Volulyte 6% Hydroxyethyl Starch 130/0.4 Electrolyte Injection

1. Indications and Usage
Hypovolemia: Indicated for the treatment and prevention of hypovolemia.
Acute Normovolemic Hemodilution (ANH): Indicated for use in acute normovolemic hemodilution.
2. Dosage and Administration
Route of Administration: Intravenous infusion.
Administration Details: The initial 10-20 mL should be administered slowly while closely observing the patient to detect any hypersensitivity reactions.
Dosage and Rate: The daily dose and rate of infusion should be determined according to blood loss, hemodynamic parameters, and dilution effect.
Maximum Dose: The daily maximum dose is 33 mL/kg or 50 mL/kg of body weight depending on clinical protocols.
Hematocrit: In patients without cardiovascular or pulmonary risks, hematocrit should not fall below 30%.
3. Mechanism of Action
Volume Expansion: As a blood volume expander, its volume expansion effect and hemodilution effect depend on molecular weight, molar substitution, and concentration.
Duration: After infusing 500 mL over 30 minutes in healthy volunteers, the volume expansion effect equals 100% of the infused volume and can be maintained stably for 4 to 6 hours.
4. Safety and Warnings
Renal Impairment: Contraindicated in patients with renal failure or undergoing dialysis due to the risk of renal injury.
Bleeding: May cause dose-related coagulation abnormalities and dilute plasma proteins and clotting factors.
Hypersensitivity: Hypersensitivity and anaphylactoid reactions may occur.
Fluid Overload: Care must be taken to avoid fluid overload, especially in patients with heart failure or severe renal impairment.
5. Adverse Reactions
Hypersensitivity: Rare cases of allergy, anaphylactoid reactions (including bradycardia, tachycardia, bronchospasm, and non-cardiogenic pulmonary edema) have been reported.
Coagulation: Dose-related coagulation disorders and bleeding time prolongation may occur with long-term or high-dose use.
Laboratory Interference: May cause elevated blood amylase levels, which can interfere with the diagnosis of pancreatitis.
6. Drug Interactions
Nephrotoxic Drugs: Concomitant use with potentially nephrotoxic drugs, such as aminoglycosides, may enhance adverse effects on the kidneys.
Electrolyte-Related Drugs: Caution is advised when administering with drugs that cause potassium and sodium retention due to the electrolyte content in the solution.
7. Pharmaceutical Information
Composition: 1 liter contains 60.00 g of Hydroxyethyl Starch 130/0.4, sodium acetate, sodium chloride, potassium chloride, and magnesium chloride.
Appearance: A colorless to pale yellow, slightly viscous, clear liquid.
Storage: Store in a well-closed container; do not freeze.