HYDROXYETHYL STARCH IN SODIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

B. Braun Medical Inc.

INN (International Name):

HYDROXYETHYL STARCH 130/0.4

Composition:

HYDROXYETHYL STARCH 130/0.4 6 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

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. - Do not use hydroxyethyl starch (HES) products, including 6% hydroxyethyl starch 130/0.4 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).  - Do not use HES products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with severe liver disease. - Do not use HES products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch [see General Warnings and Precautions (5.1) ] - Do not use HES products in clinical conditions with volume overload.  - Do not use HES products in patients with pre-existing coagulation or bleeding disorders.  - Do not use H

Product summary:

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection for intravenous infusion is supplied supplied sterile and nonpyrogenic in EXCEL® Containers. The 500 mL containers are packaged 12 per case. NDC                        REF                          Volume 0264-1968-10         L9681                      500 mL Store at 15° to 25°C (59° to 77°F). Do not freeze. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYETHYL STARCH IN SODIUM CHLORIDE- HYDROXYETHYL STARCH IN SODIUM
CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 6%
HYDROXYETHYL STARCH 130/0.4 IN 0.9%
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR 6% HYDROXYETHYL STARCH
130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION.
6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM CHLORIDE INJECTION
FOR ADMINISTRATION BY INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2007
WARNING: MORTALITY
RENAL REPLACEMENT THERAP_Y_
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SEPSIS, USE
OF HYDROXYETHYL STARCH (HES)
PRODUCTS, INCLUDING 6% HYDROXYETHYL STARCH 130/0.4 IN 0.9% SODIUM
CHLORIDE INJECTION, INCREASES RISK
O F
MO RTALITY
RENAL REPLACEMENT THERAPY
DO NOT USE HES PRODUCTS, INCLUDING 6% HYDROXYETHYL STARCH 130/0.4 IN
0.9% SODIUM CHLORIDE
INJECTION, IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH
SEPSIS.
INDICATIONS AND USAGE
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is a
plasma volume substitute indicated for the
treatment and prophylaxis of hypovolemia in adults and children. (1)
DOSAGE AND ADMINISTRATION
ADMINISTER BY INTRAVENOUS INFUSION ONLY.
Daily dose and rate of infusion depend on the patient's blood loss,
hemodynamics and on the hemodilution effects. (2)
RECOMMENDED DAILY DOSE
Adults (2.1) Up to 50 mL/kg body weight
RECOMMENDED DAILY DOSE MEAN DAILY DOSE ± SD IN CLINICAL TRIALS (2.2)
Pediatric age groups (2.2)
Up to 50 mL/kg
body weight in all
age groups
-
< 2 years
16 ± 9 mL/kg body weight
2-12 years
36 ± 11 mL/kg body weight
> 12 years
-
Initiate infusion slowly due to possible anaphylactoid reactions (2,
5.1)
See full prescribing information for pediatric administration (2.2,
8.4)
DOSAGE FORMS AND STRENGTHS
500 mL EXCEL® Container. Each 100 mL contains 6 g hydroxyethyl starch
130/0.4 in isotonic sodium chloride in