Reviews Human)


No reviews yet.

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 Human) on web:

Humans, known taxonomically as Homo sapiens (Latin: "wise man" or "knowing man"), are the only living species in the Homo genus of bipedal primates in Hominidae, the great ape ... Human - Wikipedia, the free encyclopedia


human n. A member of the genus Homo and especially of the species H. sapiens. A person: the extraordinary humans who explored Antarctica human: Definition, Synonyms from Answers.com


–adjective. 1. of, pertaining to, characteristic of, or having the nature of people: human frailty. 2. consisting of people: the human race. 3. of or pertaining to the social ... Human | Define Human at Dictionary.com


Tyria. Humans have been on the Tyrian continent since 205 BE / 305 CC / -5 DR. In Tyria, the four most prominent human organizations are the nation of Ascalon, the White Mantle ... Human - Guild Wars Wiki (GWW)


...we fight for our homes, our Gods, and our Queen. Nothing can break our spirit. — Logan Thackeray. Once the dominant species of Tyria, the humans have not fared well in the ... Human - Guild Wars 2 Wiki (GW2W)


Human nature is the concept that there is a set of inherent distinguishing characteristics, including ways of thinking, feeling and acting, that humans tend to have. Human nature - Wikipedia, the free encyclopedia


hu├é┬Ěman (hy m n) n. 1. A member of the genus Homo and especially of the species H. sapiens. 2. A person: the extraordinary humans who explored Antarctica. human - definition of human by the Free Online Dictionary ...


Health insurance plans and related healthcare benefits for Medicare, individual or group health insurance. Manage your healthcare choices with Humana. HUMANA - Guidance when you need it most.


In biological terms, a human being, or human, is any member of the mammalian species Homo sapiens, a group of ground-dwelling, tailless primates that are distributed worldwide ... Human being - New World Encyclopedia


adjective. of, belonging to, or typical of man (Homo sapiens): the human race; consisting of or produced by people: human society; having or showing qualities, as rationality ... human - Definition of human at YourDictionary.com





Featured Reviews

Reviews Lopid

Lopid Drug Description LOPID® (gemfibrozil) Tablets, USP DRUG DESCRIPTION What are the possible side effects of gemfibrozil (Lopid)? Get emergency medical help if you have any of these signs of an allergic reaction: hives;...
Read More  |  Review This
Reviews Fluocinolone Acetonide Intravitreal Implant

Retisert Drug Description RETISERT (fluocinolone acetonide intravitreal) Implant 0.59mg DRUG DESCRIPTION What are the possible side effects of fluocinolone ophthalmic implant (Retisert)? For the first 1 to 4 weeks after receiving...
Read More  |  Review This
Reviews Estradiol Transdermal System

Vivelle-Dot Drug Description Vivelle-Dot® (estradiol transdermal system) Continuous delivery for twice-weekly application ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens...
Read More  |  Review This
Reviews Xylocaine

Xylocaine Drug Description Xylocaine® (lidocaine HCl) Injection, USP Xylocaine® (lidocaine HCl and epinephrine) Injection, USP For Infiltration and Nerve Block DRUG DESCRIPTION Xylocaine (lidocaine HCl) Injections are sterile,...
Read More  |  Review This
Reviews Penicillin G potassium

Pfizerpen Drug Description Buffered PFIZERPEN (penicillin G potassium) for Injection To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pfizerpen® and other antibacterial drugs, Pfizerpen should...
Read More  |  Review This
Recent News
59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....