产地国家：美国 处 方 药：是 所属类别：100单位 5墨盒x3毫升 包装规格：100单位 5墨盒x3毫升 计价单位：盒 生产厂家中文参考译名: 诺和诺德 生产厂家英文名: Novo Nordisk 原产地英文商品名: FIASP PenFill 100units/mL 5x3ml 原产地英文药品名: insulin aspart 中文参考商品译名: FIASP注射药筒 100单位 5墨盒x3毫升 中文参考药品译名: 门冬胰岛素

简介

近日，新型1型糖尿病胰岛素注射剂Fiasp(insulin aspart)获批上市。Fiasp是目前门冬胰岛素的一种新配方，添加了两种新赋形剂(维生素B3和L-精氨酸)，以确保药物更及时、快速和更好的被吸收，从而使胰岛素更迅速的起效。与门冬胰岛素相比，Fiasp可以更真实地模拟内源性胰岛素对进餐后的反应，这也是HbA1c达标的最佳途径。截止目前，Fiasp已获美国、欧盟、加拿大、澳大利亚、瑞士以及其他一些国家批准，用于1型糖尿病和2型糖尿病成人患者，改善血糖控制。 批准日期：公司：诺和诺德(Novo Nordisk) FIASP(门冬胰岛素[insulin aspart])注射，用于皮下或静脉使用 美国最初批准：2000年 作用机制 FIASP®的主要活动是调节葡萄糖代谢。 胰岛素(包括门冬胰岛素，FIASP®中的活性成分)通过与胰岛素受体结合发挥其特异性作用。 受体结合的胰岛素通过促进细胞摄取葡萄糖进入骨骼肌和脂肪组织并通过抑制肝脏葡萄糖的输出来降低血糖。胰岛素抑制脂肪细胞中的脂肪分解，抑制蛋白水解，增强蛋白质合成。 适应症和用法 •FIASP®是一种速效人胰岛素类似物，用于改善糖尿病患者的血糖控制。 剂量和给药 •根据给药途径，个体代谢需求，血糖监测结果和血糖控制目标，个性化和调整FIASP®的剂量。 •当转换其他胰岛素时，可能需要调整剂量，改变身体活动，改变不一致的药物，改变膳食模式，改变肾功能或肝功能或急性疾病。 •皮下注射： o在开始进餐时或在餐后20分钟内注入腹部，上臂或大腿。 o在同一区域内旋转注射部位。 o通常应用于中效或长效胰岛素治疗方案。 •静脉输液：在使用聚丙烯输液袋在输液系统中稀释至0.5至1单位/ mL胰岛素浓度后，仅在医疗监督下进行。 剂型和强度注射：100单位/mL(U-100)： •10 mL多剂量小瓶 •3mL单患者使用的FIASP®FlexTouch®笔 •3mL单患者使用的PenFill®药筒，用于PenFill®cartridge设备 禁忌症 •在低血糖发作期间。 •对门冬胰岛素或FISASP®中的一种赋形剂过敏。 警告和注意事项 •切勿在患者之间共用FIASP®FlexTouch®笔，PenFill®药筒或PenFill®药筒装置，即使针头已更换。 •胰岛素治疗方案改变的高血糖或低血糖症：在严密的医疗监督下进行，并增加血糖监测的频率。 •低血糖：可能危及生命。增加葡萄糖监测的频率，改变：胰岛素剂量，共同给予降糖药物，膳食模式，身体活动;并且在患有肾功能不全或肝功能不全或低血糖的患者中无意识。 •由于用药错误导致的低血糖：可能发生胰岛素产品之间的意外混淆。在注射前指导患者检查胰岛素标签。 •低钾血症：可能危及生命。监测有低钾血症风险的患者的钾水平，并进行治疗。 •过敏反应：可能发生严重，危及生命，全身过敏，包括过敏反应。如果有指示，请停止使用FIASP®，进行监测和治疗。 •伴随使用噻唑烷二酮(TZDs)的液体潴留和心力衰竭：观察心力衰竭的体征和症状;如果发生心力衰竭，考虑减少剂量或停药。 不良反应 用FIASP®观察到的不良反应包括：低血糖，过敏反应，过敏反应，注射部位反应，脂肪营养不良和体重增加。 要报告疑似不良反应，请致电1-800-727-6500联系诺基诺德公司，或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。 药物相互作用 •增加低血糖风险或增加或减少血液葡萄糖降低作用的药物：可能需要调整剂量;密切监测血糖。 •钝性低血糖症和症状的药物(例如，β-受体阻滞剂，可乐定，胍乙啶和利血平)：可能需要增加葡萄糖监测的频率。 包装提供/存储和处理 提供 FIASP®(门冬胰岛素注射)100单位门冬胰岛素/毫升(U-100)可作为透明无色溶液在以下 演示和包装配置： 一箱10mL多剂量小瓶NDC 0169-3201-11 纸箱五个3毫升单患者使用NDC 0169-3204-15 FIASP®FlexTouch®笔 纸箱五个3毫升单患者使用NDC 0169-3205-15 PenFill®墨盒* FIASP®FlexTouch®笔以1个单位为增量拨号。 FIASP®PenFill®药筒设计用于Novo Nordisk胰岛素输送设备建议储存未使用的FIASP®样品瓶应存放在冰箱中2°至8°C(36°至46°F)之间，但不应存放在冷冻室内或附近。 FIASP®不应暴露在过热或过热的环境中，不得冷冻。不要冻结FIASP®，如果已经冷冻，请不要使用FIASP®。不应将FIASP®吸入注射器中并存放以备后用。只有在产品具有清晰和无色外观的情况下才能使用。 将盖子放在笔上以防止光线照射。将未使用的塑料瓶和FIASP®FlexTouch®放在纸箱中，以保持其清洁和避光。 每次注射后务必取下针头并在没有连接针头的情况下存放FIASP®FlexTouch®。 这可以防止污染和/或感染或胰岛素泄漏，并确保准确的剂量。每次注射时务必使用新的针头以防止污染。 小瓶和FIASP®FlexTouch®笔的储存条件在表9中进行了总结： 表9.样品瓶，FIASP®FlexTouch和PenFill®滤芯的储存条件 FIASP介绍 未使用(未开封) 使用中(已打开) 房间 冷藏 房间 冷藏 温度(2°C至8°C) 温度 (2°C至8°C) (低于30°C) (低于30°C) 10毫升小瓶 28天 到期之前日期 28天 28天 3 mL FIASP® FlexTouch® 28天 到期之前日期 28天 28天 3mLPenFill® 墨盒 28天 到期之前日期 28天 不要冷藏 FIASP®在静脉输液中的储存： 如剂量和给药所示制备的输注袋在室温下稳定24小时。

