Oxytocin

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.

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策 01 调整时间节点与品种规模 关键时间规划：2025年12月启动基层医疗机构需求申报（县级以下医疗机构逐级上报，工业企业不参与），同步或发布征求意见稿；2026年一季度前完成调整方案落地，正式目录同期出台。 品种数量变化：基药目录品种将从现行685个扩容至约980个，净增近300个（计划调入约300个、调出约20个）。此次调整主要基于7年来医疗疾病谱变迁、创新药上市、医保目录动态调整及经典名方获批等多重因素，扩容势在必行。 02 政策优先级与核心矛盾 卫健委工作定位：巩固基本药物制度为药政工作核心优先级，3月28日专题会议明确其重点地位，要求强化与医保甲类目录衔接。工作聚焦基层病种需求，以县域为单位推进采购协同、用报联动，由地方卫健委制定用药指南并收集基层需求；目录调整将围绕临床价值、创新属性、儿童用药、短缺药等核心维度，深化与医保、集采政策的联动机制，保障药品供应与优先使用。 基层用药痛点：医联体、医共体建设进入高峰期，基层现行685个基药品种已无法满足临床需求，而县域医共体2000+品种的用药目录与基层基药目录存在合规冲突，基层卫生院使用非基药目录品种面临合规风险，目录扩容与统一成为紧迫需求。 03 管理办法优化方向 总体调整原则：延续"防治必需、安全有效、价格合理、使用方便、中西药并重"核心原则，整体调整幅度温和。安全有效性评价将进一步细化，要求采用近8年临床数据支撑，杜绝过时数据应用；中成药循证医学要求强化，重点回应临床有效性争议，需通过高质量循证研究或临床数据验证其疗效。 多部门协同要点：本次调整涉及卫健委、医保局等多部门，各部门权责清晰：医保局聚焦价格合理性审核，卫健委按病种开展临床价值评估，基层医疗机构强调用药便捷性，三级医院关注疾病谱变化与创新药纳入，调整方案将充分吸纳各方诉求。  04 中成药纳入标准与重点品类 纳入规模与类型：新版目录计划调入的300个品种中，中成药占比约40%（约120个），涵盖近年上市创新中成药、经典名方（如苓桂术甘汤、一贯煎颗粒等）及民族药物（以藏药、维药、蒙药为主，壮药、傣药、彝药等为辅）。 核心纳入要素：以临床需求为核心导向，兼顾产品规模、循证数据与价格亲民性。临床端，现行目录仅13个儿科中成药，远不能满足儿童常见病治疗需求；产品端，纳入品种多为年销售额2-3亿元以上的大品种（如小儿豉翘等）；数据端，大品种积累了丰富临床数据（含头对头对比研究）；价格端，经医保谈判、中成药集采后，相关品种价格已具备亲民属性，契合医保管控要求。高纳入概率品种集中在儿童用药（开喉剑、小儿豉翘等）、肾病用药（海昆肾喜）、骨科用药（盘龙七）等领域。 05 调出品种筛选标准 核心调出逻辑：以"OTC属性强、临床用量极低"为主要筛选依据，重点调出零售端销量占比超80%、院内销售额不足千万（如槐角丸）的临床价值有限品种。中药注射剂（如参麦注射液）调出风险较高；部分院内销售额达2-3亿元但临床必要性存疑的普通中成药，其保留资格将由卫健委综合评估。 06 调整后市场放量预期 放量驱动因素：需求端，二三级医院基药使用比例分别不足50%、30%，临床需求未充分释放；政策端，目录扩容精准匹配县域医共体需求，配套基层与医共体目录统一政策；进院效率端，新增品种可在目录公布后2个月内完成县域医共体进院，部分品种无需药事会审批即可直接采购；价格端，新增品种多已纳入集采，价格合规性满足医保管控要求。 增长幅度预测：受集采常态化影响，新增品种将呈现"销量快速增长、销售额增速放缓"特征，预计销售数量增长率维持在30%-40%区间，较2018年前集采未大规模开展时期的销售额爆发式增长模式有所差异。 