百达扬说明书

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达优 ELISPOT 试剂盒 Mouse IFN-γ 说明书

Mouse IFN-γprecoated ELISPOT kit（strips）Cat#:2210005产品描述：深圳市达科为生物工程有限公司生产的达优®系列ELISPOT预包被试剂盒采用原装进口高亲和力高效价抗体对，经预包被PVDF板、低温干燥、真空密封包装等工艺流程制备。

成品PVDF板上预包被的抗体分布均匀、效价稳定，2-8ºC可存放12个月。

达优®系列预包被ELISPOT试剂盒使实验检测时间从3天缩短为2天，大幅度减少无菌操作的实验步骤，减轻实验者的劳动强度和减少污染的几率。

使得实验者能够轻松、高效地完成复杂的ELISPOT检测实验。

试剂盒提供的试剂、规格：名称规格×数量Biotinylated Antibody100μL×1支Streptavidin-HRP100μL×1支Dilution Buffer R(1×)10mL×2瓶Washing Buffer(50×)15mL×1瓶AEC Dilution10mL×1瓶AEC SolutionⅠ(20×)500μL×1支AEC SolutionⅡ(20×)500μL×1支AEC SolutionⅢ(200×)50μL×1支阳性刺激物50T预包被PVDF可拆板1块实验者自备的试剂与仪器：1.RPMI-1640基础培养基（需要添加双抗）2.无血清培养基（完全培养基，即用型），推荐使用达优@ELISPOT无血清培养基。

3.超净工作台4.CO2细胞培养箱5.微量移液器及配套Tip头6.8通道微量移液器7.0.5mL，1.5mL EP管8.酶联斑点分析仪检测操作：第一天：接种细胞，加入刺激物，培养（严格注意无菌操作）试剂配制1.阳性刺激物：现配现用。

2.无血清培养基：如果没有ELISPOT无血清培养基，可用含5-10%胎牛血清的RPMI-1640培养基代替。

Millipore Mobius FlexReady Solution 说明书

Mobius ®FlexReady Solution for ClarificationFast setup. Maximum adaptability. Pre-designed and optimized.Part of the Mobius FlexReady family of application-specific solutions, the Mobius FlexReady Solution for Clarification is an easy-to-use system featuring an optimized single-use flowpath designed to fully support your clarification needs. It features Millipore’s innovative, high-performance Millistak+® Pod disposable depth filters which are ideally suited for primary and secondary clarification. The Mobius FlexReady Solution for Clarification consists of single-use Flexware ™ assemblies, innovative separation devices and process-ready hardware systems to deliver optimal operational flexibility, from process development to clinical production to small-scale commercial manufacturing. The self-contained anddisposable nature of the system eliminates maintenance as well as cleaning validation requirements. Accompanied by extensive Millipore support and services, the Mobius FlexReady Solution for Clarification can help you maximize resource productivity and reduce risk.2EFFiciEnt ProcESSing FroMlab to PilotThe Mobius FlexReady Solution for Clarification is designedto process up to 250 liters of high cell density, low viabilitymammalian cell culture using Millistak+ Pod disposabledepth filters without centrifugation. Processing volumescan range up to 500L or even higher, depending uponthe feed quality and the use of the centrifuge. TheMobius solution enables clarification operations acrossa membrane area range of 0.054 m2 to 5.5 m2. The CL-1system is designed for lab scale processing, and the CL-2system efficiently manages pilot scale processing.•CL-2 system features an ergonomic cart that supportspilot scale Pod filters•Innovative low dead volume t-connectors, enabling theuse of traditional pressure transducers•Peristaltic pump with preset pressure controls•High-pressure cut-off switch ensures operator safety•Presized sterilizing-grade filter and product collectionassembly•Flexware assemblies designed to fit the hardware andinstall quickly and easilyFigure 2. Hardware system components moveand connect easily for maximum mobility.Figure 1. the filter end cart works with all MobiusFlexready Solutions for optimum equipmentutilization.MoDular, oPtiMizED DESignMobius FlexReady Solutions are ergonomically designedfor fast setup, maximum adaptability to changing processneeds and reduced operator error. Specially designedhardware conveniently holds pumps, instrumentation,filters and containers, right where you need them. Amodular, interlocking multi-cart system offers maximummobility. The filter end cart is designed to work with allMobius FlexReady Solutions, leveraging your investment incapital equipment and maximizing resource utilization.3novEl intEgratED tEcHnologiESlow Dead volume t-connectorsMobius FlexReady Systems feature Millipore’s innovative low dead volume t-connector built into the flowpath which is specifically designed for use with traditional pressure transducers. A LLDPE septum provides the barrier between the process fluid and the transducer that eliminates the need to clean sensors while eliminating the risk of contamination.SaFE anD EaSy loaDing oF Pilot ScalE PoD FiltErSThe Mobius FlexReady Solution , CL-2, for pilot scaleprocessing is uniquely designed with user safety and utility in mind. The Pod cart includes a Pod holder and extension kit, and is ergonomically designed at a convenient height to load pilot scale Pod filters. This cart also includes an easy to clean drip tray, and convenient drawer for supply storage.Millistak+ Pod Disposable Depth Filter SystemMillistak+ depth filter media is offered in a scalable, single-use format, the Pod Filter System. The Millistak+ Podsystem is ideal for a wide variety of primary and secondary clarification applications, including cell cultures, yeast and E. coli lysates post centrifuge, E. coli refolds, media, vaccines, plasma proteins and sera. Millistak+ Pod filters are available in three distinct series of media grades in order to meet your specific application needs. Millistak+ DE, CE and HC media deliver optimal performance through a gradient density matrix as well as positive surface charge properties. Although the Mobius FlexReady Solutions forclarification are designed to accommodate applications from lab to pilot, the Pod depth filter system is also scalable to process scale applications. See datasheet DS0217EN00 to learn more about Pod for process scaleapplications.Figure 3. the innovative low dead volumet-connector protects the process fluid from contami-nation.Figure 4. Ergonomic cart for easy loading of pilot scale Pod depth filters.Figure 5. Easy to clean drip tray.4StanDarDizED conFigurationS For rEliablE rESultSThe flowpath has been carefully designed and tested by our design and applications engineers, resulting in a consistent, standardized flowpath. The flexware assemblies are gamma-irradiated for low bioburden operations and include a sterilizing-grade filter for final product collection to safeguard product quality. The flowpath (See Fig. 6) consists of:• Core Flexware assemblies which includes pump tubing assembly, Pod drain & sampling assembly, filter drain line, and Pod vent line• Sterilizing-grade filter assembly for final collection with sampling containers and NovaSeal ™ Crimping Sleeve for sterile disconnect• Optional process containers for source, buffer, WFI, waste and sampling •Millistak+ Pod Disposable Depth Filter5The system is manufactured according to the ISO® 9001 quality standard. The system is designed to be compliant with CE and EN 60204. 67Collapsible Containers250L bin (holds 100L or 250L process containers)MBSACC006U 500 - 1,000L bin (holds 500L process container designed for this system)MBSACC007UContainment trays10L tray (holds 5 or 10L process containers)MBSACC005U 50L tray (holds 20L or 50L process container)MBSACC004UWeigh Scales60 kg (132.3 lbs) for CL-1 MBSACC019U 600 kg (1,328 lbs) for CL-2 MBSACC020U Display 100 -110 VAC 50/60Hz MBSACC022U Display 230VAC 50/60HzMBSACC023UorDEring inForMationAll Millistak + Pod depth filters must be purchased separately.See datasheets DS0217EN00 for ordering information.Choose from a suite of services, including installation,commissioning validation, training and annual performance review to meet your specific processing requirements. Allservices are performed by Mobius FlexReady services certified engineers.Factory Acceptance TestingSVCMBSCFAT Installation and Operational Qualification Protocol Performance Zone* 1SVCMBSCIQOQZ1Installation and Operational Qualification Protocol Performance Zone* 2SVCMBSCIQOQZ2Installation and Operational Qualification Protocol Performance Zone* 3SVCMBSCIQOQZ3Installation and Operational Qualification Protocol, CL-1DOCMBSC1IQOQ Installation and Operational Qualification Protocol, CL-2DOCMBSC2IQOQ Annual Performance Review Zone* 1SVCMBSCAPRZ1Annual Performance Review Zone* 2SVCMBSCAPRZ2Annual Performance Review Zone* 3SVCMBSCAPRZ3For flowpath drawing, see Fig. 6 on pg. 4. Consult with your sales representative to configure your Clarification flowpath using standard, optimized options.Each system has a dedicated flowpath, and the flowpath components are not interchangeable between CL-1 and CL-2. Ensure you order the flowpath for the hardware system you have selected.* For Zone and pricing information, contact your local Milliporerepresentative.The flowpath includes the NovaSeal Crimping Sleeve for sterile disconnect of sample containers. The NovaSeal Crimping Tool is sold separately. See datasheet DS1040EN00 Rev. B for ordering information.8Millipore, Mobius, Millistak+, Durapore, Opticap and Millipore Express are registered trade-marks of Millipore Corporation.ISO is a registered trademark of the International Standards Organization.Bioprene is a registered trademark of Watson-Marlow Ltd.SmartSite is a registered trademark of Cardinal Health, Inc.The M mark and Advancing Life Science Together, FlexReady, Flexware, PureFlex and NovaSeal are trademarks of Millipore Corporation.Lit. No. DS1065EN00 Rev. B 07/09 DP SBU-09-01811 Printed in U.S.A. © 2009 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved./mobiusto PlacE an orDEr or rEcEivE tEcHnical aSSiStancEFor additional information call your nearest Millipore office:In the U.S. and Canada, call toll-free 1-800-MILLIPORE (1-800-645-5476)In the U.S., Canada and Puerto Rico, fax orders to 1-800-MILLIFX (1-800-645-5439)Outside of North America contact your local office.To find the office nearest you: /offices Internet: Technical Service: /techservice。

百达扬说明书

【药品名称】商品名称：百达扬通用名称：注射用艾塞那肽微球英文名称：Exenatide Microspheres for Injection【成份】注射用艾塞那肽微球活性成份为艾塞那肽。

辅料：注射用艾塞那肽微球：乙交酯丙交酯共聚物（50:50），蔗糖。

注射用溶剂：羧甲基纤维素钠、氯化钠、聚山梨酯20、磷酸二氢钠一水合物、磷酸氢二钠七水合物、注射用水。

【适应症】用于改善2型糖尿病患者的血糖控制，适用于单用二甲双胍、磺脲类以及二甲双胍合用磺脲类血糖仍控制不佳的患者。

【用法用量】推荐用量注射用艾塞那肽微球（2mg）应每7天（每周）皮下注射一次。

可在一天中的任何时间注射，空腹或进食后均可。

漏用如漏用一次且距离下次预定用药至少3天以上，应在发现后尽快注射。

此后，患者可恢复其每7天（每周）一次的常规用药计划。

如漏用一次且距离下次预定用药1或2天，患者不应给予漏掉剂量而应在下次预定用药时按照常规计划注射。

改变每周用药方案如果有需要可改变每周的用药日，只要与上次注射至少间隔3天。

用法注射用艾塞那肽微球由患者自行给药，需要混合药物和填充注射器。

一旦将药物混合后，必须立即注射。

用药应在腹部、大腿或上臂区域皮下（SC）注射。

告知患者在同一区域注射时，每周选择不同的部位。

禁止静脉注射或肌肉注射。

给药前，患者应接受医疗专业人员的培训。

完整的用药说明（带图示）请参见注射用艾塞那肽微球的使用手册。

【不良反应】肾功能损害重度肾功能损害（肌酐清除率<30mL/min）或终末期肾病患者不应使用注射用艾塞那肽微球，在肾移植患者中应谨慎使用。

接受透析的终末期肾病患者，由于发生胃肠道不良反应，不能很好地耐受单剂量5μg塞那肽注射液。

由于注射用艾塞那肽微球可能引起恶心、呕吐伴一过性低血容量，故治疗可能造成肾功能损害加重。

中度肾功能损害患者（肌酐清除率30至50mL/min）使用注射用艾塞那肽微球时应谨慎。

尚未在终末期肾病或重度肾功能损害患者中研究注射用艾塞那肽微球。

百灵达操作手册7500型光度计

查看历史记录................................................................................. 8 背照光............................................................................................. 8 语言选项......................................................................................... 8 单位................................................................................................. 8 样品序号......................................................................................... 9 序号累加......................................................................................... 9 稀释比............................................................................................. 9 日期和时间..................................................................................... 9 日期格式......................................................................................... 9 电池电量....................................................................................... 10 系统模式锁定设置....................................................................... 10 四舍五入....................................................................................... 10 自动关机....................................................................................... 10 用户自定义检测项目................................................................... 11 USB 接口...................................................................................... 11 端口连接和历史记录................................................................... 11 读取光度计测量值............................................................................... 12 程序编号和检测说明................................................................... 12 做空白所需试管和样品试管....................................................... 13 遮光帽........................................................................................... 13 测量操作以及注意事项............................................................... 13 读取测量值................................................................................... 14 连续测量（特定的检测）........................................................... 16

