Brussels, Belgium – 29 August 2025 – 7:00AM CEST– UCB

比利时布鲁塞尔 – 2025年8月29日 – 欧洲中部夏令时间上午7:00 – UCB

, a global biopharmaceutical company, today announced it will present 26 abstracts from its epilepsy portfolio at the International Epilepsy Congress (IEC) Congress, Lisbon, Portugal, August 30 – September 3, 2025. Data will focus on developmental and epileptic encephalopathies (DEEs), such as Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), as well as prolonged seizures, seizure emergencies and early pipeline research. .

，一家全球生物制药公司，今天宣布将在2025年8月30日至9月3日于葡萄牙里斯本举行的国际癫痫大会（IEC）上展示其癫痫产品组合中的26篇摘要。数据将重点关注发育性和癫痫性脑病（DEEs），如Dravet综合征（DS）和Lennox-Gastaut综合征（LGS），以及长时间发作、癫痫急症和早期管线研究。

Dimitrios Bourikas, Global Epilepsy Medical Head of DEE and Epilepsy, UCB, commented: “At UCB, we are committed to driving improvements in all aspects of care for people living with epilepsies and severe epileptic conditions. The breadth of data we are presenting at the International Epilepsy Congress reflects our dedication to advancing innovative solutions that address real-world patient needs.

UCB全球癫痫医学负责人、DEE和癫痫部门主管迪米特里奥斯·布里卡斯评论道：“在UCB，我们致力于推动改善癫痫和严重癫痫患者护理的各个方面。我们在国际癫痫大会上展示的数据广度反映了我们对推进满足现实世界患者需求的创新解决方案的承诺。”

By deepening insights into disease mechanisms, treatment outcomes, and the experiences of both patients and caregivers, we strive to shape a better future for those affected by epileptic conditions.”.

通过深入洞察疾病机制、治疗结果以及患者和护理人员的体验，我们致力于为受癫痫疾病影响的人群塑造更美好的未来。"

Highlights of data to be presented at IEC:

将在IEC上展示的数据亮点：

Fenfluramine:

芬氟拉明：

A combined open-label extension (OLE) study enrolled 412 patients with DS or LGS who had participated in three previous fenfluramine studies, reporting no new or unexpected safety signals and long-term sustained benefit.

一项开放标签扩展（OLE）联合研究招募了412名曾参与过三项先前芬氟拉明研究的DS或LGS患者，报告显示没有新的或意外的安全性信号，并且长期持续获益。

2

2

Barriers and benefits of identifying patients with DEE in adult care settings:

识别成人护理环境中的DEE患者面临的障碍和益处：

Although the diagnosis of developmental and epileptic encephalopathies (DEEs) in children has become routine, significant diagnostic gaps remain for adults. This qualitative study, based on interviews with caregivers and healthcare professionals in the UK, Germany, France, and Spain, found that a confirmed diagnosis fosters holistic care, which may improve quality of life (QoL), enhance communication and reduce risk of hospitalisation for patients..

尽管儿童发育性和癫痫性脑病（DEEs）的诊断已成为常规，但成年人在诊断方面仍存在显著差距。这项基于对英国、德国、法国和西班牙的护理人员及医疗专业人员访谈的定性研究发现，确诊有助于提供整体护理，这可能改善患者的生活质量（QoL）、加强沟通并降低住院风险。

4

4

Unpredictable seizures and disruptive behavior in DEEs: Interim results of a caregiver survey:

DEEs中的不可预测的癫痫发作和破坏性行为：照顾者调查的中期结果：

An internet-based anonymous 63-question survey was distributed to caregivers of patients with DEEs by multiple DEE-specific patient groups. Nearly half of caregivers reported that high rates of disruptive seizures/behavior led to temporary loss in abilities, previously associated with reduced quality of life..

一份基于互联网的匿名63题调查问卷通过多个针对DEE的患者群体分发给了DEE患者的照料者。近一半的照料者报告称，频繁的癫痫发作/行为问题导致了患者某些能力的暂时丧失，而这些能力的丧失此前已被认为会降低生活质量。

3

3

Prolonged seizures:

长时间癫痫发作：

Research characterizing patient and caregiver experiences of prolonged seizures describes unmet needs and the significant short-term and long-term negative impact on quality of life.

