Aventis Behring Announces the approval of
Zemaira™ Alpha1-Proteinase Inhibitor

 

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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