百灵达中文说明书

‎‎‎‎百灵达中文‎说明书篇‎一：‎百灵达V‎-AMP说‎明书百灵‎达V-AM‎P中文说明‎书９V-‎600MA‎：‎这时插入随‎机附带的电‎源。

‎ INP‎U T：‎这里插‎入吉它。

‎M‎O NO(A‎M P)：‎这里‎是它的输出‎，它主要是‎输出给吉它‎音箱的后级‎，注意一定‎是后级，千‎万不要插‎入吉它音箱‎的前级，否‎则音色会变‎得失真、尖‎锐不好听。

‎另外它是单‎声道输出！‎STER‎E O(PH‎O NES)‎：‎这里是双声‎道输出，一‎般输出给调‎音台，或者‎耳机，如果‎你用单声道‎的线插到‎调音台上，‎也合适。

另‎我它是立体‎声输出，具‎体用到那里‎，你可结合‎实际情况，‎选择。

‎看一‎下，下图，‎相信有一定‎的效果器使‎用常识的话‎，光看图也‎能看得明白‎。

‎演奏相关‎的操作校‎音：‎打开校音‎非常简单，‎两个换音色‎的踏板（B‎Y PASS‎/TUNE‎R），一起‎踏下，就打‎开了校音‎模式，把吉‎它音量扭打‎开，即可方‎便的校音了‎，这里注一‎下，校音使‎用常识，吉‎它琴弦的英‎文字母，‎从一弦到六‎弦，依次为‎E B G‎D A ‎E，使用的‎时候，只要‎把这些弦，‎调成相应的‎英文字母‎，吉它的音‎高自然就被‎订准了。

如‎果在校音时‎，希望听到‎吉它的声音‎，这时可以‎扭动 GA‎I N钮，使‎音量达到一‎个合适的位‎置。

另外在‎些模式下，‎按住TAP‎键，扭动G‎A IN钮，‎可以改变‎我们平时常‎用的４４０‎H Z校音模‎式，除非你‎明白，若不‎知道自己在‎做什么，我‎劝你还是‎不要动这个‎钮的好。

嘎‎嘎嘎‎＠＠，，，‎按一下换音‎踏板，即可‎反回演奏状‎态图上红‎线标的，这‎两个踏板，‎就是了。

‎换‎音色：‎最下面‎两块黑色的‎板板，就是‎换音色的了‎，你要是不‎明白，就给‎我打电话吧‎，对此偶‎不能多说。

‎不知你明白‎了没有。

呵‎嘎呵嘎。

‎使‎用表情踏板‎：‎最右边的，‎看着能个脚‎上去的，能‎上下动的，‎黑色的，上‎面印有GE‎H RING‎E R的LO‎G O的，踏‎板，就是表‎情踏板了。

百灵达V-amp2.0使用说明书

我们再一次接受了制造出在未来的几年中仍然会被不断谈论的出色设备的挑战。V-AMP2 是能满足您所有要求的，提供了 32 种前级模拟，模拟了更特殊的音箱音色，并且不会给您带来任何搭配连接麻烦的产品。他还拥有 STATE-OF-THE-ART 合成效果处理技术。简单来说：V-AMP2 是满足了乐手所有要求的声音工具。
BEHRINGER 是扎根于专业录音室技术的公司。多年来我们在开发录音室与现场演出设备方面取得了成功。包括麦克风和各种 19”设备（压限器、激励器、噪音门、电子管处理器、耳放、数码效果设备、直驳盒等等），监听和 P.A.音箱以及专业演出与录音用调音台等。我们上述的技术与经验都被毫无保留的运用到了您所购买的 V-AMP2 中。
1.2.1 用户界面
7.1 音频连接插头
1.2.2 V-AMP2 侧面板的接口
7.2 MIDI 连接
2 不同模式的使用范例
7.2.1 发送/接收 MIDI
2.1 选择输出模式
数据
2.2 基本的吉他，踏板开关和外部回放 8 附录
2.3 录音模式
8.1 默认 AMP/音箱搭配
2.4 外接吉他功率放大器的演出模式
与您分享我们的乐趣是我们的理念之一，这是因为您是我们队伍中最重要的成员。是您对我们的新产品提出的出色建议造就了我们公司的发展与成功。作为回报我们会为您提供质量可靠、音质出色、技术领先并且价格合理的产品，让您得以摆脱价格的困扰，释放您的创造力。
经常有人问我们怎么能为这么低价格的产品赋予如此优异的品质。答案很简单：是您让这一切成为可能！大量对我们产品感到满意的顾客意味着销量的提高，销量的提高带来了行销渠道的完善。毕竟，您的成功也是我们的成功！
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Delta DOP-100 Series Manual Transition说明书

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＝主ω2Z ω－4J 垃r�！￥�！�S 付，a rte 仁Series DOP-100 Manual Transition Industrial Automation Headquarters Delta Electronics, Inc.AsiaDelta Electronics (Jiangsu) Ltd.Sales CompanyZhangjiagang Haina Automation Equipment Co., Ltd.No. 11, Yuefeng Road, Economic Development Zone, Zhangjiagang, Jiangsu, China (Mainland)TEL:0086-0512-******** 0086152********EMAIL:*******************www.haina-auto .c 。

mPrefaceThank you for purchasing this product. This manual provides information about the conversion from theDOP-B series HMI to the DOP-100 series HMI.This manual includes:⏹Replacement model selections⏹Project conversion steps⏹Software interface conversion and function differences⏹Print function⏹File encryption function⏹COM port conversion⏹Driver updateProduct features:Delta's all new advanced DOP-100 series HMI adopts the Cortex-A8 high-performance processorwith high-brightness and high-contrast color display, as well as providing user-friendly operationinterfaces. In response to the increasing popularity of cloud applications and smart manufacturing,the DOP-100 series HMI also supports network functions, such as FTP, e-mail, VNC remotemonitoring, NTP network timing, etc.How to use this manual:When transitioning from DOP-B to DOP-100, you can use this manual as a reference for modelselection, setup, and product usage. Please first read Chapter 1 before you start converting to theDOP-100 series HMI. You can also use the Table of Contents to quickly locate the information youneed.Delta technical services:Please consult your Delta equipment distributor or Delta Customer Service Center if you encounter any problems.(This page is intentionally left blank.)Table of ContentsReplacement Model Selection1.1 Corresponding replacement models ·····································································1-21.2 Project conversion····························································································1-3Software Interface Conversion2.1 Button············································································································2-22.1.1 Button color ······························································································2-22.1.2 Previous page ···························································································2-42.2 Security level and password ···············································································2-52.3 Multimedia······································································································2-62.4 Multi-language input ·························································································2-82.5 Printer ···········································································································2-92.6 File encryption·······························································································2-112.7 Conversion of COM port ··················································································2-132.8 Update ICD OpenGL driver ··············································································2-17(This page is intentionally left blank.)Replacement ModelSelectionThis chapter describes the steps to convert from the DOP-B series models to theDOP-100 series models.試1.1Corresponding replacement models·····················································1-21.2Project conversion ···········································································1-3Replacement Model Selection DOP-100 Series Transition Manual1.1 Corresponding replacement modelsThe DOP-100 series models support conversion from the DOP-B series models, as shown in the following table. When you use a DOP-100 series model to open a project file of the corresponding DOP-B series model, the software automatically converts it to the DOP-100 series model project. For example, if you use DOPSoft 4.0 to open a project file edited onDOP-B03S210, it automatically converts the project file to that of the corresponding modelDOP-103BQ.Compatible models indicate that the DOP-100 series models are the same as the DOP-B series models in terms of the mounting dimensions and number of COM ports. Partially compatible models indicate that the mounting dimensions are the same, but the number of COM ports is different*1, so you need to note the number of COM ports when selecting the suitable model for transition. Incompatible models indicate that there is currently no corresponding model for transition, and the compatible models will be released in Q2 2019.Note:1. In the partially compatible models, the DOP-B series has three physical COM ports, while the DOP-100series has two physical COM ports. The replacement model DOP-107IV (coming soon) forDOP-B07S415 and DOP-B07E415 has three physical COM ports.DOP -100 Series Transition Manual Replacement Model Selection1.2 Project conversionWhen you use DOPSoft 4.0 to open a DOP -B project file, the software automatically determinesif there is a corresponding compatible model or partially compatible model. If there is, the projectis automatically converted and opened on the DOP -100 series model; otherwise, a pop -upwindow prompts you to select a replacing DOP -100 series model. For example, if you use DOPSoft 4.0 to open a DOP -B03S210 project file, the software automatically converts andopens it as a DOP -103BQ project file. However, if you open a DOP -B05S111 project file,a window pops up for you to select the alternative DOP -100 series model (i.e. DOP -103BQ orDOP -107CV) because there is currently no corresponding model for transition.Replacement Model Selection DOP-100 Series Transition Manual(This page is intentionally left blank.)Software InterfaceConversionThis chapter introduces the differences between the operation interfaces and functions for the DOP-B series and the DOP-100 series.試2.1Button ···························································································2-22.1.1Button color··············································································2-22.1.2Previous page···········································································2-42.2Security level and password ·······························································2-52.3Multimedia······················································································2-62.4Multi-language input ·········································································2-82.5Printer ···························································································2-92.6File encryption················································································2-112.7Conversion of COM port ··································································2-132.8Update ICD OpenGL driver ······························································2-17Software Interface Conversion DOP-100 Series Transition Manual2-2 February, 201922.1 Button2.1.1Button colorButton fill style of the DOP-B series is fixed.DOP-100 Series Transition Manual Software Interface ConversionFebruary, 2019 2-32⏹You can select [Fixed] or [Gradient] for the button fill style on the DOP-100 series.⏹Buttons are displayed in fixed colors when a DOP-B project is converted to a DOP-100project.⏹You can then change the fill style of the button to gradient.Software Interface Conversion DOP-100 Series Transition Manual2-4 February, 201922.1.2Previous page⏹DOP-B has two separate buttons for [Goto Screen] and [Previous Page]. ⏹For DOP-B, you can only change the element function on the property window.⏹ DOP-100 integrates [Goto Screen] and [Previous Page] into one button as [Goto Screen]. ⏹For DOP-100, you can change the element function on the property window, as well as double-clicking the button element to go to the property setting window.DOP-100 Series Transition Manual Software Interface ConversionFebruary, 2019 2-522.2 Security level and password⏹For DOP-B, you do not need to enter a user account for the Security Level and Password.⏹For DOP-100, you need to enter a user account for the Security Level and Password.⏹When you open a DOP-B project with DOP-100, the Security Level and Password is thesame, meaning you only need to enter the password without a user account to log in.⏹If you prefer to switch to the DOP-100 login mode, click to change the Security Leveland Password login setting.Software Interface Conversion DOP-100 Series Transition Manual2-6 February, 20192.3 Multimedia⏹DOP-B07E415, DOP-B07E515, DOP-B08E515, DOP-B10E515, and DOP-B10E615 models have the audio output function. ⏹ Only DOP-107EG and DOP-110ES of the DOP-100 replacement models have the audio output function.⏹If you open a DOP-B project with audio function on a DOP-100 replacement model that does not support this function, the interface for the audio output function is automatically removed and the [Audio Output Setting] in the [Options] drop-down list becomes unavailable. ⏹The following figures show the difference when you open a DOP-B07E415 project on DOP-107EV.DOP-100 Series Transition Manual Software Interface Conversion2 February, 2019 2-7Software Interface Conversion DOP-100 Series Transition Manual2-8 February, 20192.4 Multi-language input⏹ The Multi-language Input function is only available on the following models: DOP-103WQ,DOP-107WV, DOP-110WS, DOP-112WX, DOP-112MX, DOP-115WX, and DOP-115MX. ⏹ You can see the Multi-language Input option on the interface for the models that support thisfunction:⏹ Currently, DOP-103WQ is the replacement model for the DOP-B series that supports theMulti-language Input function.DOP-100 Series Transition Manual Software Interface ConversionFebruary, 2019 2-922.5 PrinterThe specified printer of the DOP-B project changes to ePrinter by default when converted to a DOP-100 project.Software Interface Conversion DOP-100 Series Transition ManualThe Report List button of the DOP-B project changes to the Print Output button whenconverted to a DOP-100 project.22-10 February, 2019DOP-100 Series Transition Manual Software Interface ConversionFebruary, 2019 2-1122.6 File encryptionEncrypt files from the HMI end:⏹You can encrypt files from the HMI end with DOP-B.⏹You cannot encrypt files from the HMI end with DOP-100.Software Interface Conversion DOP-100 Series Transition Manual2Encrypt files from the computer end:⏹DOP-B uses [Enable USB updating check] to encrypt files.⏹DOP-100 uses [Create Screen Data File…] and [Create Auto Update Data File] to encryptfiles.DOP-100 Series Transition Manual Software Interface Conversion2.7 Conversion of COM portTransitioning from DOP-B to DOP-100 does not cause changes to the COM port. Only thecommunication interface switches from COM1 to COM2 when converting from DOP-B03S210and DOP-B07S410. DOP-B03S210When you set COM1 of DOP-B03S210 as RS422, it automatically converts to COM2 as RS422on DOP-103BQ.Software Interface Conversion DOP-100 Series Transition Manual 2DOP-100 Series Transition Manual Software Interface Conversion2 DOP-B07S410When you set COM1 of DOP-B07S410 as RS422, it automatically converts to COM2 as RS422on DOP-107BV.Software Interface Conversion DOP-100 Series Transition Manual 2DOP-100 Series Transition Manual Software Interface Conversion2.8 Update ICD OpenGL driverAfter compiling the DOP-100 screen, an OpenGL driver error message pops up.2Go to the following link to download the latest driver:https:///download/27484/Graphics-Intel-Graphics-Driver-for-Windows-15-65-?product=80939Software Interface Conversion DOP-100 Series Transition Manual(This page is intentionally left blank.)。