对患者和护理人员长期癫痫发作经历的研究描述了未满足的需求，以及对生活质量产生的显著短期和长期负面影响。

7

7

A Real-world data from Adelphi’s Prolonged Seizure Disease Specific Programme™ characterizes the definition, prevalence, and patient population of prolonged seizures finding that people living with epilepsy experiencing prolonged seizures experience significant seizure worry due to their seizure. In addition, these seizures regularly progress to status epilepticus and/or seizure clusters, leading to emergency care and hospital admissions, despite best practice..

Adelphi的长时间癫痫发作疾病特定计划™ 的真实世界数据描述了长时间癫痫发作的定义、流行率和患者群体，发现癫痫患者因癫痫发作而经历显著的发作担忧。此外，这些发作经常进展为癫痫持续状态和/或癫痫簇，尽管采取了最佳实践，仍然导致紧急护理和住院治疗。

5

5

A post hoc analysis of video-EEG recordings from 725 patients explores seizure duration and time-point cutoffs for statistically defining possible and probable prolonged seizures by seizure type, supporting the 2-minute cutoff for tonic-clonic seizures (focal/generalised onset) and suggesting a 1 to 3 minutes cut-off for other seizures, confirming that most seizure are abnormally prolonged at 2 minutes or less.

对725名患者的视频脑电图记录进行的事后分析探讨了不同发作类型中可能和很可能的长时间发作的持续时间及时间点截断值，支持全面性强直-阵挛发作（局灶性/全面性发作）使用2分钟作为截断值，并建议其他类型的癫痫发作使用1到3分钟作为截断值，证实大多数癫痫发作在2分钟或更短时间内属于异常延长。

6

6

Seizure pathways

癫痫发作通路

: A qualitative study aimed to understand the end-to-end care process for acute seizure emergencies found that a stronger focus on outpatient guidelines could empower patients and caregivers to manage prolonged seizures in the outpatient setting, potentially avoiding unnecessary seizure escalation, injury, hospitalisation and death..

：一项旨在了解急性癫痫发作全程护理过程的定性研究发现，更加关注门诊指南可以增强患者和护理人员在门诊环境中管理长时间癫痫发作的能力，从而可能避免不必要的癫痫发作升级、受伤、住院和死亡。

8

8

Acute medication landscape

急性药物治疗格局

: A global analysis assessed the availability and reimbursement coverage of seizure acute medications for use in the outpatient setting.

：一项全球分析评估了门诊使用癫痫急性发作药物的可获得性和报销覆盖情况。

9

九

Lennox-Gastaut syndrome:

Lennox-Gastaut 综合征：

Diagnosing Lennox-Gastaut syndrome (LGS) is challenging due to the heterogeneity of its clinical presentation and symptom evolution over time. A group of ten epilepsy experts from seven countries convened to develop a simple-to-use checklist for non-specialists to support LGS diagnosis, using the International League Against Epilepsy criteria as a framework..

诊断Lennox-Gastaut综合征（LGS）具有挑战性，因为其临床表现多样且症状会随时间演变。来自七个国家的十位癫痫专家召开会议，旨在开发一个易于使用的清单，以帮助非专科医生支持LGS的诊断，并以国际抗癫痫联盟的标准为框架。

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10

UCB-sponsored symposium: Time matters in developmental and epileptic encephalopathies

UCB赞助的研讨会：时间在发育性和癫痫性脑病中至关重要

Date

日期

: Monday, September 1st, 13:55 – 15:05

：星期一，九月一日，13:55 – 15:05

Overview

概述

: The upcoming symposium aims to enhance knowledge and awareness of the broader impact of DEEs in adulthood - beyond seizure control. The session will focus on improving diagnosis, understanding treatment journeys and addressing barriers to care in order to drive better individual outcomes.

即将举行的研讨会旨在加强对DEEs在成年期更广泛影响的认识和了解——超越癫痫发作的控制。会议将专注于改进诊断、理解治疗过程并解决护理障碍，以推动更好的个体治疗效果。

UCB presentations during the International Epilepsy Congress (IEC) Congress Annual Meeting

在国际癫痫大会（IEC）年会期间的UCB演讲

For further information, contact UCB:

如需更多信息，请联系UCB：

Global Communications

全球通讯

Anna Clark

安娜·克拉克

T: +44 07386 686779

电话：+44 07386 686779

Anna.Clark@ucb.com

安娜.克拉克@ucb.com

Corporate Communications

企业传播

Laurent Schots

劳伦特·肖茨

T: +32.2.559.92.64

电话：+32.2.559.92.64

laurent.schots@ucb.com

laurent.schots@ucb.com

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T: +32.2.559.94.14

T：+32.2.559.94.14

antje.witte@ucb.com

antje.witte@ucb.com

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023.

