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当前本网站药物产品种数共 8524 处方药 8148 非处方药 269 保健品/医疗用具 107

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  药店国别: 西班牙药房
产地国家: 西班牙
所属类别: 泌尿生殖系统及泌乳药物->治疗肾病药物
处方药:处方药
包装规格: 1000毫克 90粉末包
计价单位: 粉末包
   
生产厂家中文参考译名:
希尔制药
生产厂家英文名:
SHIRE PHARMACEUTICALS
该药品相关信息网址1:
http://www.fosrenol.com/
原产地英文商品名:
Fosrenol 1000 mg powder 90 Powder envelopes (minimum order qty: 2)
原产地英文药品名:
Lantano Carbonato, Glucosa
中文参考商品译名:
FOSRENOL 1000毫克 90粉末包 (最低订货量:2)
中文参考药品译名:
碳酸镧
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
ESRD
英文适应病症2:
Hyperphosphatemia
临床试验期:
完成
中文适应病症参考翻译1:
终末期肾病
中文适应病症参考翻译2:
高磷酸盐血症
药品信息:

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 详细处方信息以本药内容附件PDF文件(201412717573137.pdf)的“原文Priscribing Information”为准
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部分中文FOSRENOL处方资料(仅供参考)

    FOSRENOL是针对终末期肾病 (ESRD) 患者控制高磷酸盐血症(1)(患者体内的磷酸盐过多,身体无法排出(2))的一种有效的单一疗法。高磷酸盐血症是一种影响全球范围内需要接受透析治疗的150万名肾病患者中70%以上人群的疾病(3)(4)。
  慢性肾病 (CKD) 是一种分为五期的渐进性疾病,第五期即为终末期肾病,即肾功能完全丧失,通常需要患者进行透析或肾移植治疗。
  慢性肾病被视为一种扩散的“无声的流行疾病”,每10个人中就有一人受到这种疾病的困扰(5),部分原因是上升的肥胖率和糖尿病患者人数的增加。(6) 慢性肾病可导致各种严重的健康问题,其中包括高磷酸盐血症。
  有效的磷酸盐控制对于这些患者而言至关重要。如果不能进行有效控制,高磷酸盐血症可导致严重的健康危机,包括慢性肾病相关的骨矿物质代谢紊乱,引起疼痛、骨骼脆弱,这可能导致骨折或骨变形,以及心血管病(所有透析患者死亡病例中几乎有一半存在这种情况)(7),(8)。
  Shire 肾病业务部门高级副总裁 David Milton 表示:“随着慢性肾病的恶化,如何控制它成为患者日益严峻的挑战,而饮食和液体摄入限制变得极为关键。在慢性肾病发展到第五期前,患者可能不需要透析,但经常接受10至12种不同的药物治疗(9)。由于高磷酸盐血症等慢性肾病的各种并发症,患者每日服用的药物可能高达25个药片或更多。
  Milton 补充道:“Shire 很自豪通过研究分子研发出面向医疗市场的 FOSRENOL,为患有高磷酸盐血症的终末期肾病患者提供了这种有效的不含钙的单一疗法选择。FOSRENOL 是一种简单的治疗方案,大多数患者仅需在每顿饭间咀嚼一片即可。”
  他又说道:“Shire 近期与其他磷酸盐结合剂生产商参加了该公司请求召开的一次美国食品与药物管理局心血管与肾脏药物部咨询委员会的会议。该委员会的大部分成员投票支持在慢性肾病四期患者的高磷酸盐血症治疗中使用磷酸盐结合剂的建议。因此,Shire 正在研究在这些患者使用 FOSRENOL 的调控路径。”
  迄今为止,超过5200名患者在一项范围广泛的临床开发项目中接受了 FOSRENOL 治疗。(10) 自2005年推出以来,FOSRENOL 已被用作全球100000多名患者的处方药物。(10) FOSRENOL 拥有一项长达六年的广泛的长期安全数据跟踪记录。
  在西班牙面市后,FOSRENOL 已在全球24个国家有售。

