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详细处方信息以本药内容附件PDF文件（20194116485739.pdf）的“原文Priscribing Information”为准
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部分中文Firdapse处方资料（仅供参考）

【英文名称】Firdapse

【适用证】

成人Lambert-Eaton肌无力综合征（LEMS）的对症治疗

【用法用量】

治疗应在有治疗疾病经验的医生的监督下开始。

剂量学

FIRDAPSE应分开给药，一天三到四次。推荐的开始 剂量为每天15毫克氨苄西林，可以每4至5天以5毫克的增量增加至a 每天最多60毫克。单剂量不应超过20毫克。

平板电脑应与食物一起服用。有关进食和禁食状态下氨苄西林的生物利用度的更多信息，请参阅第5.2节。

N-乙酰转移酶的遗传差异可以解释氨苄西林的可变全身暴露（见4.4和5.2节）。

如果停止治疗，患者可能会出现LEMS的某些症状。

肾脏或肝脏损害 对于患有肾脏或肝脏损害的患者，应谨慎使用FIRDAPSE。对于中度或重度肾功能或肝功能损害的患者，建议每天一次起始剂量为5 mg氨苄西林（半片）。对于轻度肾功能或肝功能损害的患者，建议每天起始剂量为10 mg氨苄西林（5 mg，每天两次）。患者应该比没有肾脏或肝脏损伤的患者滴定更慢，剂量每7天增加5毫克。如果发生任何不良反应，应停止向上剂量滴定（见4.4和5.2节）。

儿科人群

FIRDAPSE在0至17岁儿童中的安全性和有效性尚未确定。没有数据可用。

给药方法

仅供口服使用

【注意事项】

•对活性物质或6.1节中列出的任何赋形剂过敏

•癫痫病

•不受控制的哮喘

•与sultopride同时使用（见4.5和5.1节）

•同时使用治疗窗狭窄的药品（参见第4.5节）

•同时使用已知可能导致QTc延长的药品

•先天性QT综合征患者（见4.4节）

【Therapeutic indications】

Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults

【Posology and method of administration】

Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.

Posology

FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day. No single dose should exceed 20 mg.

Tablets are to be taken with food. Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.

Genetic differences in N-acetyl transferase enzymes can account for the variable systemic exposure of amifampridine (see sections 4.4 and 5.2).

If treatment is discontinued, patients may experience some of the symptoms of LEMS.

Renal or hepatic impairment

FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function. For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established. No data are available.

Method of administration

For oral use only

【Contraindications】

• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1

• Epilepsy

• Uncontrolled asthma

• Concomitant use with sultopride (see sections 4.5 and 5.1)

• Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)

• Concomitant use with medicinal products with a known potential to cause QTc prolongation

• In patients with congenital QT syndromes (see section 4.4)

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详细处方信息以本药内容附件PDF文件（20194116485739.pdf）的“原文Priscribing Information”为准
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