优时比（UCB），比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物及解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。公司在约40个国家拥有约9,000名员工，并在2023年实现了53亿欧元的收入。

UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news..

UCB在布鲁塞尔泛欧交易所上市（股票代码：UCB）。关注我们的Twitter：@UCB_news。

Forward looking statements

前瞻性声明

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management.

本新闻稿可能包含前瞻性陈述，包括但不限于含有“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”以及类似表述的声明。这些前瞻性陈述基于管理层当前的计划、估计和信念。

All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results.

所有声明，除历史事实声明外，均可能被视为前瞻性声明，包括对收入、营业利润率、资本支出、现金、其他财务信息、预期法律、仲裁、政治、监管或临床结果或实践以及其他此类估计和结果的声明。

By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release.

由于此类前瞻性陈述的性质，其并非未来业绩的保证，并且受已知和未知风险、不确定性及假设的影响，这些因素可能导致UCB的实际结果、财务状况、业绩或成就，或行业结果，与本新闻稿中包含的此类前瞻性陈述所表达或暗示的内容存在重大差异。

Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability .

可能导致此类差异的重要因素包括：新冠疫情的全球传播和影响、宏观经济、商业和竞争状况的变化、无法获得必要的监管批准或在预期时间内以可接受的条件获得批准、与研发相关的成本、UCB在研产品或开发中产品的前景变化、未来司法裁决或政府调查的影响、安全、质量、数据完整性或生产问题；潜在或实际的数据安全和隐私泄露，或我们信息技术系统的中断、产品责任。

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. .

鉴于这些不确定性，您不应过分依赖任何此类前瞻性声明。无法保证本新闻稿中描述的在研或已获批产品将会在任何市场提交或获批销售，或用于任何额外适应症或标签，或在任何特定时间获批，也无法保证此类产品在未来将会或将继续取得商业成功。

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

UCB仅在本新闻稿发布之日提供此信息，包括前瞻性声明，除非另有说明，否则该信息并未反映不断演变的COVID-19大流行可能带来的影响。UCB正在密切关注全球发展，以评估这场大流行对UCB的财务重要性。

UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. .

UCB明确表示，不对本新闻稿中包含的任何信息承担更新义务，除非根据适用的法律法规要求，无论是为了确认实际结果，还是为了报告或反映与其前瞻性声明相关的任何变化，或任何此类声明所基于的事件、条件或情况的任何变化。

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction..

此外，本文件中包含的信息不构成出售或征求购买任何证券的要约，也不得在任何管辖区域内进行证券的要约、征求或销售，因为在此类管辖区域中，此类要约、征求或销售在根据其证券法进行注册或资格认定之前是非法的。

Important Safety Information about FINTEPLA▼ (fenfluramine) in the EU

关于芬氟拉明（FINTEPLA▼）在欧盟的重要安全信息

1

1

Indications

适应症

: Treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

：作为其他抗癫痫药物的辅助治疗，用于治疗2岁及以上患者的Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作。

Dosage and Administration

剂量与用法

: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are

：有关完整信息，请参阅SmPC。应由有癫痫治疗经验的医生启动和监督。Fintepla根据Fintepla管控访问计划进行处方和分发。Dravet综合征：患者

not

不是

taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose.

服用司替戊醇：起始剂量为每天两次0.1毫克/千克（每天0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每天两次0.2毫克/千克（每天0.4毫克/千克）。再过7天后，如果耐受良好且需要进一步减少癫痫发作，可将剂量增加至最大值每天两次0.35毫克/千克（每天0.7毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose.

需要更快滴定的患者可以每4天增加一次剂量。每日最大剂量不得超过26毫克（每日两次，每次13毫克）。正在服用司替戊醇的患者：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每日两次0.2毫克/千克（每日0.4毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated.

需要更快滴定的患者可以每4天增加一次剂量。总剂量不应超过17毫克（每日两次，每次8.6毫克）。Lennox-Gastaut综合征：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。如果耐受良好，7天后剂量应增加至每日两次0.2毫克/千克（每日0.4毫克/千克）。

After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus.

