GELASPAN SOLUTION FOR INFUSION [SIN15336P]

Product Info

GELASPAN SOLUTION FOR INFUSION

[SIN15336P]

Indication

4.1 Therapeutic indications

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

• 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. priming of heart-lung machines)

Dosing

4.2 Posology and Method of Administration

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 sections 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In severe, acute situations, Gelaspan may be infused rapidly by pressure infusion, 500 ml can be administered in 5 – 10 min., 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. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Intravenous use

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.

Contraindications

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Hypervolaemia

• Hyperhydration

• Acute congestive cardiac failure