Therapy and prophylaxis of volume deficiency (hypovolaemia) and shock (volume replacement therapy) in connection with surgery (haemorrhagic shock). Injuries (traumatic shock), infections (septic shock), bums (bum shock). Savings of donor blood during surgery e,g acute normovolaemic haemodilution. Therapeutic dilution of blood (haemodilution)

Plasma expanders

Colloidal solution volume expander that contains hydroxyethyl starch.

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:  2-12 years: Mean dose of 36 mL/kg IV

Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

The safety and compatibility of other additives, other than citrate anticoagulant, have not been established. Incompatibilities: In the absence of incompatibility studies this medicinal product must not be mixed with other medicinal products.

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.

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 influenzalike 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.

Use in pregnancy: Animal reproduction studies have not been conducted with Hydroxyethyl Starch in Sodium Chloride infusion and it is also not known whether it can cause fetal harm or affect reproductive capacity when administered during pregnancy. This infusion should be given during pregnancy only if clearly needed

Use during lactation: It is not known whether Hydroxyethyl starch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hydroxyethyl Starch in Sodium Chloride infusion is administered to a nursing woman.

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).