ALBUKED (albumin- human solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

KEDRION BIOPHARMA, INC.

INN (Միջազգային անվանումը):

Albumin Human

Կազմը:

Albumin Human 2.5 g in 50 mL

Կառավարման երթուղին:

INTRAVENOUS

Թերապեւտիկ ցուցումներ:

Emergency Treatment of Hypovolemic Shock Albuked 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 (Albuked 5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked™ 25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Albuked 25 is used, appropriate additional crystalloid should be administered.(1) Crystalloid solutions in volumes several times greater than that of Albuked 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 could be insti

Ապրանքի ամփոփագիր:

Albuked 5 is available in 50 mL and 250 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts: 76125-790-05 76125-790-25

Լիազորման կարգավիճակը:

Biologic Licensing Application

Ապրանքի հատկությունները

ALBUKED - ALBUMIN (HUMAN) SOLUTION
KEDRION BIOPHARMA, INC.
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ALBUMIN (HUMAN) 5%, USP
ALBUKED™ 5
DESCRIPTION
Albumin (Human) 5%, USP (Albuked™ 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.
Albuked 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. Albuked 5 is clear,
slightly viscous, almost colorless to yellow, amber or green.
Each vial of Albuked 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 Albuked 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
Albuked 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 Albuked 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 hemorrhage, surgery, trauma,
burns, bacteremia, renal failure, and cardiovascular collapse.(