新型降糖药汇总

目录
VS DPP-4i VS SGLT-2i VS Other GLP-1RA
国内已上市的SGLT-2抑制剂概览
化学名
商品名
常用剂量
上市时制药公
间
司
价格/片
生物利用度
肝肾代谢清除
半衰期（小时）
不良反应恩格列净欧唐源自静10~25mg QD 晨服
2017.11
礼来
4.42元
达格列净
安达唐
钠-葡萄糖共转运体2抑制剂之间的区别:化学结构
恩格列净
达格列净
卡格列净
logP (HPLC)
恩格列净
1.7
达格列净
2.3
logP：疏水参数， LogP值越大，说明该物质越亲油；LogP值越小，则说明该物质越亲水 HPLC：高效液相色谱
卡格列净
3.5
真实世界研究: SGLT2i可有效降低HbA1c, 早期减重后逐渐反弹
后发现,2型糖尿病治疗药物卡格列净会导致腿部和足部截肢风险升高 FDA要求在卡格列净的药品说明书上增加新的警示信息,包括
黑框警告,以警示腿部和足部截肢风险
CVOT研究的意义
心血管并发症是大部分糖尿病患者死亡的主要原因，因此降低糖尿病患者的心血管系统总体风险水平是防治糖尿病的一个重要目标。
SGLT-2抑制剂有哪些心血管安全性研究
恩格列净
达格列净
卡格列净
EMPA-REG OUTCOME研究
DECLARE研究
CANVAS研究
全球42个国家590个医疗中心开展的随机、双盲、安慰剂对照研究，共纳入7020名具有心血管事件高风险的2型糖尿病患者（年龄≥18岁，身体质量指数≤45kg/m2，肾小球滤过率预计值 ≥30mL/min/1.73m2）。

达格尔Polytron 5100产品说明书

SIMPLE INSTRUMENT MANAGEMENT AND SETUPThe Polytron 5100 instrument provides a simple, menu-driven user interface for quick configuration. Identifying the status and performing routine maintenance are made easy using simple commands. It can be installed in either “d” (flameproof) or “e” (increased-safety) configurations. The local display provides complete information including measurement, status indication, and any warning messages. The analogue output also allows for easy remote monitoring of the instrument and the area where it is located.PROVEN – AND STILL IMPROVING: DRÄGER MEASUREMENT TECHNOLOGYDräger has been developing and manu-facturing sensors and gas detectors for industrial use for more than 40 years.And with each new instrument generation, we drive our measurement technology a bit further. With the Polytron 5100, you will definitely benefit from this experience and power of innovation: –durable sensors–short response times –high sensitivity –high accuracy–low sensitivity to other gases or changing ambient conditionsOPTIONAL: TWO MOUNTING SETS FOR EASY FLANGE-MOUNTINGThe housing has four mounting holes.Two different mounting sets are available for installing the Polytron 5100: a duct-mount and a pipe-mount set. This means that the transmitter can be easily installed anywhere – e.g. on a smooth wall, a pipe, or an exhaust duct.Dräger Polytron® 5100Stationary Gas Detector (EC)D -24180-2010The microprocessor-based transmitter can be equipped with various electrochemical DrägerSensors to easily detect oxygen and various toxic gases in ambient air. In addition, the Polytron® 5100 can be integrated into your facility control and safety system, thus providing additional diagnostic functions.D -52603-2012D -12417-2014Dräger Polytron® 5100Flameproof transmitter for monitoring toxic gases and oxygen.Same Design, Same Operating Principle: The Polytron 5000 SeriesThe Dräger Polytron 5100 is part of the Polytron 5000 series. All transmitters of this series have the same design and user interface,which ensures a uniform operating philosophy. For you, this means: less training required and easier maintenance.Other transmitters of the Polytron 5000 series:– D räger Polytron 5000GP (EC stationary gas detector)– D räger Polytron 5310(DSIR stationary gas detector)– D räger Polytron 5700(PIR 7000 stationary gas detector)– D räger Polytron 5720(PIR 7200 stationary gas detector)DRÄGER POLYTRON® 5000 – STATIONARY GAS DETECTOR (EC)02 |OPTIONAL: THREE RELAYS FOR CONTROLLING EXTERNAL EQUIPMENTOn request, the Dräger Polytron 5100 can be equipped with three integrated relays. This enables you to use it as an independent gas detection system with two user-adjust able concentration alarms and one fault alarm. Audio alarms, signal lights, and similar devices can thus be controlled locally – without an additio-nal cable between the transmitter and a central controller. The sensor signal can be monitored using the 4-to-20-mA signal.INTELLIGENT SENSORSThe Dräger Polytron 5100 can detect a wide variety of gases. DrägerSensors are specifically designed for the demands of round-the-clock, year-round operation. The large DrägerSensor size gives them their renowned long life and superior measurement performance. The integrated sensor memory contains all relevant sensor data. This also allows the Polytron 5100 to accept the pre-calibrated DrägerSensors. The smart DrägerSensor EC downloads the gas type, calibration data, default alarm set points, and other measurement data onto the Polytron 5100.POLYTRON 5100Using proven, advanced electrochemical DrägerSensors for the best measurement performance, the Polytron 5100 offers a great cost-performance value to the user. It adds features that were not available in the previous model: –2- or 3-wire device –10 to 30 VDC 3-wire (18 to 30 VDC 2-wire)–galvanic isolator sensor coupling –4-digit, 9-segment display, with backlight (3-wire mode only)–15 sensors available for XP operation –optional relays (3-wire mode only) –optional remote sensor mounting –increased-safety (Ex e) version availableIn addition, the Polytron 5100 can operate using the low-cost MEC sensors offered by Dräger. For more information on these sensors contact your local Dräger repre-sentative.AccessoriesAccessories for remote mount, duct or pipe mounting, and more, allow for use in a wide variety of applications.FURTHER ADVANTAGES:–Easy and cost-effective: one-person calibration –Quick and easy wiring–Available as flameproof or increased safety version–Aluminium or 316 L stainless steel housing for the most extreme industrial conditions –Extremely user-friendly software thanks to a minimum number of menu items–Backlit display: easy to read, even in low light conditions. –Traffic light status indicator(green = no danger, yellow = error, flashing red = gas alarm)–Intelligent sensors for predictive maintenance–User-adjustable measuring ranges (within permitted ranges)–Matrix display allows the flexible setting of measuring ranges and unitsDRÄGER POLYTRON 5100UNIT CONFIGURED WITH DOCKING STATION FOR “E” INSTALLATION (INCREASED SAFETY)D -15037-2010DRÄGER POLYTRON® 5000 – STATIONARY GAS DETECTOR (EC)| 03TECHNICAL DATADRÄGER POLYTRON® 5100Type Flameproof “d” or combined increased-safety “d/e” transmitterGases Toxic gases and oxygen (depending on the sensor used)Measuring ranges User-adjustable (see sensor data sheet)Display Backlit 4-digit LCD; 3 status LEDs (green/yellow/red)Electrical data Analogue signal output Normal operation4-to-20-mAMaintenance Steady 3.4 mA or 3 to 5 mA 1 Hz modulation;user-selectableFault< 1.2 mA, 3-wire (< 3 mA, 2-wire)Supply voltage10 to 30 V DC, 3-wire (18 to 30 V DC, 2-wire)Relay rating (option) 2 alarms, 1 fault relay, SPDT1 A to 5 A @ 230 VAC, 0.1 A to 5 A @ 30 VDC, 0 resistive loadAmbient conditions Temperature-40 to +150 °F / -40 to +65 °C(see sensor data sheet)Pressure20.7 to 38.4 inch Hg / 700 to 1,300 mbarHumidity0 to 100% RH, non-condensingEnclosure Transmitter housing Epoxy-coated copper-free aluminiumor 316L stainless steelSensor housing PolyamideEnclosure rating NEMA 4× & 7, IP65/66/67Cable entry3/4" NPT female conduit or M20 cable glandSize (l × w × d, approx.)without Docking Station11.0" × 5.9" × 5.1" / 280 × 150 × 130 mmwith Docking Station11.0" × 7.1" × 7.5" / 280 × 180 × 190 mmWeight (approx.)without Docking Station,aluminium6.6 lbs / 3.0 kgwithout Docking Station,316 stainless steel11.0 lbs / 5.0 kgwith Docking Station,aluminum9.9 lbs / 4.5 kgwith Docking Station,316 stainless steel14.3 lbs / 6.5 kgApprovals *)UL Class I, Div 1, Groups A, B, C, D;Class II, Div 1, Groups E, F, GClass I, Zone 1, Group IIC; T-Code T6 / T4CSA Class I, Div 1, Groups A, B, C, D;Class II, Div 1, Groups E, F, GClass I, Zone 1, Group IIC; T-Code T6 / T4IECEX Ex d [ia] IIC T6/T4 Gb, -40 ≤ Ta ≤ +40/+70 °C;“d” versionEx de [ia] IIC T6/T4 Gb, -40 ≤ Ta ≤ +40/+70 °C;“e” versionEx tb [ia] IIIC T135 °C DbATEX II 2G Ex d [ia] IIC T6/T4 Gb, -40 ≤ Ta ≤ +40/+70 °C;“d” versionII 2G Ex de [ia] IIC T6/T4 Gb, -40 ≤ Ta ≤ +40/+70 °C;“e” versionII 2D Ex tb [ia] IIIC T135 °C DbCE markings ATEX (Directive 94/9/EC)Electromagnetic Compatibility (Directive 2004/108/EC)Low Voltage (Directive 2006/95/EC)*)All “e” versions are only ATEX- / IECEX-approved.DRÄGER POLYTRON® 5000 – STATIONARY GAS DETECTOR (EC)04 |DrägerSensorsPH 3/AsH 3 68 09 695NO 2 68 09 655O 2 LS 68 09 630H 2S HC 68 09 710Cl 2 68 09 665H 2O 2 LC 68 09 705NH 3 HC 68 09 645OV1 68 10 740CO 68 09 605H 2S 68 10 435NO LC 68 09 625SO 2 68 09 660H 2S LC68 09 610NH 3 LC68 09 680H 268 09 685ORDER INFORMATIONDRÄGER POLYTRON® 5100Aluminium “d”SS316L “d”Aluminium “e”SS316L “e”Without relays 45 44 86045 44 86245 44 124 *)45 44 126 *)With relays 45 44 12145 44 12345 44 125 **)45 44 127 **)*) Order Docking Station 68 12 420 for power-only wires separately.**) Order Docking Station 68 12 275 for power and/or relay wires separately.Magnetic wand for menu access (blue body, white logo)45 44 101Docking Station power-only version (includes 1 cable gland) / Docking Station68 12 420Docking Station Power, Relay and/or Remote version (includes 2 cable glands) / Docking Station 68 12 275Cable Gland for use with Docking Station 68 12 868Pipe Mount Kit 45 44 198Duct Mount Kit68 12 725Duct Mount Adapter for Remote EC Sensing Head 83 17 617EC Sensing Head Remote w/ mount kit 68 12 684MEC Sensor Adapter68 12 695IR Connection Kit Polytron® 5000/8000 Series 45 44 197PolySoft Configuration Software83 23 405Connection cable w/ plug for Remote EC Sensing Head 16 ft / 5 m 49 ft / 15 m 98 ft / 30 m83 23 305 83 23 315 83 23 330AccessoriesSplash guard68 12 510Calibration Adapter PE (with hose)45 09 314Calibration Adapter PE (without hose)68 06 978Calibration Adapter Viton®68 10 536Viton® is a registered trademark of DuPont.90 45 996 | 15.02-1 | C o m m u n i c a t i o n s & S a l e s M a r k e t i n g | P P | L E | P r i n t e d i n G e r m a n y | C h l o r i n e -f r e e – e n v i r o n m e n t a l l y c o m p a t i b l e | S u b j e c t t o m o d i f i c a t i o n s | © 2015 D r äg e r w e r k A G & C o . K G a A。