7天后，如果耐受，剂量应增加到每日两次0.35 mg/kg（每日总量0.7 mg/kg），这是推荐的维持剂量。每日最大剂量不应超过26 mg（每次13 mg，每日两次）。停药：停药时应逐渐减少剂量。与所有抗癫痫药物一样，尽可能避免突然停药，以减少癫痫发作频率增加和癫痫持续状态的风险。

A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. Renal impairment: Generally, no dose adjustment is recommended when administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are rep.

应在芬氟拉明治疗的最后一剂后3-6个月进行最终的超声心动图检查。肾功能损害：一般而言，对于轻至重度肾功能损害的患者，无需调整剂量，但可以考虑较慢的滴定速度。如果出现不良反应，请报告。

Contraindications

禁忌症

: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome.

对活性物质或任何辅料过敏者禁用。主动脉或二尖瓣心脏病和肺动脉高压患者禁用。在使用单胺氧化酶抑制剂14天内，由于增加血清素综合征的风险，应避免使用。

Warnings and Precautions

警告和注意事项

: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter.

主动脉或二尖瓣瓣膜性心脏病和肺动脉高压：在开始治疗前，患者必须接受超声心动图检查，以建立基线并排除任何已有的瓣膜性心脏病或肺动脉高压。在治疗的前2年，每6个月进行一次超声心动图监测，之后每年一次。

If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist.

如果超声心动图显示病理性瓣膜变化，应考虑提前随访，以评估异常是否持续存在。如果超声心动图上发现病理性异常，应与开药医生、护理人员和心脏病专家一起评估继续使用芬氟拉明治疗的益处与风险。

Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings.

一旦因任何原因停止治疗，应在最后一次服用芬氟拉明后3-6个月内进行最终的超声心动图检查。如果超声心动图结果显示可能存在肺动脉高压，应尽快并在3个月内重复进行超声心动图以确认这些结果。

If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped.

如果超声心动图结果确认提示肺动脉高压的中间概率，应由开处方者、护理人员和心脏病专家对继续使用芬特拉进行风险效益评估。如果超声心动图提示高概率，建议停止芬氟拉明治疗。

Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient’s weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa.

食欲减退和体重减轻：芬氟拉明可导致食欲减退和体重减轻——与其它抗癫痫药物（如司替戊醇）合用时可能会产生叠加效应。监测患者的体重。如果患者有神经性厌食症或神经性贪食症病史，在开始治疗前进行风险-收益评估。

Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use .

Fintepla管控访问计划：已创建一个管控访问计划，以1）防止标签外使用。

efficacy may be reduced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Discontinue therapy in patients with acute decreases in visual acuity. Consider discontinuation if ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine.

疗效可能会降低。青光眼：芬氟拉明可引起瞳孔散大并可能诱发闭角型青光眼。若患者视力急性下降，应停止治疗。如果出现不明原因的眼痛，应考虑停药。CYP1A2或CYP2B6诱导剂的影响：与强效CYP1A2诱导剂或CYP2B6诱导剂联合使用会降低芬氟拉明的血浆浓度，这可能会减弱芬氟拉明的疗效。

If co-administration is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the.

如果认为共同给药是必要的，应监测患者是否出现药效降低，并且在不超过两倍的情况下，可以考虑增加芬氟拉明的剂量。

maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment with fenfluramine, consider gradual reduction of the fenfluramine dosage to the dose administered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibitors: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients.

最大日剂量（52毫克/天）。如果在使用芬氟拉明维持治疗期间停用强效CYP1A2或CYP2B6诱导剂，应考虑逐步减少芬氟拉明的剂量至诱导剂开始前的剂量。CYP1A2或CYP2D6抑制剂的影响：与强效CYP1A2或CYP2D6抑制剂同时开始治疗可能导致更高的暴露量，因此应监测不良事件，并且部分患者可能需要减少剂量。

Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions.

辅料：含对羟基苯甲酸乙酯钠（E 215）和对羟基苯甲酸甲酯钠（E 219）——可能引起过敏反应。

(possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially ‘sodium-free’.

（可能有延迟）。它还含有二氧化硫 (E 220)，这可能会极少数情况下引起严重的过敏反应和支气管痉挛。患有罕见的葡萄糖-半乳糖吸收不良的患者不应服用此药。该产品每最大日剂量 12 毫升含钠量少于 1 毫摩尔（23 毫克）；基本上“无钠”。

Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An.

