GELASPAN

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.

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.

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. 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. 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.

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.

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

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. 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. 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. g. the biuret method. 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. 6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of Gelaspan in pregnant women.

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. 7 Effects on ability to drive and use machines Gelaspan has no or negligible influence on the ability to drive and use machines.

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.

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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.

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.

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

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. 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. 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. g. the biuret method.

1. 4) • hypervolaemia • hyperhydration • Acute congestive cardiac failure