百灵达DCX2496中文说明书

百灵达DCX2496中文说明书2、控制元件1、DCX - 2496 提供6 段的?號指示LED 供A、B、C 三組輸入端做調整用。

2、最上端的?號LED 指示CLIP過載的?號。

3、最下端的?號LED 指示MUTE靜音動作開起的指示。

4、三組輸入端的功能選擇按健，可各自調整Delay 的時間及觀看輸入的路由。

5、功能顯示板，提供所有選取欲調整___的頁面功調整指示使用。

6、使用這幾個呼叫鍵，將DCX -2496 的內部功能呼叫出?硪怨?更改，包括系統的設定、儲存、調整等。

7、頁面章?選擇鍵，就是當呼叫出?淼娜我唤M功能頁面後，再利用此選擇鍵去選取要修改的位置。

8、頁面章?參數個別調整鍵。

9、參數調整飛梭。

10、確認鍵OK、CANCEL 參數確定。

11、PCMCIA 卡及插槽( PCMCIA card slot ) 可將資料儲存於卡上，日後供呼叫及更改。

PCMCIA ( Personal ComputerMemory Card InternationalAssociation ) 是一個成立於1989 年的國際性組織目前已有超過300 個以上的會員同時在運作。

其主要的目的是建立一個省電、小體積的整合性電子卡片的標準。

在1991 年的時候，PCMCIA 推出了第一個適用於這個標準的產品記憶卡。

在這個同時，68 pin 的規格也同時的。

被確定下?砹恕?DCX - 2496 電子卡是使用“5 V12、1 - 6 聲道輸出指示，每一波段的?號指示LED 內包括MUTE、CLIP 及LIMITER 限制動作的LED 指示。

