泰索帝最新版说明书

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安维汀-抗血管生成治疗

安维汀-抗血管生成治疗

VEGF单抗安维汀®通过多种机制提高化疗疗效
现有肿瘤血管系统1–3
退化
新生血管生长1–3, 8
抑制
现存血管系统11–13
抗通透性
持续提高缓解率4–7 持续控制肿瘤生长8–10 减少胸水和渗出液2, 3, 11, 14–20
1. Hurwitz H, et al. N Engl J Med 2004; 350: 2335-2342. 2. Jain RK. Nat Med 2001; 7(9): 987-990. 3. Margolin K. Curr Oncol Rep 2002; 4: 20-28. 4. Hu L, et al. Am J Pathol 2002; 161(5): 1917-1924. 5. Kaya A, et al. Respir Med 2004; 98: 632-636. 6. Des Guetz G, et al. Br J Cancer 2006; 94: 1823-1832. 7. O'Byrne KJ, et al. Br J Cancer 2000; 82(8): 1427-1432. 8. Yuan A, et al. Int J Cancer (Pred Oncol) 2000; 89: 475-483. 9. Escudier B, et al. Lancet 2007; 370: 2103-2111. 10. Dickson PV, et al. Clin Cancer Res 2007; 13: 3942-3950. 11. Sandler A, et al. N Engl J Med 2006; 355: 2542-2550. 12. Miller K, et al. N Engl J Med 2007; 357: 2666-2676. 13. Gerber HP, Ferrara N. Cancer Res 2005; 65: 671-680. 14. Mabuchi S, et al. Clin Cancer Res 2008; 14: 7781-7789. 15. Wild R, et al. Int J Cancer 2004; 110: 343-351. 16. Mesiano S, et al. Am J Pathol 1998; 153(4): 1249-1256. 17. Willett CG, et al. Nat Med 2004; 10(2): 145-147. 18. O’Connor JPB, et al. Clin Cancer Res 2009; 15: 6674-6682. 19. Prager GW, et al. Mol Oncol 2010; 4: 150-160. 20. Ribeiro SCC, et al. Respirology 2009; 14: 1188-1193. 21. Watanabe M, et al. Hum Gene Ther 2009; 20: 598-610. 22. Bellati F, et al. Invest New Drugs 2010; 28: 887-894. 23. Huynh H, et al. J Hepatol 2008; 49: 52-60. 24. Ninomiya S, et al. J Surg Res 2009; 154: 196-202. 25. Bergers G, Benjamin LE. Nat Rev Cancer 2003; 3: 401-410. 26. Kim KJ, et al. Nature 1993; 362(6423): 841-844. 27. Folkman. In: DeVita, Hellman, Rosenberg, eds. Cancer: Principles & Practice of Oncology. Vol 2. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005. 28. Ferrara N, et al. Nat Med 2003; 9(6): 669-676. 29. Inoue M, et al. Cancer Cell 2002; 1: 193-202. 30. Melnyk O, et al. J Urol 1999; 161: 960-963.

