Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
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)
B. Braun Medical Inc.
HYDROXYETHYL STARCH 130/0.4
HYDROXYETHYL STARCH 130/0.4 6 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Soma hati kamili