13、最上端的?號LED 指示CLIP 。

過載的?號。

14、LIMITER 電平限制指示LED，當你設定了LIMITER 參數後，輸出的電平量若到達所設定的位置時，LIMITER 指示燈即會___亮起。

15、最下端的?號LED 指示MUTE 靜音動作開起的指示。

16、輸出端功能選擇鍵，利用此功___能鍵?磉x取MUTE 的動作，或進入另一個調整頁面。

Savaysa(edoxaban)使用说明书2015-09版本

批准时间：2015-01-08Savaysa (edoxaban)药品使用说明书用于预防心房颤动（房颤）患者发生中风和全身性栓塞（SE）HAOEYOU ( 好医友)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use SAVAYSA™safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA(edoxaban) tablets for oral useInitial U.S. Approval: 2015______________________INDICATIONS AND USAGE ____________________ SAVAYSA is a factor Xa inhibitor indicated:To reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF) (1.1)•Limitation of Use for NVAFSAVAYSA should not be used in patients with creatinine clearance (CrCL)> 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1)SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant (1.2) ___________________DOSAGE AND ADMINISTRATION__________________•Treatment of NVAF:Assess CrCL before initiating therapy (2.1)The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min (2.1) Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min (2.1)•Treatment of DVT and PE:The recommended dose is 60 mg once daily (2.2)The recommended dose is 30 mg once daily for patients with CrCL 15 to50 mL/min or body weight less than or equal to 60 kg or who use certainP-gp inhibitors (2.2)__________________DOSAGE FORMS AND STRENGTHS_________________•Tablets: 60 mg, 30 mg, and 15 mg (3)_______________________CONTRAINDICATIONS_______________________•Active pathological bleeding (4)___________________WARNINGS AND PRECAUTIONS___________________•Bleeding: Serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss (5.2)•Mechanical heart valves or moderate to severe mitral stenosis: Use is not recommended (5.5)________________________ADVERSE REACTIONS______________________ Treatment of NVAF: The most common adverse reactions (≥5%) are bleeding and anemia (6.1)Treatment of DVT and PE: The most common adverse reactions (≥1%) are bleeding, rash, abnormal liver function tests and anemia (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or /medwatch._______________________DRUG INTERACTIONS______________________•Anticoagulants: Avoid concomitant use (7.1)•Rifampin: Avoid concomitant use (7.2)___________________USE IN SPECIFIC POPULATIONS__________________•Nursing mothers: Discontinue drug or discontinue nursing (8.3)•Impaired renal function (CrCL 15 to 50 mL/min): Reduce dose (2.1, 2.2, 8.6)•Moderate or severe hepatic impairment: Not recommended (8.7)See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.Revised: 9/2015WARNING (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLA-TION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS(C) SPINAL/EPIDURAL HEMATOMASee full prescribing information for complete boxed warning.(A)REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN: SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonval -vular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used (5.1).(B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS: Premature discontinuation of any oral anticoagu-lant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guid-ance (2.4, 5.2, 14).(C) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anes-thesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures (5.4).FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMA-TURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMA1INDICATIONS AND USAGE1.1Reduction in the Risk of Stroke and Systemic Embolism in NonvalvularAtrial Fibrillation1.2Treatment of Deep Vein Thrombosis and Pulmonary Embolism2DOSAGE AND ADMINISTRATION2.1Nonvalvular Atrial Fibrillation2.2Treatment of Deep Vein Thrombosis and Pulmonary Embolism2.3Administration Information2.4Transition to or from SAVAYSA2.5Discontinuation for Surgery and Other Interventions3DOSAGE FORMS AND STRENGTHS4CONTRAINDICATIONS5WARNINGS AND PRECAUTIONS5.1Reduced Efficacy in Nonvalvular Atrial Fibrillation Patients withCrCL > 95 mL/min5.2Increased Risk of Stroke with Discontinuation of SAVAYSA in Patientswith Nonvalvular Atrial Fibrillation5.3Risk of Bleeding5.4Spinal/Epidural Anesthesia or Puncture5.5Patients with Mechanical Heart Valves or Moderate to Severe MitralStenosis6ADVERSE REACTIONS6.1Clinical Trials Experience 7DRUG INTERACTIONS7.1Anticoagulants, Antiplatelets, and Thrombolytics7.2P-gp Inducers7.3 P-gp Inhibitors8USE IN SPECIFIC POPULATIONS8.1Pregnancy8.2Labor and Delivery8.3Nursing Mothers8.4Pediatric Use8.5Geriatric Use8.6Renal Impairment8.7Hepatic Impairment8.8Low Body Weight Consideration for Patients treated for DVT and/or PE 10OVERDOSAGE11DESCRIPTION12CLINICAL PHARMACOLOGY12.1Mechanism of Action12.2Pharmacodynamics12.3Pharmacokinetics13NONCLINICAL TOXICOLOGY13.1Carcinogenesis, Mutagenesis, Impairment of Fertility14CLINICAL STUDIES14.1Nonvalvular Atrial Fibrillation14.2Treatment of Deep Vein Thrombosis and Pulmonary Embolism16HOW SUPPLIED/STORAGE AND HANDLING17PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.FULL PRESCRIBING INFORMATION1INDICATIONS AND USAGE1.1 Reduction in the Risk of Stroke and Systemic Embolism in NonvalvularAtrial FibrillationSAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).Limitation of Use for NVAFSAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Clinical Studies(14.1)].1.2 Treatment of Deep Vein Thrombosis and Pulmonary EmbolismSAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.2DOSAGE AND ADMINISTRATION2.1 Nonvalvular Atrial FibrillationThe recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1),Clinical Studies (14.1)]. Assess creatinine clearance, as calculated using the Cockcroft-Gault equation*, before initiat-ing therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min.Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to50 mL/min [see Use in Specific Populations (8.6) and Clinical Pharmacol-ogy (12.3)].*Cockcroft-Gault CrCL = (140-age) x (weight in kg) x (0.85 if female) /(72 x creatinine in mg/dL).2.2 Treatment of Deep Vein Thrombosis and Pulmonary EmbolismThe recommended dose of SAVAYSA is 60 mg taken orally once daily fol-lowing 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2)].The recommended dose of SAVAYSA is 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medicationsbased on clinical study data in this indication [see Clinical Studies (14.2)].2.3 Administration InformationIf a dose of SAVAYSA is missed, the dose should be taken as soon as pos-sible on the same day. Dosing should resume the next day according to the normal dosing schedule. The dose should not be doubled to make up for a missed dose.SAVAYSA can be taken without regard to food [see Clinical Pharmacology(12.3)].2.4 Transition to or from SAVAYSATransition to SAVAYSAFrom To RecommendationWarfarin or SAVAYSA Discontinue warfarin and start SAVAYSA other Vitamin K when the INR is ≤ 2.5AntagonistsOral SAVAYSA Discontinuecurrent oral anticoagulant and anticoagulants start SAVAYSA at the time of the nextother than scheduled dose of the other oralwarfarin or other anticoagulantVitamin KAntagonistsLow Molecular SAVAYSA Discontinue LMWH and start SAVAYSA at Weight Heparin the time of the next scheduled administration (LMWH)of LMWHUnfractionated SAVAYSA Discontinue the infusion and start SAVAYSA heparin 4 hours laterTransition from SAVAYSAFrom To RecommendationOral option:For patients taking 60 mg ofSAVAYSA, reduce the dose to 30 mg andbegin warfarin concomitantly. For patientsreceiving 30 mg of SAVAYSA,reduce the dose SAVAYSA Warfarin to 15 mg and begin warfarin concomitantly.INR must be measured at least weekly andjust prior to the daily dose of SAVAYSAto minimize the influence of SAVAYSAon INR measurements. Once a stable INR≥ 2.0 is achieved, SAVAYSA should bediscontinued and the warfarin continuedParenteral option:Discontinue SAVAYSAand administer a parenteral anticoagulant andwarfarin at the time of the next scheduled SAVAYSA WarfarinSAVAYSA dose. Once a stable INR ≥ 2.0 isachieved the parenteral anticoagulant shouldbe discontinued and the warfarin continued SAVAYSA Non-Vitamin- Discontinue SAVAYSA and start the otherK-Dependent oral anticoagulant at the time of the next doseOral of SAVAYSAanticoagulantsSAVAYSA Parenteral Discontinue SAVAYSA and start the paren-anticoagulants teral anticoagulant at the time of the nextdose of SAVAYSAAbbreviations: INR=International Normalized Ratio2.5 Discontinuation for Surgery and Other InterventionsDiscontinue SAVAYSA at least 24 hours before invasive or surgical proce-dures because of the risk of bleeding [see Warnings and Precautions (5.3)].If surgery cannot be delayed, there is an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention [see Warnings and Precautions (5.3)].SAVAYSA can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established noting that the time to onset of pharmacodynamic effect is 1-2 hours [see Warnings and Precautions(5.2)]. Administer a parenteral anticoagulant and then switch to oralSAVAYSA, if oral medication cannot be taken during or after surgicalintervention.WARNING (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLA-TION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMAA. REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MINSAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used [see Dosage and Adminis-tration (2.1), Warnings and Precautions (5.1), and Clinical Studies(14.1)].B. PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTSPremature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance [see Dosage and Administration (2.4), Warnings and Precautions (5.2), and Clinical Studies (14.1)].C. SPINAL/EPIDURAL HEMATOMAEpidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paraly-sis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:•use of indwelling epidural catheters•concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants•a history of traumatic or repeated epidural or spinal punctures•a history of spinal deformity or spinal surgery•optimal timing between the administration of SAVAYSA and neuraxial procedures is not known[see Warnings and Precautions (5.4)].Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is nec-essary [see Warnings and Precautions (5.4)].Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.4)].3DOSAGE FORMS AND STRENGTHS•60 mg, yellow round shaped, film-coated tablets, debossed with DSC L60 on one side•30 mg, pink round shaped, film-coated tablets, debossed with DSC L30 on one side•15 mg, orange round shaped, film-coated tablets, debossed with DSC L15 on one side4CONTRAINDICATIONSSAVAYSA is contraindicated in patients with:•Active pathological bleeding [see Warnings and Precautions (5.3) andAdverse Reactions (6.1)].5WARNINGS AND PRECAUTIONS5.1 Reduced Efficacy in Nonvalvular Atrial Fibrillation Patients with CrCL > 95 mL/minSAVAYSA should not be used in patients with CrCL > 95 mL/min. In the randomized ENGAGE AF-TIMI 48 study, NVAF patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg daily com-pared to patients treated with warfarin. In these patients another anticoagu-lant should be used [see Dosage and Administration (2.1),Clinical Studies (14.1)].5.2 Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial FibrillationPremature discontinuation of any oral anticoagulant in the absence of ade-quate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anti -coagulant as described in the transition guidance [see Dosage and Admin -istration (2.4) and Clinical Studies (14.1)].5.3 Risk of BleedingSAVAYSA increases the risk of bleeding and can cause serious and poten-tially fatal bleeding. Promptly evaluate any signs or symptoms of blood loss.Discontinue SAVAYSA in patients with active pathological bleeding. Concomitant use of drugs affecting hemostasis may increase the risk of bleeding. These include aspirin and other antiplatelet agents, other anti -thrombotic agents, fibrinolytic therapy, and chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.1)].There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance [see Clinical Pharmacology (12.3)]. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagu-lant activity of SAVAYSA.5.4 Spinal/Epidural Anesthesia or PunctureWhen neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for pre-vention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 12 hours after the last administration of SAVAYSA. The next dose of SAVAYSA should not be administered earlier than 2 hours after the removal of the catheter. The risk may also be increased by trau-matic or repeated epidural or spinal puncture.Monitor patients frequently for signs and symptoms of neurological impair-ment (e.g., numbness or weakness of the legs, bowel, or bladder dysfunc-tion). If neurological compromise is noted, urgent diagnosis and treatment is necessary. Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.5.5 Patients with Mechanical Heart Valves or Moderate to Severe Mitral StenosisThe safety and efficacy of SAVAYSA has not been studied in patients with mechanical heart valves or moderate to severe mitral stenosis. The use of SAVAYSA is not recommended in these patients [see Clinical Studies (14.1)].6ADVERSE REACTIONSThe following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.•Increased risk of stroke with discontinuation of SAVAYSA in patients with NVAF [see Warnings and Precautions (5.2)]•Spinal/epidural anesthesia or puncture [see Warnings and Precautions(5.4)]The most serious adverse reactions reported with SAVAYSA were related to bleeding [see Warnings and Precautions (5.3)].6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions,adverse reaction rates observed in the clinical trials of a drug cannot bedirectly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety of SAVAYSA was evaluated in the ENGAGE AF-TIMI 48 andHokusai VTE studies including 11,130 patients exposed to SAVAYSA 60 mg and 7002 patients exposed to SAVAYSA 30 mg once daily [see ClinicalStudies (14)].The ENGAGE AF-TIMI 48 StudyIn the ENGAGE AF-TIMI 48 study, the median study drug exposure for the SAVAYSA and warfarin treatment groups was 2.5 years.Bleeding was the most common reason for treatment discontinuation.Bleeding led to treatment discontinuation in 3.9% and 4.1% of patients in the SAVAYSA 60 mg and warfarin treatment groups, respectively.In the overall population, Major Bleeding was lower in the SAVAYSA group compared to the warfarin group [HR 0.80 (0.70, 0.91), p<0.001]. Table 6.1 shows Major Bleeding events (percentage of patients with at least onebleeding event, per year) for the indicated population (CrCL ≤95 mL/min). Table 6.1: Adjudicated Bleeding Events for NVAF Patients with CrCL≤95 mL/min*Event a SAVAYSA 60 mg b Warfarin SAVAYSAN = 5417N = 548560 mg vs. Warfarinn (%/year)n (%/year)HR (95% CI) Major Bleeding c357 (3.1)431 (3.7)0.84 (0.73, 0.97) IntracranialHemorrhage 53 (0.5)122 (1.0)0.44 (0.32, 0.61) (ICH)dHemorrhagicStroke33 (0.3)69 (0.6)0.49 (0.32, 0.74) Other ICH20 (0.2)55 (0.5)0.37 (0.22, 0.62) Gastrointestinal e205 (1.8)150 (1.3) 1.40 (1.13, 1.73) Fatal Bleeding f21 (0.2)42 (0.4)0.51 (0.30, 0.86) ICH19 (0.2)36 (0.3)0.54 (0.31, 0.94) Non-intracranial 2 (<0.1) 6 (<0.1)----Abbreviations: HR = Hazard Ratio versus Warfarin, CI = Confidence Interval,n = number of patients with events, N = number of patients in Safety population * The on treatment period is during treatment or within 2 days of stopping study treatment. The difference in hemorrhagic stroke rate from Table 14.1 is because Table 14.1 includes events occurring during treatment or within 3 days of stopping study treatment and this table only includes patients with CrCL≤95 mL/min.a A subject can be included in multiple sub-categories if he/she had an event for those categories.b Includes all patients with CrCL ≤95 mL/min randomized to receive 60 mg once daily, including those who were dose-reduced to 30 mg once daily because of prespecified baseline conditions.c A Major Bleeding event (the study primary safety endpoint) was defined as clinically overt bleeding that met one of the following criteria: fatal bleeding; symptomatic bleeding in a critical site such as retroperitoneal, intracranial, intraocular, intraspinal, intra-articular, pericardial, or intramuscular with com-partment syndrome; a clinically overt bleeding event that caused a fall in hemoglobin of at least 2.0 g/dL (or a fall in hematocrit of at least 6.0% in the absence of hemoglobin data), when adjusted for transfusions (1 unit of trans-fusion = 1.0 g/dL drop in hemoglobin).d ICH includes primary hemorrhagic stroke, subarachnoid hemorrhage, epidural/subdural hemorrhage, and ischemic stroke with major hemorrhagic conversion.e Gastrointestinal (GI) bleeds include bleeding from upper and lower GI tract. Lower GI tract bleeding includes rectal bleeds.f Fatal bleed is a bleeding event during the on treatment period and adjudicated as leading directly to death within 7 days.The most common site of a Major Bleeding event was the gastrointestinal (GI) tract. Table 6.2 shows the number of and the rate at which patientsexperienced GI bleeding in the SAVAYSA 60 mg and warfarin treatmentgroups.Table 6.2 Gastrointestinal Bleeding Events for NVAF Patients withCrCL ≤95 mL/min*SAVAYSA Warfarin N= 5417N= 5485n (%/year)n (%/year)Major Gastrointestinal (GI) Bleeding a205 (1.78)150 (1.27)- Upper GI 123 (1.06)88 (0.74)- Lower GI b85 (0.73)64 (0.54)GUSTO cSevere GI bleeding16 (0.14)17 (0.14)Fatal GI bleeding1 (<0.1)2 (<0.1)* During or within 2 days of stopping study treatment a GI bleeding was defined by location as upper or lower GI b Lower GI bleeding included anorectal bleedingc GUSTO – Severe or life-threatening bleeding that caused hemodynamic com-promise and requires interventionThe rate of anemia-related adverse events was greater with SAVAYSA 60 mg than with warfarin (9.6% vs. 6.8%).The comparative rates of Major Bleeding on SAVAYSA and warfarin weregenerally consistent among subgroups (see Figure 6.1). Bleeding ratesappeared higher in both treatment arms (SAVAYSA and warfarin) in the fol-lowing subgroups of patients: those receiving aspirin, those in the UnitedStates, those more than 75 years old and those with reduced renal function. Figure 6.1: Adjudicated Major Bleeding in the ENGAGE AF-TIMI 48* Study*During or within 2 days of stopping study treatmentNote: The figure above presents effects in various subgroups all of which are baseline characteristics and most of which were pre-specified. The 95% confi-dence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.Other Adverse ReactionsThe most common non-bleeding adverse reactions (≥1%) for SAVAYSA 60 mg versus warfarin were rash (4.2% vs. 4.1%), and abnormal liver func-tion tests (4.8% vs. 4.6%), respectively.Interstitial Lung Disease (ILD) was reported as a serious adverse event on treatment for SAVAYSA 60 mg and warfarin in 15 (0.2%) and 7 (0.1%)patients, respectively. Many of the cases in both treatment groups were confounded by the use of amiodarone, which has been associated with ILD,or by infectious pneumonia. In the overall study period, there were 5 and 0fatal ILD cases in the SAVAYSA 60 mg and warfarin groups, respectively.The Hokusai VTE StudyIn the Hokusai VTE study, the duration of drug exposure for SAVAYSA was ≤6 months for 1561 (37.9%) of patients, > 6 months for 2557 (62.1%) of patients and 12 months for 1661 (40.3%) of patients.Bleeding was the most common reason for treatment discontinuation and occurred in 1.4% and 1.4% of patients in the SAVAYSA and warfarin arms,respectively.Bleeding in Patients with DVT and/or PE in the Hokusai VTE StudyThe primary safety endpoint was Clinically Relevant Bleeding, defined as the composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding that occurred during or within three days of stopping study treatment. The incidence of Clinically Relevant Bleeding was lower in SAVAYSA than war-farin [HR (95% CI): 0.81 (0.71, 0.94); p =0.004].Table 6.3 shows the number of patients experiencing bleeding events in the Hokusai VTE Study.n = number of events; CRNM = clinically relevant non-major a Primary Safety Endpoint: Clinically Relevant Bleeding (composite of Major and CRNM).b A Major Bleeding event was defined as clinically overt bleeding that met oneof the following criteria: associated with a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of packed red cells or whole blood; occurring in a critical site or organ: intracranial, intraspinal,intraocular, pericardial, intra-articular, intramuscular with compartment syn-drome, retroperitoneal; contributing to death.c CRNM bleeding was defined as overt bleeding not meeting the criteria for a Major Bleeding event but that was associated with a medical intervention, an unscheduled contact (visit or telephone call) with a physician, temporary ces-sation of study treatment, or associated with discomfort for the subject such as pain, or impairment of activities of daily life.Patients with low body weight (≤60 kg), CrCL ≤50 mL/min, or concomi-tant use of select P-gp inhibitors were randomized to receive SAVAYSA 30 mg or warfarin. As compared to all patients who received SAVAYSA or warfarin in the 60 mg cohort, all patients who received SAVAYSA or warfarin in the 30 mg cohort (n= 1452, 17.6% of the entire study population) were older (60.1 vs 54.9 years), more frequently female (66.5% vs 37.7%), more fre-quently of Asian race (46.0% vs 15.6%) and had more co-morbidities (e.g., history of bleeding, hypertension, diabetes, cardiovascular disease,cancer). Clinically relevant bleeding events occurred in 58/733 (7.9%) of the SAVAYSA patients receiving 30 mg once daily and 92/719 (12.8%) of warfarin patients meeting the above criteria.In the Hokusai VTE study, among all patients the most common bleeding adverse reactions (≥1%) are shown in Table 6.4.Table 6.4: Adverse Reactions Occurring in ≥1% of Patients Treated in ing Major and CRNM)b Gender specific vaginal bleeding percentage is based on number of female subjects in each treatment group7DRUG INTERACTIONS7.1 Anticoagulants, Antiplatelets, and ThrombolyticsCo-administration of anticoagulants, antiplatelet drugs, and thrombolytics may increase the risk of bleeding. Promptly evaluate any signs or symp-toms of blood loss if patients are treated concomitantly with anticoagulants, aspirin, other platelet aggregation inhibitors, and/or NSAIDs [see Warnings and Precautions (5.3)].Long-term concomitant treatment with SAVAYSA and other anticoagulants is not recommended because of increased risk of bleeding [see Warnings and Precautions (5.3)]. Short term co-administration may be needed for patients transitioning to or from SAVAYSA [see Dosage and Administration (2.4)].In clinical studies with SAVAYSA concomitant use of aspirin (low dose≤100 mg/day) or thienopyridines, and NSAIDs was permitted and resulted in increased rates of Clinically Relevant Bleeding. Carefully monitor for bleeding in patients who require chronic treatment with low dose aspirin and/or NSAIDs [see Warnings and Precautions (5.3) and Clinical Pharma-cology (12.3)].7.2 P-gp InducersAvoid the concomitant use of SAVAYSA with rifampin [see Clinical Pharma-cology (12.3)].7.3 P-gp InhibitorsTreatment of NVAFBased on clinical experience from the ENGAGE AF-TIMI 48 study, dose reduction in patients concomitantly receiving P-gp inhibitors resulted in edoxaban blood levels that were lower than in patients who were given the full dose. Consequently, no dose reduction is recommended for concomi-tant P-gp inhibitor use [see Dosage and Administration (2.1),Clinical Phar-macology (12.3) and Clinical Studies (14.1)].Treatment of Deep Vein Thrombosis and Pulmonary Embolism[see Clinical Studies (14.2)]8USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category CRisk SummaryThere are no adequate and well-controlled studies in pregnant women. SAVAYSA should be used during pregnancy only if the potential benefit jus-tifies the potential risk to the fetus.Human DataIn the Hokusai VTE study there were 10 pregnancy cases reported in patients receiving SAVAYSA with exposure in the first trimester and estimated dura-tion of exposure for up to approximately 6 weeks. Among these there were 6 live births (4 full term, 2 pre-term), 1 first-trimester spontaneous abortion, and 3 cases of elective termination of pregnancy.Animal DataEmbryo-fetal development studies were conducted in pregnant rats and rab-bits during the period of organogenesis. In rats, no teratogenic effects were seen when edoxaban was administered orally at doses up to 300 mg/kg/day, or 49 times the human dose of 60 mg/day normalized to body surface area. Increased post-implantation loss occurred at 300 mg/kg/day, but this effect may be secondary to the maternal vaginal hemorrhage seen at this dose. In rabbits, no teratogenic effects were seen at doses up to 600 mg/kg/day (49 times the human exposure at a dose of 60 mg/day when based on AUC). Embryo-fetal toxicities occurred at maternally toxic doses, and included absent or small fetal gallbladder at 600 mg/kg/day, and increased post-implantation loss, increased spontaneous abortion, and decreased live fetuses and fetal weight at doses equal to or greater than 200 mg/kg/day, which is equal to or greater than 20 times the human exposure.In a rat pre- and post-natal developmental study, edoxaban was adminis-tered orally during the period of organogenesis and through lactation day 20 at doses up to 30 mg/kg/day, which is up to 3 times the human exposure when based on AUC. Vaginal bleeding in pregnant rats and delayed avoid-ance response (a learning test) in female offspring were seen at 30 mg/kg/day.8.2 Labor and DeliverySafety and effectiveness of SAVAYSA during labor and delivery have not been studied in clinical studies. The risks of bleeding should be balanced with the risk of thrombotic events when considering the use of SAVAYSA in this setting.8.3 Nursing MothersIt is not known if edoxaban is excreted in human milk. Edoxaban was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from SAVAYSA, a decision should be made to discontinue nursing or the drug, taking into account the importance of the drug to the mother.8.4 Pediatric UseSafety and effectiveness in pediatric patients have not been established.8.5 Geriatric UseOf the total patients in the ENGAGE AF-TIMI 48 study, 5182 (74%) were65 years and older, while 2838 (41%) were 75 years and older. In Hokusai VTE,1334 (32%) patients were 65 years and older, while 560 (14%) patients were 75 years and older. In clinical trials the efficacy and safety of SAVAYSA in elderly (65 years or older) and younger patients were similar [see Adverse Reactions (6.1),Clinical Pharmacology (12.3),and Clinical Studies (14)].8.6 Renal ImpairmentRenal clearance accounts for approximately 50% of the total clearanceof edoxaban. Consequently, edoxaban blood levels are increased inpatients with poor renal function compared to those with higher renal func-tion. Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL15-50 mL/min. There are limited clinical data with SAVAYSA in patientswith CrCL < 15 mL/min; SAVAYSA is therefore not recommended in these patients. Hemodialysis does not significantly contribute to SAVAYSA clear-ance [see Dosage and Administration (2.1, 2.2) and Clinical Pharmacology(12.3)].As renal function improves and edoxaban blood levels decrease, the risk for ischemic stroke increases in patients with NVAF [see Indications and Usage(1.1),Dosage and Administration (2.1),and Clinical Studies (14.1)].8.7 Hepatic ImpairmentThe use of SAVAYSA in patients with moderate or severe hepatic impair-ment (Child-Pugh B and C) is not recommended as these patients may have intrinsic coagulation abnormalities. No dose reduction is required inpatients with mild hepatic impairment (Child-Pugh A) [see Clinical Pharma-cology (12.3)].8.8 Low Body Weight Consideration for Patients treated for DVT and/or PEBased on the clinical experience from the Hokusai VTE study, reduceSAVAYSA dose to 30 mg in patients with body weight less than or equal to60 kg [see Dosage and Administration (2.2) and Clinical Studies (14.2)]. 10OVERDOSAGEA specific reversal agent for edoxaban is not available. Overdose ofSAVAYSA increases the risk of bleeding.The following are not expected to reverse the anticoagulant effects ofedoxaban: protamine sulfate, vitamin K, and tranexamic acid.Hemodialysis does not significantly contribute to edoxaban clearance [see Pharmacokinetics (12.3)].11DESCRIPTIONEdoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate mono -hydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N'-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c] pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzene -sulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S•C7H8O3S•H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is:It is a white to pale yellowish-white crystalline powder. The solubility ofedoxaban tosylate (pKa 6.7) decreases with increasing pH. It is slightly sol-uble in water, pH 3 to 5 buffer, very slightly soluble at pH 6 to 7; and practi-cally insoluble at pH 8 to 9.SAVAYSA is available for oral administration as a 60 mg, 30 mg, or 15 mg round shaped, film-coated tablet, debossed with product identificationmarkings. Each 60 mg tablet contains 80.82 mg edoxaban tosylate mono-hydrate equivalent to 60 mg of edoxaban. Each 30 mg tablet contains40.41 mg edoxaban tosylate monohydrate equivalent to 30 mg of edoxaban.Each 15 mg tablet contains 20.20 mg edoxaban tosylate monohydrateequivalent to 15 mg of edoxaban. The inactive ingredients are: mannitol, pregelatinized starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, talc, and carnauba wax. The color coatings contain hypromellose, titanium dioxide, talc, polyethylene glycol 8000, iron oxide yellow (60 mg tablets and 15 mg tablets), and iron oxide red (30 mg tablets and 15 mg tablets).12CLINICAL PHARMACOLOGY12.1 Mechanism of ActionEdoxaban is a selective inhibitor of FXa. It does not require antithrombin IIIfor antithrombotic activity. Edoxaban inhibits free FXa, and prothrombinase。