含有葡萄糖 - 可能对牙齿有害。相互作用：与其他中枢神经系统抑制剂的药效学相互作用会增加中枢神经系统抑制加重的风险。

increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations.

与利福平或强效CYP1A2或CYP2B6诱导剂联合使用时，可能需要增加剂量。在体外研究中，与强效CYP1A2或CYP2D6抑制剂联合使用可能导致更高的暴露量（见SmPC第4.4节）。与CYP2D6底物或MATE1底物联合使用可能会增加其血浆浓度。

Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal.

与CYP2B6或CYP3A4底物共同给药可能会降低其血浆浓度。妊娠与哺乳：孕妇中的数据有限。作为预防措施，避免在妊娠期间使用Fintepla。目前尚不清楚芬弗拉明/代谢物是否排泄到人乳中。动物。

data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines.: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue.

数据显示芬氟拉明/代谢物会排泄到乳汁中。必须权衡母乳喂养对婴儿的益处和该药物治疗对妇女的益处，从而决定是否停止母乳喂养或停止/避免使用Fintepla。驾驶和操作机器：Fintepla对驾驶/操作机器的能力有中等影响，因为它可能引起嗜睡和疲劳。

Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely.

建议患者在没有足够经验判断是否会产生不良影响之前，不要驾驶或操作机器。

affects their abilities.

影响他们的能力。

Adverse effects

不良反应

: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic).

Dravet综合征：很常见（≥1/10）：上呼吸道感染、食欲减退、嗜睡、腹泻、发热、疲劳、血糖降低、超声心动图异常（包括微量和轻度二尖瓣反流以及微量主动脉瓣反流，这些均被视为生理现象）。

Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue.

常见（≥1/100 至 <1/10）：支气管炎、异常行为、攻击性、焦虑、失眠、情绪波动、共济失调、肌张力减退、嗜睡、癫痫发作、癫痫持续状态、震颤、便秘、唾液分泌过多、体重减轻和血泌乳素升高。Lennox-Gastaut 综合征：很常见（≥1/10）：上呼吸道感染、食欲下降、嗜睡、腹泻、呕吐、疲劳。

Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. .

常见（≥1/100 至 <1/10）：支气管炎、流感、肺炎、癫痫发作、癫痫持续状态、嗜睡、震颤、便秘、唾液分泌过多、血泌乳素升高、体重减轻、跌倒。有关其他不良反应，请参阅 SmPC。

▼

▼

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

该药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结中的其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

.

。

FINTEPLA

芬特普拉

®

®

is a registered trademark of the UCB Group of Companies.

是UCB集团公司注册商标。

Important Safety Information about BRIVIACT® (brivaracetam) in the EU

关于BRIVIACT®（布立西坦）在欧盟的重要安全信息

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Therapeutic indications

治疗适应症

: BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

BRIVIACT作为辅助治疗，用于治疗2岁及以上患有癫痫的成人、青少年和儿童的部分性发作（伴或不伴继发性全身性发作）。

Posology and method of administration

用法和用量

: The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer BRIVIACT oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. BRIVIACT solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.

医生应根据体重和剂量开具最合适的剂型和强度。建议父母和护理人员使用包装盒内提供的测量装置（10毫升或5毫升口服注射器）给予BRIVIACT口服溶液。当暂时无法口服时，BRIVIACT注射/输注溶液是患者的另一种给药途径。

There is no experience with twice daily intravenous administration of.

没有每日两次静脉注射的经验。

brivaracetam for a period longer than 4 days. Adults: The recommended starting dose is 50 or 100 mg/day based on physician’s assessment of required for seizure reduction versus potential side effects. Brivaracetam can be taken with or without food. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

服用布瓦西坦超过4天。成人：根据医生对减少癫痫发作与潜在副作用的评估，推荐起始剂量为每天50或100毫克。布瓦西坦可随餐或不随餐服用。根据患者的个体反应和耐受性，剂量可在每日50毫克至200毫克的有效剂量范围内调整。

Children and adolescents weighing 50 kg or more: The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

体重在 50 公斤或以上的儿童和青少年：推荐的起始剂量为每天 50 毫克。根据医生对癫痫控制需求的评估，布立西坦也可以从每天 100 毫克开始使用。推荐的维持剂量为每天 100 毫克。根据个别患者的反应，可在每天 50 毫克至 200 毫克的有效剂量范围内调整剂量。

Children and adolescents weighing from 20 kg to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day.

