Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Anaphylactic/anaphylactoid reactions
Solutions containing modified fluid gelatins should be administered with caution to patients with a history of allergic diseases, e.g. asthma.
As with all volume substitutes, solutions with modified fluid gelatin 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 20ml should be infused slowly and the patient should be under careful observation particularly at the start of the infusion (For symptoms of anaphylactoid reactions, see section 4.8).

Due to possible cross-reactions with the allergan galactose-alpha-1,3-galactose (alpha-gal), the risk of sensitisation and subsequent anaphylactic reaction to gelatin-containing solutions could be much higher in patients with a history of allergy to red meat (mammalian meat) and offal and/or patients who have 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 4% B.Braun 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 oliguria or anuria.
- with severely impaired renal function
- with oedema with water/salt retention
- with severe hypernatraemia
- with severe hyperchloraemia
- 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 (potassium-sparing diuretics, ACE inhibitors, non-steroidal anti- inflammatory agents, cyclosporine, tacrolimus or suxamethonium) can lead to an increased serum potassium level. The concomitant administration of those medicinal products with potassium-containing solutions may lead to severe hyperkalaemia, which may in turn result in cardiac arrhythmia
- of advanced age (elderly patients), as these are more prone to develop disorders such as cardiac or renal insufficiency.

Clinical 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 impaired renal function. Gelaspan 4% B.Braun contains supraphysiological concentrations of sodium (151 mmol/L).

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

The haemodynamic, haematological and coagulation systems must be monitored.
During compensation of severe blood losses by infusion of large amounts of Gelaspan 4% B.Braun, 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 these situations, the dilution effect on coagulation factors should also be observed, especially in patients with existing blood clotting disorders.
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”.
Gelaspan 4% B.Braun must not be infused concurrently through the same infusion line with blood or blood products (packed cells, plasma and plasma fractions). Two separate infusion systems must be used.

Pediatric population
There is no sufficient experience with the use of Gelaspan 4% B.Braun in children. Therefore, Gelaspan 4% B.Braun should be administered to these patients only if the expected benefit clearly outweighs the potential risks. (See also section 4.2).

Influence on diagnostic methods
Laboratory blood tests (blood group or irregular antibodies) can be performed after infusion of Gelaspan 4% B.Braun. Nevertheless, drawing of blood tests before the infusion of Gelaspan 4% B.Braun is recommended to avoid complicating the interpretation of the results.
Gelaspan 4% B.Braun may have an influence on the following clinical-chemical tests, leading to false raised values:
– Erythrocyte sedimentation rate,
– Specific gravity of urine,
– Unspecific protein assays, e.g. the Biuret method.

Effects on Driving

4.7   Effects on ability to drive and use machines

No relevant studies have been conducted. Gelaspan 4% B.Braun has no or negligible influence on the ability to drive and use machines.