帕里骨化醇英文说明书.pdfVIP

ZEMPLAR - paricalcitol injection, solution Abbott Laboratories ZEMPLAR® (paricalcitol) Injection Fliptop Vial DESCRIPTION Paricalcitol, USP, the active ingr edient in Zemplar Injection, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease(CKD) Stage 5. Zemplar is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v). Paricalcitol is a white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta- 5(Z),7(E),22(E)-triene and has the following structural formula : Molecular formula is C H O . 27 44 3 Molecular weight is 416.64. CLINICAL PHARMACOLOGY FDA approved labeling sent by Abbott on 3/31/11 1 of 16 Reference ID: 2928215 Secondary hyperparathyroidism is characterized by an elevation in parathyroid hormone (PTH) associated with inadequate levels of active vitamin D hormone. The source of vitamin D in the body is from synthesis in the skin and from dietary intake. Vitamin D requires two sequential hydroxylations in the liver and the kidney to bind to and to activate the vitamin D receptor (VDR). The endogenous VDR activator, calcitriol [1,25(OH) D ], is a hormone that binds to VDRs that are present in the 2 3 parathyroid gland, intest