TE Connectivity Kissling Series 35 200A 电池断开开关说明书

TE Connectivity Kissling Series 35 200A 电池断开开关说明书

KISSLINGBATTERY DISCONNECTORSeries 35 / 200A - from TE Connectivity (TE)Our manually operated battery disconnector up to 200 amps meets the most demanding requirements in all vehicle applications. The nom-inal current ratings refer to continuous DC current at up to 100% duty cycle and the switches are built to switch under full load. Our battery disconnector can handle up to five times the continuous current level for up to 10 seconds as overload current. (Overload current of 1000 amps for 30 seconds)All series 35 battery disconnectors are sealed with a technology that meets the IP67 and IP6K9K (steam preassure cleaning) standards and the switches are designed to operate at temperatures between -40°C and +85°C.Options include single or dual pole configurations, various mounting and locking (security) alternatives as well as different shapes and colors of the operating handles to serve your requirements.Battery disconnectors from our KISSLING product family are able to be operated under fall load, to ensure a safe disconnection from the battery in emergency conditions. The range also has optional protec-tion against theft or unauthorized use of vehicles or equipment by re-movable or lockable operating elements.Features• Sealed housing conforms to IP6K9K • Robust design• 6G shock and 4G vibration resistant • Main contact current rated for continu-ous current and 100% duty cycle • Battery disconnection under load in case of an emergency• Variable or scalable mounting options • Safety in the vehicle service by so called “LOCK” options (only two pole)Applications • Truck • Bus• Ground support vehicles• Construction and agricultural vehicles • Railway •AircraftSpecificationTechnical Data Temperature range -40°C to +85°C Protection IP67 / IEC 529Vibration 4g (50-2000 HZ)Shock6g, 11 msecThread sizes / Torque M8 = 12 - 13Nm | M10 = 15 - 20NmElectrical DataMin. insulation resistance 100M ΩDielectric withstanding voltage 1050V / 1 min at 50Hz Max. contact drop max. load 150 mVVoltage rangeup to 32VDC (optional up to 80VDC)Duty rating continuous 200A @ 70mm 2 / 300A @ 95mm 2Overload 500A - 180sec / 1000A - 30sec Wire section min 70mm 2 / min 95mm 2Mounting position optionalAvailable KeysKeyholderNot for switches with central mounting / optional available for 2-pole version1345Technical drawingsCircuitCircuitCircuitCircuit1-pole standard mounitng1-pole with longflange1-pole with central mounting2-poles with longflangeTE Connectivity, TE, TE connectivity (logo) and KISSLING (word) are trademarks owned or licensed by the TE Connectivity family of companies. All other logos, products and/or company names referred to herein might be trademarks of their respective owners.The information given herein, including drawings, illustrations and schematics which are intended for illustration purposes only, is believed to be reliable. However, TE Connectivity makes no warranties as to its accuracy or completeness and disclaims any liability in connection with its use. TE Connectivity‘s obligations shall only be as set forth in TE Connectivity‘s Standard Terms and Conditions of Sale for this product and in no case will TE Connectivity be liable for any incidental, indirect or consequential damages arising out of the sale, resale, use or misuse of the product. Users of TE Connectivity products should make their own evaluation to determine the suitability of each such product for the specific application.© 2020 TE Connectivity | All Rights Reserved. K1166706 | Version 08/2020Ordering InformationMounting option 1,3 and 4 also available for 1-pole version。

