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Albuminar Drug Description
Albuminar®-25
[albumin (Human)] USP, 25%
DRUG DESCRIPTION
Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.
Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albumin (Human) 25%,
Albuminar®-25, pasteurization of the final container at 60°C for 10 hours,
has been validated in a series of in vitro experiments for its capacity
to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following
model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as
a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus),
and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each
virus studied, three independent experiments were conducted using Albumin (Human)
5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following
results.1



Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)


Virus
Albumin (Human) 5%, Albuminar®-5


HIV-1
>5.44, >6.38 and >6.31


BVDV
>6.01, >6.76 and >6.55


PrV
>7.30, >7.68 and >7.63


EMC
>7.38, >7.97 and >7.97


Virus
Albumin (Human) 25%, Albuminar®-25


HIV-1
>5.50, >6.57 and >6.64


BVDV
>5.99, >5.81 and >5.32


PrV
>7.32, >7.20 and >7.42


EMC
>7.10, >7.89 and >7.87



1. Data on file.Last reviewed on RxList: 7/21/2008




Albuminar Drug Description
Albuminar®-25
[albumin (Human)] USP, 25%
DRUG DESCRIPTION
Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.
Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albumin (Human) 25%,
Albuminar®-25, pasteurization of the final container at 60°C for 10 hours,
has been validated in a series of in vitro experiments for its capacity
to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following
model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as
a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus),
and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each
virus studied, three independent experiments were conducted using Albumin (Human)
5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following
results.1



Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)


Virus
Albumin (Human) 5%, Albuminar®-5


HIV-1
>5.44, >6.38 and >6.31


BVDV
>6.01, >6.76 and >6.55


PrV
>7.30, >7.68 and >7.63


EMC
>7.38, >7.97 and >7.97


Virus
Albumin (Human) 25%, Albuminar®-25


HIV-1
>5.50, >6.57 and >6.64


BVDV
>5.99, >5.81 and >5.32


PrV
>7.32, >7.20 and >7.42


EMC
>7.10, >7.89 and >7.87



1. Data on file.Last reviewed on RxList: 7/21/2008




Albuminar Drug Description
Albuminar®-25
[albumin (Human)] USP, 25%
DRUG DESCRIPTION
Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.
Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albumin (Human) 25%,
Albuminar®-25, pasteurization of the final container at 60°C for 10 hours,
has been validated in a series of in vitro experiments for its capacity
to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following
model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as
a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus),
and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each
virus studied, three independent experiments were conducted using Albumin (Human)
5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following
results.1



Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)


Virus
Albumin (Human) 5%, Albuminar®-5


HIV-1
>5.44, >6.38 and >6.31


BVDV
>6.01, >6.76 and >6.55


PrV
>7.30, >7.68 and >7.63


EMC
>7.38, >7.97 and >7.97


Virus
Albumin (Human) 25%, Albuminar®-25


HIV-1
>5.50, >6.57 and >6.64


BVDV
>5.99, >5.81 and >5.32


PrV
>7.32, >7.20 and >7.42


EMC
>7.10, >7.89 and >7.87



1. Data on file.Last reviewed on RxList: 7/21/2008




Albuminar Drug Description
Albuminar®-25
[albumin (Human)] USP, 25%
DRUG DESCRIPTION
Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.
Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albumin (Human) 25%,
Albuminar®-25, pasteurization of the final container at 60°C for 10 hours,
has been validated in a series of in vitro experiments for its capacity
to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following
model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as
a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus),
and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each
virus studied, three independent experiments were conducted using Albumin (Human)
5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following
results.1



Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)