体重在20公斤至不足50公斤的儿童和青少年：推荐的起始剂量为1毫克/公斤/天。根据医生对癫痫控制需求的评估，布立西坦也可从高达2毫克/公斤/天的剂量开始使用。推荐的维持剂量为2毫克/公斤/天。根据个体患者的反应，剂量可在1毫克/公斤/天至4毫克/公斤/天的有效剂量范围内进行调整。

Children weighing from 10 kg to less than 20 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day.

体重在10公斤至小于20公斤的儿童：推荐的起始剂量为每天1毫克/公斤。根据医生对癫痫控制需求的评估，布立西坦也可从高达每天2.5毫克/公斤的剂量开始使用。推荐的维持剂量为每天2.5毫克/公斤。根据患者的个体反应，剂量可在每天1毫克/公斤至5毫克/公斤的有效剂量范围内进行调整。

For adults, adolescents and children from 2 years of age, the dose should be administered in two equally divided doses,.

对于2岁及以上的成人、青少年和儿童，剂量应分为两等份给予。

approximately 12 hours apart.

大约相隔12小时。

If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. Brivaracetam oral solution can be diluted in water or juice shortly before swallowing; a nasogastric tube or a gastrostomy tube may also be used.

如果患者漏服一次或多次剂量，建议他们一旦想起便立即服用单次剂量，并在通常的早晨或晚上时间服用下一剂量。布立西坦口服溶液可在吞咽前短时间用水或果汁稀释；也可以使用鼻胃管或胃造口管。

Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained. Brivaracetam may be administered as an intravenous bolus without dilution or diluted in a compatible diluent and administered as a 15-minute intravenous infusion.

布瓦西坦可通过静脉或口服给药启动治疗。在口服与静脉给药之间转换时，应保持每日总剂量和给药频率不变。布瓦西坦可以不稀释直接静脉推注，或稀释于相容的稀释剂中，并以15分钟静脉输注的方式给药。

This medicinal product must not be mixed with other medicinal products. Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions, e.g. status epilepticus, and is therefore not recommended for such conditions. For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis.

本药品不得与其他药品混合使用。布立西坦推注注射或静脉输注尚未在急性条件下进行研究，例如癫痫持续状态，因此不建议用于此类情况。对于16岁及以上的患者，如果必须停用布立西坦，建议每周将剂量逐步减少50毫克/天。

For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.

对于16岁以下的患者，如果必须停止使用布立西坦，建议每周最多减少一半的剂量，直到达到每天1毫克/千克（体重小于50公斤的患者）或每天50毫克（体重50公斤或以上的患者）的剂量。

After 1 week of treatment at 50 mg/day, a final week of treatment at 20 mg/day is recommended. No dose adjustment is needed for elderly patients (≥65 years of age) or for those with renal impairment. Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.

在以每天50毫克的剂量治疗1周后，建议再以每天20毫克的剂量进行最后一周的治疗。老年患者（≥65岁）或肾功能受损者无需调整剂量。根据成人数据，肾功能受损的儿科患者也无需调整剂量。

No clinical data are available on paediatric patients with ren.

没有关于肾病儿科患者的临床数据可用。

Contraindications

禁忌症

: Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients.

对活性物质、其他吡咯烷酮衍生物或任何辅料过敏。

Special warnings and precautions for use

特别警告和使用注意事项

: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge.

在多种适应症中，包括布立西坦，用抗癫痫药物（AEDs）治疗的患者报告了自杀意念和行为。应监测患者是否有自杀意念和行为的迹象，并考虑适当的治疗。应告知患者（及护理人员），若出现任何自杀意念或行为的迹象，需寻求医疗建议。

Clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment are limited. Dose adjustments are recommended for patients with hepatic impairment. Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take brivaracetam..

针对已有肝功能损害患者的布立西坦临床数据有限。建议对肝功能受损患者调整剂量。布立西坦薄膜衣片含有乳糖。患有罕见的半乳糖不耐受、完全乳糖酶缺乏或葡萄糖-半乳糖吸收不良的患者不应服用布立西坦。

Brivaracetam film-coated tablets, solution for injection/infusion and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively, that is to say essentially ‘sodium free’. Brivaracetam oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

布瓦西坦薄膜衣片、注射/输注溶液和口服溶液每片/瓶/毫升分别含有少于1毫摩尔钠（23毫克），即基本上“无钠”。布瓦西坦口服溶液每毫升含168毫克山梨醇（E420）。遗传性果糖不耐受（HFI）患者不应服用此药物。

The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). .