诺泰 mystique平板电脑用户手册说明书

诺泰 mystique平板电脑用户手册说明书

Philips 7900 series Smart LED TV189 cm (75") 4K Ambilight TV Supports major HDR formats Pixel Precise Ultra HDGoogle TV™75PUT7908Fits anywhere. Fine-looking it is. 4K Ambilight TVWant to enjoy the latest releases? Just tell this TV’s built-in Google Assistant what you’re looking for, then sit back as immersive Ambilight draws you deeper into the drama! You’ll enjoy an ultra-sharp picture and Dolby Atmos sound too.Looks great, whatever you watch or play.•Compatible with all major HDR formats•Pixel Precise Ultra HD. Smooth motion, noticeable depth.Smart. Fun. Easy to control.•Google Assistant. Control the TV with your voice.•Google Play store. More to love•Entertainment you love, with a little help from Google.4K LED Ambilight TV. Super-sharp and immersive•Immerse in what you love. Ambilight TV.•Ultra-sharp picture. Vibrant viewing.•Cinematic vision and sound. Dolby Vision and Dolby Atmos.HighlightsTV contentGo beyond traditional TV programming with Google Play Store . Experience endless movies, TV, music, apps and games online. More to love.Ambilight TVAmbilight TVs are the only TVs with LED lights behind the screen that react to what you watch, immersing you in a halo of colorful light. It changes everything: your TV seems bigger, and you'll be drawn deeper into your favorite shows, movies, and games.Ultra-sharp pictureNo matter what you watch, this 4K LED Ambilight TV gives you a bright, ultra-sharp picture with vivid colors. The TV is compatible with all major HDR formats-so you'll see more detail, even in dark and bright areas, when you're streaming HDR content.Compatible with HDR formats Compatible with all major HDR formatsDolby Vision and Dolby AtmosWith Dolby Vision and Dolby Atmos on board, your films, shows, and games look and sound incredible. See the picture the director wanted you to see-no more disappointing scenes thatare too dark to make out! Hear every word clearly. Experience sound effects like they're really happening around you.Pixel Precise Ultra HDThe beauty of 4K Ultra HD TV is in savoring every detail. Philips Pixel Precise Ultra HD engine converts any input picture into stunning UHD resolution on your screen. Enjoy a smooth, yet sharp moving image andexceptional contrast. Discover deeper blacks, whiter whites, vivid colors and natural skin tones-every time, and from any source.Google AssistantControl your Philips Google TV with your voice. Want to play a game, watch Netflix, or find content and apps in the Google Play store? Just tell your TV. You can even command all Google Assistant-compatible smart home devices-like dimming the lights and setting the thermostat on movie night. Without leaving the sofa.Google TV™What do you want to watch? Google TV brings together movies, shows, and more, from across your apps and subscriptions-and organises them just for you. You'll getsuggestions based on what you like, and you can even use the Google TV app on yourphone to curate your watchlist on the go.Issue date 2023-09-01 Version: 8.8.1EAN: 87 18863 03890 1© 2023 Koninklijke Philips N.V.All Rights reserved.Specifications are subject to change without notice. Trademarks are the property of Koninklijke Philips N.V. or their respective owners.SpecificationsAmbilight•Ambilight Features: Built in Ambilight, Game Mode, Lounge mode, Wall colour adaptive •Ambilight Version: 3-sidedPicture/Display•Aspect ratio: 16:9•Display: 4K Ultra HD LED•Panel resolution: 3840 x 2160•Picture engine: Pixel Precise Ultra HD •Picture enhancement: HDR10, HLG (Hybrid Log Gamma), Dolby Vision, HDR10+ compatible, Pixel Precise UltraHDSupported Display Resolution •Computer inputs on all HDMI: HDR supported, HDR10/ HLG•Video inputs on all HDMI: HDR supported, HDR10/HLG (Hybrid Log Gamma)Tuner/Reception/Transmission•Digital