Soft Tissue Injuries

来源：国家药监局     编辑：wangxinglai20042024年03月26日，国家药监局发布了非处方药转换公告，涉及品种为七叶皂苷钠搽剂，要求持有人于2024年12月20日前，完成修订说明书事项向省级药品监督管理部门备案。公告主要内容根据《处方药与非处方药分类管理办法（试行）》（原国家药品监督管理局令第10号）的规定，经国家药品监督管理局组织论证和审核，七叶皂苷钠搽剂由处方药转换为非处方药。品种名单及其非处方药说明书范本一并发布。  请相关药品上市许可持有人在2024年12月20日前，依据《药品注册管理办法》等有关规定，向省级药品监督管理部门提交修订说明书备案，并将说明书修订内容及时通知相关医疗机构、药品经营企业等单位。非处方药说明书范本规定内容之外的说明书其他内容按原批准证明文件执行。药品标签涉及相关内容的，应当一并修订。药品上市许可持有人提交备案之日起生产的药品，不得继续使用原药品说明书。非处方药说明书范本 七叶皂苷钠搽剂说明书  请仔细阅读说明书并按说明使用或在药师指导下购买和使用  [药品名称]  通用名称：七叶皂苷钠搽剂  商品名称：  英文名称：  汉语拼音：  [成份]  [性状]  [作用类别]本品为镇痛类非处方药药品。  [适应症]用于急性闭合性的软组织损伤,如肌腱、韧带、肌肉和关节部位的扭伤、压伤和瘀斑等。  [规格]1%  [用法用量]取本品适量涂搽于患处。每次搽两遍，以不溢出为度。每天2-4次,疗程为一周。  [不良反应]国外有使用七叶皂苷外用制剂发生接触性荨麻疹的个例报道。  [禁忌]  1.禁用于破损皮肤及黏膜。  2.孕妇禁用。  3.肾损伤、肾衰竭、肾功能不全患者禁用。  [注意事项]  1.本品不适用于慢性软组织损伤、骨折、肌腱、韧带断裂的疾患。  2.对本品过敏者禁用，过敏体质者慎用。  3.哺乳期妇女应在医师指导下使用。  4.本品性状发生改变时禁止使用。  5.请将本品放在儿童不能接触的地方。  6.儿童必须在成人监护下使用。  7.如正在使用其他药品，使用本品前请咨询医师或药师。  [药物相互作用]如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。  [药理作用]  本品能降低病理性毛细血管通透性增高，增加静脉张力，减少炎性物质渗出，具有抗炎、消肿、止痛、改善血液循环、促进急性闭合性软组织损伤恢复的作用。  [贮藏]  [包装]  [有效期]  [执行标准]  [批准文号]  [说明书修订日期]  [药品上市许可持有人]  名称：  注册地址：  邮政编码：  电话号码：  传真号码：  网址：  [生产企业]  企业名称：  生产地址：  邮政编码：  电话号码：  传真号码：  网址：  如有问题可与药品上市许可持有人联系

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has been named the Preferred Sports Medicine Technology Partner of UFC – the world’s premier mixed martial arts organization and one of the foremost global brands in all of sports. Under the terms of the multi-year partnership, Smith+Nephew will activate its brand through UFC’s immense global presence to promote the repair, regeneration and recovery of Sports Medicine injuries through advanced technologies. “We’re thrilled to have Smith+Nephew join us for the first time as an Official UFC Partner,” said Robby Miller, Vice President, UFC Global Partnerships. “Through hard work, significant investment, and groundbreaking innovations like the UFC Performance Institute, UFC has become the industry leader in athlete health and safety in combat sports. We’re looking forward to advancing that mission by also promoting better health and recovery through technology solutions, such as those offered by Smith+Nephew, that will benefit UFC athletes and fans alike.” Smith+Nephew offers world-class Sports Medicine solutions including advanced technologies, instruments and implants that enable surgeons to perform minimally invasive surgery including the repair of soft tissue injuries and degenerative conditions of the shoulder, knee, hip and small joints. Recent advancements in its biological healing portfolio include the REGENETEN◊ Bioinductive Implant and the newly acquired CARTIHEAL◊ AGILI-C◊ Cartilage Repair Implant. Backed by impressive clinical evidence, both technologies are transforming the way healthcare professionals treat soft tissue repair and helping improve patient outcomes versus the current standard of care.1,2 “Smith+Nephew’s purpose is Life Unlimited – helping restore people’s bodies and their self-belief by using technology to take the limits off living. We are proud to partner with UFC and share a common goal to get patients back in the game quickly, safely, and effectively,” said Scott Schaffner, President Sports Medicine, Smith+Nephew. “The global reach and influence of UFC is unmatched by any other sports organization, and we look forward to this partnership spotlighting Smith+Nephew’s leading-edge portfolio of Sports Medicine technology solutions with the UFC’s global audience.” Beyond the Octagon, UFC and Smith+Nephew will collaborate on original content that will be distributed through UFC’s popular digital and social channels, which reach more than 259 million users worldwide. Smith+Nephew will also have a branded presence throughout the UFC Performance Institutes in Las Vegas, Shanghai and Mexico City - the world’s first mixed martial arts performance training, research, rehabilitation, and nutrition centers. The agreement also provides for an annual Brand Ambassador fund that will bring the partnership to life through appearances, content, and creative campaigns with UFC athletes. - ends - Enquiries MediaDavid Snyder +1 978-749-1440Smith+Nephew References Altschuler N, Zaslav KR, Di Matteo B, et al. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023;51(4):957-967. doi:10.1177/03635465231151252Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023. About Smith+NephewSmith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 18,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.5 billion in 2023. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise. For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook. About UFC®UFC® is the world’s premier mixed martial arts organization (MMA), with more than 700 million fans and 259 million social media followers. The organization produces more than 40 live events annually in some of the most prestigious arenas around the world while broadcasting to over 975 million TV households across more than 170 countries. UFC’s athlete roster features the world’s best MMA athletes representing more than 80 countries. The organization’s digital offerings include UFC FIGHT PASS®, one of the world’s leading streaming services for combat sports. UFC is part of TKO Group Holdings (NYSE: TKO) and is headquartered in Las Vegas, Nevada. For more information, visit UFC.com and follow UFC at Facebook.com/UFC and @UFC on X, Snapchat, Instagram, and TikTok: @UFC. Forward-looking StatementsThis document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations. ◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.

