HETASTARCH IN SODIUM CHLORIDE- hetastarch injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

HETASTARCH (UNII: 875Y4127EA) (HETASTARCH - UNII:875Y4127EA)

Mevcut itibaren:

Hospira, Inc.

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

6% Hetastarch in 0.9% Sodium Chloride Injection 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 6% Hetastarch in 0.9% Sodium Chloride Injection 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 6% Hetastarch in 0.9% Sodium Chloride Injection, 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

Ürün özeti:

6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic containers. NDC 0409-7248-03 30 g Hetastarch/500 mL Case containing 12 Flexible Plastic Containers (6 g Hetastarch/100 mL) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1287-4.0

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

HETASTARCH IN SODIUM CHLORIDE- HETASTARCH INJECTION, SOLUTION
HOSPIRA, INC.
REFERENCE LABEL SET ID: 25E5DCB2-4A6B-4D84-B4F1-DA17F0931BFF
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 6%
HETASTARCH IN 0.9%
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR 6%
HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION.
6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
WARNING: MORTALITY;
KIDNEY INJURY; COAGULOPATHY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
•
•
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 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
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
USE OF HYDROXYETHYL STARCH (HES) PRODUCTS, INCLUDING 6% HETASTARCH IN
0.9%
SODIUM CHLORIDE INJECTION, INCREASES RISK OF
o
o
o
MORTALITY
KIDNEY INJURY (5.1)
COAGULOPATHY (5.2)
DO NOT USE HES PRODUCTS, INCLUDING 6% HETASTARCH IN 0.9% SODIUM
CHLORIDE
INJECTION, UNLESS ADEQUATE ALTERNATIVE TREATMENT IS UNAVAILABLE. (1)
6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch
indicated for treatment of
hypovolemia when plasma volume expansion is desired in settings where
adequate alternative
treatment is unavailable. (1)
6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has
shown to be safe and
efficacious in improving the harvesting and increasing the yield of
granulocytes by centrifugal means.
(1)
30 g hetastarch in 500 mL 0.9% sodium chloride injection. (3)
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride Injection, unless
adequate alternative treatment is unavailable.
Avoid use in patients with pre-existing renal dysfunction (5.1)
Increased risk of mortality and acute ki