TV: DVB-T/T2•MPEG Support: MPEG2, MPEG4•TV Program guide*: 8 day Electronic Program Guide•HEVC supportSmart TV•OS:Google TV™•Memory size (Flash)*: 16GBSmart TV Features•SmartTV apps*: Open internet browser, Youtube, Netflix, Amazon Prime Video, Google Search, YouTube Music, Google Play Movies*, Google Play Music*•Ease of Use: Onscreen usermanual, One-stop smart menu button•Firmware upgradeable: Online firmware upgrade •Remote Control: with Voice•Voice assistant*: Google Assistant built-in, RC with Mic., Works with Google Assistant Multimedia Applications•Video Playback Formats: Containers: AVI, MKV, H264/MPEG-4 AVC, MPEG-1, MPEG-2, MPEG-4, VP9, AV1, HEVC (H.265)•Music Playback Formats: AAC, MP3, WAV, WMA (v2 up to v9.2), WMA-PRO (v9 and v10), FLAC •Subtitles Formats Support: .SMI, .SRT, .SUB, .TXT,.ASS, .SSA•Picture Playback Formats: JPEG, GIF, PNG, HEIF,BMPUser Interaction•Remote Control: Voice*•Electronic Program Guide*: 8days ElectronicProgram GuideSound•Output power (RMS): 20W•Speaker configuration: 10Wx2 speaker•Sound Enhancement: Clear Dialogue, DolbyVolume LevelerConnectivity•Number of HDMI connections: 4•HDMI features: Audio Return Channel, 4K•EasyLink (HDMI-CEC): One touch play, Remotecontrol pass-through, System audio control,System standby•Number of USBs: 2•Wireless connection: Bluetooth 5.0, Wi-Fi802.11ac, 2x2, Dual band•Other connections: Headphone out, AntennaIEC75, Service connector, Digital audio out(optical), Ethernet-LAN RJ-45•HDCP 2.2: Yes on all HDMI•HDMI ARC:Yes on HDMI1•HDMI 2.1 features: ALLM, HDMI VRRSupported HDMI video features•HDR: Dolby Vision, HDR10, HDR10+, HLGPower•Mains power: AC 220--240 V 50/60Hz•Ambient temperature: 5 °C to 35 °C•Standby power consumption: <0.5W•Power Saving Features: Auto switch-off timer, Ecomode, Picture mute (for radio)Accessories•Included accessories: 2 x AAA Batteries, Powercord, Quick start guide, Legal and safety brochure,Table top stand, Remote ControlDimensions•Set Width: 1670.5 mm•Set Height: 960 mm•Set Depth: 85 mm•Product weight: 28.5 kg•Set width (with stand): 1670.5 mm•Set height (with stand): 1032 mm•Set depth (with stand): 350 mm•Product weight (+stand): 29 kg•Box width: 1897 mm•Box height: 1106 mm•Box depth: 190 mm•Weight incl. Packaging: 38 kg•Wall mount dimensions: 300 x 300 mm*EPG and actual visibility (up to 8 days) is country and operatordependent.*Philips TV does not gaurantee 100% interoperability with all HDMICEC devices*Its functionality is subject to ChromeCast built-in apps and smartdevises. For more details, please visit ChromeCast built-in productpages.*Image depicted on the website are non-contractual pictures. Pleasealways refer to the actual TV that are sold in the retail or stores.*Amazon Prime is available in selected languages and countries.*Disney+ subscription required. Subject to terms at https:// (c) 2020 Disney and its related entities.Disney+ is available in selected languages and countries.*Netflix subscription required. Subject to terms at https://*Google TV is the name of this device's software experience and atrademark of Google LLC.*Google TV is the name of this device's software experience and atrademark of Google LLC. YouTube,Ok Google and other marks aretrademarks of Google LLC.*Smart TV app offerings vary per TV model and country. For moredetails please visit: /smarttv.*Due to the transmission limitations of Bluetooth wirelesstechnology, a slight sound delay might occur when you hear audiofrom your bluetooth headphone or bluetooth speakers. When thisoccur, you might see the character moving his or her mouth butthere is a slight delay in spoken dialog accompany*Philips TV Remote app and related functionalities vary per TV model,operator, and country, as well as smart device model and OS. Formore details please visit: /TVRemoteapp.。