Virus
Albumin (Human) 5%, Albuminar®-5


HIV-1
>5.44, >6.38 and >6.31


BVDV
>6.01, >6.76 and >6.55


PrV
>7.30, >7.68 and >7.63


EMC
>7.38, >7.97 and >7.97


Virus
Albumin (Human) 25%, Albuminar®-25


HIV-1
>5.50, >6.57 and >6.64


BVDV
>5.99, >5.81 and >5.32


PrV
>7.32, >7.20 and >7.42


EMC
>7.10, >7.89 and >7.87



1. Data on file.Last reviewed on RxList: 7/21/2008




Albuminar Drug Description
Albuminar®-25
[albumin (Human)] USP, 25%
DRUG DESCRIPTION
Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.
The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.
Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium - 130-160 mEq; and potassium - n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.
Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.
The heat treatment step employed in the manufacture of Albumin (Human) 25%,
Albuminar®-25, pasteurization of the final container at 60°C for 10 hours,
has been validated in a series of in vitro experiments for its capacity
to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following
model viruses: Bovine Viral Diarrhea Virus (BVDV - an enveloped virus used as
a model for hepatitis C virus), Pseudorabies (PrV - a large, enveloped virus),
and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each
virus studied, three independent experiments were conducted using Albumin (Human)
5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following
results.1



Pasteurization (60° C for 10 hours)
Viral Reduction Studies (log10 reduction)


Virus
Albumin (Human) 5%, Albuminar®-5


HIV-1
>5.44, >6.38 and >6.31


BVDV
>6.01, >6.76 and >6.55


PrV
>7.30, >7.68 and >7.63


EMC
>7.38, >7.97 and >7.97


Virus
Albumin (Human) 25%, Albuminar®-25


HIV-1
>5.50, >6.57 and >6.64


BVDV
>5.99, >5.81 and >5.32


PrV
>7.32, >7.20 and >7.42


EMC
>7.10, >7.89 and >7.87



1. Data on file.Last reviewed on RxList: 7/21/2008





Other reviews about Albumin on wordpress

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A weary pathology resident was called one evening and was requested to calculate the dose of 25% human albumin for a 100 kilogram patient with ascites scheduled for […]


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Author Cornelius Griffin makes a case for the many particular uses of our favorite Desert Biologicals product, Bovine Serum Albumin (BSA). BSA is mostly used for scientific and […]


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  by rulifriady
Bovine serum albumin is widely used as both a carrier protein and stabilizing agent in enzymatic reactions. BSA is also commonly used as a blocking agent in dot […]


Bovine Serum Albumin: The Uses of BSA in Industry
  by rulifriady
Bovine serum albumin is widely used as both a carrier protein and stabilizing agent in enzymatic reactions. BSA is also commonly used as a blocking agent in dot […]


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  by drsvenkatesan
In the diagnosis of ACS, we have definite bio  markers for acute MI . Further, ECG  has a good  spcecificity  for STEMI . While ,clinical and ECG features of ischemia are […]



Other reviews about Albumin on web:

Albumin (Latin: albus, white) refers generally to any protein that is water soluble, which is moderately soluble in concentrated salt solutions, and experiences heat ... Albumin - Wikipedia, the free encyclopedia


Explains how the albumin test is used, when an albumin test is ordered, and what the results of an albumin test might mean Albumin: The Test


albumin n. A class of simple, water-soluble proteins that can be coagulated by heat and are found in egg white, blood serum, milk, and many other albumin: Definition from Answers.com


Serum albumin, often referred to simply as albumin is a protein that in humans is encoded by the ALB gene. Serum albumin is the most abundant plasma protein in mammals. Serum albumin - Wikipedia, the free encyclopedia


Includes a list of published albumin mutations with references, accession numbers for nucleotide sequences and a list of registered cases of analbuminemia with references, plus ... (albumin)


Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Albumin - serum: MedlinePlus Medical Encyclopedia


albumin /al·bu·min/ (al-bu´min) 1. any protein that is soluble in water and also in moderately concentrated salt solutions. 2. the major plasma protein, responsible for much of ... albumin - definition of albumin in the Medical dictionary - by the ...


–noun Biochemistry. any of a class of simple, sulfur-containing, water-soluble proteins that coagulate when heated, occurring in egg white, milk, blood, and other animal and ... Albumin | Define Albumin at Dictionary.com


Overview of the albumin blood test, used to screen for a liver disorder, kidney disease, or a nutritional deficiency Albumin: At a Glance


Albumin is a type of protein which is water soluble. There are many types of albumin, and some are vitally important to... What Is Albumin?





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