沙格列汀fda原版使用说明书最新版（Shah Glenn Dean FDA original manual, latest version）.docVIP

沙格列汀fda原版使用说明书最新版（Shah Glenn Dean FDA original manual, latest version） Onglyza (Shah Glenn Dean, saxagliptin) tablet user manual, July 2009 Edition Approval date: July 31, 2009, FDA, October 1, 2009, EU EMEA, Inc.: Bristol-Myers, Squibb and AstraZeneca. Http:///drugsatfda_docs/label/2009/022350lbl.pdf 11. general description: Shah Glenn Dean is an oral active two peptide peptidase -4 (DPP4) inhibitor. Chemical name: Shah Glenn Dean monohydrate (1S, 3S, 5S) -2-[(2S) -2-Amino-2- (3-hydroxytricyclo[3,7]dec-1-yl) acetyl]-2-azabicyclo [3.1.0]hexane-3-carbonitrile (1S, monohydrate, or 3S, 5S) -2-[(2S) -2-Amino-2- (3-hydroxyadamantan -1-yl) acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile hydrate. Molecular formula: C18H25N3O2, H2O, molecular weight: 333.43. Structural formula: Shah Glenn Dean monohydrate is a white or pale yellow or light brown, no moisture absorption, crystalline powder. At 24 degrees C + 3 degrees C, insoluble in water, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropanol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400). For oral use of the ONGLYZA film coated tablets containing 2.79 or Mg Shah Glenn Dean hydrochloride (anhydrous) equivalent to 2.5 mg or 5.58 mg Shah Glenn Dean Shah Glenn Dean hydrochloride (anhydrous) equivalent to 5 mg Shah Glenn Dean and the following non active ingredients: lactose monohydrate, microcrystalline cellulose, cross-linked Suo Jiaji cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxide. 1 indications and uses: 1.1 monotherapy and combination therapy Onglyza applies to dietary and exercise therapy in adults with type 2 diabetes to improve glycemic control [see clinical research (14)]. 1.2 important restrictions on use Onglyza is not used in type 1 diabetes or diabetic ketoacidosis because it may be ineffective in these cases. No association with ins