Norepinephrine Bitartrate

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced two new products in its Simplist® portfolio of ready-to-administer prefilled syringes: Simplist® Ephedrine Sulfate Injection, USP and Simplist® Succinylcholine Chloride Injection, USP. Both medications are used in anesthesia and critical care, and their introduction extends the Simplist line’s use into operating rooms, supporting clinicians with safe, efficient and reliable medication delivery. Fresenius Kabi has expanded its Simplist® ready-to-administer portfolio, introducing new presentations that extend its use into operating rooms and support clinicians in anesthesia and critical care. Simplist Succinylcholine Chloride Injection, USP, is a paralytic used in addition to general anesthesia for intubation and during mechanical ventilation in pediatric and adult patients. Simplist Ephedrine Sulfate Injection, USP is indicated for the treatment of clinically important hypotension (low blood pressure) during anesthesia. “As part of our commitment to simplify medication delivery and improve patient safety, the expansion of our Simplist portfolio into the operating room demonstrates how we’re supporting anesthesiologists and nurse anesthetists in their vital work,” said Arun Verma, president of Fresenius Kabi Region U.S. and member of the Executive Leadership Team at Fresenius Kabi AG. “These ready-to-administer medications are designed to help clinicians throughout the hospital by helping to reduce complexity, help minimize waste, and reduce the number of drug-preparation steps where errors can occur.” About the Products: Simplist Succinylcholine Chloride Injection, USP is available in 100 mg per 5 mL (20 mg per mL) and 200 mg per 10 mL (20 mg per mL) strengths. It offers an 18-month shelf life and is stored in a refrigerator at 36°F (2°C) to 46°F (8°C). The single dose prefilled syringes are stable for up to 14 days at room temperature without loss of potency. Simplist Ephedrine Sulfate Injection, USP is available in 25 mg per 5 mL (5 mg per mL) and 50 mg per 10 mL (5 mg per mL) presentations. It can be stored at room temperature and has a 24-month shelf life. Both prefilled syringes are manufactured and prepared by Fresenius Kabi, eliminating the need for assembly or dilution at the point of care to simplify medication administration, enhance workflow efficiency, and support best practices in medication administration safety. To learn more about Fresenius Kabi’s expanding manufacturing and other operations in the U.S., visit www.MoreInAmerica.com. IMPORTANT SAFETY INFORMATION Succinylcholine Chloride Injection, USP WARNING: VENTRICULAR DYSRHYTHMIAS, CARDIAC ARREST, AND DEATH FROM HYPERKALEMIC RHABDOMYOLYSIS IN PEDIATRIC PATIENTS CONTRAINDICATIONS In patients with skeletal muscle myopathies In patients with known hypersensitivity to succinylcholine After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury In patients with a personal or familial history or suspected genetic susceptibility to malignant hyperthermia WARNINGS AND PRECAUTIONS Anaphylaxis: Severe anaphylactic reactions to neuromuscular blocking agents, including succinylcholine, have been reported. Some cases have been life-threatening and fatal. Take necessary precautions, such as the immediate availability of appropriate emergency treatment. Risk of Death due to Medication Errors: Unintended administration of Succinylcholine Chloride Injection may result in paralysis, respiratory arrest and death. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. Hyperkalemia: Succinylcholine Chloride Injection may induce serious cardiac arrhythmias or cardiac arrest due to hyperkalemia. Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. Bradycardia: Intravenous bolus administration may result in profound bradycardia or, rarely asystole. The incidence is higher following a second dose of succinylcholine. Pretreatment with anticholinergic agents (e.g. atropine) may reduce the occurrence of bradyarrhythmias. ADVERSE REACTIONS Adverse reactions reported with succinylcholine are cardiac arrest, malignant hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged respiratory depression or apnea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. INDICATIONS AND USAGE Succinylcholine Chloride Injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: As an adjunct to general anesthesia To facilitate tracheal intubation To provide skeletal muscle relaxation during surgery or mechanical ventilation This Important Safety Information does not include all the information needed to use Succinylcholine Chloride Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Succinylcholine Chloride Injection, USP 100 mg per 5 mL and 200 mg per 10 at www.fresenius-kabi.com/us. Ephedrine Sulfate Injection, USP WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs: Pressor effect of sympathomimetic pressor amines is potentiated. Tachyphylaxis and Tolerance: Repeated administration of ephedrine may cause tachyphylaxis. ADVERSE REACTIONS Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Interactions that Augment Pressor Effect: clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. Interactions that Antagonize the Pressor Effect: Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine. Monitor blood pressure. Guanethidine: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly. Rocuronium: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed. Epidural anesthesia: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia. Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine. INDICATIONS AND USAGE Ephedrine Sulfate Injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. This Important Safety Information does not include all the information needed to use Ephedrine Sulfate Injection, USP safely and effectively. Please see full prescribing information, for Ephedrine Sulfate Injection, USP at www.fresenius-kabi.com/us.” About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月1日，上海阳光医药采购网发布通知，因未按时调整价格，暂停上海医药集团股份有限公司（下称上海医药）旗下上海信谊金朱药业生产的甲硫酸新斯的明注射液（规格：2ml:1mg*1支/支，中硼硅玻璃安瓿装）采购资格。 截图来源：上海医药阳光医药网 甲硫酸新斯的明注射液最初由日本盐野义株式会社研发，于1936年在日本上市。甲硫酸新斯的明注射液作为胆碱酯酶抑制剂的典型代表，在麻醉术后治疗领域发挥着重要作用，尤其擅长缓解术后腹部胀气与尿潴留症状，是临床上的常用药。 院内销售突破10亿元，信谊金朱占据半壁江山 2016年，甲硫酸新斯的明注射液凭借出色的疗效与安全性，被纳入国家首批急抢救示范药目录，同时跻身国家基本药物及医保甲类药品行列。自纳入医保后，其医院端市场销售额持续攀升，摩熵医药数据显示：2023年全终端医院市场销售额突破10亿元，同比增长18.37%；2024年销售额达6.78亿元；至2025年上半年，销售额已逼近2亿元。 截图来源：摩熵医药全终端医院销售数据库 在甲硫酸新斯的明注射液的市场角逐中，上海信谊金朱药业展现出强劲实力。2024年，该企业凭借53.19%的市场份额，在院内市场独占鳌头。截至当下，全国已有20家药企的甲硫酸新斯的明注射液产品获批且通过一致性评价。值得一提的是，上海医药旗下子公司上海信谊金朱药业于2022年3月率先获批，成为国内首家过评企业，在竞争中抢占先机。 截图来源：摩熵医药全终端医院销售数据库  价格涨幅近21倍，三家药企垄断被罚 今年3月21日，上海市场监管”公众号发文指出：上海信谊联合医药药材、河南润弘制药、成都汇信医药3家公司将甲硫酸新斯的明注射液的售价从3.5～6.8元/支暴涨至约79.33元/支，涨幅近21倍，严重扰乱市场秩序。上海市场监管局迅速出手，对这三家药企的垄断行为予以严厉打击，没收违法所得并处罚款合计2.23亿元，对达成垄断协议负有个人责任的自然人罚款50万元。 截图来源：上海市市场监督管理局 从价格对比来看，目前上海信谊的甲硫酸新斯的明注射液在全国各省挂网价格约为每支3.56 - 6.8元，河南润弘、成都汇信则约为1元多，和3家公司联合的价格相差悬殊。在集采政策的强力推动下，市场秩序正逐步回归正轨。甲硫酸新斯的明注射液作为第十批集采品种，价格降幅超过94%，让患者能够以更合理的价格获得所需药品。 此外，12月1日发布的《2025年9月部分短缺药全国平均价的公告》显示，甲硫酸新斯的明注射液（2ml:1mg）、重酒石酸去甲肾上腺素注射液（1ml:2mg）、注射用硫酸长春新碱（1mg）这三款短缺药，每支/瓶的全国平均价分别为1.70元、0.97元、164.09元，价格趋于合理。 截图来源：上海医药阳光医药网 重酒石酸去甲肾上腺素注射液作为急救低血压的核心用药，截至目前，国内已有26家药企获得该品种的生产批文。在2024年，该品种于全终端医院的销售额突破20亿元，并且已成功纳入多省集采目录。 截图来源：摩熵医药全终端医院销售数据库  长春新碱是治疗儿童急性淋巴细胞白血病的关键抗肿瘤药，需严格静脉给药以防外渗。这三款短缺药均为国家医保甲类品种，享受医保报销，并通过短缺药保供机制稳定临床供应。 结语 这些药品从价格混乱到回归合理、供应稳定的过程，深刻凸显了市场监管的重要性。只有加强监管，才能遏制不良企业的逐利冲动，维护市场秩序；同时，也充分展现了政策保障下短缺药供应的积极成效，让患者能够用上放心药、平价药。 END 本文为原创文章，转载请留言获取授权 近期热门资源获取 中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取 联系我们，体验摩熵医药更多专业服务 会议 合作 园区 服务 数据库 咨询 定制 服务 媒体 合作 点击上方图片，即可开启摩熵化学数据查询 点击阅读原文，申请摩熵医药企业版免费试用！