6% HETASTARCH IN 0.9% SODIUM CHLORIDE injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

HF Acquisition Co LLC, DBA HealthFirst

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. 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 hydroxyethyl starch (HES) products, including 6% Hetastarch 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% Hetastarch in 0.9% Sodium Chloride Injection, in patients with severe liver disease • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in patients with known hypersensitivity to hydroxyethyl starch • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in clinical conditions where volume overload is a potential problem (such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia). • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, in patients with pre-existing coagulation or bleeding disorders 8.1 Pregnancy 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 maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.

उत्पाद समीक्षा:

6% HETASTARCH IN 0.9% SODIUM CHLORIDE is supplied in the following dosage forms. NDC 51662-1317-1 6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION 500mL BAG NDC 51662-1317-2 6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION 500mL BAG supplied in a Case NDC 51662-1317-3 6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION 500mL BAG, 12 Containers of 51662-1317-2 in a Case of 51662-1317-3 HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-use flexible plastic containers. 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-1287-3.0

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

6% HETASTARCH IN 0.9% SODIUM CHLORIDE- 6% HETASTARCH IN 0.9% SODIUM
CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
6% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION 500ML BAG
BOXED WARNING
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
INDICATIONS AND USAGE
•
6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch
indicated for treatment
of hypovolemia when plasma volume expansion is desired. ( 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)
DOSAGE AND ADMINISTRATION
For intravenous use only.
DOSAGE FORMS AND STRENGTHS
•
30 g hetastarch in 500 mL 0.9% sodium chloride injection. ( 3)
CONTRAINDICATIONS
•
Do not use hydroxyethyl starch (HES) products, including 6% Hetastarch
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). (
4)
•
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride Injection, in
patients with severe liver disease ( 4)
•
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride Injection, in
patients with known hypersensitivity to hydroxyethyl starch ( 4)
•
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride Injection, in
clinical conditions where volume overload is a potential problem. ( 4)
•
Do not use HES products, including 6% Hetastarch in 0.9% Sodium
Chloride Injection, in
patients with pre-existing coagulation or bleeding disorders ( 4)
WARNINGS AND PRECAUTIONS
•
Avoid use in patients with pre-existing r