PLASBUMIN (albumin- human solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

GRIFOLS USA, LLC

INN (الاسم الدولي):

Albumin Human

تركيب:

Albumin Human 5 g in 20 mL

طريقة التعاطي:

INTRAVENOUS

الخصائص العلاجية:

Emergency Treatment of Hypovolemic Shock Plasbumin-25 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 (Plasbumin® -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 Plasbumin-5 is to be preferred for the usual volume deficits, Plasbumin-25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.(2) Removal of ascitic flu

ملخص المنتج:

Plasbumin-25 is available in 20 mL, 50 mL, and 100 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts:

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

PLASBUMIN - ALBUMIN (HUMAN) SOLUTION
GRIFOLS USA, LLC
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ALBUMIN (HUMAN) 25%, USP
PLASBUMIN -25
DESCRIPTION
Albumin (Human) 25%, USP (Plasbumin -25) 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-25 is a 25% sterile solution of albumin in an aqueous
diluent. The preparation
is stabilized with 0.02 M sodium caprylate and 0.02 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-25 is clear, slightly viscous,
almost colorless to
yellow, amber or green. It contains no preservative. Plasbumin-25 must
be administered
intravenously.
Each vial of Plasbumin-25 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 Plasbumin-25 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 20 mL vial of Plasbumin-25 supplies the oncotic equivalent of
approximately 100
mL citrated plasma; 50 mL supplies the oncotic equivalent of
approximately 250 mL
citrated plasma.
When administered intravenously to an adequately hydrated subject, the
oncotic (colloid
osmotic) effect of 20 mL Plasbumin-25 is such that it will draw
approximately a furthe