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Aventis Behring
proudly announces the approval of highly-purified Zemaira
Alpha1-Proteinase Inhibitor (human), a new choice in
Alpha-1 therapy. Zemaira will be available soon.
About New
Zemaira
Zemaira is a new choice for the treatment of Alpha-1. Zemaira
offers several significant features you and your doctor should
consider. These include:
Low infusion volume-20 mL diluent per gram
Approximately
15-minute infusion time
Convenient
storage-store and transport at room temperature, no refrigeration
required.
The US Food and
Drug Administration (FDA) has approved Zemaira for chronic
augmentation and maintenance therapy in individuals with alpha1-proteinase
inhibitor deficiency (Alpha-1) and clinical evidence of emphysema.
Zemaira increase antigenic and functional (ANEC) serum levels
and lung epithelial fluid levels of A1-PI.
Clinical data
demonstrating the long-term effects of chronic augmentation therapy
of individual with Zemaira are not available. Safety and
effectiveness in pediatric patients have not been established.
In clinical studies,
Zemaira has been shown to be a safe and effective therapy
that consistently maintains levels of alpha1-proteinase inhibitor
(A1-PI) above the historical target threshold. Zemaira also
offers high purity, with at least 90% of the protein as A1-PI.
Zemaira
may not be suitable for everyone; for example, those with known
hypersensitivity to components used to make Zemaira or other
A1-PI products or to those with certain IgA deficiencies.
You should ask your doctor if you think this may apply to you.
Zemaira was generally well tolerated in clinical studies
although the following treatment-related adverse events were reported
in 1% of cases: fatigue, injection-site pain, dizziness, headache,
tingling, and itching.
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