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  药店国别: 欧洲共同体药房
产地国家: 欧洲共同体国家
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: 50毫克/毫升 10毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Vifor Pharma Deutschland GmbH
生产厂家英文名:
Vifor Pharma Deutschland GmbH
该药品相关信息网址1:
http://www.ferinject.com/
该药品相关信息网址2:
http://www.drugs.com/uk/ferinject-spc-8462.html
该药品相关信息网址3:
http://www.medicines.org.uk/EMC/medicine/24167/SPC/Ferinject+(ferric+carboxymaltose)/
原产地英文商品名:
FERINJECT SOLUTION INJECTABLE 50MG/ML 10ML/VIAL
原产地英文药品名:
FERRIC OXIDE POLYMALTOSE COMPLEXES
中文参考商品译名:
FERINJECT血管注射溶液剂 50毫克/毫升 10毫升/瓶
中文参考药品译名:
羟基麦芽糖铁复合物
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anemia
英文适应病症2:
Iron deficiency anemia
临床试验期:
完成
中文适应病症参考翻译1:
贫血
中文适应病症参考翻译2:
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(20126322574111.PDF)的“原文Priscribing Information”为准
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 部分中文Ferinject处方资料(仅供参考)

缺铁性贫血药物Injectafer临床试验证明药效显著
    Galenica和他的美国合作伙伴—Luitpold制药公布了,Injectafer对心血管安全状况的多中心、随机、对照临床试验数据,评估了他的药效。
    Injectafer(美国商标名是Ferinject)是一种Ferric carboxymaltose含铁羧基麦芽糖替代铁静脉注射剂的治疗药,同时是一种活性医药成分。
    第一次试验是将Injectafer与口服或铁静脉注射治疗各种病因引起的缺铁性贫血患者的结果作比较。
    第二次试验,包括2,561的病人,把Injectafer和Venofer(蔗糖铁注射液)作比较,结果显示两个750毫克剂量的 Injectafer比五个以上200毫克剂量的Venofer,血蛋白含量有所提升。试验显示药效和安全性都达到了终末点。
    用Injectafer的患者在两次试验中血红蛋白的平均变化较高,而且同口服或静脉注射相比,Injectafer组复合心血管安全终结点达到率和他们差不多。
    羟基麦芽糖铁的商品名为Ferinject,由这项研究的资助者Vifor制药公司生产。该药每周注射1次,每次注射时间不少于15 min。

积极治疗铁缺乏可以改善慢性心衰患者的症状、心功能和生活质量
    在AHA2009年会上,公布了一项新的临床研究FAIR-HF研究(Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure)的结果。该研究的两大亮点为:1)静脉给予ferric carboxymaltose铁剂治疗可以显著改善II和III级慢性心衰患者的症状、新功能和生活质量。2)这种治疗对于有无贫血的患者有同样的效果。结果显示,静脉给予ferric carboxymaltose纠正铁缺乏可以显著改善心衰患者的症状、运动耐量和生活质量。主持该研究的德国Stefan D. Anker教授报告了该研究,显示:对于慢性心衰伴贫血的患者给予静脉ferric carboxymaltose治疗24周可以改善症状并且很安全。Anker教授说:“这个实验是多年来对于慢性心衰治疗药物第一个获得完全成功的3期实验”。除了改善症状,我们的治疗还可以改善6分钟步行试验评价的运动耐量以及生活质量,而且患者可以很好地耐受这种治疗。
    该研究主要在欧洲和阿根廷的75个研究单位进行,共入选459例伴铁缺乏的心衰患者。将其中的三分之二患者随机分到治疗组,每周一次静脉注射铁剂直到铁缺乏被纠正,之后给予每月一次治疗。其余的三分之一患者给予安慰剂(生理盐水)。结果显示,静脉铁剂治疗组的两个主要临床终点均有显著改善:1)24周后自我报告的患者整体评价(PGA)评分(P<0.0001);2)NYHA分级评价的心衰严重程度(P<0.0001)。对于PGA评分,在ferric carboxymaltose治疗组有50%的患者在24周得到“很大改善”和“中度改善”,而对照组仅有28%的患者能达到这种程度的改善。对于NYHA分级,24周后达到心功能I级或II级的患者在治疗组可达47%,而对照组仅有30%。无论按照血红蛋白或铁蛋白水平、年龄和性别分组,在所有预先规定的亚组人群中PGA and NYHA结果都是一致的。Anker 教授说,“重要的是,无论是否诊断贫血,都可以观察到静脉注射铁剂的益处,提示铁缺乏本身就是心衰患者一个非常重要的治疗靶点,并不依赖是否有贫血”。同时,研究发现,次级终点也有显著改善。24周后,静脉铁剂治疗患者行6分钟步行试验,较治疗前可以增加39.1米的步行距离,而对照组仅增加8.6米。从研究的4周始直到研究结束,铁剂治疗都显示可以改善患者的生活质量(P<0.001)。治疗组和对照组在死亡率和负性事件发生率(包括住院率)方面没有显著差异。采用简单的检测很容易发现铁缺乏,因此Anker教授建议,临床医师应该评价患者是否有铁缺乏。如果确定有铁缺乏,应考虑静脉注射铁剂改善患者症状。

