DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S.

伊利诺伊州迪尔菲尔德。-（商业新闻短讯）--百特国际公司（纽约证券交易所代码：BAX）是注射剂、麻醉和药物配制领域的全球领导者，宣布将继续扩大其药品组合，在美国推出五款注射剂产品。

“These launches demonstrate Baxter’s focus on differentiated products that address unmet patient needs in key therapeutic areas, including anti-infective and anti-hypotensive medications,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “We are proud to offer important new options for our customers and look forward to continuing to bring new innovations to the market.”.

巴克斯特制药公司执行副总裁兼集团总裁阿洛克·索尼格（Alok Sonig）表示：“这些产品的推出表明，巴克斯特专注于解决关键治疗领域未满足患者需求的差异化产品，包括抗感染和抗低血压药物。”。“我们很自豪能为客户提供重要的新选择，并期待着继续为市场带来新的创新。”。

Product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, Important Risk Information and links to full Prescribing Information below.

巴克斯特在美国的药品组合中的产品发布包括以下内容。对于所有产品，请参阅下面的完整适应症，重要风险信息和完整处方信息的链接。

Norepinephrine Bitartrate in 5% Dextrose Injection in a new 16 mg/250 mL strength, which is indicated to raise blood pressure in adult patients with severe, acute hypotension. Baxter offers the first and only FDA-approved ready-to-use Norepinephrine in Dextrose, and now provides Norepinephrine in 4 mg/250 mL, 8 mg/250 mL and 16 mg/250 mL strengths..

酒石酸去甲肾上腺素在5%葡萄糖注射液中的新浓度为16 mg/250 mL，这表明成年严重急性低血压患者的血压升高。巴克斯特提供了第一个也是唯一一个FDA批准的葡萄糖中即用去甲肾上腺素，现在提供的去甲肾上腺素浓度分别为4 mg/250 mL、8 mg/250 mL和16 mg/250 mL。。

Vasopressin in 0.9% Sodium Chloride Injection, the first and only FDA-approved ready-to-use Vasopressin in a flexible container. Vasopressin uses Baxter’s proprietary sterile, closed system container, which is collapsible and does not require a vented intravenous set.1 Manufactured closed drug-delivery systems decrease the need for manual admixture and reduce the possibility of contamination.2 Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

0.9%氯化钠注射液中的加压素是FDA批准的第一个也是唯一一个在柔性容器中即用加压素。加压素使用巴克斯特专有的无菌封闭系统容器，该容器可折叠，不需要通风的静脉注射装置。1制造的封闭式药物输送系统减少了手动混合的需要，并减少了污染的可能性。2加压素可增加血管扩张性休克成年人的血压，尽管有液体和儿茶酚胺，但他们仍然保持低血压。

Baxter offers Vasopressin in 20 units/100 mL and 40 units/100 mL strengths..

巴克斯特提供20单位/100毫升和40单位/100毫升强度的加压素。。

Vancomycin Injection, USP in 5% Dextrose in new 1.25 g/250 mL and 1.5 g/300 mL strengths. These launches are Baxter’s first frozen ready-to-use offerings in 250 mL and 300 mL volumes. Vancomycin is indicated for serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.

万古霉素注射液，USP在5%葡萄糖中的新浓度为1.25 g/250 mL和1.5 g/300 mL。这些产品是百特第一款250毫升和300毫升容量的速冻即用产品。万古霉素适用于由耐甲氧西林（β-内酰胺抗性）葡萄球菌的易感菌株引起的严重或严重感染。

Baxter now offers Vancomycin in 500 mg/100 mL, 750 mg/150 mL, 1 g/200 mL, 1.25 g/250 mL and 1.5 g/300 mL strengths..

巴克斯特现在提供500毫克/100毫升、750毫克/150毫升、1克/200毫升、1.25克/250毫升和1.5克/300毫升浓度的万古霉素。

Ropivacaine Hydrochloride Injection, USP in a ready-to-use, single-dose infusion bag. Ropivacaine is indicated in adults to produce local or regional anesthesia for surgery and for acute pain management. Baxter offers Ropivacaine in 200 mg/100 mL and 400 mg/200 mL strengths.