泰索帝最新版说明书

泰索帝最新版说明书

泰索帝最新版说明书核准日期:2006年11月修改日期:2008年1月2009年3月多西他赛注射液说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:多西他赛注射液商品名称:泰索帝® TAXOTERE®英文名称:DOCETAXEL INJECTION汉语拼音:DUO XI TA SAI ZHUSHEYE【成份】化学名称:(2R,3S)-N-羧基-3-苯基异丝氨酸,N-叔丁基酯,13-酯链上5β-20-环氧-1,2α, 4,7β,10β, 13α-六羟紫杉醇-11-烯-9-酮4-乙酸2-苯甲酸酯三水合物泰索帝® 0.5ml:20mg –每支0.5ml:20mg注射液为将相当于20mg 多西他赛(无水)的多西他赛三羟化合物,溶解于0.5ml吐温80中而制成。

泰索帝® 2.0ml:80mg –每支2.0ml:80mg注射液为将相当于80mg 多西他赛(无水)的多西他赛三羟化合物,溶解于2.0ml吐温80中而制成。

每毫升泰索帝®注射液含有40 mg无水多西他赛。

泰索帝®溶剂-浓度为13% w/w 的注射用乙醇(以95%计)水溶液。

化学结构式:•3H2O分子式:C43H53NO14•3H2O分子量:861.9本注射剂的全部辅料为:浓溶液:吐温80和氮气;溶剂:95%乙醇和注射用水。

【性状】黄至棕黄色的粘稠液体,配有溶剂。

几乎不溶于水,高脂溶性。

【适应症】多西他赛的适应症如下:乳腺癌1. 适用于局部晚期或转移性乳腺癌的治疗。

2.泰索帝(多西他赛)联合曲妥珠单抗,用于HER2基因过度表达的转移性乳腺癌患者的治疗,此类患者先期未接受过转移性癌症的化疗。

3. 泰索帝(多西他赛)联合阿霉素及环磷酰胺用于淋巴结阳性的乳腺癌患者的术后辅助化疗。

非小细胞肺癌适用于局部晚期或转移性非小细胞肺癌的治疗,即使是在以顺铂为主的化疗失败后。

【规格】(1)0.5ml:20mg;(2)2.0ml:80mg【用法用量】多西他赛只能用于静脉滴注。

紫杉类抗肿瘤药物特点及临床合理应用

紫杉类抗肿瘤药物特点及临床合理应用
在没有常规承受G-CSF的病人中,中性粒细胞减少是最 常见的血液学不良反响
在多西他赛用药后平均8天,中性粒细胞计数降到最低 点(400/mm3)
可对逆于及中性非粒蓄细胞积的性下降的,可以采取G-CSF预防性用药
很少并发感染及发热
非血液学不良反响
紫杉醇
多西他赛
过敏反响
过敏反响
心血管毒性
皮肤及皮下组织异常
紫杉类药物药理作用机制
星状体微管束
3’位与 β-tubulin N末端的1-31氨基酸残基结合 2位与β-tubulin 217-233氨基酸结合 7位与β-tubulin Arg282结合
He LF, Orr GA, Horwitz SB drug Discovery Today 2001 :1153
紫杉醇研发过程
年代


1958
NCI开始大规模植物药研发筛选
1967
发现紫杉醇抗癌活性
1968
从红豆杉中分离出紫杉醇
1971
完成结构鉴定
1979
发表作用机制
1983
临床Ⅰ试验
1985
临床II期
1991
临床III期
1992
FDA批准上市
national cancer institute 〔NCI〕〕

、心动过缓等,但通
常不用治疗)
5. 肌痛、关节痛胃肠道反 应,口腔皮肤质 体
1.骨髓抑制:严重粒缺达47%
2.外周神经毒:62%,严重 达6%
3.过敏反应:潮红、皮疹、 呼吸困难、低血压、心 动过速。曾发生过敏禁 用。
4.心血管毒:低血压、心动 过缓肌肉关节疼痛。, 呈剂量依赖型。
溶剂型紫杉醇促使循环中胶束的形成

参附注射液临床应用的文献梳理

参附注射液临床应用的文献梳理

参附注射液临床应用的文献梳理柏冬;刘丽梅;岳广欣;王瑞海【摘要】目前参附注射液在临床中广泛应用,本文拟对文献报道中参附注射液的临床适应症及其联合用药情况进行梳理.本文以"参附注射液"为检索词,检索中国期刊全文数据库涉及参附注射液的临床使用报道,共检索文献719篇,共涉及疾病104种,例如心力衰竭、肺源性心脏病、心肌梗死、休克、心律失常、冠心病等疾病.其中单独使用参附注射液治疗文献519篇,涉及疾病76种,联合其他药物治疗文献200篇,涉及疾病54种.希望通过本文为参附注射液的临床使用提供指导.【期刊名称】《环球中医药》【年(卷),期】2014(007)001【总页数】5页(P68-72)【关键词】参附注射液;临床应用;单独使用;联合用药【作者】柏冬;刘丽梅;岳广欣;王瑞海【作者单位】100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所;100700,北京,中国中医科学院中医基础理论研究所【正文语种】中文【中图分类】R605.975参附注射液由红参、黑附片的提取物组成,该品种收载于卫生部药品标准中药成方制剂第十八册中,为内科用药,属于温里剂中的回阳救逆剂。