Ferinject® receives MHRA approval for a simplified dosing regimen for the treatment of iron deficiency
Vifor Pharma announced today that Ferinject® (ferric carboxymaltose) has received approval for a new, simplified dosing regimen, which eliminates the need to calculate the iron dose with the complex Ganzoni formula.1,2 The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Mutual Recognition Procedure Reference Member State for Ferinject®, has approved a new version of its Summary of Product Characteristics (SmPC) reflecting this change. National approvals are expected to follow.

_The new, simplified and convenient dosing regimen means Ferinject® can now be delivered in a standardised cumulative dose of 1000mg, 1500mg or 2000mg of iron, depending on the individual patient’s body weight and haemoglobin level. The recommended iron dose is shown in a simple table in the SmPC, aiding clinicians in administering the correct dose of iron to each patient. The new easy-to-use dosing regimen is expected to save clinicians time as determining the individual dose will be quicker.

_In an additional change to the SmPC, the maximum amount of Ferinject® that can now be administered in a single intravenous (I.V.) injection has been increased from 200mg to 1000mg iron, excluding haemodialysis dependent chronic kidney disease.1 This gives clinicians greater flexibility and allows them to treat a larger patient population than before with a single dose of 1000mg.

_The advantages of the simplified Ferinject® dosing regimen were compared with the standard treatment regimen of the most widely used I.V. iron compound, iron sucrose (Venofer®), in the FERGIcor study (see below). In this study, patients who received Ferinject® based on the convenient and simplified dosing regimen were iron replete in up to three infusions versus up to 11 infusions for Venofer®.3 Reducing the need for multiple applications may be more convenient in medical practice.3

_Iron deficiency is common among patients with a number of medical conditions.4,5,6,7 Ferinject® has been shown to be a clinically effective I.V. iron treatment for patients with iron deficiency with inflammatory bowel disease, non-dialysis chronic kidney disease, chronic heart failure, and postpartum bleeding.3,8-13

About FERGIcor
_FERGIcor (FERinject in GI disorders [IBD] to correct iron deficiency) was a large, phase III, multicentre,randomised, comparative study showing a significantly greater improvement in the correction of iron deficiency due to inflammatory bowel disease (IBD) with a simplified Ferinject® dosing regimen.3

About Ferinject®
_Ferinject® is an innovative non-dextran intravenous iron (i.v.) replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® has gained marketing authorisation in 30 countries in Europe as well as in South Korea, Argentina, Russia, Australia and Lebanon, for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and gynaecology are ongoing.

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 详细处方信息以本药内容附件PDF文件(20126322574111.PDF)的“原文Priscribing Information”为准
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更新日期: 2012-6-4
附件:


20126322574111.PDF    

 
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