FDA approves Xellia Pharmaceuticalready pre-mixed vancomycin injection
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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, XelliaPharmaceutical(http://company(http://announced that the U.SFood andMedicines(http://Administration (
FDA(http://) has approved the ready-to-use (RTU) premixed vancomycin injectionFebruary 2018, the FDA granted theProduct(http://Qualified Infectious Disease Products (QIDP) to theAbout Vancomycin InjectionVancomycin Injection RTU is apatented(http://formula of vancomycin, provided as a premixed solution in a single-dose flexible bag, stable for 16 months at room temperature (up to 25 degrees C)Itspackaging(http://are 100 ml, 200 ml, 300 ml, 400 ml, respectively, containing 500 mg, 1 g, 1.5 g, 2.0 g vancomycinEach 100 ml solution contains 1.8 ml of polyglycol 400, 1.36 grams N-acetyl-D-alanine, 1.26 grams of L-lysine hydrochloride in water injection waterSodium hydrochloric acid and sodium hydroxide are used to regulate acidity and alkalinityVancomycin injection is a glycopeptide antibacterial agent for adults and children (1 month and above) to treat sepsis, infectious endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infectionsVancomycin injection RTU is a new vancomycin preparation, which was approved based on more than 60 non-clinical studies, including studies confirming that the new formulation will not adversely affect the efficacy of the active ingredient vancomycin
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