英文版说明书

FIASP ® (insulin aspart injection) for subcutaneous or intravenous use Contraindications Fiasp® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Fiasp® or one of its excipients. Warnings and Precautions Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge device between patients, even if the needle is changed. Patients using Fiasp® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. Fiasp®(insulin aspart injection) 100 U/mL Indications and Usage Fiasp®(insulin aspart injection) 100 U/mL is a rapid-acting insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Important Safety Information Contraindications Fiasp® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Fiasp® or one of its excipients. Warnings and Precautions Never share a Fiasp® FlexTouch® Pen, PenFill® cartridge or PenFill® cartridge device between patients, even if the needle is changed. Patients using Fiasp® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. Hypoglycemia is the most common adverse reaction of insulin, including Fiasp®, and may be life-threatening. Increase glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. To avoid medication errors and accidental mix-ups between Fiasp® and other insulin products, instruct patients to always check the insulin label before injection. As with all insulins, Fiasp® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including Fiasp®. Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Fiasp®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered. Adverse Reactions Adverse reactions observed with Fiasp® include hypoglycemia, allergic reactions, hypersensitivity, injection site reactions, lipodystrophy, and weight gain. Use in Specific Populations The safety and effectiveness of Fiasp® in pediatric patients have not been established. Like all insulins, Fiasp® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments. Please click here for Fiasp® Prescribing Information. NovoLog® (insulin aspart injection) 100 U/mL Indications and Usage NovoLog® (insulin aspart injection) 100 U/mL is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Important Safety Information Contraindications NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients. Warnings and Precautions Never Share a NovoLog® FlexPen, NovoLog® FlexTouch®, PenFill® Cartridge, or PenFill® Cartridge Device Between Patients, even if the needle is changed. Patients using NovoLog® vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. Hypoglycemia is the most common adverse effect of insulin therapy. The timing of hypoglycemia may reflect the time-action profile of the insulin formulation. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. To avoid medication errors and accidental mix-ups between NovoLog® and other insulin products, instruct patients to always check the insulin label before injection. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with insulin products, including NovoLog®. As with all insulins, NovoLog® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including NovoLog®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered. Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. NovoLog® continuous subcutaneous infusion route (insulin pump): Do not mix NovoLog® with any other insulin or diluent. Adverse Reactions Adverse reactions observed with NovoLog® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Use in Specific Populations NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age. Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment. These patients may require more frequent blood glucose monitoring and dose adjustments.