高磷酸盐血症简介
  磷酸盐几乎可在所有的食物中找到,它从胃肠道被吸收进血液中。当肾脏出问题时,就不能有效地滤出磷酸盐,即使借助于洗血透析器也无济于事。正常成年人的磷酸盐水平在0.8mmol/L(2.5 mg/dL) 与 1.4mmol/L(4.5 mg/dL)之间,而许多透析患者血液中的磷水平超过 2.1mmol/L (6.5 mg/dL )。如此高的水平可能使那些接受了至少一年透析(11)的患者面临明显更高的并发症与死亡的风险,70%以上的这些患者患有高磷酸盐血症(3)。
  慢性肾病破坏了身体中钙、甲状旁腺激素 (PTH) 和维生素 D 之间微妙的相互关系,引起高磷酸盐血症。时间一长,高磷酸盐血症最终会导致心脏、肺和一些动脉的硬化(12)。越来越多的证据显示,高磷酸盐血症会导致心血管疾病,所有的透析患者死亡病例中几乎有一半存在这种情况(13)。研究显示,年龄在25岁至34岁之间的透析患者的心血管疾病死亡率比65岁至74岁的普通人群的5倍还要高(14)。
  由于单独的透析和控制饮食一般来说不能控制磷酸盐的水平,因而通常来说患者通过在每次进食时摄入磷酸盐结合剂 (phosphate binding agent)来治疗高磷酸盐血症。这些结合剂能在磷酸盐被吸收进血液之前在胃肠道把它们“结合消灭”了。

FOSRENOL(R) 简介(碳酸镧)
  FOSRENOL 旨在降低 ESRD 成人患者身体中的血清磷酸盐水平。(1)
  FOSRENOL 通过在胃肠道内与食物中的磷酸盐相结合发挥作用。一旦与食物中的磷酸盐结合,镧/磷酸盐化合物就无法穿过肠壁进入血液而被人体排出。因此,食物中磷酸盐的总吸收量就会显著降低。
  市面上的 FOSRENOL 包括 500-milligram (mg)、750-mg 和 1000-mg 等多种不同剂量的药片。(1) 患者只需每餐服用一片 FOSRENOL,其身体中的血磷酸盐含量就可降低到目标水平。
  FOSRENOL 于2004年10月获美国食品及药物管理局 (FDA) 的批准。2005年3月,欧盟监管部门批准 FOSRENOL 在欧盟的16个成员国内销售。这是该药品在欧洲各地赢得销售许可的第一步。此后,在欧洲销售的审批程序的最后步骤也已经完成,被推荐批准在欧盟余下的11个成员国境内销售。FOSRENOL 目前在24个国家上市销售,包括意大利、法国、德国、英国和美国等国家,而且还将在全球其它的新市场中上市推出。该公司已经将在日本开发、推广和销售 FOSRENOL 的权利授予了 Bayer Yakuhin Ltd。
  肾功能不全患者有可能罹患低钙血症 (hypocalcemia)。这类患者的血钙水平因而需要定期监测,并需要适当补钙。
  目前还没有 FOSRENOL 用于严重肝损伤患者的数据。所以,对于这类患者需要注意,因为所摄入的镧的排出量有可能会减少。
  孕妇妊娠期禁用 FOSRENOL
  FOSRENOL 的临床研究没有涵盖急性胃溃疡、溃疡性结肠炎、克隆氏病和肠梗阻的患者。
  最常见的药物不良反应主要是腹部疼痛、便秘、腹泻、消化不良、肠胃气胀、反胃和呕吐之类的肠胃反应。通过与食物一起服用 FOSRENOL,这些反应的激烈程度会被降到最低,一般来说,其激烈程度也会随着持续用药而递减。低钙血症是唯一一种常见的其它不良反应。