白蛋白紫杉醇说明书

白蛋白紫杉醇说明书核准日期：2021年06月30日修改日期：2021年12月10日 2021年09月29日2021年08月03日处方用药注射用紫杉醇（白蛋白结合型）说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名：注射用紫杉醇（白蛋白结合型）英文商品名：Abraxane?英文名称：Paclitaxel for Injection（Albumin Bound）汉语拼音：Zhusheyong Zishanchun（BaidanbaiJiehexing）【成份】每瓶含紫杉醇100mg及人血白蛋白约900mg。

紫杉醇是药物活性成分，人血白蛋白作为辅料起分散、稳定微粒和运载主药作用。

紫杉醇化学名称：5β, 20-环氧-1,2α, 4,7β,10β, 13α-六羟基紫杉烷-11-烯-9-酮-4,10-二乙酸酯-2-苯甲酸酯-13-(2R,3S)-N-苯甲酰-3-苯基异丝氨酸酯。

化学结构式：分子式：C47H51NO14 分子量：853.91 【性状】本品为白色至淡黄色无菌冻干块状物或粉末。

【适应症】适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。

除非有临床禁忌症，既往化疗中应包括一种蒽环类抗癌药。

【规格】100mg 【用法用量】对联合化疗失败的转移性乳腺癌或辅助化疗后复发的乳腺癌患者，建议使用剂量260mg/m2，静脉滴注30分钟，每3周给药一次。

肝功能异常：尚未进行对肝功能异常患者使用本药的临床研究，对血胆红素>1.5mg/dL的患者，本药的适宜剂量尚不清楚。

肾功能异常：尚未进行对有肾功能损害的患者使用本药的临床研究，在随机对照试验中，排除了血肌酐>2mg/dL的患者。

对有肾功能损害的患者，本药的适宜剂量尚不清楚。

降低剂量：治疗期间如患者出现严重中性粒细胞减少（ANC<500/mm3持续1周或1周以上）或出现严重感觉神经毒性则应将后续疗程的治疗剂量减到220mg/m2。

百灵达1832FX英文说明书

Version 1.0 January 2006Technical SpecificationsX E N Y X1832FXXENYX 1832FX 1832FX XENYXPremium 18-Input 3/2-Bus Mixer with XENYX Mic Preamps, British EQs, 24-Bit Multi-FX Processor and USB/Audio Interfaces Premium ultra low-noise, high headroom analog mixers6 state-of-the-art XENYX Mic Preamps comparable to stand-alone boutique preampss Neo-classic ´British´ 3-band EQs with semi-parametric mid band for warm and musical sounds Studio-grade 24-bit stereo FX processor with 100 awesome presets including reverb, chorus, flanger, delay, pitch shifter and various multi-effectss USB/Audio Interface included to connect directly to your computer. Free audio recording and editing software downloadable at s9-band stereo graphic EQ allows precise frequency correction of monitor or main mixess Revolutionary FBQ Feedback Detection System instantly reveals critical frequenciess Breathtaking XPQ 3D stereo surround effect for more vitality and enhanced stereo images Voice Canceller function for easy-to-use sing-along applicationss Channel inserts on each mono channel for flexible connection of outboard equipments3 aux sends per channel: 1 pre fader for monitoring, 1 pre/post fader switchable for monitoring/FX applications,1 post fader (for internal FX or as external send)s Peak LEDs, mute, main mix and subgroup routing switches, solo and PFL functions on all channelss2 subgroups with separate outputs for added routing flexibility and 2 multi-functional stereo aux returns with flexible routings Balanced main mix outputs with ¼" jack and gold-plated XLR connectors, separate control room, headphones and stereo tape outputss Control room/phones outputs with multi-input source matrix; Tape inputs assignable to main mix or control room/phones outputss High-quality components and exceptionally rugged construction ensure long lifes Conceived and designed by BEHRINGER Germany23BLOCKDIAGRAMSPECIFICATIONSMicrophone inputs (XENYX Mic Preamp)Type XLR, electronically balanced,discrete input circuitMic E.I.N. (20 Hz - 20 kHz)@ 0 W source resistance-134 dB / 135.7 dB A-weighted@ 50 W source resistance-131 dB / 133.3 dB A-weighted@ 150 W source resistance-129 dB / 130.5 dB A-weightedFrequency response<10 Hz - 150 kHz (-1 dB),<10 Hz - 200 kHz (-3 dB)Gain range+10 to +60 dBMax. input level+12 dBu @ +10 dB GainImpedance approx. 2.6 k W balancedSignal-to-noise ratio110 dB / 112 dB A-weighted(0 dBu In @ +22 dB gain)Distortion (THD+N)0.005% / 0.004% A-weightedLine inputType1/4" TRS connectorelectronically balancedImpedance approx. 20 k W balanced10 k W unbalancedGain range-10 to +40 dBMax. input level+22 dBu @ 0 dB GainFade-out attenuation1(Crosstalk attenuation)Main fader closed90 dBChannel muted89 dBChannel fader closed89 dBFrequency responseMicrophone input to main out<10 Hz - 90 kHz+0 dB / -1 dB<10 Hz - 160 kHz+0 dB / -3 dBStereo inputsType1/4" TRS connector,electronically balancedImpedance approx. 20 k WMax. input level+22 dBuEQ mono channelsLow80 Hz / ±15 dBMid100 Hz - 8 kHz/ ±15 dBHigh12 kHz/ ±15 dBEQ stereo channelsLow80 Hz /±15 dBLow Mid500 Hz / ±15 dBHigh Mid 3 kHz / ±15 dBHigh12 kHz / ±15 dBAux sendsType1/4" TS connector, unbalancedImpedance approx. 120 WMax. output level+22 dBuStereo aux returnsType1/4" TRS connector,electronically balancedImpedance approx. 20 k W bal. / 10 k W unbal.Max. input level+22 dBuMain outputsType XLR, electronically balancedand 1/4" TRS balancedImpedance approx. 240 W balanced /120 W unbalancedMax. output level+28 dBuControl room outputsType1/4" TS connector unbalancedImpedance approx. 120 WMax. output level+22 dBuHeadphones outputsType1/4" TRS connector, unbalancedMax. output level+19 dBu / 150 W (+25 dBm)DSP24-bitConverter24-bit Sigma-Delta,64/128-times oversamplingSampling rate40 kHzMain mix system data2NoiseMain mix @ -o o,Channel fader @ -o o-101 dBMain mix @ 0 dB,Channel fader @ -o o-93 dBMain mix @ 0 dB,Channel fader @ 0 dB-81 dBPower supplyMains voltage100 to 240 V~, 50/60 HzPower consumption43 WFuse100 - 240 V~: T 1.6 A H 250 VMains connection Standard IEC receptaclePhysical/weightDimensions (H x W x D)approx. 3 7/8" x 16 1/16" x 14 1/16"(97 mm x 408 mm x 367 mm)Weight (net)approx. 4.7 kgMeasuring conditions:1: 1 kHz rel. to 0 dBu; 20 Hz - 20 kHz; line input; main output; unity gain.2:20 Hz - 20kHz; measured at main output. Channels 1 - 4 unity gain; EQ flat; allchannels on main mix; channels 1/3 as far left as possible, channels 2/4 as farright as possible. Reference = +6 dBu.BEHRINGER is constantly striving to manintain the highest professional standards. As aresult of these efforts, modifications may be made from time to time to existing products withoutprior notice. Specifications and appearance may differ from those listed or illustrated.4Technical specifications and appearance subject to change without notice. The information contained herein is correct at the time of printing. The names of companies, institutions or publications pictured or mentioned and their respective logos are registered trademarks of their respective owners. Their use neither constitutes a claim of the trademarks by BEHRINGER® nor affiliation of the trademark owners with BEHRINGER®. BEHRINGER® accepts no liability for any loss which may be suffered by any person who relies either wholly or in part upon any description, photograph or statement contained herein. Colours and specification may vary slightly from product. Products are sold through our authorised dealers only. Distributors and dealers are not agents of BEHRINGER® and have absolutely no authority to bind BEHRINGER® by any express or implied undertaking or representation. No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording of any kind, for any purpose, without the express written permission of BEHRINGER Spezielle Studiotechnik GmbH. BEHRINGER® is a registered trademark.ALL RIGHTS RESERVED. © 2006 BEHRINGER Spezielle Studiotechnik GmbH,Hanns-Martin-Schleyer-Str. 36-38, 47877 Willich-Münchheide II, Germany.Tel. +49 2154 9206 0, Fax +49 2154 9206 49035。

白蛋白紫杉醇说明手册

核准日期：2008年06月30日修改日期：2009年12月10日2010年09月29日2011年08月03日处方用药注射用紫杉醇（白蛋白结合型）说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名：注射用紫杉醇（白蛋白结合型）英文商品名：Abraxane?英文名称：PaclitaxelforInjection（AlbuminBound）汉语拼音：ZhusheyongZishanchun（BaidanbaiJiehexing）【成份】每瓶含紫杉醇100mg及人血白蛋白约900mg。

紫杉醇是药物活性成分，人血白蛋白作为辅料起分散、稳定微粒和运载主药作用。

紫杉醇化学名称：5β,20-环氧-1,2α,4,7β,10β,13α-六羟基紫杉烷-11-烯-9-酮-4,10-二乙酸酯-2-苯甲酸酯-13-(2R,3S)-N-苯甲酰-3-苯基异丝氨酸酯。

化学结构式：分子式：C47H51NO14分子量：853.91【性状】本品为白色至淡黄色无菌冻干块状物或粉末。

【适应症】适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。

除非有临床禁忌症，既往化疗中应包括一种蒽环类抗癌药。

【规格】100mg【用法用量】对联合化疗失败的转移性乳腺癌或辅助化疗后复发的乳腺癌患者，建议使用剂量260mg/m2，静脉滴注30分钟，每3周给药一次。

肝功能异常：尚未进行对肝功能异常患者使用本药的临床研究，对血胆红素>1.5mg/dL的患者，本药的适宜剂量尚不清楚。

肾功能异常：尚未进行对有肾功能损害的患者使用本药的临床研究，在随机对照试验中，排除了血肌酐>2mg/dL的患者。

对有肾功能损害的患者，本药的适宜剂量尚不清楚。

降低剂量：治疗期间如患者出现严重中性粒细胞减少（ANC<500/mm3持续1周或1周以上）或出现严重感觉神经毒性则应将后续疗程的治疗剂量减到220mg/m2。

如再次出现上述严重中性粒细胞减少或感觉神经毒性则应再将随后的治疗剂量减到180mg/m2。

壁挂式自动售药机使用说明书

壁挂式自动售药机使用说明书●使用前请务必仔细阅读本说明书，并请妥善保存，以备查阅●唐山高达科技有限公司保留对本产品的最终解释权，如有更改，恕不另行通知●文中提供的照片、图形等，仅用于解释和说明之用，与本产品可能存在差异，请以实物为准。

目录第一章概述 (1)技术参数 (1)产品特性 (1)产品执行的标准 (1)第二章安全注意事项 (2)安全警示符号 (2)用电注意事项 (2)使用时注意事项 (2)第三章使用前的准备及安装 (4)使用前准备 (4)顶部风机的组装 (4)设备的安装 (4)第四章设备功能说明及操作 (6)功能说明 (6)上药时药盒的摆放及调整 (6)设备启动 (6)购药操作步骤 (6)第五章主板设置及测试 (8)主板参数设置 (8)第六章流量卡的续费 (9)第七章设备常见故障和处理方法 (10)第八章产品售后服务 (11)第一章概述尊敬的用户您好，感谢您使用本公司壁挂式自动售药机。

壁挂式自动售药机是药品零售智能设备，也是本公司智能自动售货系统服务平台的核心终端产品。

该产品能有效解决药品零售存在的时空不对称等诸多问题，可以为消费者提供24小时高效、便捷、智能、安全、人性化的零售服务。

本产品存储盒装药品品种可达49种，存储量≥49盒。

适用于常用药和急救药品的零售(存储药品的种类和数量也可随用户需求而定)。

技术参数●外部展示: 27吋广告屏●储药种类: 盒装≤49种●电源: AC 220V ±10%；50Hz●工作环境：相对湿度：10% ～90%（25℃）环境温度：-25～+40℃产品特性●缺货即时提醒，上货及时高效●药品高密度储存●出货精准无误●货道尺寸适应多种多类药品产品执行的标准Q/TGD01-2016 《唐山高达科技有限公司企业标准》第二章安全注意事项安全警示符号该符号表示禁止的事项，不遵守指示可能会导致产品损坏或危及使用者人身安全。

该符号表示必须遵守的事项，其行为必须严格按照要求操作执行，不遵守可能会导致产品损坏或危及使用者人身安全。

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百达扬说明书 Prepared on 22 November 2020【药品名称】商品名称：百达扬通用名称：注射用艾塞那肽微球英文名称：Exenatide Microspheres for Injection【成份】注射用艾塞那肽微球活性成份为艾塞那肽。

