HETASTARCH Dosage and Administration

(6% hetastarch in 0.9% sodium chloride injection)

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.

2.1 Adults

The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].

2.2 Leukapheresis

250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The 6% Hetastarch in 0.9% Sodium Chloride Injection and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

2.3 Direction for use for 6% Hetastarch in 0.9% Sodium Chloride Injection

•
Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.
•
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.
•
Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
•
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.

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Dosage and Administration

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.

2.1 Adults

The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5)].

2.2 Leukapheresis

250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The 6% Hetastarch in 0.9% Sodium Chloride Injection and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

2.3 Direction for use for 6% Hetastarch in 0.9% Sodium Chloride Injection

•
Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.
•
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.
•
Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
•
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.

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