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ARALAST NP (alpha-1-proteinase inhibitor- human kit

Patient Information

Inform patients of the early signs of hypersensitivity reactions, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Advise patients to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.
Inform patients that ARALAST NP is made from human plasma, therefore the possibility of transmitting infectious agents cannot be totally excluded. Explain that the risk of transmitting an infectious agent has been reduced by screening donors, testing plasma for certain virus infections, and a manufacturing process to inactivate and/or remove certain viruses.
Inform patients that administration of ARALAST NP has been demonstrated to raise the levels of Alpha1-PI in the blood and in the lung, but that the effect of this augmentation on the frequency of pulmonary exacerbations and on the rate of progression of emphysema has not been established by clinical trials.

ARALAST NPis a trademark of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc. SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Prolastin is a trademark of Talecris Biotherapeutics, Inc.

Manufactured by:
Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

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