HETASTARCH IN SODIUM CHLORIDE injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HETASTARCH (UNII: 875Y4127EA) (HETASTARCH - UNII:875Y4127EA)

Available from:

Hospira, Inc.

INN (International Name):

HETASTARCH

Composition:

HETASTARCH 6 g in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HETASTARCH IN SODIUM CHLORIDE- HETASTARCH INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 6%
HETASTARCH IN 0.9% SODIUM CHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
6% HETASTARCH IN 0.9% SODIUM CHLORIDE
INJE C TIO N.
6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
WARNING: MORTALITY
RENAL REPLACEMENT THERAPY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
RECOMMENDED DOSAGE
DO SE
Adults (2.1)
500 to 1000 mL
Le ukaphe re sis
(2.2)
250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with
citrate
anticoagulant is added to the input line of the centrifugation
apparatus.
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SEPSIS, USE
OF HYDROXYETHYL STARCH (HES)
PRODUCTS, INCLUDING 6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION,
INCREASES RISK OF
o
o
MO RTALITY
RENAL REPLACEMENT THERAPY
DO NOT USE HES PRODUCTS, INCLUDING 6% HETASTARCH IN 0.9% SODIUM
CHLORIDE INJECTION, IN CRITICALLY
ILL ADULT PATIENTS INCLUDING PATIENTS WITH SEPSIS
6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch
indicated for treatment of hypovolemia when plasma
volume expansion is desired. (1)
6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has
shown to be safe and efficacious in improving
the harvesting and increasing the yield of granulocytes by centrifugal
means. (1)
30 g hetastarch in 500 mL 0.9% sodium chloride injection. (3)
Do not use hydroxyethyl starch (HES) products, including 6% Hetastarch
in 0.9% Sodium Chloride Injection, in
critically ill adult patients, including patients with sepsis, due to
increased risk of mortality and renal replacement
therapy (RRT). (4)
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride I