恩多扩展了ADRENALIN®即用型预混袋系列，推出新浓度产品-动脉网

Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with New Concentration

CISION 等信源发布 2025-05-16 04:30

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Endo's products are the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed intravenous (IV) bag

Endo公司的产品是首个获得FDA批准并且目前唯一商业可用的制造商预混肾上腺素静脉注射袋。

MALVERN, Pa.

马尔文，宾夕法尼亚州

，

May 15, 2025

2025年5月15日

/PRNewswire/ -- Endo, Inc. (OTCQX:

NDOI

印度东北部发展局

) announced today the launch of ADRENALIN

）今天宣布推出ADRENALIN

(epinephrine in 0.9% sodium chloride injection) 8 mg/250 mL premixed bag and will begin shipping the product the week of

（肾上腺素溶于0.9%氯化钠注射液）8毫克/250毫升预混袋，并将于下周开始发货。

May 19, 2025

2025年5月19日

. ADRENALIN

. 肾上腺素

is the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed IV bag.

是第一个获得FDA批准并且是目前唯一商业可用的由制造商预先配制的肾上腺素预混静脉注射袋。

'Hospital pharmacists and healthcare providers are working harder than ever, and we are committed to supporting them with ready-to-use medicines that help reduce complexity and streamline operations so they can focus on what matters most—patient care,' said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics.

“医院药剂师和医疗保健提供者比以往任何时候都更加努力，我们致力于通过即用型药物来支持他们，这些药物有助于减少复杂性并简化操作，使他们能够专注于最重要的事情——患者护理，”Endo注射解决方案和仿制药高级副总裁兼总经理Scott Sims表示。

'With this new ADRENALIN.

‘有了这个新的ADRENALIN。

premixed bag concentration, plus the additional concentrations in our pipeline, we are proud to offer options and choice through our TruDelivery

预混袋装浓度，加上我们生产线上的额外浓度，我们很自豪通过我们的TruDelivery提供多种选择。

portfolio.'

投资组合。

Key product benefits include:

主要产品优势包括：

No compounding or preparation required

无需配制或准备

Single-port IV tubing to reduce the risk of inadvertent mixture

单端口 IV 管路，以降低意外混合的风险

24-month shelf life at room temperature

在室温下24个月的保质期

The ADRENALIN

肾上腺素

premixed bag is part of Endo Injectable Solutions'

预混袋是Endo Injectable Solutions的一部分

TruDelivery

真实交付

product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care..

产品线和平台。即用型产品通过消除在患者给药前准备或转移产品的需要，简化了医院的操作流程。这可能会减少浪费和成本，优化便利性和工作流程，并降低准备错误的几率——所有这些都有助于提供高质量的患者护理。

In addition to the new 8 mg/250 mL bag, Endo offers ADRENALIN

除了新的8毫克/250毫升袋装，Endo还提供ADRENALIN

4 mg/250 mL premixed bag and plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations. The company also offers ADRENALIN

4毫克/250毫升预混袋，并计划推出5毫克/250毫升和10毫克/250毫升的浓度。该公司还提供ADRENALIN。

(epinephrine injection, USP) 1 mL single-dose and 30 mL multi-dose vials.

（肾上腺素注射液，USP）1 mL单剂量和30 mL多剂量小瓶。

ADRENALIN

肾上腺素

is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

适用于提高与脓毒性休克相关的低血压成年患者的平均动脉血压。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypertension:

高血压：

Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine..

由于个体对肾上腺素的反应可能会有很大差异，应频繁监测血压并进行调整，以避免血压过度升高。正在接受单胺氧化酶抑制剂 (MAOI) 或三环类或丙咪嗪类抗抑郁药的患者在使用肾上腺素时可能会出现严重且持久的高血压。

Pulmonary Edema:

肺水肿：

Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.

肾上腺素增加心输出量并引起外周血管收缩，这可能导致肺水肿。

Cardiac Arrhythmias and Ischemia:

心律失常和缺血：

Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.

肾上腺素可能会诱发患者的心律失常和心肌缺血，尤其是患有冠状动脉疾病或心肌病的患者。

Extravasation and Tissue Necrosis with Intravenous Infusion:

静脉输液渗漏和组织坏死：

Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.

避免肾上腺素外渗到组织中，以防止局部坏死。当静脉注射肾上腺素时，需经常检查输注部位是否通畅。沿静脉输注路径出现的苍白现象，有时并无明显外渗，可能是由于血管壁的血管收缩和静脉壁通透性增加，导致少量渗漏。

This also may progress on rare occasions to superficial slough..

这也可能在少数情况下进展为浅表性坏死。

Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.

