品牌名称:Triferic
通用名称:ferric pyrophosphate citrate solution
中文名称:焦磷酸铁柠檬酸
制药公司:Rockwell Medical, Inc.
Triferic
作用机理
Triferic含有铁中的焦磷酸铁的柠檬酸的形式,并加入到hemodialysate溶液通过穿过透析膜转移施用于患者。铁递送到循环结合到转铁蛋白运输到被纳入血红蛋白类红细胞前体细胞。
适应症和用法
TRIFERIC指示用于更换铁保持在成年患者血液透析相关的慢性肾脏病(HDD- CKD)血红蛋白。
使用限制
Triferic不用于对收到腹膜透析患者使用。
Triferic尚未收到家庭血液透析患者进行了研究。
用法用量
1 Triferic安瓿加入碳酸氢钠浓缩物2.5加仑实现在2微米(110微克/升)的最终hemodialysate Triferic铁(III)的最终浓度。
Triferic
禁忌症
无
警告和注意事项
过敏反应:在血液透析后,直到临床稳定的观察和体征过敏症状。
不良反应
在对照临床研究中最常见的不良反应包括:头痛,血管神经性水肿,乏力,AV瘘血栓,尿路感染,AV瘘部位出血,发热,乏力,程序性低血压,肌肉痉挛,疼痛下肢,背部疼痛和呼吸困难。
Triferic
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC.
TRIFERIC ? (ferric pyrophosphate citrate) solution, for addition to bicarbonate concentrate
Initial U.S. Approval: [2015]
INDICATIONS AND USAGE
TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD- CKD). (1)
Limitation of Use
Triferic is not intended for use in patients receiving peritoneal dialysis. (1.1)
Triferic has not been studied in patients receiving home hemodialysis (1.1)
DOSAGE AND ADMINISTRATION
Add one Triferic ampule to 2.5 gallons of bicarbonate concentrate to achieve a final concentration of Triferic iron (III) in the final hemodialysate of 2 μM (110 mcg/L). (2.1)
DOSAGE FORMS AND STRENGTHS
Ampule: 27.2 mg of iron (III) per 5 mL (5.44 mg of iron (III) per mL). (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable. (5.1)