盐酸罗哌卡因注射液，USP，一次性使用，单剂量输液袋。罗哌卡因适用于成人，用于手术和急性疼痛管理的局部或区域麻醉。巴克斯特提供200毫克/100毫升和400毫克/200毫升强度的罗哌卡因。

Regadenoson Injection pre-filled syringe, a coronary vasodilator that is commonly used in pharmacologic stress testing. Baxter offers Regadenoson in a 0.4 mg/5 mL strength.

Regadenoson注射液预充注射器，一种冠状动脉血管扩张剂，通常用于药物压力测试。Baxter提供0.4 mg/5 mL强度的Regadenoson。

Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination2 and avoiding potential errors that may occur when medications are compounded.3.

常用处方药标准浓度的即用格式可能为医疗保健提供者提供操作效率。配制供患者使用的药物是一个多步骤的手动过程，需要药房工作人员的监督。即用产品可以通过减少污染的机会2和避免药物复合时可能发生的潜在错误来简化制备过程并支持患者安全。

These newly launched products are now available for use in the U.S.

这些新推出的产品现在可在美国使用。

About Baxter

关于巴克斯特

Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen.

每天，数以百万计的患者、护理人员和医疗保健提供者依赖巴克斯特领先的诊断、重症监护、肾脏护理、营养、医院和外科产品组合，这些产品用于患者之家、医院、医生办公室和其他护理场所。90多年来，我们一直在关键的十字路口运营，在那里，拯救和维持生命的创新与实现这一目标的医疗保健提供者相遇。

With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X/Twitter, LinkedIn and Facebook..

百特在全球100多个国家提供产品、数字健康解决方案和疗法，百特的全球员工现在正以公司丰富的医学突破传统为基础，推动下一代变革性医疗创新。要了解更多信息，请访问www.baxter.com，并在X/Twitter、LinkedIn和Facebook上关注我们。。

Norepinephrine Bitartrate in 5% Dextrose Injection

5%葡萄糖注射液中酒石酸去甲肾上腺素

Indications

适应症

Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.

右旋糖注射液中的酒石酸去甲肾上腺素可提高成人严重急性低血压患者的血压。

Important Risk Information

重要风险信息

Contraindications: None.

禁忌症：无。

Tissue Ischemia: Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure.

组织缺血：向低血容量低血压患者注射右旋糖中的酒石酸去甲肾上腺素可导致严重的外周和内脏血管收缩，肾灌注减少和尿量减少，组织缺氧，乳酸性酸中毒，尽管血压“正常”，但全身血流量减少。

Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection. Avoid use in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction..

在葡萄糖注射中开始酒石酸去甲肾上腺素之前解决血容量不足。避免用于肠系膜或外周血管血栓形成患者，因为这可能会增加缺血并扩大梗塞面积。。

Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients.

患有闭塞性或血栓性血管疾病或接受长时间或高剂量输注的患者会发生四肢坏疽。监测易感患者四肢皮肤的变化。

Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation.

右旋糖注射液中酒石酸去甲肾上腺素外渗可能导致周围组织坏死和脱落。为了减少外渗的风险，注入大静脉，经常检查输液部位是否有自由流动，并监测是否有外渗迹象。

Avoid administration into the veins in the leg in elderly patients.

避免给老年患者腿部静脉注射。

Emergency Treatment of Extravasation: Infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults.

外渗的紧急治疗：尽快渗入缺血区域，使用注射器和细皮下注射针，在10至15毫升的0.9%氯化钠注射液中加入5至10毫克甲磺酸酚妥拉明。

Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the infusion rate while expanding blood volume with intravenous fluids.

突然停药后低血压：突然停止输注速度可能导致明显的低血压。停止输注时，逐渐降低输注速度，同时用静脉输液扩大血容量。

Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.

心律失常：右旋糖注射液中的酒石酸去甲肾上腺素会升高细胞内钙浓度，并可能引起心律失常，特别是在缺氧或高碳酸血症的情况下。对心律失常患者进行连续的心脏监测。

Elderly Patients: May be at a greater risk of developing adverse reactions.

老年患者：发生不良反应的风险可能更大。

Adverse Reactions: Most common adverse reactions are hypertension and bradycardia.

不良反应：最常见的不良反应是高血压和心动过缓。

Drug Interactions:

药物相互作用：

Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) or with tricyclic antidepressants can cause severe, prolonged hypertension.

右旋糖注射液中酒石酸去甲肾上腺素与单胺氧化酶（MAO）抑制剂或其他具有MAO抑制特性的药物（例如利奈唑胺）或三环类抗抑郁药共同给药可导致严重的长期高血压。

Anti-diabetics: Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose.

抗糖尿病：右旋糖注射液中的酒石酸去甲肾上腺素可降低胰岛素敏感性并升高血糖。

Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.

右旋糖注射液与卤化麻醉药同时使用酒石酸去甲肾上腺素可能导致室性心动过速或心室纤颤。监测同时服用卤化麻醉药的患者的心律。

Please see accompanying full Prescribing Information for Norepinephrine Bitartrate in 5% Dextrose Injection.

请参阅随附的5%葡萄糖注射液中酒石酸去甲肾上腺素的完整处方信息。

Vasopressin in 0.9% Sodium Chloride Injection

0.9%氯化钠注射液中的加压素

Indications

适应症

Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

氯化钠注射液中的加压素可增加患有血管扩张性休克的成年人的血压，尽管有液体和儿茶酚胺，但他们仍保持低血压。

Important Risk Information

重要风险信息

Contraindications: Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin.

禁忌症：氯化钠注射液中的加压素禁用于已知对8-L-精氨酸加压素过敏或超敏的患者。

Worsening Cardiac Function: A decrease in cardiac index may be observed with the use of vasopressin.

心功能恶化：使用加压素可观察到心脏指数下降。

Reversible Diabetes Insipidus: Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation.

可逆性尿崩症：患者停止使用加压素治疗后，可能会出现可逆性尿崩症，表现为多尿，尿液稀释和高钠血症。停用加压素后监测血清电解质，体液状态和尿量。

Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts..

一些患者可能需要重新服用加压素或去氨加压素来纠正液体和电解质的变化。。

Adverse Reactions:

不良反应：

The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital).

最常见的不良反应包括心输出量减少，心动过缓，快速性心律失常，低钠血症和缺血（冠状动脉，肠系膜，皮肤，数字）。

Drug Interactions:

药物相互作用：

Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive.

儿茶酚胺和加压素在氯化钠注射液中的升压作用预计是相加的。

Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection.

消炎痛可延长加压素在氯化钠注射液中的作用。

Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antidiuretic hormone secretion) may increase the pressor response.

共同服用神经节阻滞剂或引起SIADH（抗利尿激素分泌不适当综合征）的药物可能会增加升压反应。

Co-administration of drugs causing diabetes insipidus may decrease the pressor response.

共同服用引起尿崩症的药物可能会降低升压反应。

Pregnancy: May induce tonic uterine contractions that could threaten the continuation of pregnancy.

怀孕：可能引起强直性子宫收缩，可能威胁怀孕的持续。

Please see accompanying full Prescribing Information for Vasopressin in 0.9% Sodium Chloride Injection.

请参阅随附的0.9%氯化钠注射液中加压素的完整处方信息。

Vancomycin Injection, USP in 5% Dextrose

万古霉素注射液，USP在5%葡萄糖中

Indications

适应症

Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs..

万古霉素用于治疗由耐甲氧西林（耐β-内酰胺）葡萄球菌敏感菌株引起的严重或严重感染。它适用于青霉素过敏患者，无法接受或对其他药物无反应的患者，以及由对其他抗菌药物具有耐药性的万古霉素敏感生物引起的感染。。

Vancomycin is effective in the treatment of:

万古霉素可有效治疗：

Infective Endocarditis (staphylococcal endocarditis; endocarditis caused by Streptococcus viridans or S. bovis, alone or in combination with an aminoglycoside; endocarditis caused by enterococci (e.g., E. faecalis), only in combination with an aminoglycoside; diphtheroid endocarditis; early-onset prosthetic valve endocarditis caused by S.

感染性心内膜炎（葡萄球菌性心内膜炎；由绿色链球菌或牛链球菌引起的心内膜炎，单独或与氨基糖苷类药物联合使用；由肠球菌（例如粪便）引起的心内膜炎，仅与氨基糖苷类药物联合使用；白喉样心内膜炎；S引起的早发性人工瓣膜心内膜炎。

epidermidis or diphtheroids in combination with either rifampin, an aminoglycoside, or both).

表皮葡萄球菌或白喉类药物与利福平，氨基糖苷或两者联合使用）。

Septicemia

败血症

Skin and Skin Structure Infections

皮肤和皮肤结构感染

Bone Infections

骨感染

Lower Respiratory Tract Infections

下呼吸道感染

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

为了减少耐药细菌的发展并维持万古霉素和其他抗菌药物的有效性，万古霉素应仅用于治疗或预防已证实或强烈怀疑由易感细菌引起的感染。

Important Risk Information

重要风险信息

Contraindications: Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

禁忌症：万古霉素禁用于已知对该抗生素过敏的患者。对于已知对玉米或玉米制品过敏的患者，可能禁用含有葡萄糖的溶液。

Infusion Reactions: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest.

输注反应：快速推注给药（例如超过几分钟）可能与过度低血压有关，包括休克，很少有心脏骤停。

During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“vancomycin infusion reaction”) or pain and muscle spasm of the chest and back..

在快速输注万古霉素期间或之后不久，患者可能会出现过敏反应，包括低血压，喘息，呼吸困难，荨麻疹或瘙痒。快速输注也可能导致上半身潮红（“万古霉素输注反应”）或胸部和背部疼痛和肌肉痉挛。。

Vancomycin should be administered over a period of not less than 60 minutes. Stopping the infusion usually results in prompt cessation of these reactions.

万古霉素的给药时间应不少于60分钟。停止输注通常会导致这些反应迅速停止。

Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients; especially with underlying renal impairment, with co-morbidities, and receiving concomitant therapy with a known nephrotoxic drug..

肾毒性：全身性万古霉素暴露可能导致急性肾损伤（AKI）。随着全身暴露/血清水平的增加，AKI的风险增加。监测所有患者的肾功能；尤其是潜在的肾功能损害，合并症，并接受已知肾毒性药物的伴随治疗。。

Ototoxicity: It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency..

耳毒性：它可能是短暂的或永久的。据报道，这主要发生在服用过量剂量，潜在听力损失或同时接受另一种耳毒性药物（如氨基糖苷类药物）治疗的患者中。肾功能不全患者应谨慎使用万古霉素。。

Severe Dermatologic Reactions: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters.

严重的皮肤病反应：中毒性表皮坏死松解症（TEN），史蒂文斯-约翰逊综合征（SJS），嗜酸性粒细胞增多和全身症状的药物反应（DRESS），急性全身性发疹性脓疱病（AGEP）和线性IgA大疱性皮肤病（LABD）已有报道。报告的皮肤体征或症状包括皮疹，粘膜病变和水疱。

Discontinue vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Dosage of vancomycin must be adjusted for patients with renal dysfunction..

在首次出现TEN，SJS，DRESS，AGEP或LABD的体征和症状时停止万古霉素注射。肾功能不全患者必须调整万古霉素的剂量。。

Clostridioides difficile associated diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

艰难梭菌相关性腹泻（CDAD）：严重程度可能从轻度腹泻到致命性结肠炎。所有使用抗生素后出现腹泻的患者都必须考虑CDAD。如果怀疑或确认CDAD，可能需要停止不针对艰难梭菌的持续抗生素使用。

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated..

应根据临床指示进行适当的液体和电解质管理，蛋白质补充，艰难梭菌的抗生素治疗以及手术评估。。

Hemorrhagic Occlusive Retinal Vasculitis: Including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established..

出血性闭塞性视网膜血管炎：包括永久性视力丧失，发生在白内障手术期间或之后接受万古霉素前房内或玻璃体内给药的患者。万古霉素通过前房内或玻璃体内途径给药的安全性和有效性尚未确定。。

Adverse Reactions: Not already mentioned above, patients have been reported to have neutropenia, phlebitis, drug fever, nausea, chills, and vasculitis in association with administration of vancomycin.

不良反应：如上所述，据报道患者与万古霉素给药有关，患有中性粒细胞减少症，静脉炎，药物热，恶心，寒战和血管炎。

Drug Interactions:

药物相互作用：

Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions.

麻醉剂：万古霉素和麻醉剂的同时给药与红斑和组胺样潮红和类过敏反应有关。

Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.

监测接受万古霉素治疗的患者的肾功能，并同时和/或顺序全身或局部使用其他潜在的神经毒性和/或肾毒性药物，如两性霉素B，氨基糖苷类，杆菌肽，多粘菌素B，粘菌素，紫霉素或顺铂。

Please see accompanying full Prescribing Information for Vancomycin Injection, USP.

请参阅随附的美国药典万古霉素注射液的完整处方信息。

Ropivacaine Hydrochloride Injection, USP

盐酸罗哌卡因注射液

Indications

适应症

Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management.

盐酸罗哌卡因注射液是一种酰胺类局部麻醉剂，用于成人生产局部或区域麻醉，用于手术和急性疼痛管理。

Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration.

手术麻醉：硬膜外阻滞用于包括剖宫产在内的手术；主要神经阻滞；局部渗透。

Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.

急性疼痛管理：硬膜外持续输注或间歇性推注，例如术后或分娩；局部渗透。

Important Risk Information

重要风险信息

Contraindications: Ropivacaine Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

禁忌症：盐酸罗哌卡因注射液禁用于已知对罗哌卡因或任何酰胺类局部麻醉剂过敏的患者。

General Warning: Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.

一般警告：延迟适当管理剂量相关毒性，通气不足和/或敏感性改变可能导致酸中毒，心脏骤停和死亡。

The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies.

局部麻醉药的安全有效使用取决于适当的剂量，正确的技术，充分的预防措施以及对紧急情况的准备。

It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection.

在注射任何局部麻醉剂（包括原始剂量和所有后续剂量）之前，必须进行血液或脑脊液（如适用）的抽吸，以避免血管内或蛛网膜下腔注射。

Unintended Intravenous Injection: In performing Ropivacaine Hydrochloride Injection blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. Ropivacaine hydrochloride injection should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary..

非预期静脉注射：在进行盐酸罗哌卡因注射阻滞时，可能会进行非预期静脉注射，并可能导致心律失常或心脏骤停。盐酸罗哌卡因注射液应以递增剂量给药。不建议在紧急情况下使用，因为需要快速开始手术麻醉。。

Intra-Articular Infusions and Risk of Chondrolysis: Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine Hydrochloride Injection is not approved for this use.

关节内输注和软骨溶解的风险：局部麻醉剂的关节内输注可能导致软骨溶解。盐酸罗哌卡因注射液不被批准用于此用途。

Risk of Methemoglobinemia: Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition.

高铁血红蛋白血症的风险：患有葡萄糖-6-磷酸脱氢酶缺乏症，先天性或特发性高铁血红蛋白血症，心脏或肺部损害，6个月以下婴儿以及同时暴露于氧化剂或其代谢物的患者更容易发展为该病的临床表现。

If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure. Immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.

如果这些患者必须使用局部麻醉药，建议密切监测高铁血红蛋白血症的症状和体征。高铁血红蛋白血症的迹象可能会立即发生，也可能在暴露后数小时延迟。需要立即治疗以避免更严重的中枢神经系统和心血管不良反应，包括癫痫发作，昏迷，心律不齐和死亡。

Discontinue ropivacaine hydrochloride injection and any other oxidizing agents..

停止盐酸罗哌卡因注射液和任何其他氧化剂。。

Central Nervous System Toxicity: Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be performed after each local anesthetic injection.

中枢神经系统毒性：每次局部麻醉药注射后，应仔细持续监测心血管和呼吸系统生命体征以及患者的意识状态。

Hepatic Disease: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations..

肝病：由于酰胺类局部麻醉药（如罗哌卡因）由肝脏代谢，因此肝病患者应谨慎使用这些药物，尤其是重复剂量。患有严重肝病的患者发生有毒血浆浓度的风险更大。。

Adverse Reactions: Most common adverse reactions (incidence ≥ 5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

不良反应：最常见的不良反应（发生率≥5%）是低血压，恶心，呕吐，心动过缓，发烧，疼痛，术后并发症，贫血，感觉异常，头痛，瘙痒和背痛。

Drug Interactions:

药物相互作用：

Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects.

与酰胺型局部麻醉剂结构相关的药物：同时使用可能会产生累加效应。

Please see accompanying full Prescribing Information for Ropivacaine Hydrochloride Injection, USP.

请参阅随附的USP盐酸罗哌卡因注射液的完整处方信息。

Regadenoson Injection

Regadenoson注射液

Indications

适应症

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Regadenoson注射液是一种药物应激剂，适用于无法承受足够运动压力的患者的放射性核素心肌灌注成像（MPI）。

Important Risk Information

重要风险信息

Contraindications: Do not administer regadenoson injection to patients with: Second- or third-degree AV block, or Sinus node dysfunction, unless these patients have a functioning artificial pacemaker.

禁忌症：不要给患有二度或三度房室传导阻滞或窦房结功能障碍的患者注射regadenoson，除非这些患者有功能正常的人工起搏器。

Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration..

心肌缺血：发生致命的心脏事件。避免用于有急性心肌缺血症状或体征的患者，例如不稳定型心绞痛或心血管不稳定，这些患者的风险可能更高。给药前应提供心脏复苏设备和训练有素的工作人员。。

Sinoatrial (SA) and Atrioventricular (AV) Nodal Block: Adenosine receptor agonists, including regadenoson injection, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia.

窦房结（SA）和房室结（AV）阻滞：腺苷受体激动剂（包括regadenoson注射）可抑制SA和AV结，并可能导致一级，二级或三级房室传导阻滞或窦性心动过缓。

Atrial Fibrillation/Atrial Flutter: New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported.

心房颤动/心房扑动：据报道，新发或复发性心房颤动伴有快速心室反应和心房扑动。

Hypersensitivity, Including Anaphylaxis: Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. Have personnel and resuscitative equipment immediately available.

超敏反应，包括过敏反应：发生过敏反应，血管性水肿，心脏或呼吸停止，呼吸窘迫，血氧饱和度降低，低血压，喉咙紧绷，荨麻疹和皮疹。立即配备人员和复苏设备。

Hypotension: Adenosine receptor agonists, including regadenoson injection, induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia..

低血压：腺苷受体激动剂，包括regadenoson注射液，可引起血管舒张和低血压。患有自主神经功能障碍、狭窄性瓣膜性心脏病、心包炎或心包积液、颈动脉狭窄伴脑血管功能不全或血容量不足的患者发生严重低血压的风险可能更高。。

Hypertension: Adenosine receptor agonists, including regadenoson injection, may induce clinically significant increases in blood pressure particularly in patients with a history of hypertension and when the MPI includes low level exercise.

高血压：腺苷受体激动剂，包括regadenoson注射液，可能会引起临床上显着的血压升高，特别是在有高血压病史的患者和MPI包括低水平运动时。

Bronchoconstriction: Adenosine receptor agonists, including regadenoson injection, may induce dyspnea, bronchoconstriction and respiratory compromise, especially in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available.

