COMPOSITION:

Each 100ml contains:
Hydroxyethyl Starch (130/0.4) 6.0 gms
Sodium Chloride 0.9 gm
Water for Injections q. s.
Average Molecular Weight 130,000 Dalton
Degree of substitution 0.38-0.45
mOsmol/L 308
mEq/L Na+ 154,Cl- 154

AVAILABILITY:

Domestic Yes Export Yes Domestic Product insert

DESCRIPTION:

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment. the final solution pH is 4.0 to 5.5.

The hydroxyethyl starch is a synthetic colloid for use in plasma volume replacement. The chemical name of hydroxyethyl starch is poly(O-2-hydroxyethyl) starch.

THERAPEUTIC INDICATIONS:

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is indicated for the treatment and prophylaxis of hypovolemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma.

WARNING & PRECAUTIONS:

Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) occur 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 Equilibrium: Avoid fluid overload; adjust dosage in patients with cardiac or renal dysfunction

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.

Monitoring: Laboratory Tests: 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 Hydroxyethyl starch

Interference with Laboratory Tests: Elevated serum amylase levels may be observed temporarily following administration of the HES and can interfere with the diagnosis of pancreatitis.

At high dosages, the dilutional effects may result in decreased levels of coagulation factors and other plasma proteins and a decrease in hematocrit.

DOSAGE AND ADMINISTRATION:

hydroxyethyl starch is administered by intravenous infusion only. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of hemodynamics and on the hemodilution (dilution effect). hydroxyethyl starch can be administered repetitively over several days.
The initial 10 to 20 mL should be infused slowly, keeping the patient under close observation due to possible anaphylactoid reactions.
Adult Dose: Up to 50 mL of hydroxyethyl starch per kg of body weight per day. This dose is equivalent to 3500 mL of hydroxyethyl starch for a 70 kg patient.
Pediatric Dose: The safety and efficacy have not been established in the age group of 2 to 12 years

PRESENTATION:

500 ml Non-PVC bag.