药品名称
通用名:碳酸镧
英文名:Lanthanum carbonate
商品名:FOSRENOL
上市厂商:Shire

药理作用  
本品在上消化道的酸性环境下解离,与食物中的磷酸盐结合形成不溶性的磷酸镧复合物以抑制磷酸盐的吸收,从而降低体内血清磷酸盐和磷酸钙的水平。为了更有效地结合食物中的磷酸盐,本品宜随餐或在餐后立即服用。
健康志愿者服用本品后,血浆中的镧浓度很低;而终末期肾病患者服用本品的平均血浆镧峰浓度(C)为1.0mg/ml。剂量增加,血浆镧浓度也会随之小幅提升。本品在进食期间和进食后30分钟服用,对体内镧浓度几无影响。
体外试验显示,镧与a1-酸性糖蛋白、血清白蛋白及转铁蛋白等人血浆蛋白高度结合(>99%)。动物试验表明,大多数组织中的镧浓度系逐渐增加,且比血浆镧浓度高几个数量级(尤其在消化道、骨骼及肝脏中)。目前尚无证据表明镧可以透过血脑屏障。

药代动力学
本品既不是细胞色素P450(CYP)的底物,也不是其抑制剂。枸橼酸盐与本品单剂1000mg同服不影响本品的吸收。本品和地高辛、美托洛尔、华法林等药物同服时不影响这些药物的吸收。停止治疗后,镧从血浆中清除的消除半衰期(tl/2)为53小时。动物试验表明,胆汁排泄是镧消除的主要途径。在终末期肾病患者的透析液中未检测到镧。

适应症
本品适用于治疗终末期肾病患者的高磷酸盐血症。

Fosrenol
Generic Name: lanthanum carbonate (LAN than um CAR bo nayt )
Brand Names: Fosrenol

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What is Fosrenol?
Fosrenol is a phosphate binder used for reducing serum phosphate levels in patients with end stage kidney (renal) disease. High levels of phosphate can lead to complications with calcium absorption, resulting in serious medical problems.

Fosrenol prevents the body from absorbing phosphate, allowing it to be removed the body.

Fosrenol may also be used for purposes other than those listed in this medication guide.

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Important information about Fosrenol
Fosrenol tablets should be completely chewed before swallowing. Do not swallow the tablet whole.

Take Fosrenol with meals or immediately after eating.

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Before taking Fosrenol
Before taking this medication, tell your doctor if you have:
a stomach ulcer;
ulcerative colitis;
Crohn's disease; or
a bowel obstruction.

If you have any of the conditions listed above, you may not be able to use Fosrenol or you may require a dosage adjustment or special monitoring during treatment.

Fosrenol is in the FDA pregnancy category C. This means that it is not known if it will be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Taking this medication may affect the results of certain x-ray tests of your stomach. Tell the doctor or x-ray technician that you are using Fosrenol before having any x-rays.

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How should I take Fosrenol?
Fosrenol should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take Fosrenol for longer than your doctor has prescribed.

Chew the this medication tablet completely before swallowing. Do not swallow the tablet whole.

Fosrenol is usually taken with meals or immediately after eating. Store this medication at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms from Fosrenol are unlikely to occur.

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What should I avoid while taking Fosrenol?
Avoid making any changes to your diet while you are taking this medication.

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Fosrenol side effects
Stop using Fosrenol and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other, less serious side effects may be more likely to occur. Continue to take Fosrenol and tell your doctor if you have:
nausea or vomiting;
diarrhea or constipation;
stomach pain; or
dialysis graft blockage.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Fosrenol?
There may be other drugs that can affect Fosrenol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist has additional information about Fosrenol written for health professionals that you may read.

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What does my medication look like?
Lanthanum carbonate is available with a prescription under the brand name Fosrenol. Each chewable tablet is round with a beveled edge, and white or off-white in color. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

更新日期: 2015-03-01
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