Volulyte 6% Special Precautions

Use with caution in elective surgery patients, trauma patients, patients undergoing open heart surgery in association with cardiopulmonary bypass.
Anaphylactic/anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary oedema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. (See Adverse Reactions.)
Avoid use in patients with pre-existing renal dysfunction.
Discontinue use of Voluven at the first sign of clinically relevant renal injury.
Continue to monitor renal function in hospitalised patients for at least 90 days as use of renal replacement therapy has been recorded up to 90 days after administration of HES products.
Monitor the coagulation status in patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with other HES solutions in this population. Discontinue the use of Voluven at the first sign of clinically relevant coagulopathy.
Avoid fluid overload; adjust dosage in patients with cardiac dysfunction. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency.
In cases of severe dehydration a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration.
Particular care must be taken in patients with electrolyte abnormalities.
In metabolic alkalosis and clinical situations where alkalisation should be avoided, saline based solutions like a similar product containing HES 130/0.4 in 0.9% sodium chloride solution should be preferred over alkalising solutions like Volulyte.
Clinical evaluation and periodic laboratory determinations are necessary to monitor fluid balance, serum electrolyte concentrations, kidney function, acid-base balance, and coagulation parameters during prolonged parenteral therapy or whenever the patient's condition warrants such evaluation. Monitor liver function in patients receiving HES products, including Voluven.
Effects on ability to drive and use machines: Volulyte has no influence on the ability to drive and use machines.