ALBUKED (albumin- human solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

KEDRION BIOPHARMA, INC.

INN (International Name):

Albumin Human

Composition:

Albumin Human 10 g in 50 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

Emergency Treatment of Hypovolemic Shock Albuked 20 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.(1) If the patient is dehydrated, additional crystalloids must be given,(4) or alternatively, Albumin (Human) 5%, USP (Albuked™ 5) should be used. The patient’s hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual; i.e., about 2 g per kg body weight in the absence of active bleeding. Although Albuked 5 is to be preferred for the usual volume deficits, Albuked 20 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2) Removal of ascitic fluid from a

Product summary:

Albuked 20 is available in 50 mL and 100 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts: 76125-791-50 76125-791-10

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ALBUKED - ALBUMIN (HUMAN) SOLUTION
KEDRION BIOPHARMA, INC.
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ALBUMIN (HUMAN) 20%, USP
ALBUKED™ 20
DESCRIPTION
Albumin (Human) 20%, USP (Albuked™ 20) 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 20 is a 20% sterile solution of albumin in an aqueous diluent.
The preparation is stabilized with
0.016 M sodium caprylate and 0.016 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 20 is clear,
slightly viscous, almost colorless to yellow, amber or green. It
contains no preservative. Albuked 20
must be administered intravenously.
Each vial of Albuked 20 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.(11-14) The
production steps from Pooled Plasma to Effluent IV-1 in the Albuked 20
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
Each 50 mL vial of Albuked 20 supplies the oncotic equivalent of
approximately 200 mL citrated
plasma.
When administered intravenously to an adequately hydrated subject, the
oncotic (colloid osmotic) effect
of 50 mL Albuked 20 is such that it will draw approximately a further
125 mL of fluid from the
extravascular tissues into the circulation within 15 minutes