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Summary Albumin (Human) 25%
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Albumin (Human) 25%U.S. License No.
Rx only
DESCRIPTION I
Albumin (Human) 25% is a sterile, liquid preparation of albumjn derived from large pools of
human plasma. All units of human plasma used in the manufacture of Albumin (Human) 25%
are provided by FDA approved blood establishments only.
The product is manufactured by the Cohn-Oncley cold ethanol fractionation process followed
by ultra- and diafiltration. The manufacturing process includes final container pasteurisation
and an additional bulk pasteurisation at 60 f 0.5"C for 10 - 11 hours. The Albumin (Human)
25% manufacturing process provides a significant viral reduction i n in vitro studies (table 1).
These reductions are achieved through a combination of process steps including Cohn
fractionation and final container pasteurisation.
Table 1: Inrvitro reduction factor during Albumin (Human) 25% manufacturing
In vitro reduction factor [loglo]
Production step Enveloped viruses Non-enveloped viruses
PRV SBV HIV- 1 RE0 3 PPV HAV
Precipitation of
4.58 4.28 Not done 5.55 6.89 7.41
Fraction l+II+III
Cohn
fractions Precipitation of > 5.50 >6.02 >7.08 > 7.84 6.29 . > 7.45
tion* Fraction IV
Precipitation of
7.7 1 3.55 Not done 5.35 , 5.76 6.19
Fraction V
Pasteurization final
container
> 8.67 > 8.79 >7.23 5.36 3.22 2.45
Global reduction factor > 14.17 >14.81 > 14.31 > 13.20 9.51 > 9.90
* Due to the similar mode of action of the individual process steps only precipitation of Fraction IV was used to
calculate the global reduction factor.
PRV: Pseudorabies Virus -
SBV: Sindbis Virus
HIV-1: Human Immunodeficiency Virus - I
Reo 3:: Reovirus Type 3
PPV: Porcine Panovirus
HAV: Hepatitis A Virus
16-71
page 1 of 8
, The composition of Albumin (Human) 25% is as follows:
Component Quantity11000 ml
Protein, of which 2 96% is
human albumin 250 g
Sodium 130 - 160 mmol
Potassium 12 mmol
N-acetyl -DL-tryptophan 0.064 - 0.096 mmollg protein
,Caprylic acid ' 0.064 - 0.096 mmollg protein
Water for Injections ad. 1000 ml
Albumin (Human) 25% contains no preservative. Albumin (Human) 2 5 % is a clear, slightly
viscous liquid; it is almost colorless or slightly yellow or green.
+
Albumin (Human) 25% is heated at 6 0 0.5"C for 10-1 1 hours. No positive assertion can be
made, however, that this procedure completely destroys the causative agents of viral hepatitis.
There are no known cases of viral hepatitis which have resulted from the administration of
Albumin (Human) 25%.
CLINICAL PHARMACOLOGY
. Albumin is responsible for 70-80% of the colloid pressure of normal plasma, thus making it
useful in regulating the volume of circulatory blood. Albumin stabilises circulating blood
volume and is a camer of hormones, enzymes, medicinal products and toxins.[l-41
The colloid osmotic effect of Albumin (Human) 25% is approximately 5 times its volume of
human plasma. When injected intravenously it will increase the circulating plasma volume by
an amount of about 3.5 times the volume infused within 15 minutes if the patient is adequately
hydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and
duration of volume expansion depends upon the initial blood volume. When treating patients
with diminished blood volume, the effect of infused albumin may persist for many hours. The
hemodilution lasts for a shorter time when albumin is administered to individuals with normal
blood volume.[5]
Albumin is distributed throughout the extracellular compartments, more than 60% of the body
albumin pool is located in the extravascular fluid compartment. The total body albumin in a 7 0
kg man is estimated to be 350g, it has a half live of about 13-19 days with a turnover of
approximately 15g per day.[2-41
INDICATIONS AND DOSAGE
Restoration and maintenance of circulating blood volume where volume deficiency has been
demonstrated, and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the
individual patient, based on official recommendations. [8]
2006 1002pil_643_USA-02.0 1-en.doc page 2 of 8
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