第4类药品缺陷通知：Sandoz Limited，口服混悬液用阿莫西林克拉维酸钾粉末 250/62.5 mg/5mL，EL(26)A/46
正文 · 中文译文
第4类药品缺陷通知：Sandoz Limited，Co-Amoxiclav口服混悬液粉末 250/62.5 mg/5mL，EL(26)A/46 Sandoz Limited已向MHRA通报，Co-amoxiclav 250/62.5 mg/5 ml口服混悬液粉末的产品特性摘要（SmPC）中的给药表存在错误。 来自： 药品和保健产品监管局 发布日期： 2026年11月5日 最后更新： 2026年11月5日 — 查看所有更新 信息类型： 药品召回/通知 医学专科： 麻醉与重症监护、母乳喂养、癌症、心血管疾病与脂质学以及护理院工作人员 显示另外34项 美容外科、重症监护、牙科、皮肤科、配药全科诊所、耳鼻喉科、急诊医学、内分泌学、糖尿病学与代谢、全科医学、普通外科、胃肠、肝病与胰腺疾病、血液学与肿瘤学、免疫学与疫苗接种、免疫抑制与移植、感染预防、传染病、神经病学、营养与饮食学、妇产科与生育、眼科、骨科、儿科与新生儿科、疼痛管理与姑息治疗、病理学、药学、妊娠、精神病学、放射学与影像学、肾脏医学、呼吸系统疾病与过敏、风湿病学、手术室从业人员、泌尿外科与肾脏病学以及血管与心脏外科 签发日期： 2026年11月5日 目录 发布后说明——2026年11月5日 DMRC参考编号 上市许可持有人 药品详情 Co-Amoxiclav口服混悬液粉末 250/62.5 mg/5mL 受影响批号 背景 给医疗专业人员的建议 医疗专业人员应向患者提供的建议 附加信息 下载文件 发布后说明——2026年11月5日 药品详情表中最初提供的产品规格有误。正确规格：250/62.5 mg/5ml。 DMRC参考编号 DMRC- 41234128 上市许可持有人 Sandoz Limited 药品详情 Co-Amoxiclav口服混悬用粉末 250/62.5 mg/5mL PL：04416/0515 活性成分：阿莫西林三水合物、克拉维酸钾 SNOMED：43647311000001107 GTIN：05015915880116 受影响批号 目前所有批次均受影响。 背景 Sandoz Limited已通知MHRA，Co-Amoxiclav 250/62.5 mg/5 ml口服混悬用粉末的产品特性摘要（SmPC）中的给药表存在错误。该缺陷不影响口服混悬用粉末的质量。 有缺陷的SmPC第4.2节中提供按体重调整给药说明的给药表不正确，不应使用。该有缺陷的SmPC已从MHRA产品和电子药物汇编（eMC）网站移除。 有缺陷的SmPC给药表所指示的口服混悬液用量约为预期推荐剂量的两倍。 给医疗专业人员的建议： Sandoz Limited提供的更正后给药信息见附件1。 不要使用山德士（Sandoz）的产品特性摘要（SmPC）来计算该药品按体重调整给药的剂量。有缺陷的SmPC已从MHRA产品及电子药物汇编（eMC）网站上移除；待山德士就其新SmPC获得上市许可变更批准后，这些内容将重新提供。 根据有缺陷的SmPC说明，存在过量用药的可能性，这可能增加已知的剂量相关不良反应的发生概率，例如： 胃肠道症状风险增加：抗生素相关性腹泻、恶心、呕吐、腹痛及脱水、液体和电解质平衡紊乱 超敏反应及其他不良反应风险增加 已有阿莫西林结晶尿（包括急性肾损伤/肾衰竭）的报告，但描述为非常罕见，且主要与肠外给药相关。 给医疗专业人员的患者指导建议： 患者应继续按处方服用该药物。如果您认为自己服用或给予了较高剂量的复方阿莫西林克拉维酸钾，且目前出现任何副作用如腹泻、恶心、呕吐或腹痛，请立即就医。 如果您不确定或有任何疑问，请咨询您的药房或参与您治疗的其他医疗专业人员。 出现不良反应或对药物有任何疑问的患者应就医。任何疑似不良反应还应通过MHRA黄卡计划报告。 附加信息： 如有任何医疗信息咨询及本产品相关信息，请发送电子邮件至 mi.uk@sandoz.com 或致电 01276 698101。 本药品召回通知的接收者应通过本通知副本将此告知相关联系人。请NHS区域团队将此转发给社区药剂师和配药全科医生以供参考。 此致敬礼 缺陷药品报告中心 10 South Colonnade Canary Wharf London E14 4PU 电话 +44 (0)20 3080 6574 DMRC@mhra.gov.uk 下载文件 第4类药品缺陷通知：Sandoz Limited，Co-Amoxiclav口服混悬液粉末 250/62.5 mg/5mL，EL(26)A/46 本页更新 最后更新： 2026年11月5日 显示所有更新 2026年11月5日 药品详情表中最初提供的产品规格有误。正确规格：250/62.5 mg/5ml。 2026年11月5日 首次发布。 目录 探索主题 警报和召回
正文 · 英文原文
Class 4 Medicines Defect Notification: Sandoz Limited, Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL, EL(26)A/46 Sandoz Limited have informed the MHRA of errors in the dosing table in the Summary of Product Characteristics (SmPC) for Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension. From: Medicines and Healthcare products Regulatory Agency Published: 5 November 2026 Last updated: 5 November 2026 — See all updates Message type: Medicines recall/notification Medical specialty: Anaesthetics and intensive care, Breastfeeding, Cancer, Cardiovascular disease and lipidology and Care home staff Show 34 more Cosmetic surgery, Critical care, Dentistry, Dermatology, Dispensing GP practices, Ear, nose and throat, Emergency medicine, Endocrinology, diabetology and metabolism, General practice, General surgery, GI, hepatology and pancreatic disorders, Haematology and oncology, Immunology and vaccination, Immunosuppression and transplantation, Infection prevention, Infectious disease, Neurology, Nutrition and dietetics, Obstetrics & gynaecology and fertility, Ophthalmology, Orthopaedics, Paediatrics and neonatology, Pain management and palliation, Pathology, Pharmacy, Pregnancy, Psychiatry, Radiology and imaging, Renal medicine, Respiratory disease and allergy, Rheumatology, Theatre practitioners, Urology and nephrology, and Vascular and cardiac surgery Issued: 5 November 2026 Contents Post Publication Note - 5 November 2026 DMRC reference number Marketing Authorisation Holder