PLASBUMIN (albumin- human solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)

Доступна с:

GRIFOLS USA, LLC

ИНН (Международная Имя):

Albumin Human

состав:

Albumin Human 2.5 g in 50 mL

Администрация маршрут:

INTRAVENOUS

Терапевтические показания :

Emergency Treatment of Hypovolemic Shock Plasbumin-5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Plasbumin-5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Plasbumin® -25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Plasbumin-25 is used, appropriate additional crystalloid should be administered.(1) Crystalloid solutions in volumes several times greater than that of Plasbumin-5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy cou

Обзор продуктов:

Plasbumin-5 is available in 50 mL, 250 mL, and 500 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts:

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

PLASBUMIN - ALBUMIN (HUMAN) SOLUTION
GRIFOLS USA, LLC
----------
ALBUMIN (HUMAN) 5%, USP
PLASBUMIN -5
DESCRIPTION
Albumin (Human) 5%, USP (Plasbumin -5) is made from large pools of
human venous
plasma by the Cohn cold ethanol fractionation process. Part of the
fractionation may be
performed by another licensed manufacturer. It is prepared in
accordance with the
applicable requirements established by the U.S. Food and Drug
Administration.
Plasbumin-5 is a 5% sterile solution of albumin in an aqueous diluent.
The preparation is
stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan.
The aluminum
content of the product is not more than 200 µg/L. The approximate
sodium content of
the product is 145 mEq/L. Plasbumin-5 is clear, slightly viscous,
almost colorless to
yellow, amber or green. It contains no preservative. Plasbumin-5 must
be administered
intravenously.
Each vial of Plasbumin-5 is heat-treated at 60°C for 10 hours against
the possibility of
transmitting the hepatitis viruses.
Additionally, the manufacturing process was investigated for its
capacity to decrease the
infectivity of an experimental agent of transmissible spongiform
encephalopathy (TSE),
considered as a model for the variant Creutzfeldt-Jakob disease (vCJD)
and Creutzfeldt-
Jakob disease (CJD) agents.(8-11) The production steps from Pooled
Plasma to Effluent
IV-1 in the Plasbumin-5 manufacturing process have been shown to
decrease TSE
infectivity of that experimental model agent (a total of ≥7.0 logs).
These studies provide
reasonable assurance that low levels of vCJD/CJD agent infectivity, if
present in the
starting material, would be removed.
CLINICAL PHARMACOLOGY
Plasbumin-5 is oncotically equivalent volume for volume to normal
human plasma.
When administered intravenously to an adequately hydrated subject, the
oncotic (colloid
osmotic) effect of Plasbumin-5 is to expand the circulating blood
volume by an amount
approximately equal to the volume infused. It is primarily used in the
treatment of shock
associated with hemorrh