因此，如果出现苍白，考虑定期更换输液部位，以使局部血管收缩的效果消退。当在踝关节静脉注入儿茶酚胺时，下肢有可能发生坏疽。

Antidote for Extravasation Ischemia

外渗性缺血的解毒剂

: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance.

为了防止发生外渗的区域出现组织脱落和坏死，使用含5至10毫克酚妥拉明（一种肾上腺素能阻滞剂）的10至15毫升盐水溶液浸润该区域。使用带有细针头的注射器，将溶液充分渗透到整个受影响区域，该区域通常因冰冷、坚硬和苍白的外观而易于辨认。

Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours..

如果在12小时内浸润该区域，使用酚妥拉明进行交感神经阻滞会引起立即且明显的局部充血变化。

Renal Impairment:

肾功能损害:

Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment.

肾上腺素收缩肾血管，可能导致少尿或肾功能损害。

ADVERSE REACTIONS:

不良反应：

Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred..

最常见的全身给药肾上腺素的不良反应包括头痛、焦虑、恐惧感、不安、震颤、虚弱、头晕、出汗、心悸、苍白、四肢冰冷、恶心/呕吐和/或呼吸困难。心律失常（包括致命的室颤）、快速血压升高导致的脑出血以及心绞痛也有发生。

DRUG INTERACTIONS:

药物相互作用：

Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids.

能够对抗肾上腺素升压作用的药物包括α受体阻滞剂、硝酸盐类等血管扩张剂、利尿剂、降压药以及麦角生物碱。

Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines.

能够增强肾上腺素作用的药物包括拟交感神经药、β受体阻滞剂、三环类抗抑郁药、单胺氧化酶抑制剂（MAO inhibitors）、儿茶酚-O-甲基转移酶（COMT）抑制剂、可乐定、多沙普仑、催产素、左旋甲状腺素钠和某些抗组胺药。

Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias.

增加肾上腺素致心律失常可能性的药物包括β受体阻滞剂、环丙烷和卤代烃麻醉剂、抗组胺药、外源性甲状腺激素、利尿剂、强心苷和奎尼丁。注意观察心脏心律失常的发生。

Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.

包括皮质类固醇、利尿剂和茶碱在内的耗钾药物会增强肾上腺素的低钾效应。

USE IN SPECIFIC POPULATIONS:

在特定人群中使用：

Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.

老年患者和孕妇在肾上腺素通过非肠道途径给药时，可能面临更大的不良反应风险。

Click for

点击获取

Full Prescribing Information

完整处方信息

。

About Endo

关于Endo

Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at

Endo是一家多元化的制药公司，大胆地将洞察力转化为提升生命的疗法。我们充满热情的团队成员通力合作，开发并提供这些重要的药物。我们共同致力于帮助每一位我们服务的人过上最美好的生活。欲了解更多信息，请访问

www.endo.com

or connect with us on

或通过以下方式联系我们

领英

。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的谨慎声明

This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product shipments, commercial availability, product benefits, reduction of waste, costs and errors, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts.

本新闻稿包含前瞻性陈述，包括但不限于 Sims 先生的声明以及任何有关产品发货、商业可用性、产品优势、减少浪费、成本和错误的声明，以及任何提及预期、估计或预计未来结果的声明或不完全与历史事实相关的声明。

Statements including words such as 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plan,' 'will,' 'may,' 'look forward,' 'intends,' 'guidance,' 'future,' 'potential' or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict.

包含“相信”、“预期”、“预计”、“打算”、“估计”、“计划”、“将”、“可能”、“展望”、“指导”、“未来”、“潜力”或类似表达的陈述均为前瞻性声明。由于这些声明反映了Endo对未来的事件当前的看法、期望和信念，因此它们涉及风险和不确定性，其中一些可能是Endo目前无法预测的。

Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions.

尽管恩多认为这些前瞻性陈述和其他信息是基于合理的假设和预期，但读者不应过分依赖这些或任何其他前瞻性陈述和信息。实际结果可能与当前预期有重大差异，并受到多种因素的不利影响，包括但不限于：法规合规性、意外的诉讼或纠纷、恩多成功实施和执行其战略及举措的能力，以及竞争、市场或监管条件的变化。

Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S.

恩多不承担公开更新任何前瞻性陈述的义务，无论这种更新是由于新信息、未来发展或其他原因，除非适用的证券法要求。有关风险因素的更多信息，包括上述提及的内容，可以在恩多的新闻稿及其向美国提交的公开文件中找到。

Securities and Exchange .

证券交易。

SOURCE Endo, Inc.

来源：Endo公司

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