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1 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 ? In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including Voluven? , increases risk of o Mortality o Renal replacement therapy ? Do not use HES products, including Voluven? , in critically ill adult patients, including patients with sepsis. 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 freeflex? 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 products, including Voluven? , in patients with severe liver disease. (4) ? Do not use HES products, including Voluven? , in patients with known hypersensitivity to hydroxyethyl starch. (4) ? Do not use HES products in clinical conditions with volume overload. (4) ? Do not use HES products in patients with pre-existing coagulation or bleeding disorders. (4) ? Do not use HES products in patients with renal failure with oliguria or anuria not related to hypovolemia. (4) ? Do not use HES products in patients receiving dialysis. (4) ? Do not use HES products in patients with severe hypernatremia or severe hyperchloremia. (4) ? Do not use HES products in patients with intracranial bleeding. (4) WARNINGS AND PRECAUTIONS- ? Anaphylactoid and hypersensitivity reactions. (5.1, 6) ? Avoid use in patients with pre-existing renal dysfunction. (5.2) ? Discontinue use of Voluven? at the first sign of renal injury. (5.2) ? Continue to monitor renal function in hospitalized patients for at least

90 days as use of renal replacement therapy has been reported up to

90 days after administration of HES products. (5.2) ? Monitor the coagulation status of patients undergoing open heart surgery in association with cardiopulmonary bypass as excess bleeding has been reported with HES solutions in this population. Discontinue use of Voluven? at the first sign of coagulopathy. (5.3) ? Avoid fluid overload;

adjust dosage in patients with cardiac or renal dysfunction. (5.4) ? In severe dehydration, a crystalloid solution should be given first. (5.4) ? Monitor liver function in patients receiving HES products, including Voluven? (5.5) ? Monitor kidney function, fluid balance and serum electrolytes (5.5) ? Elevated serum amylase values may occur and interfere with the diagnosis of pancreatitis (5.5) ? High dosages may cause dilution of blood components (5.5) ADVERSE REACTIONS- ? Serious adverse reactions reported in clinical trials were increased mortality and need for renal replacement therapy in critically ill patients including sepsis. Most common adverse reactions (incidence >