FDA approves Jetbelin Zemaira ® 4g and 5g small bottles to treat alpha1 antitrypsin deficiency
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, CSL Behring announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved 4 grams and 5 grams of small bottles of Zemaira ® (alpha1 protease inhibitors) to treat alpha1 antitryline deficiency (AATD)the approval is important to the AATD community because Zemaira previously had only 1 gram of small bottlesThe 4g and 5gpacking(http://will reduce the number of vials required for reconstruction, increasing convenience by saving patient time and reducing wasteZemaira's therapeutic dose is based on weight, so a 184-pound (about 83.4 kg) patient currently needs five small 1g bottlesAs the size of the bottle increases and fewer bottles are reconstructed and stored, most patients will be able to simplify the preparation of each dose of Zemaira into one bottle, saving time and reducing wasteRoom temperature storage, coupled with the size of a new large bottle, reduces the therapeutic burden of AATD'
Zemaira is a natural, human plasma source of alpha1 antitrypsin (AAT) that has been shown to improve and maintain serum AAT levels in patients The drug has been available in the U.S market for more than 15 years and is manufactured in Kankakee, Illinois Zemaira is a highly purified AAT (human) approved in the United States, Canada, Brazil and New Zealand for chronic enhancement and maintenance therapy in adult patients with emphysema clinical evidence In Europe, Zemaira is listed under the brand name Respreeza ®
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