辅料：注射用艾塞那肽微球：乙交酯丙交酯共聚物（50:50），蔗糖。

注射用溶剂：羧甲基纤维素钠、氯化钠、聚山梨酯20、磷酸二氢钠一水合物、磷酸氢二钠七水合物、注射用水。

【适应症】用于改善患者的血糖控制，适用于单用二甲双胍、磺脲类以及二甲双胍合用磺脲类血糖仍控制不佳的患者。

【用法用量】推荐用量注射用艾塞那肽微球（2mg）应每7天（每周）皮下注射一次。

可在一天中的任何时间注射，空腹或进食后均可。

漏用如漏用一次且距离下次预定用药至少3天以上，应在发现后尽快注射。

此后，患者可恢复其每7天（每周）一次的常规用药计划。

如漏用一次且距离下次预定用药1或2天，患者不应给予漏掉剂量而应在下次预定用药时按照常规计划注射。

改变每周用药方案如果有需要可改变每周的用药日，只要与上次注射至少间隔3天。

用法注射用艾塞那肽微球由患者自行给药，需要混合药物和填充注射器。

一旦将药物混合后，必须立即注射。

用药应在腹部、大腿或上臂区域皮下（SC）注射。

告知患者在同一区域注射时，每周选择不同的部位。

禁止静脉注射或肌肉注射。

给药前，患者应接受医疗专业人员的培训。

完整的用药说明（带图示）请参见注射用艾塞那肽微球的使用手册。

【不良反应】肾功能损害重度肾功能损害（肌酐清除率<30mL/min）或终末期肾病患者不应使用注射用艾塞那肽微球，在肾移植患者中应谨慎使用。

接受透析的终末期肾病患者，由于发生胃肠道不良反应，不能很好地耐受单剂量5μg塞那肽注射液。

由于注射用艾塞那肽微球可能引起恶心、呕吐伴一过性低血容量，故治疗可能造成肾功能损害加重。

中度肾功能损害患者（肌酐清除率30至50mL/min）使用注射用艾塞那肽微球时应谨慎。

尚未在终末期肾病或重度肾功能损害患者中研究注射用艾塞那肽微球。

已有使用艾塞那肽出现肾功能改变的上市后报告（包括血清肌酐升高、肾功能损害、慢性肾衰加重和急性肾衰），有时需要进行血液透析或肾移植。

其中有些事件发生在接受一种或多种已知会影响肾功能或脱水状态的药物（例如血管紧张素转化酶抑制剂、非甾体抗炎药和利尿剂）的患者中。

有些事件发生在出现恶心、呕吐或腹泻（伴或不伴脱水）的患者中。

在给予支持治疗并停用可能为诱因的药物（包括艾塞那肽）后，观察到许多病例的肾功能改变是可逆的。

在临床前或临床研究中未发现艾塞那肽具有直接肾毒性。

胃肠道疾病尚未在严重胃肠道疾病（包括胃轻瘫）患者中进行艾塞那肽研究。

患者在使用艾塞那肽时通常可出现胃肠道不良反应，包括恶心、呕吐和腹泻。

不推荐有严重胃肠道疾病的患者使用注射用艾塞那肽微球。

免疫原性患者在接受注射用艾塞那肽微球治疗后可能出现艾塞那肽抗体。

在6项为期24-30周的注射用艾塞那肽微球对照药物研究中，有5项测定了注射用艾塞那肽微球治疗患者的抗艾塞那肽抗体。

在6%接受注射用艾塞那肽微球治疗的患者中，抗体形成与血糖反应减弱有关。

如血糖控制疗效降低或未能达到血糖控制目标，应考虑其它降糖治疗【禁忌】甲状腺髓样癌：有甲状腺髓样癌（MTC）个人或家族史患者或有多发性内分泌腺瘤病2型（MEN 2）患者禁用注射用艾塞那肽微球。

超敏反应：既往对艾塞那肽或注射用艾塞那肽微球任何组分有严重超敏反应的患者禁用注射用艾塞那肽微球。

【注意事项】甲状腺C细胞肿瘤的风险注射用艾塞那肽微球禁用于有MTC个人史或家族史的患者或患有MEN 2的患者。

告知患者使用注射用艾塞那肽微球时有发生甲状腺髓样癌的潜在风险，同时让患者知晓甲状腺肿瘤相应的症状（如颈部肿块、吞咽困难、呼吸困难、持续声嘶）。

接受注射用艾塞那肽微球治疗的患者中，为早期发现MTC而进行常规血清降钙素监测或甲状腺超声的价值尚不确定。

因为甲状腺疾病的高发生率以及血清降钙素检测对MTC的低特异性，所以不必要的监测可能增加风险。

血清降钙素显着升高可能提示MTC的发生，并且通常MTC患者的降钙素值>50ng/L。

如果测量血清降钙素并发现升高，患者应交由医生做进一步评价。

在体格检查或颈部影像学检查发现有甲状腺结节的患者，也应由医生做进一步评价。

急性胰腺炎根据上市后数据，急性胰腺炎包括致死性和非致死性出血或坏死性胰腺炎的发生与使用艾塞那肽有关。

开始使用注射用艾塞那肽微球后，仔细观察患者是否有胰腺炎的体征和症状（包括持续性重度腹痛，有时放射至背部，可能伴或不伴呕吐）。

如怀疑胰腺炎，应及时停用注射用艾塞那肽微球并进行适当处理。

如确诊胰腺炎，则不应重新开始注射用艾塞那肽微球治疗。

有胰腺炎史的患者应考虑除注射用艾塞那肽微球外的其他降糖治疗。

低血糖（联合使用胰岛素促分泌药物或胰岛素时）当艾塞那肽联合胰岛素促分泌药物（如磺脲类）或胰岛素时会增加低血糖风险。

患者可能要减少胰岛素促分泌药物或胰岛素的剂量，从而降低低血糖风险。

肾功能损害重度肾功能损害（肌酐清除率<30mL/min）或终末期肾病患者不应使用注射用艾塞那肽微球，在肾移植患者中应谨慎使用。

接受透析的终末期肾病患者，由于发生胃肠道不良反应，不能很好地耐受单剂量5μg塞那肽注射液。

由于注射用艾塞那肽微球可能引起恶心、呕吐伴一过性低血容量，故治疗可能造成肾功能损害加重。

中度肾功能损害患者（肌酐清除率30至50mL/min）使用注射用艾塞那肽微球时应谨慎。

尚未在终末期肾病或重度肾功能损害患者中研究注射用艾塞那肽微球。

已有使用艾塞那肽出现肾功能改变的上市后报告（包括血清肌酐升高、肾功能损害、慢性肾衰加重和急性肾衰），有时需要进行血液透析或肾移植。

其中有些事件发生在接受一种或多种已知会影响肾功能或脱水状态的药物（例如血管紧张素转化酶抑制剂、非甾体抗炎药和利尿剂）的患者中。

有些事件发生在出现恶心、呕吐或腹泻（伴或不伴脱水）的患者中。

在给予支持治疗并停用可能为诱因的药物（包括艾塞那肽）后，观察到许多病例的肾功能改变是可逆的。

在临床前或临床研究中未发现艾塞那肽具有直接肾毒性。

胃肠道疾病尚未在严重胃肠道疾病（包括胃轻瘫）患者中进行艾塞那肽研究。

患者在使用艾塞那肽时通常可出现胃肠道不良反应，包括恶心、呕吐和腹泻。

不推荐有严重胃肠道疾病的患者使用注射用艾塞那肽微球。

免疫原性患者在接受注射用艾塞那肽微球治疗后可能出现艾塞那肽抗体。

在6项为期24-30周的注射用艾塞那肽微球对照药物研究中，有5项测定了注射用艾塞那肽微球治疗患者的抗艾塞那肽抗体。

在6%接受注射用艾塞那肽微球治疗的患者中，抗体形成与血糖反应减弱有关。

如血糖控制疗效降低或未能达到血糖控制目标，应考虑其它降糖治疗。

超敏反应已有接受艾塞那肽治疗患者发生严重超敏反应（如过敏反应和血管水肿）的上市后报告。

如果发生超敏反应，患者应停用注射用艾塞那肽微球和其他可疑药物并立即就医。

注射部位反应上市后安全性监测数据已报告使用注射用艾塞那肽微球时会出现伴或不伴皮下结节的严重注射部位反应（如脓肿、蜂窝织炎、坏死）。

个别患者需进行手术干预治疗。

大血管事件风险尚没有临床研究结论显示使用注射用艾塞那肽微球可以降低发生大血管病变的风险。

中止治疗中止治疗后，注射用艾塞那肽微球的作用可能继续，因为血浆艾塞那肽水平下降需10周。

因此应考虑选择其他药物并进行剂量选择，因为不良反应可能继续，有效性可能至少部分持续直到艾塞那肽水平下降。

【特殊人群用药】儿童注意事项：尚未确定注射用艾塞那肽微球在儿童患者中的安全性和有效性。

不推荐儿童患者使用。

妊娠与哺乳期注意事项：注射用艾塞那肽微球尚无妊娠妇女的足够资料和良好的对照临床研究。

在大鼠主要器官的形成期给予母体注射用艾塞那肽微球，出现胎鼠生长迟滞和与母体效应有关的骨骼骨化缺陷；注射用艾塞那肽微球在大鼠中没有致畸性。

在动物发育研究中，注射用艾塞那肽微球的活性成分艾塞那肽引起腭裂、不规则骨骼骨化和新生鼠死亡数增加。

因此，只有当注射用艾塞那肽微球对胎儿的潜在益处大于潜在风险时，才考虑妊娠期间使用。

老人注意事项：在5项24-30周药物对照研究中，已在132例（%）≥65岁的患者和20例≥75岁的患者中对注射用艾塞那肽微球进行研究。

这些老年患者和年轻患者间没有观察到安全性（N =152）和疗效（N =52）的差异，但是由于≥75岁的患者样本量较小，因此尚未得出其它结论。

由于老年患者的肾功能下降更常见，所以在老年患者中开始注射用艾塞那肽微球治疗时应谨慎。

【药物相互作用】对乙酰氨基酚在注射用艾塞那肽微球治疗（每周2mg）14周后给予1000mg对乙酰氨基酚片（空腹或进食时服用），未观察到对乙酰氨基酚AUC与对照期相比出现显着变化。

对乙酰氨基酚Cmax降低16%（空腹）和5%（进食），Tmax从对照期的大约1小时增加为小时（空腹）和小时（进食）。

已经对艾塞那肽注射液与以下药物的相互作用进行了研究。

预计注射用艾塞那肽微球的潜在药物相互作用与艾塞那肽注射液相似。

地高辛口服地高辛（每日一次）30分钟前，合用重复剂量的艾塞那肽注射液，可降低地高辛的Cmax 降低17%，Tmax延迟了约小时；但总体稳态药代动力学暴露量（如AUC）无改变。

洛伐他汀与单独服用洛伐他汀相比，洛伐他汀（40mg、单剂量）口服给药前30分钟给予艾塞那肽注射液（10μg每日二次），使洛伐他汀AUC和Cmax分别降低约40%和28%，Tmax延迟约4小时。

在一项为期30周的艾塞那肽注射液对照临床研究中，已服用HMG-CoA还原酶抑制剂的患者使用艾塞那肽注射液，对血脂水平与基线相比无相应的改变。

赖诺普利在服用恒定剂量赖诺普利（5-20mg/天）的轻、中度高血压患者中，合用艾塞那肽注射液（10μg每日二次）不改变赖诺普利稳态Cmax或AUC，Tmax延迟2小时。

患者24小时平均收缩和舒张压没有改变。

口服避孕药在健康女性受试者中进行了艾塞那肽注射液（10μg每日二次）对单剂量和多剂量口服避孕药联用（30μg炔雌醇加150μg左炔诺孕酮）的影响的研究。

与单独服用口服避孕药相比，在艾塞那肽注射液给药后30分钟重复给予口服避孕药（OC），炔雌醇和左炔诺孕酮的Cmax分别下降45%和27%，炔雌醇和左炔诺孕酮的Tmax分别延迟了小时和小时。

与单独给予OC相比，艾塞那肽注射液给药1小时前每日重复给予OC，炔雌醇平均Cmax降低15%，但左炔诺孕酮的平均Cmax无显着变化。

对于这两种方案，艾塞那肽注射液不改变每日重复给予口服避孕药后左炔诺孕酮的平均谷浓度。

但是，与单独给予OC相比，艾塞那肽注射液注射后30分钟给予OC，炔雌醇的平均谷浓度升高20%。

在此项研究中，食物对OC可能的影响干扰了艾塞那肽注射液对OC药代动力学的影响。