Gelaspan 1000 mL Solution for infusion

Gelaspan 4 % is a colloidal plasma volume substitute in an isotonic, fully balanced electrolyte solution for:

• Treatment of relative or absolute hypovolaemia and shock.
• Prophylaxis and treatment 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).

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.

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. In severe, acute situations, Gelaspan may be infused rapidly by pressure infusion, 500 ml can be administered in 5 u2013 10 min, until signs of hypovolaemia are relieved.

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 patientu2019s prevailing clinical condition should be taken into account and the therapy should be monitored especially carefully.

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.

Method of administration:

In the special case of rapid infusion under external pressure which may be necessary in emergency situations, before starting the infusion, all air must be removed from containers with air space inside, as otherwise there is a risk of producing air embolism during the infusion. Gelaspan 4 % should be administered with caution to patients why hypernatraemia and states of dehydration. Serum electrolytes and fluid balance controls are required. Electrolytes are to be replaced as required.

Clinical-chemical parameters may be influenced so that laboratory results are are higher than expected: blood sedimentation rate, specific gravity of the urine, unspecific protein determinations (e.g. with the Biuret method). Special care and adaptation of the dosage is recommended in patents with blood clotting disturbances, renal insufficiency and chronic liver disease. There are no contraindications to the use of Gelaspan 4 % in the elderly. There is insufficient data to establish safety and efficacy in children.

Gelaspan 4 % is contraindicated:

• Know hypersensitivity to gelatine
• Hypervolaemia
• Hyperhydration
• Severe cardiac insufficiency
• Severe blood clotting disorders
• Contraindicated in children under 1 year of age

Do not use unless the solution is clear and free from particles. Do not use if the container is damaged or has been previously opened. Gelaspan 4 % can cause anaphylactoid/ anaphylactic reactions of varying severity. Ranging from benign skin symptoms (urticarial) through flushing of the face and neck to the much less frequently occurring ones. Fall in blood pressure, shock, bronchospasm, cardiac or respiratory arrest.

Such reactions can occur both in conscious and anaesthetised patients. Patients receiving Gelaspan 4 % have to be carefully observed in case of potential anaphylactoid/ anaphylactic reactions.

Gelaspan 4 % should only be administered with caution to patients:

• At risk of circulatory overload e.g patients with right or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oligo- or anuria
• With severely impaired renal function
• With oedema with water/ salt retention
• With major blood coagulation disorders
• Of advanced age as these are more prone to develop disorders such as cardiac or renal insufficiency
• Severe hypercalcaemia
• 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
• 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.

As with all colloids, Gelaspan 4 % should only be used if hypovolaemia cannot 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 cardio circulatory problems.

Check of serum electrolyte concentrations, acid base balance and water balance are necessary, particularly in patients with hypernatremia, hypochloraemia or impairment of renal function. 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 4 %, the haematocrit and electrolytes must be monitored under circumstances. 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. Gelaspan 4 % must not be infused through the same infusion line as blood or blood products (packed cells, plasma and plasma fractions).

Paediatric population: There is insufficient experience with the use of Gelaspan 4 % in children. Therefore Gelaspan 4 % should only be administered to these patients if the expected benefits clearly outweigh potential risks.

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

Potassium sparing diuretics, ACE inhibitors, non-steroidal anti-inflammatory medicines, cyclosporine, tacrolimus or suxamethonium can increase the serum potassium level. The concomitant administration of potassium containing solutions are these medicines may lead to severe hyperkalaemia, which may in turn lead to cardia arrhythmia.

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

Pregnancy

There are no adequate data from the use of Gelaspan 4 % in pregnant women. Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3). Due to the limited data available and the possibility of severe anaphylactic/ anapylactoid reactions with consecutive foetal and neonatal distress, the use of gelaspan solutions during pregnancy should be restricted to emergency situations.

Breastfeeding

There are no limited data regarding the excretion of succinylated in motheru2019s milk, but because of its high molecular weight it is not expected that the milk will contain relevant amounts. Sodium and chloride normal constituents of the human body and of food. No significant increase in the content of these electrolytes in motheru2019s milk is expected following the use of Gelaspan 4 %.

Fertility

There are no data on the effect of Gelaspan 4 % on human or animal fertility. However, because of the nature of its constituents it is considered unlikely that Gelaspan 4 % will affect fertility.

Gelaspan 4 % has no or negligible influence on the ability to drive and use machines.

(a) Summary of the safety profile: As with other colloidal plasma substitutes, side effects can occur during and after the use of Gelaspan 4 %. These will usually involve anaphylactic/ anaphylacoid reactions of varying severity.

(b) Tabulated list of adverse reactions

System Organ Class Frequency Category

• Immune system disorders Anaphylactic/ anaphylactoid reactions up to shock. In the event of an anaphylactoid reaction, the infusion must be discontinued immediately and the usual emergency treatment given. Less frequent
• Cardiac disorders Tachycardia Less frequent
• Vascular disorders Hypotension Less frequent
• General disorders and administration site conditions Fever, chills Less frequent
• Gastro intestinal disorders Nausea, vomiting, abdominal pain Frequency unknown
• Investigations Oxygen saturation decreased Frequency unknown
• Blood and lymphatic system disorders Decreased haematocrit and reduced concentration of plasma proteins. Frequent

Relatively large doses of gelaspan result in dilution of coagulation factors and can therefore affect blood coagulation. Prothombin time can be increased and activated partial throboplastin time (aPTT) can be prolonged after administration of large doses of Gelaspan 4 %. See section 4.4 Frequent

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 to SAHPRA via the u20186.04 Adverse Drug Reactions Reporting Formu2019. Found under SAHPRAu2019s publications: https://www/sahpra.org.za/Publications/Index/8

The main risk of an acute overdose would be volume overload. Treatment is symptomatic and supportive.