Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58) (HYDROXYETHYL STARCH 130/0.4 - UNII:1GVO236S58)
Hospira, Inc.
HYDROXYETHYL STARCH 130/0.4
HYDROXYETHYL STARCH 130/0.4 6 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Voluven ® (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 Voluven ® , 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 Voluven ® , in patients with severe liver disease. - Do not use HES products, including Voluven ® , 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 HES products in patients with renal failure with oliguria or anuria not related
Voluven ® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) for intravenous infusion is supplied in the following primary container and carton sizes: Polyolefin bag ( free flex ® ) with overwrap: 500 mL NDC 0409-1029-11 Carton of 15 x 500 mL NDC 0409-1029-01 Carton of 20 x 500 mL NDC 0409-1029-02 Store at 15° to 25°C (59° to 77°F). Do not freeze.
New Drug Application
VOLUVEN- HYDROXYETHYL STARCH 130/0.4 INJECTION, SOLUTION HOSPIRA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VOLUVEN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VOLUVEN . VOLUVEN (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 THERAPY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SEPSIS, USE OF HYDROXYETHYL STARCH (HES) PRODUCTS, INCLUDING VOLUVEN , INCREASES RISK OF MORTALITY RENAL REPLACEMENT THERAPY DO NOT USE HES PRODUCTS, INCLUDING VOLUVEN , IN CRITICALLY ILL ADULT PATIENTS, INCLUDING PATIENTS WITH SE PSIS. INDICATIONS AND USAGE Voluven 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 FREE_flex_ flexible plastic intravenous solution container. Each 100 mL contains 6 g hydroxyethyl starch 130/0.4 in isotonic sodium chloride injection. ( 3) CONTRAINDICATIONS Do not use hydroxyethyl starch (HES) products, including Voluven , in critically ill adult patients, including patients with sepsis due to increased risk of mortality and renal replacement therapy. ( 4) Do not use HES produ Lire le document complet