Country: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
PARICALCITOL
ABBVIE PTE. LTD.
H05BX02
5 mcg/ml
INJECTION
PARICALCITOL 5 mcg/ml
INTRAVENOUS
Prescription Only
HOSPIRA INC
ACTIVE
2003-02-14
ZEMPLAR TM (Paricalcitol Injection) DESCRIPTION Paricalcitol injection is a synthetically manufactured, metabolically active vitamin D analog with modifications to the side chain (D2) and the A (19-nor) ring. It is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each 1 mL contains paricalcitol, 5 mcg; propylene glycol, 30% (v/v); and alcohol (ethanol), 20% (v/v). Paricalcitol is a white, crystalline powder with empirical formula C 27 H 44 O 3 , which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor- 1α,3β,25-trihydroxy-9,10 secoergosta5(Z),7(E),22(E)-triene. PHARMACOLOGIC PROPERTIES PHARMACODYNAMIC PROPERTIES 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 as vitamin D 3 and from dietary intake as either Vitamin D 2 or D 3 . Both Vitamin D 2 and D 3 require 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) 2 D 3 ], is a hormone that binds to VDRs that are present in the parathyroid gland, intestine, kidney, and bone to maintain parathyroid function and calcium and phosphorus homeostasis, and to VDRs found in many other tissues, including prostate, endothelium and immune cells. VDR activation is essential for the proper formation and maintenance of normal bone. In the diseased kidney, the activation of vitamin D is diminished, resulting in a rise of PTH, subsequently leading to secondary hyperparathyroidism and disturbances in the calcium and phosphorus homeostasis. 1 Decreased levels of 1,25(OH) 2 D 3 have been obse Aqra d-dokument sħiħ
ZEMPLAR TM (Paricalcitol Injection) DESCRIPTION Paricalcitol injection is a synthetically manufactured, metabolically active vitamin D analog with modifications to the side chain (D2) and the A (19-nor) ring. It is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each 1 mL contains paricalcitol, 5 mcg; propylene glycol, 30% (v/v); and alcohol (ethanol), 20% (v/v). Paricalcitol is a white, crystalline powder with empirical formula C 27 H 44 O 3 , which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10 secoergosta5(Z),7(E),22(E)-triene. PHARMACOLOGIC PROPERTIES PHARMACODYNAMIC PROPERTIES 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 as vitamin D 3 and from dietary intake as either Vitamin D 2 or D 3 . Both Vitamin D 2 and D 3 require 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) 2 D 3 ], is a hormone that binds to VDRs that are present in the parathyroid gland, intestine, kidney, and bone to maintain parathyroid function and calcium and phosphorus homeostasis, and to VDRs found in many other tissues, including prostate, endothelium and immune cells. VDR activation is essential for the proper formation and maintenance of normal bone. In the diseased kidney, the activation of vitamin D is diminished, resulting in a rise of PTH, subsequently leading to secondary hyperparathyroidism and disturbances in the calcium and phosphorus homeostasis. 1 Decreased levels of 1,25(OH) 2 D 3 have been observed in early stages of chronic kidney disease. The decreased levels of 1,25(OH) 2 D 3 and resultant elevated PTH levels, both of which often precede abnormalities in serum calcium and phosphorus, affect bone turnover rate and may result Aqra d-dokument sħiħ