Plasmasol 500ml

Prophylaxis of Hypovolaemia and shock, Surgery (haemorrhagic shock), Injuries (traumatic shock), Burns, Therapeutic dilution of blood

Adult Dose Up to 50 mL of (hydroxyethyl starch in sodium chloride injection) per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of (hydroxyethyl starch in sodium chloride injection) for a 70 kg patient.

Pediatric Dose Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status Newborns and infants <2 yr: Mean dose of 16 mL/kg IV 2-12 years: Mean dose of 36 mL/kg IV Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

Known hypersensitivity to hydroxyethyl starch fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure renal failure with oliguria or anuria not related to hypovolemia patients receiving dialysis treatment severe hypernatremia or severe hyperchloremia intracranial bleeding.

Colloidal solution volume expander that contains hydroxyethyl starch.

Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) 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. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction. In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration. Caution should be observed before administering (hydroxyethyl starch in sodium chloride injection) to patients with severe liver disease or severe bleeding disorders (e.g., severe cases of von Willebrand´s disease).

From the accumulated clinical development experience, expected adverse reactions after administration of (hydroxyethyl starch in sodium chloride injection) occurring in less than 10% of patients are as follows: Immune system disorders (Rare, > 0.01% to < 0.1%): anaphylactoid reactions (hypersensitivity, mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema). In the event of an intolerance reaction, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated. Skin and subcutaneous tissue disorders (Common, > 1 to < 10%, dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is an undesirable effect observed with all hydroxyethyl starches.