口服溶液含有甲基对羟基苯甲酸酯（E218），可能会引起过敏反应（可能延迟）。布立西坦口服溶液含有丙二醇（E1520）。

Interaction with other medicinal products and other forms of interaction

与其他药物的相互作用及其他形式的相互作用

: In clinical studies, although patient numbers were limited, brivaracetam had no observed benefit over placebo among patients taking concomitant levetiracetam. No additional safety or tolerability concern was observed. In an interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy volunteers, there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was approximately doubled with the intake of brivaracetam.

在临床研究中，尽管患者数量有限，但在同时服用左乙拉西坦的患者中，布立西坦与安慰剂相比未观察到益处。未发现额外的安全性或耐受性问题。在一项健康志愿者中进行的布立西坦200毫克单剂量与乙醇0.6克/升连续输注的相互作用研究中，未发现药代动力学相互作用，但酒精对精神运动功能、注意力和记忆的影响在服用布立西坦后大约加倍。

Intake of brivaracetam with alcohol is not recommended. In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam® is by CYPindependent hydrolysis; a second pathway involves hydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may increase when co-administered with CYP2C19 strong inhibitors (e.g.

不建议将布瓦西坦与酒精一起摄入。体外数据显示布瓦西坦的相互作用潜力较低。布瓦西坦的主要代谢途径是通过非CYP依赖的水解；另一条途径涉及由CYP2C19介导的羟基化。与强效CYP2C19抑制剂（如某些药物）共同使用时，布瓦西坦的血浆浓度可能会增加。

fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

氟康唑、氟伏沙明），但认为临床上相关的 CYP2C19 介导的相互作用风险较低。有限的临床数据表明，同时使用大麻二酚可能会增加布瓦西坦的血浆暴露量，可能是通过 CYP2C19 抑制，但临床相关性尚不确定。

In healthy subjects, co-administration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of brivaracetam in patients starting or ending treatment with rifampicin.

在健康受试者中，与强效酶诱导剂利福平（每天600毫克，持续5天）共同给药时，布立西坦的血浆浓度曲线下面积（AUC）降低了45%。开处方者应考虑调整正在开始或结束利福平治疗的患者的布立西坦剂量。

Brivaracetam plasma concentrations are decreased when co-administered with strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Other strong enzyme inducers such as St John’s wort (Hypericum perforatum) may decrease t.

与强效酶诱导抗癫痫药物（卡马西平、苯巴比妥、苯妥英）联合使用时，布立西坦的血浆浓度会降低，但无需调整剂量。其他强效酶诱导剂，如圣约翰草（贯叶连翘），也可能降低其浓度。

plasma concentrations. Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. However, when brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, respectively, was observed without impact on suppression of ovulation.

血浆浓度。同时使用布立西坦（100 毫克/天）和含有炔雌醇（0.03 毫克）及左炔诺孕酮（0.15 毫克）的口服避孕药，并未影响任何一种物质的药代动力学。然而，当以 400 毫克/天的剂量（推荐的最大日剂量的两倍）同时使用布立西坦时，观察到雌激素和黄体酮的药时曲线下面积分别减少了 27% 和 23%，但对排卵抑制没有影响。

.

。

Pregnancy

怀孕

: Data on the use of brivaracetam in pregnant women are limited. There are no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam. In clinical studies, adjunctive brivaracetam used concomitantly with carbamazepine induced a dose-related increase in the concentration of.

：关于布立西坦在孕妇中的使用数据有限。尚无关于其在人类中胎盘转移的数据，但已证明布立西坦在大鼠中很容易穿过胎盘。其对人类的潜在风险尚不清楚。动物研究未发现布立西坦有任何致畸潜力。在临床研究中，作为辅助治疗的布立西坦与卡马西平同时使用时，会引发剂量相关的浓度升高。

the active metabolite, carbamazepine-epoxide. There are insufficient data to determine the clinical significance of this effect in pregnancy. Brivaracetam should not be used during pregnancy unless clinically necessary.

活性代谢物卡马西平环氧化物。尚无足够的数据来确定这种效应在妊娠期的临床意义。除非临床上必要，否则不应在妊娠期使用布瓦西坦。

Breast-feeding

母乳喂养

: Brivaracetam is excreted in human breast milk. The decision to discontinue either breastfeeding or brivaracetam should be made based on the benefit of the medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.

