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  药店国别: 美国药房
产地国家: 美国
所属类别: 影响血液及造血系统药物->抗贫血药物
处方药:处方药
包装规格: 510毫克/17毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
AMAG PHARMS INC
生产厂家英文名:
AMAG PHARMS INC
该药品相关信息网址1:
http://www.feraheme.com/
该药品相关信息网址2:
http://www.drugs.com/feraheme.html
该药品相关信息网址3:
http://www.rxlist.com/feraheme-drug.htm
原产地英文商品名:
FERAHEME 510MG/17ML/VIAL
原产地英文药品名:
FERUMOXYTOL
中文参考商品译名:
FERAHEME 510毫克/17毫升/瓶
中文参考药品译名:
FERUMOXYTOL
原产地国家批准上市年份:
2009/06/30
英文适应病症1:
CKD
临床试验期:
完成
中文适应病症参考翻译1:
慢性肾病缺铁性贫血
药品信息:

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 详细处方信息以本药内容附件PDF文件(201931120235430.pdf)的“原文Priscribing Information”为准
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部分中文Feraheme处方资料(仅供参考)

Feraheme(ferumoxytol)-用于慢性肾病缺铁性贫血
    AMAG公司近日表示美国已批准Feraheme(ferumoxytol)注射剂作为一种铁替代疗法用于治疗成人慢性肾病患者的缺铁性贫血。ferumoxytol为一种半合成超顺磁性氧化铁纳米粒子,目前也在开发用为核磁共振造影剂。
    Feraheme的推荐用法为首次510mg静脉滴注,3-8天后再静脉滴注510mg。对持续与反复的缺铁性贫血患者可重复每次给予510mg的Feraheme。

静脉补铁剂Feraheme已获准用于治疗成人慢性肾病缺铁性贫血
    2009年6月30日,美国AMAG制药公司宣布,美国食品药品管理局(FDA)已批准Feraheme(ferumoxytol)上市,用于治疗成人慢性肾病缺铁性贫血。据AMAG总裁兼首席执行官Brian J. G. Pereira博士称,“Feraheme为各类慢性肾病患者提供了一个治疗缺铁性贫血的新方案,且不受透析治疗的影响。”
    Feraheme可作为一种铁替代疗法,经静脉用药(IV)。推荐用法为,初始静脉滴注510 mg,3~8d后再次静脉滴注510 mg。该药静脉用药时无需稀释,给药速度达1 ml/s(即,30mg/s)。对于患有顽固性或复发性缺铁性贫血的患者,Feraheme给药时仍可采用其推荐剂量。
    此次批准是基于4项对慢性肾病缺铁性贫血患者进行的III期试验的安全性和有效性资料。这些研究包括3项开放标签、多中心、随机、安全性和有效性临床试验和1项双盲、多中心、随机、安慰剂对照、交叉的安全性试验。主要终点为基线至首剂后35d血红蛋白水平的平均变化值,在此方面,各项核心的安全性和有效性研究均达到了统计学意义。这些研究显示,无论患有何类型的慢性肾病,与口服铁剂相比,应用Feraheme与血红蛋白水平显著增加均具有相关性。研发计划中,共有1,726例患者接受Feraheme治疗,其中包括1,562例处于不同期肾病的患者。
    AMAG拟于儿童慢性肾病群体中进行2项上市后研究:一项针对接受透析的患者,另一项针对不接受透析的患者。各研究将募集大约75例患者。在这些试验中,研究人员将收集Feraheme相关的药代动力学、安全性和有效性资料,并与口服铁剂疗法作比较。公司期冀于2010年正式启动上述研究。
    在临床试验中, Feraheme治疗组患者与口服铁剂治疗的患者相比,最常报告(≥2%)的不良反应如下:腹泻(4.0%对8.2%),恶心(3.1%对7.5%),头晕(2.6%对1.8%),低血压(2.5%对0.4%),便秘(2.1%对5.7%),以及外周水肿(2.0%对3.2%)。

FERAHEME(Ferumoxytol)
制造商:
AMAG制药公司

药理分类:
补血药

活性成分:
元素铁浓度30mg/ml(如ferumoxytol 510mg/17mL),为四胶体铁损伤;含有甘露醇44mg/mL;不含防腐剂。

适应症:
铁缺乏症在成人患者与慢性肾脏病(CKD)。

药理作用:
Feraheme是铁(超顺磁性氧化铁与polyglucose山梨醇carboxymethylether涂层)是与甘露醇制定胶体形态。碳水化合物有助于隔离涂层的生物活性铁,直到铁进入复杂碳水化合物在肝脏,脾脏网状内皮系统的巨噬细胞和骨髓。从复杂的后释放,铁进入细胞内铁的储存池(如铁),或者是运输转移到红细胞的血红蛋白等离子掺入前体细胞转。
Feraheme不透析。

临床试验:
三个随机,开放标签进行了对照临床试验,以评估对缺铁性贫血对慢性肾脏疾病患者治疗的安全性和偶发的Feraheme疗效。患者被随机分为口服铁剂治疗(富马酸亚铁200毫克铁/天,每天21)或Feraheme(二510mg注射)。试验1和2不登记的慢性肾病患者透析,登记和审判3血液透析的慢性肾病患者。在这三个试验中的血红蛋白从基线(克/分升),以35天的变化分别为1.2,0.8,基于研究药物组和1.0,0.5,0.2,及口服铁剂治疗组0.5。转铁蛋白饱和度和测量也显示,相对于口服铁剂治疗组的Feraheme有改善。这些试验还包括选修失控,后续阶段中,患者持续性缺铁性贫血是由于另外两个Feraheme 510mg注射。总体而言,这些患者(70%)均经历了血红蛋白,转铁蛋白饱和度和进一步增加。血红蛋白中的血红素上升与复治的病人基线水平的平均改变为0.86g/dL,并负责所有患者0.5g/dL。

成人:
给在静脉注射稀释率高达1mL/sec(30mg/sec)。最初510mg,那么额外的剂量3-8天以后。可重复持续性或复发性缺铁性贫血。血液透析:血液透析开始后给血压稳定后至少1小时。

儿童:
不推荐。

禁忌:
铁超载。贫血不是由于缺铁。

警告/注意事项:
监控低血压,以及过敏至少30分钟,注射后。评价血红蛋白,铁蛋白,铁,转饱和至少1个月后注射第二。有设备/人员可用于治疗过敏反应。妊娠(Cat.C)。哺乳母亲:不推荐。

互动:
可瞬时(最多3个月)影响磁共振成像(见文献)的诊断能力。

不良反应:
腹泻,恶心,低血压,头晕,便秘,周围水肿,输液反应,过敏反应(如皮疹,瘙痒,荨麻疹,喘息)。

Important Safety Information
Indication and contraindication
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic-type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

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 详细处方信息以本药内容附件PDF文件(201931120235430.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-3-11
附件:
201931120235430.pdf    

 
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