支气管收缩：腺苷受体激动剂，包括regadenoson注射，可能引起呼吸困难，支气管收缩和呼吸功能损害，特别是在慢性阻塞性肺病（COPD）或哮喘患者中。应提供复苏措施。

Seizure: Regadenoson injection may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson injection..

癫痫发作：Regadenoson注射可能会降低癫痫发作阈值。发生了新的惊厥发作或复发。一些癫痫发作时间延长，需要紧急抗惊厥治疗。对于与regadenoson注射相关的癫痫发作患者，不建议使用甲基黄嘌呤。。

Cerebrovascular Accident (Stroke): Hemorrhagic and ischemic cerebrovascular accidents have occurred.

脑血管意外（中风）：发生了出血性和缺血性脑血管意外。

Adverse Reactions: The most common (incidence ≥ 5%) adverse reactions to regadenoson injection are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea.

不良反应：雷加地松注射液最常见（发生率≥5%）的不良反应是呼吸困难，头痛，潮红，胸部不适，头晕，心绞痛，胸痛和恶心。

Drug Interactions:

药物相互作用：

Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson injection.

甲基黄嘌呤，例如咖啡因，氨茶碱和茶碱，会干扰regadenoson注射液的活性。

Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson injection.

氨茶碱可用于减轻雷加地松注射液的严重和/或持续不良反应。

Dipyridamole may increase the activity of regadenoson injection. When possible, withhold dipyridamole for at least two days prior to regadenoson injection administration.

双嘧达莫可提高雷加地松注射液的活性。在可能的情况下，在注射regadenoson之前，停用双嘧达莫至少两天。

Please see accompanying full Prescribing Information for Regadenoson Injection.

请参阅随附的Regadenoson注射液的完整处方信息。

This release includes forward-looking statements concerning Norepinephrine Bitartrate in 5% Dextrose Injection, Vasopressin in 0.9% Sodium Chloride Injection, Vancomycin Injection, USP in 5% Dextrose, Ropivacaine Hydrochloride Injection, USP and Regadenoson Injection pre-filled syringe, including potential benefits associated with the use of these products.

该版本包括关于5%葡萄糖注射液中的酒石酸去甲肾上腺素，0.9%氯化钠注射液中的加压素，万古霉素注射液，5%葡萄糖中的USP，盐酸罗哌卡因注射液，USP和Regadenoson注射液预充注射器的前瞻性声明，包括与使用这些产品相关的潜在益处。

The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website.

这些报表基于对许多重要因素的假设，包括以下因素，这些因素可能导致实际结果与前瞻性报表中的结果存在重大差异：对新产品和现有产品的需求和市场接受程度；产品开发风险；无法及时创造额外的生产能力或发生其他制造或供应困难（包括自然灾害、公共卫生危机和流行病/流行病、监管行动或其他原因）；满足监管和其他要求；监管机构和其他政府机构的行动；产品质量、制造或供应或患者安全问题；法律法规变更；以及巴克斯特最近在10-K表和10-Q表上提交的文件以及其他SEC文件中确定的其他风险，所有这些都可以在巴克斯特的网站上找到。

Baxter does not undertake to update its forward-looking statements..

巴克斯特不承诺更新其前瞻性声明。。

Baxter is a registered trademark of Baxter International Inc.

Baxter是Baxter International Inc.的注册商标。

1 Baxter data on file

1 Baxter数据存档

2 Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965.

2 Mercaldi CJ，Lanes S，Bradt J.通过开放式，即时护理或封闭式输送系统接受静脉药物治疗的住院患者血流感染的比较风险。Am J Health Syst Pharm。2013；70:957-965年。

3 Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517.

3 Billstein Leber M，Carrillo CJD，Cassano AT，Moline K，Robertson JJ。ASHP关于预防医院用药错误的指南。Am J Health Syst Pharm。2018；75（19）：1493-1517年。

US-PH57-240005 (v1.0) 04/2024

US-PH57-240005（v1.0）2024年4月