolaemia during induction of epidural or spinal anaesthesia

- due to imminent significant blood loss in a surgical setting

● Procedures involving extracorporeal circulation as a component of priming fluid in combination with crystalloid solutions (e.g. heart-lung machine)

4.2. Posology and method of administration

As with all colloids, Gelaspan should only be used if hypovolaemia can not be sufficiently treated with crystalloids alone. In severe hypovolaemia colloids are usually applied in combination with crystalloids.

Volume overload due to overdose or too rapid infusion must always be avoided. The dosage must be adjusted carefully, particularly in patients with pulmonary or cardiocirculatory problems.

Posology

Dosage and infusion rate are adjusted according to the amount of blood loss and to individual needs for restoration and maintenance of a stable haemodynamic situation, respectively. The dose administered is initially 500 to 1000 ml on average, in case of severe blood loss higher doses can be applied.

Adults

In adults, 500 ml is administered at an appropriate rate depending on the haemodynamic status of the patient. In the case of more than 20 per cent blood loss usually blood or blood components should be given in addition to Gelaspan (see 4.4).

Maximum dose:

The maximum daily dose is determined by the degree of haemodilution. Care must be taken to avoid a decrease of haemoglobin or the haematocrit below critical values.

If necessary, blood or packed red cells must be transfused additionally.

Attention must also be paid to the dilution of plasma proteins (e.g. albumin and coagulation factors), which must be adequately substituted if necessary.

Infusion rate:

Up to the first 20 ml of solution should be infused slowly in order to detect anaphylactic/anaphylactoid reactions as early as possible. (see also section 4.4).

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

Paediatric population

The safety and efficacy of Gelaspan in children have not yet been completely established. Therefore, no recommendation on a posology can be made. Gelaspan should only be administered to these patients if the expected benefits clearly outweigh potential risks. In those cases the patient's prevailing clinical condition should be taken into account and the therapy should be monitored especially carefully. (See also section 4.4.)

Elderly patients

Caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that are frequently associated with advanced age (see also section 4.4).

Method of administration

Intravenous use

Before rapid infusion, Gelaspan may be warmed to not more than 37°C.

In case of pressure infusion, which might be necessary in vital emergencies, all air must be removed from the container and the infusion set before the solution is administered. This is to avoid the risk of air embolism that might otherwise be associated with the infusion.

4.3. Contraindications

• hypersensitivity to gelatin containing solutions or to any of the excipients listed in section 6.1.

• hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal (see section 4.4)

• hypervolaemia

• hyperhydration

• Acute congestive cardiac failure

4.4. Special warnings and precautions for use

Anaphylactic/ anaphylactoid reactions

Modified fluid gelatine solutions should be administered with caution to patients with a history of allergic diseases, e.g. asthma.

Modified fluid gelatine solutions may rarely cause allergic (anaphylactic/anaphylactoid) reactions of varying degrees of severity. In order to detect the occurrence of an allergic reaction as early as possible, the first 20 ml should be infused slowly and the patient should be under careful observation especially at the beginning of the infusion. For symptoms of anaphylactoid reactions, see section 4.8.

Due to possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (alpha-Gal), the risk of sensitization and consequent anaphylactic reaction to gelatin-containing solutions could be highly increased in patients with history of allergy to red meat (mammal meat) and offal and/or tested positive for anti-alpha-Gal IgE antibodies. Gelatin-containing colloidal solutions are contraindicated in these patients (see section 4.3).

In case of an allergic reaction, the infusion must be stopped immediately and appropriate treatment given.

Pre-existing conditions to be considered

Gelaspan should be administered only with caution to patients

● at risk due to circulatory overload e.g. patients with congestive heart failure, right or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oligo- or anuria.

● with severely impaired renal function

● with severe hypernatraemia

● with severe hyperchloraemia

● with oedema with water/salt retention

● with major blood coagulation disorders

● in case of pre-existing hyperkalaemia, caution should be exercised and the solution should only be administered if it is clear that the benefits outweigh the risks.

● taking medicinal products that can increase the serum potassium level, i.e. potassium-sparing diuretics, ACE inhibitors, non-steroidal anti-inflammatory agents, cyclosporine, tacrolimus or suxamethonium. The concomitant administration of potassium-containing solutions and these drugs may lead to severe hyperkalaemia, which may in turn lead to cardiac arrhythmia.

● of advanced age (elderly patients) as these are more prone to develop disorders such as cardiac or renal insufficiency

Monitoring

Clinical monitoring should include regular checks of serum electrolyte concentrations, acid-base balance and water balance, in particular in patients with hypernatraemia, hyperchloraemia, hypercalcaemia, hyperkalaemia or impairment of renal function. Gelaspan contains supraphysiological concentration of sodium (151 mmol/L).

Electrolytes and fluids should be substituted according to individual requirements if necessary.

The haemodynamic, haematological and coagulation system should be monitored.

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, see also section 4.2, “Maximum dose”.

Incompatibility

Gelaspan must not be infused through the same infusion line together with blood or blood products (packed cells, plasma and plasma fractions).

Paediatric population

There is no sufficient experience with the use of Gelaspan in children. Therefore Gelaspan should only be administered to these patients if the expected benefits clearly outweigh potential risks. (See also section 4.2)

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, leading to falsely high values:

– erythrocyte sedimentation rate,

– specific gravity of urine,

– unspecific protein assays, e.g. the biuret method.

4.5. Interaction with other medicinal products and other forms of interaction

Caution should be exercised in patients concurrently taking or receiving medicinal products that can cause sodium retention (e.g. corticosteroids, non-steroidal anti-inflammatory agents) as concomitant administration may lead to oedema.

Administration of potassium can reduce the therapeutic effect of cardiac glycosides.

ACTH, corticosteroids and loop diuretics can increase the renal elimination of potassium.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Gelaspan in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

Due to the limited data available and the possibility of severe anaphylactic/anaphylactoid reactions with consecutive foetal and neonatal distress due to maternal hypotension, the use of modified fluid gelatin solutions during pregnancy should be restricted to emergency situations.

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 discontinue/abstain from Gelespan therapy taking into account the benefit of breast feeding 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 usually 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 immediately and the usual acute treatment given.

Paediatric population

There are no data relating to a special pattern or incidence of adverse reactions in paediatric 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 significant 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, dyspnoea, 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 symptomatically and electrolytes should be monitored with monitoring of electrolytes.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Succinylated gelatin, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • GELOPLASMA 3 g/100 ml prescription partial — not the same combinationGELATINUM · injection / infusion
  • GELASPAN 40 mg/ml prescription partial — not the same combinationGELATINUM · injection / infusion
  • GELOFUSINE 4 g/100 ml prescription partial — not the same combinationGELATINUM · injection / infusion
  • MAGNESII SULFURICI POLPHARMA 200 mg/ml prescription partial — not the same combinationMAGNESII SULFAS · injection / infusion
  • MAGNESIUM SULFATE KALCEKS 200 mg/ml prescription partial — not the same combinationMAGNESII SULFAS · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Not the same combination. This medicine contains Succinylated gelatin, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • Inj. Magnesii Sulfurici 20% Polpharma partial — not the same combinationMagnesii sulfas · injection / infusion
  • Veto-Mag partial — not the same combinationMagnesium sulfuricum · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Gelaspan solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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