布立西坦可分泌至人乳中。是否停止哺乳或停止使用布立西坦应根据该药物对母亲的益处来决定。如果同时使用布立西坦和卡马西平，可能会增加卡马西平环氧化物在母乳中的分泌量。

The clinical significance remains unknown. .

临床意义尚不清楚。

Fertility

生育能力

: No human data on the effect of brivaracetam on fertility are available. There was no effect on fertility in rats.

：关于布立西坦对生育能力影响的人体数据尚无。在大鼠中未发现对生育能力的影响。

Effects on ability to drive and use machines

对驾驶和使用机器能力的影响

: Brivaracetam has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.

布瓦拉西坦对驾驶和操作机器的能力有轻微或中度影响。应建议患者在熟悉布瓦拉西坦对其从事此类活动能力的影响之前，不要驾驶汽车或操作其他潜在危险的机器。

Undesirable effects

不良反应

: The most frequently reported adverse reactions with brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usually mild-to-moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. Very common adverse reactions (≥1%-<10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue.

：使用布立西坦最常见的不良反应为嗜睡（14.3%）和头晕（11.0%）；这些反应通常为轻至中度。随着剂量增加，报告的嗜睡和疲劳发生率更高。非常常见的不良反应（≥1%-<10%）包括流感、食欲减退、抑郁、焦虑、失眠、易怒、惊厥、眩晕、上呼吸道感染、咳嗽、恶心、呕吐、便秘和疲劳。

Neutropenia was reported in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treated patients. Four of these subjects had decreased neutrophil counts at baseline. None of the neutropenia cases were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.

中性粒细胞减少症在1099名服用布立西坦的患者中有6例（0.5%），而在459名服用安慰剂的患者中无一例。其中四名患者在基线时中性粒细胞计数已减少。这些中性粒细胞减少症病例均不严重，无需特殊治疗，也未导致布立西坦停药，并且没有出现相关感染。

Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and 0.7% (3/459) of placebo-treated patients. In short-term clinical studies of brivaracetam in patients with epilepsy, there were no cases of completed suicide and suicide attempt; however, both were reported in open-label extension studies.

在接受布立西坦治疗的患者中，有0.3%（3/1099）报告了自杀意念，而接受安慰剂治疗的患者中有0.7%（3/459）报告了自杀意念。在癫痫患者中进行的布立西坦短期临床研究中，并未出现自杀完成和自杀企图的案例；然而，在开放性扩展研究中确实报告了这两种情况。

The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.

布立伐酰胺在一个月及以上儿童中的安全性特征与在成人中观察到的安全性特征一致。在开放标签、无对照的长期研究中，6岁及以上儿童患者中有4.7%报告了自杀意念（青少年中更为常见），而成人中这一比例为2.4%；同时，儿童患者中有24.8%报告了行为障碍，而成人中这一比例为15.1%。

The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adve.

大多数事件的强度为轻度或中度，不严重，且并未导致研究药物的停用。儿童中报告的另一个不良反应是精神运动过度活跃（4.7%）。未发现特定的不良反应模式。

increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.

此年龄组中特定不良事件（AE）的发生率增加。由于2岁以下儿童的数据有限，不建议在此年龄段使用布立西坦。新生儿中的临床数据也很有限。在临床开发期间，有少数布立西坦患者（9/3022）报告了提示即时（I型）超敏反应的症状。

Overdose: There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the postmarketing experience.

过量服用：目前对人类服用布立西坦过量的临床经验有限。有健康受试者单次服用了1400毫克布立西坦后报告出现嗜睡和头晕。在上市后经验中，以下不良反应被报告与布立西坦过量有关：恶心、眩晕、平衡障碍、焦虑、疲劳、易怒、攻击性、失眠、抑郁以及自杀念头。

In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since <10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance..

一般来说，与布瓦西坦过量相关的不良反应与其已知的不良反应一致。布瓦西坦过量没有特定的解毒剂。过量治疗应包括一般支持性措施。由于<10%的布瓦西坦通过尿液排泄，预计血液透析不会显著增强布瓦西坦的清除率。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结中的其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

BRIVIACT

布立伐克

®

®

is a registered trademark of the UCB Group of Companies.

是UCB集团公司注册商标。

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芬特普

®

®

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布里瓦克特

®

®

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