Hetastarch

Avoid use in patients with pre-existing renal dysfunction Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis; surgical patients; and blunt trauma patients Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection Monitor liver function in patients receiving HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection 5.1 Mortality and Renal Dysfunction Critically ill patients, including patients with sepsis, are at increased risk of mortality and acute kidney injury (AKI), including need for renal replacement therapy (RRT)

2 DOSAGE AND ADMINISTRATION Dosage for Acute Use in Plasma Volume Expansion 6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration. For intravenous use only. [See table below.] 2.1 Adults The amount usually administered is 500 to 1000 mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion.

For single use only. The solution contains no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and is intended only for single-dose injection. When smaller doses are required the unused portion should be discarded. CAUTION: Before administering to the patient, review these directions: Visual Inspection Do not remove the plastic infusion container from its overwrap until immediately before use.

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. To Open 1. Tear overwrap down at notch and remove solution container. 2.

Check for minute leaks by squeezing solution container firmly. 3. If any leaks are found, discard solution as sterility may be impaired. Preparation for Administration 1. Remove plastic protector from sterile set port at bottom of container. 2. Attach administration set. Refer to complete directions accompanying set. When stored at room temperature, 6% Hetastarch in 0.9% Sodium Chloride Injection admixtures of 500–560 mL with citrate concentrations up to 2.5% were compatible for 24 hours.

The safety and compatibility of additives other than citrate have not been established.