07 化药/生物药纳入规则 重点纳入品类：靶向药、生物药（含部分罕见病药物）将重点纳入，不受中成药30元价格限制，核心考量临床疗效确切性；近年研发活跃的靶向类生物制剂具备较高纳入概率。 品种替代趋势：副作用较大的传统化药面临替代风险，如塞来昔布替代双氯芬酸（规避胃肠反应）、非布司他替代秋水仙碱（毒副作用更低、价格亲民）、卡贝缩宫素替代缩宫素（疗效更确切）。替代品种中，非布司他、塞来昔布等仿制药因生产企业众多，替代逻辑明确；具备创新属性的生物药，需结合企业产品定位判断纳入可能性。  08 基药相关问题问答Q&A Q:基本药物目录调整的关键政策节点及当前进展如何？ A:基本药物目录调整工作即将推进，预计2025年12月左右发布征求意见稿或启动基层医疗机构需求上报，2026年一季度目录出台。品种数量预计增至约980个。本次调整因7年未动，疾病谱变化、创新药及医保目录调整等因素推动，需匹配当前医疗需求。 Q:过往三年基药目录政策低于市场预期的原因是什么？当前卫健委对基药目录政策的优先级如何？影响政策执行的潜在卡点有哪些？ A:3月28日国家卫健委药政工作会议将巩固完善国家基本药物制度列为重点工作，基药目录调整是卫健委药政工作的核心优先级。调整将依据临床需要、创新药、儿童用药、短缺药等，推动与医保、国谈、集采联动，保障药物供应和优先使用。影响政策执行的潜在卡点包括基层医疗机构仅使用685个基药产品无法满足需求，县域医共体建设高峰期导致基药目录与医共体用药目录冲突，需通过目录扩容和统一解决矛盾。 Q:今年三季度管理基药目录的司可能存在人事变动，且近两年卫健委有人事变动，这些对基药目录政策推进节奏有何影响？ A:人事变动对基药目录政策推进节奏不会产生特别大的影响。曹雪涛不再担任卫健委副主任，郑哲9月新任副主任，但药物政策和基本药物司张峰司长已任职近两年；基药目录是卫健委核心工作，不以领导变动影响推进节奏，因此政策推进速度不会因相关人员变动而放缓或加快。 Q:预计12月底出台的基药目录管理办法，相较于两年前的征求意见稿是否会有较大调整？ A:基药目录管理办法整体大方向不变，仍遵循防治必须、安全有效、价格合理、使用方便、中西药并重的原则，但会重点围绕安全有效补充细节要求，如需提供最近周期内的科学评估及临床数据（更多实时纪要加微信：aileesir）以证明有效性；此外，办法制定涉及医保局、中医药管理局等多部门参与，各部门关注重点不同——医保局侧重价格合理性，卫健委按病种管理，基层医疗机构强调使用方便，三级医疗机构关注创新药纳入，整体方向不变，仅个别环节会明确具体规则。 Q:能够进入新版基药目录的中药产品，具备哪些高概率特征？ A:中药产品纳入新版基药目录的比例将保持40%左右，本次预计调入的300个品种中约120个为中成药。高概率纳入的中药产品主要包括近年新上市的创新型中成药、经典名方及藏药、维药、蒙药三大民族药；从临床需求看，儿童用药、骨伤类、肿瘤类、肾病类、骨科类等方向的产品概率较高。此类产品通常具备规模大、循证医学数据充足、临床需求明确且价格通过医保谈判或集采趋于亲民的特征。 Q:临床需求、临床价值、价格等核心因素在卫健委基本药物目录调整考量中的权重分别是多少？医保局可接受的中药日费用区间是多少？ A:医保局可接受的中药日费用区间约为30元，打破以往个位数限制，且本次调整的产品均来自医保目录。卫健委考量中，循证医学占比约60%，防治必须占比约20%，价格占比约10%；此外还综合考虑使用便捷性。 Q:上一轮基药目录调整口子较宽松，部分纳入已七八年的品种体量较小，本次中药品种调出的方向是什么？是否涉及独家或较大独家品种？ A:本次中药品种调出方向主要是OTC属性强、临床销量少的品种，此类产品占基药名额意义不大；中药因部分品种体量不小但临床无销售，不便具体点名；中药注射剂调出可能性较大。 