HESPAN- hetastarch in sodium chloride injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

HETASTARCH (UNII: 875Y4127EA) (HETASTARCH - UNII:875Y4127EA), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

थमां उपलब्ध:

B. Braun Medical Inc.

INN (इंटरनेशनल नाम):

HETASTARCH

रचना:

HETASTARCH 6 g in 100 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

HESPAN® is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunctive use of HESPAN® in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. - Do not use HES products, including HESPAN®, unless adequate alternative treatment is unavailable. Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the m

उत्पाद समीक्षा:

HESPAN® (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCEL® Containers packaged 12 per case. NDC                          REF                            Volume 0264-1965-10         L6511                       500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. 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.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

HESPAN- HETASTARCH IN SODIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HESPAN® (6%
HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION) SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR HESPAN® (6% HETASTARCH IN 0.9% SODIUM
CHLORIDE
INJECTION).
HESPAN® (6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION) IN EXCEL®
CONTAINER,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
USE OF HYDROXYETHYL STARCH (HES) PRODUCTS, INCLUDING HESPAN®,
INCREASES RISK OF
MORTALITY
KIDNEY INJURY
COAGULOPATHY
DO NOT USE HES PRODUCTS, INCLUDING HESPAN®, UNLESS ADEQUATE
ALTERNATIVE
TREATMENT IS UNAVAILABLE.
INDICATIONS AND USAGE
HESPAN® is a hetastarch indicated for treatment of hypovolemia when
plasma volume expansion is
desired in settings where adequate alternative treatment is
unavailable. (1)
HESPAN® in leukapheresis has shown to be safe and efficacious in
improving the harvesting and
increasing the yield of granulocytes by centrifugal means. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY. RECOMMENDED DOSAGE
DOSE
Adults (2.1)
500 to 1000 mL
Leukapheresis
(2.2)
250 to 700 mL of HESPAN® (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
30 g hetastarch in 500 mL 0.9% sodium chloride injection. (3)
CONTRAINDICATIONS
Do not use HES products, including HESPAN®, unless adequate
alternative treatment is unavailable.
WARNINGS AND PRECAUTIONS
Avoid use in patients with pre-existing renal dysfunction (5.1)
Increased risk of mortality and acute kidney injury (AKI) in
critically ill patients, including patients with
sepsis; surgical patients; and blunt trauma patients (5.1)
Discontinue use of HESPAN® at the first sign of renal injury (5.1)
Continue to monitor renal function for at le