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【drug-news】FDA发布更昔洛韦的儿童用量指导原则

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FDA issues new dosing guidance for children using Valcyte

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant. The update is intended to prevent drug overdosing of children with low body weight, low body surface area, and very low serum creatinine. The revised dosing instructions now appear in the product’s label.

The revised pediatric dosing recommendations now include an upper limit on “calculated creatinine clearance,” a measurement of kidney function. Creatinine is a waste product produced by the body during energy production and is eliminated by the kidneys.
Creatinine levels in the blood are used to estimate how well kidneys are functioning. High creatinine levels may signal poor kidney function, while low creatinine levels may be observed in patients who are not muscular.

Valcyte is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children from 4 months to 16 years of age who have undergone a kidney or heart transplant and who are at a higher risk of getting the disease. CMV is a virus that can cause severe disease such as pneumonia or colitis in people with weakened immune systems, including organ transplant patients.

People using the medication should speak with their health care professional if they have questions about their Valcyte dose.

The medication is also approved to treat CMV retinitis (when the virus infects the eyes) in adults who have acquired immunodeficiency syndrome (AIDS) and is used to prevent CMV disease in people who have received a heart, kidney, or kidney-pancreas transplant with a high risk of getting CMV disease.

Health care professionals and patients may report serious adverse events (side effects) with Valcyte to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225887.htm

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2010-09-16 08:14 浏览 : 2059 回复 : 2

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FDA issues new dosing guidance for children using Valcyte

FDA发布儿童应用万赛维的新用量指导

The U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant.

美国食品与药品管理局正在通知医护专业人员关于最新万赛维（缬更昔洛韦）口服药片用量推荐和接受肾脏或心脏移植的儿童和青少年使用的解决办法。

The update is intended to prevent drug overdosing of children with low body weight, low body surface area, and very low serum creatinine. The revised dosing instructions now appear in the product’s label.

最新信息意图预防低体重、低体表面积和很低血清肌酸酐的儿童药物过量。现在经修改的用量说明出现在产品标签中。

The revised pediatric dosing recommendations now include an upper limit on “calculated creatinine clearance,” a measurement of kidney function. Creatinine is a waste product produced by the body during energy production and is eliminated by the kidneys.

现在经修改的儿科用量推荐包括根据肾功能指标“计算肌酐清除率”的上限。肌酐是一种机体在能量合成中生产的和被肾脏清除的废物。

Creatinine levels in the blood are used to estimate how well kidneys are functioning. High creatinine levels may signal poor kidney function, while low creatinine levels may be observed in patients who are not muscular.

机体肌酐水平被用来评估肾脏功能的好坏。高肌酐水平可以表示肾功能不好，而低肌酐水平可以在肌肉不发达的患者中被观察到。

Valcyte is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children from 4 months to 16 years of age who have undergone a kidney or heart transplant and who are at a higher risk of getting the disease.

万赛维是一种抗病毒药物，它可以有效预防经历肾脏或心脏移植和患病高危患者、年龄4个月到16岁儿童的巨细胞病毒疾病。

CMV is a virus that can cause severe disease such as pneumonia or colitis in people with weakened immune systems, including organ transplant patients.

巨细胞病毒是一种病毒，它可导致伴免疫系统缺陷的人们（包括器官移植患者）患严重疾病，例如肺炎或大肠炎。

People using the medication should speak with their health care professional if they have questions about their Valcyte dose.

使用该药物的人们如果有关于万赛维用量的问题，应该和他们的医护专业人员讲。

The medication is also approved to treat CMV retinitis (when the virus infects the eyes) in adults who have acquired immunodeficiency syndrome (AIDS) and is used to prevent CMV disease in people who have received a heart, kidney, or kidney-pancreas transplant with a high risk of getting CMV disease.

这种药在治疗获得性免疫缺陷综合征成年人患巨细胞病毒视网膜炎（当病毒感染眼睛）方面也是经过检验的，它被用来预防患巨细胞病毒疾病高危的已接受心脏、肾脏或胰肾联合移植人们患巨细胞病毒疾病。

Health care professionals and patients may report serious adverse events (side effects) with Valcyte to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

医护专业人员与患者可以通过网络、常规邮件、传真或电话向FDA药品监督网页不良事件报告规划报告万赛维的严重副反应（副作用）。

2010-09-16 16:15

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albmu 编辑于 2010-09-16 21:31

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FDA发布儿童应用万赛维的新用量指导

美国食品与药品管理局正在通知医护专业人员关于最新万赛维（缬更昔洛韦）口服药片用量推荐和接受肾脏或心脏移植的儿童和青少年使用的解决办法。

最新信息意图预防低体重、低体表面积和很低血清肌酸酐的儿童药物过量。现在经修改的用量说明出现在产品标签中。

现在经修改的儿科用量推荐包括根据肾功能指标“计算肌酐清除率”的上限。肌酐是一种机体在能量合成中生产的和被肾脏清除的废物。

机体肌酐水平被用来评估肾脏功能的好坏。高肌酐水平可以表示肾功能不好，而低肌酐水平可以在肌肉不发达的患者中被观察到。

万赛维是一种抗病毒药物，它可以有效预防经历肾脏或心脏移植和患病高危患者、年龄4个月到16岁儿童的巨细胞病毒疾病。巨细胞病毒是一种病毒，它可导致伴免疫系统缺陷的人们（包括器官移植患者）患严重疾病，例如肺炎或大肠炎。

使用该药物的人们如果有关于万赛维用量的问题，应该和他们的医护专业人员讲。

这种药在治疗获得性免疫缺陷综合征成年人患巨细胞病毒视网膜炎（当病毒感染眼睛）方面也是经过检验的，它被用来预防患巨细胞病毒疾病高危的已接受心脏、肾脏或胰肾联合移植人们患巨细胞病毒疾病。

医护专业人员与患者可以通过网络、常规邮件、传真或电话向FDA药品监督网页不良事件报告规划报告万赛维的严重副反应（副作用）。

2010-09-16 21:32

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