Grant awards to fund novel clinical projects and scientific tools aimed at improving quality of life for individuals impacted by spinal cord injury SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments. Two grants have been awarded to .NeuroRestore, a research, innovation and treatment center that develops and applies bioengineering strategies involving neurosurgical interventions to restore neurological functions. PsychoGenics, a CNS-focused contract research organization that designs and executes preclinical drug discovery and early development programs, received the third grant. Together, the grants will fund projects designed to help catalyze and energize the field of SCI science by channeling resources for a robust clinical pipeline to rapidly increase the number of potential treatments, as well as drive progress and investment in spinal cord injury research by addressing the barriers that limit ambitious engagement. The projects include clinical trials focused on: bladder dysfunction – a major quality-of-life issue for the SCI community; and a trial to advance novel brain-spine interface (BSI) technology, which has been shown to enable thought to control movement. Finally, a preclinical study will focus on innovative techniques and technologies to provide standardized lab research resources that do not currently exist. Specifically: Brain-Spine Interface to Reverse Upper Limb Paralysis: .NeuroRestore will also receive $1.1 million over two years to support its Brain-Spinal Interface (BSI) technology to determine if thoughts, via cortical brain implants, can control not just lower extremity movement (which has been demonstrated in prior research), but also arm and hand function for those with cervical injuries. This technology is being developed by ONWARD® Medical, a medical technology company creating therapies to restore movement, function, and independence in people with SCI and movement disabilities. It is the only company currently advancing both brain-computer interface (BCI) and spinal cord stimulation technology together – a "digital bridge" connecting brain signals with movement. In late February, ONWARD Medical was awarded its 10th Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for its ARC-BCI™ System, which uses brain-BCI technology in conjunction with the company's ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). Neuroprosthetic System to Manager Lower Urinary Tract Dysfunction After Spinal Cord Injury: With a $1.5 million grant, .NeuroRestore will apply epidural stimulation implants to participants with chronic incomplete spinal cord injuries to examine if the technology can be used to assist in the functionality and control of the bladder. This proof-of-concept, safety, and feasibility study over two years will determine if epidural stimulation, which has seen success in movement and blood pressure, can be used for voiding and storage of the bladder. This early-stage study will utilize ONWARD Medical's targeted ARC Therapy stimulation, which the company is actively developing with .NeuroRestore. Standardized Testing Research InVivo Endeavor (STRIVE): A preclinical grant for $522,000 is awarded to PsychoGenics to develop an in-house standardized model for testing potential therapeutics. This project will help accelerate therapeutic development by providing a validated tool to the SCI research community. The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis. Decade by decade, the Reeve Foundation has worked to change what was deemed possible, collaborating with equally determined scientists and labs to map a path toward progress and build a vibrant research field that delivers real improvements for people living with paralysis. Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research. "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation. "It is our goal to facilitate rapid scientific advancement, and these grants are an important step in ensuring that the most promising science of the day is primed for accelerated success." About the Reeve Foundation The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation's National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community's voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau's standards for charity accountability and hold the BBB's Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292. SOURCE Christopher & Dana Reeve Foundation