Medicine Details Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL Affected Lot Batch Numbers Background Advice for Healthcare Professionals Advice for Healthcare Professionals to Provide to Patients Additional information Download document Post Publication Note - 5 November 2026 The incorrect strength of product was initially provided in the Medicine Details table. The correct strength: 250/62.5 mg/5ml. DMRC reference number DMRC- 41234128 Marketing Authorisation Holder Sandoz Limited Medicine Details Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL PL: 04416/0515 Active Ingredient: amoxicillin trihydrate, potassium clavulanate SNOMED: 43647311000001107 GTIN: 05015915880116 Affected Lot Batch Numbers All batches are currently impacted. Background Sandoz Limited have informed the MHRA of errors in the dosing table in the Summary of Product Characteristics (SmPC) for Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension. The quality of the powder for oral suspension is not impacted by this defect. The dosing table in Section 4.2 of the defective SmPC, that provides the instruction for weight adjusted dosing, is incorrect and should not be used. The defective SmPC has been removed from the MHRA products and electronic medicines compendium (eMC) websites. The defective SmPC dosing table instructed an amount of oral suspension that provided approximately twice the intended, recommended dose. Advice for Healthcare Professionals: The corrected dosing information provided by Sandoz Limited is included in Annex 1. Do not use the Sandoz SmPC for calculating the dosing for weight adjusted administration of this medicine. The defective SmPC has been removed from the MHRA products and electronic medicines compendium (eMC) websites; these will be available once Sandoz has received a granted variation to their market authorisation for the new SmPC. Based on the defective SmPC instruction, there is a potential for an overdose, this may increase the likelihood of known dose-related adverse effects, such as: Increased risk of gastrointestinal symptoms antibiotic-associated diarrhoea, nausea, vomiting and abdominal pain and dehydration, of fluid and electrolyte balance Increased risk of hypersensitivity and other adverse reactions Amoxicillin crystalluria, including acute renal injury/renal failure, has been reported but is described as very rare and predominantly associated with parenteral therapy. Advice for Healthcare Professionals to Provide to Patients: Patients should continue to take this medication as prescribed. If you believe you have taken or administered the higher dose of co-amoxiclav and are currently experiencing any side effects such as diarrhoea, nausea, vomiting or abdominal pain then please seek immediate medical advice. If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals involved in your treatment. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme. Additional information: For all medical information enquiries and information on this product, please email mi.uk@sandoz.com or telephone 01276 698101. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 DMRC@mhra.gov.uk Download document Class 4 Medicines Defect Notification: Sandoz Limited, Co-Amoxiclav powder for oral suspension 250/62.5 mg/5mL, EL(26)A/46 Updates to this page Last updated: 5 November 2026 Show all updates 5 November 2026 The incorrect strength of product was initially provided in the Medicine Details table. The correct strength: 250/62.5 mg/5ml. 5 November 2026 First published. Contents Explore the topic Alerts and recalls