部份中文利鲁唑处方资料（仅供参考）
英文名：Riluzole
商品名：Rilutek Filmtabletten
中文名：利鲁唑薄膜片
生产商：赛诺菲-安万特
药品简介
Rilutek(Riluzole，利鲁唑片)是唯一治疗肌萎缩侧索硬化症的高效药物，用于延长肌萎缩侧索硬化(ALS)患者的生命或延长其发展至需要机械通气支持的时间。临床试验已经证明利鲁唑可延长ALS患者的存活期。存活的定义为不需插管进行机械通气也未接受气管切开的存活患者。
作用机理
尽管还没有完全阐明ALS的发病机制，但提示谷氨酸（中枢神经系统中的主要兴奋性神经递质）在该疾病的细胞死亡中起着重要作用。
提出利鲁唑通过抑制谷氨酸过程起作用。作用方式尚不清楚。
适应症
RILUTEK可以延长肌萎缩性侧索硬化症（ALS）患者的寿命或延长机械通气时间。
临床试验表明，RILUTEK可延长ALS患者的生存期。存活的定义是活着的，没有因机械通气和无气管切开术而插管的患者。
没有证据表明RILUTEK对运动功能，肺功能，束缚，肌肉力量和运动症状具有治疗作用。尚未证明RILUTEK在ALS的晚期有效。
仅在ALS中研究了RILUTEK的安全性和有效性。因此，RILUTEK不应用于患有任何其他形式的运动神经元疾病的患者。
用法与用量
成人或老年人的建议每日剂量为100毫克（每12小时50毫克）。
每日更高剂量不会带来明显的益处增加。
特殊人群
肾功能受损
不建议将RILUTEK用于肾功能不全的患者，因为尚未对该人群进行重复剂量的研究。
老年人
根据药代动力学数据，没有关于在此人群中使用RILUTEK的特殊说明。
肝功能受损
参见第4.3、4.4和5.2节
小儿
不推荐将RILUTEK用于儿童人群，因为缺乏有关利鲁唑在儿童或青少年中发生的任何神经退行性疾病中的安全性和有效性的数据。
给药方法
口服使用
禁忌症
对活性物质或所列的任何赋形剂过敏。
肝病或基线转氨酶大于正常上限的3倍。
怀孕或哺乳的患者。
保质期
3年
特殊的储存注意事项
该药品不需要任何特殊的存储条件。
容器的性质和内容
片剂包装在不透明的pvc /铝泡罩卡中。
每个包装包含56片。
完整说明资料附件：
https://www.medicines.org.uk/emc/product/1101/smpc
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Rilutek - Rilutek is not a cure for ALS, but it may delay progression of the disease and prolong your life.
Rilutek may also be used for purposes not listed in this medication guide. Used for: Treating patients with amyotrophic lateral sclerosis (ALS, Lou
Gehrig disease) to prolong survival and/or to delay the need for surgery to help breathing (tracheostomy).
It may also be used for other conditions as determined by your doctor.
Rilutek is a benzothiazole. Exactly how Rilutek works is not known.
It may  prevent further damage to certain brain cells (motor neurons) responsible for controlling muscle function.
Rilutek, a member of the benzothiazole class, is indicated for the treatment of patients
with amyotrophic lateral sclerosis (ALS). Rilutek extends survival and/or time to tracheostomy.
It is also neuroprotective in various in vivo experimental models of neuronal injury involving excitotoxic mechanisms.
The etiology and pathogenesis of amyotrophic lateral sclerosis (ALS) are not known, although a number of hypotheses have been advanced. One hypothesis is that motor neurons, made vulnerable through either genetic predisposition or environmental factors, are injured by glutamate. In some cases of familial ALS the enzyme superoxide dismutase has been found to be defective.
Indication: For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig\'s Disease) Rilutek is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
Rilutek extends survival and/or time to tracheostomy.
Indications: amyotrophic lateral sclerosis To extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek extends survival for patients with ALS(see Pharmacodynamics under Actions). Survival was defined as
patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Rilutek has not been shown to be effective in the late stages of ALS. Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor neurone disease.
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附件:
201412220341422.pdf