It is a plasma volume substitute indicated for the treatment and prophylaxis of hypovolemia in adults and children.
Expansol (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride IV infusion) is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution. The chemical name of Hydroxyethyl Starch is poly (O-2-hydroxyethyl) starch. Expansol contains Hydroxyethyl Starch in a colloidal solution which expands plasma volume when administered intravenously.
Administer by intravenous infusion only. ? Daily dose and rate of infusion depend on the patient’s blood loss, hemodynamics and on the hemodilution effec Recommended Daily Dose Adults Up to 50 mL/kg body weight Recommended Daily Dose Mean Daily Dose ? SD in Clinical Trials Pediatric age groups Up to 50 mL/kg body weight in all age groups - < 2 years 16 ? 9 mL/kg body weight 2 - 12 years 36 ? 11 mL/kg body weight > 12 years - ? Initiate infusion slowly due to possible anaphylactoid reactions ? See full prescribing information for pediatric administration
No interactions with other drugs or nutritional products are known.
? Do not use hydroxyethyl starch (HES) products,including It,in critically ill adult patients,including patients with sepsis due to increased risk of mortality and renal replacement therapy. (4) ? Do not use HES products,including It,in patients with severe liver disease
Pruritus,elevated serum amylase,hemodilution (resulting in dilution of blood components,e.g., coagulation factors and other plasma proteins,and in a decrease in hematocrit). Anaphylactoid/hypersensitivity reactions can occur.
There are no adequate and well-controlled studies in pregnant women. Hydroxyethyl starch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk.
Over dosage can lead to overloading of the circulatory system (e.g., pulmonary edema). In this case, the infusion should be stopped immediately and if necessary, a diuretic should be administered.
Keep this medicine out of the sight and reach of children. Do not freeze. Do not store above 25°C.
Each 100 ml solution contains:
Poly (O-2-hydroxyethyl) Starch BP 6.0 g
(Molar substitution: 0.37-0.43; Molecular weight: 110,000-150,000 daltons)
Sodium Chloride BP 0.9 g
(Na+: 154 mmol/L; Cl-: 154 mmol/L)
Water for Injections BP q.s.
Osmolality: 300±30 mOsm/kg
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