понедельник, 6 июня 2011 г.

Baxter Receives Approval To Process ARALAST NP

Baxter received Food
and Drug Administration approval to transfer ARALAST processing from a
third party to Baxter. ARALAST NP is a brand name referring to the therapy
completely processed by Baxter. It is biologically equivalent to currently
marketed ARALAST.


ARALAST is a human alpha1 -- proteinase inhibitor (A1PI) indicated for
chronic augmentation therapy in patients with hereditary emphysema, which
is a genetic condition caused by a deficiency of A1PI in the lungs. People
with this deficiency have reduced serum levels of A1PI, an important blood
protein processed in the liver that can protect lung tissue from damage
caused by enzymes that are released by white blood cells.


Alpha1-Antitrypsin deficiency affects an estimated 60,000 to 100,000 people
in the United States. It is estimated more than 95 percent of those with
AAT deficiency are undiagnosed. Without sufficient quantities of A1PI,
patients develop lung damage. If untreated, A1PI deficiency can result in
emphysema and premature death.



Important Safety Information



ARALAST is contraindicated in individuals with selective IgA
deficiencies (IgA level less than 15mg/dL) who have known antibody against
IgA, since they may experience severe reactions, including a severe,
potentially life-threatening allergic reaction to IgA, which may be
present. The most common symptoms during the clinical study were headache
(0.3%) and sleepiness (0.3%). Post-market adverse event data have indicated
reports of infusion site pain associated with the administration of
ARALAST. Pregnancy Category C, reproduction studies have not been conducted
with ARALAST. As with all plasma-derived therapeutics, the potential to
transmit infectious agents cannot be totally eliminated. Please see
accompanying ARALAST Prescribing Information for full prescribing details.



For more information on ARALAST, including full prescribing
information, please visit aralast.



About Baxter



Baxter Healthcare Corporation is the principal U.S. operating
subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International
Inc., through its subsidiaries, assists healthcare professionals and their
patients with the treatment of complex medical conditions, including
cancer, hemophilia, immune disorders, kidney disease and trauma. The
company applies its expertise in medical devices, pharmaceuticals and
biotechnology to make a meaningful difference in patients' lives.


Baxter International Inc.

baxter

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