Q:上一轮基药目录纳入的中药品种实现较好放量，结合卫健委推行基层医疗医共体工作，新版基药目录落地后，卫健委对其在基层及等级医院的使用推动力度是否强于上一周期，以及调整后销量增长的预期如何？ A:对调整后销量增长抱有较好预期，主要驱动因素包括：其一，过去二三级医疗机构基药需求未满足，本次调整重点针对县域医共体，新增300个品种将快速进入县域医共体，两个月内可实现医院进院；其二，过去因基药品种不足，二级医疗机构基药占比不足50%、三级不足30%，机构反馈目录无法满足需求，本次目录统一、中心药房设置等政策将加速放量；其三，多数新增品种已通过中成药或化药集采，价格亲民且符合医保管控要求，销量将快速增长；虽销售金额增速不及2018年前，但销售数量有望保持30%-40%的增长率。 Q:化药与生物药中确定性较高、值得关注的纳入品种有哪些？ A:化药不受中成药30元价格限制，临床确切的靶向药、罕见病药物大概率纳入。此外，部分疗效更优、副作用更低的仿制药确定性较高，包括止痛类的塞来昔布、治疗痛风的非布司他、产科用的卡贝缩宫素。上述品种均为生产企业较多的仿制药，而具有创新药属性的生物药不便直接点名。 Q:基药调整后是否会限制基层医疗机构药物品种数量，或要求其仅能使用基药目录内产品？ A:本次基药调整后目录内约980个品种，可满足卫生院常见病需求；调整后不会硬性要求基层医疗机构使用基药目录内产品，基药目录为指导方向。基层可与县域医共体采用同一目录，加入后理论上可使用该目录内所有产品，但优先使用基药。报销比例方面，基药目录内产品报销90%，医保内非基药报销70%-80%，政策为引导而非行政干预。 Q:基层医疗按2000种用药目录计算的基药品种配备占比可能在50%-60%，这与986政策是否存在冲突？ A:986政策是特殊时期的硬性行政干预手段，未来随着县域医共体与卫生院用药目录统一，该政策要求将不再具有直接意义，因此不会再强行要求执行986政策，转而推动建立县域医共体用药目录。 Q:此前卫健委对等级医院基药使用的品种配备、使用金额占比及处方占比的考核是否会宽松，还是仍将提出每年增长目标？ A:考核会宽松。原因在于，卫健委制定基药目录强调临床需要，但价格管控属医保局职责，医保部门实际主导用药选择；同时DRG、DIP等改革已推动用药目录调整，因此接下来不会要求相关比例，且不要求反而更有利于新纳入临床所需品种的增量。 Q:因疾病谱及指南变化已成为一线主导用药的PD-1类药物，是否会纳入本次范围？ A:PD-1类靶向药会纳入，具体取决于病种；本次将有较多生物制药纳入，因近七八年PD-1等靶向药市场变化显著。 Q:目前是否已形成生物制药纳入的预选目录？ A:预选目录分为两个层面，其一为国家卫健委已有的1000余个产品目录，由企业临床数据及政府、相关部门立项推动形成，基于临床用量数据动态调整；其二为通过医保局国谈、集采降价后价格更适配的产品，生物制药会纳入该预选目录且数量较多。 Q:适应症较多且同一适应症存在多个产品的PD1类药物，如何进入基药目录？ A:PD1类药物进入基药（更多实时纪要加微信：aileesir）目录的核心依据是临床研究数据的健全性，样本量更大、数据更完善的产品将优先纳入，本次完全以数据为标准，不凭主观判断。 Q:PD1产品是否会仅纳入部分企业的产品？ A:PD1产品很难完全按通用名纳入，不排除针对特定病种进行考量，虽仍以通用名为主，但纳入考量较复杂；生物药的纳入评估难度高于中成药、化药。 (来源：京药圈 作者：李九原 ） 药闻康策 新媒体矩阵微信公众号 点击下方  一键关注 【免责声明】 1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。 欢迎转发分享、点赞、点在看