自1983年开始有临床报道以来[1],发表了大量关于参附注射液的临床使用文献,涉及疾病种类较多。

为了明确参附注射液的临床适应症及其使用方法,为其临床应用提供指导,本文采用文献学方法,对目前有关参附注射液临床使用的文献进行梳理。

1.1 资料来源以“参附注射液”为检索主题词,在中国学术期刊网络出版总库中检索自建国以来的全部文献,将文献信息导入医学文献王3.0中。

1.2 文献的纳入、分类及排除文献的纳入标准:所有涉及参附注射液临床使用报道的文献。

文献的排除标准:排除所有参附注射液动物药理实验文献、综述文献、临床医案文献、Meta分析类文献、临床病例数小于10例的文献、参附注射液非主要治疗药物、参附注射液为对照药物类文献。

常见抗肿瘤药物储存配置使用注意事项

常见抗肿瘤药物储存配置使用注意事项

根据患者用药史,依据使用时间,药代动力学特点等进行排查,考虑丙戊酸钠和左乙拉西坦两者关联最大。

从时间相关性看,患者用药-天后出现不良反应,丙戊酸钠片药物的半衰期为4~4h,连续服药3~4天后药物的血药浓度达到稳态42,左乙拉西坦半衰期为6~3h0日9次用药9天后达到稳态坪浓度〔-,存在时间合理性。

单一药物长期治疗脑卒中后癫痫的效果不理想,左乙拉西坦作为新型抗癫痫药物高生理利用度和低蛋白结合率,治疗癫痫具有一定优势4-,上市前临床研究表明服用本品并不影响其他已有的抗癫痫药物血药浓度;而且这些抗癫痫药的应用也不影响本品的药代动力学特性⑷。

皮疹是左乙拉西坦最常见的不良反应之一。

丙戊酸可引起皮肤反应4-,如皮疹。

在某些病例有毒性上皮坏死溶解,StevenDohnse综合征,多形性红斑也有报导,符合已知不良反应类型。

大疱性表皮松解型药疹是最严重的不良反应之一,严重且可能危及生命〔-。

大多数大疱性表皮松解型药疹并没有特异性治疗。

多采用支持治疗,包括伤口处理、控制感染、营养支持以及预防和治疗并发症3-。

因此,早期的识别非常重要,临床药师应该始终保持高度的警惕性,一旦发生药疹早发现,早治疗。

参考文献[1-齐庆华,王红霞,王佳虹.丙戊酸钠与左乙拉西坦治疗小儿癫痫的临床疗效分析4〕.当代医学,263,25(4)9306.〔2〕陈娇,刘晓鸣,岳璇.左乙拉西坦添加治疗对难治性癫痫患儿外周血多药耐药相关蛋白32表达的影响〔J〕.中华实用儿科临床杂志963,34(24):1757-1740.4〕王艳0长晓鑫,杨清成•脑卒中后癫痫的临床治疗及效果研究3〕北方药学96405(4):3899.3〕张晓毅S午莉,常凯琴.丙戊酸钠致不良反应46例临床分析中国疗养医学3〕263,8(5):279O75.4〕张志清0长燕梅,胡永福•药源性剥脱性皮炎分析3-.中国医院药学杂志,501,46):4403.3〕El Hachem M,Zamdruac G,BouPon-Lanoy Ept ai.MulPcentre con­sensus ucommeuUatUus for skis core is inhedteU epiSermolysis dullc-sa J〕Ophanet J Rare DO,2910,9:96.-经营与管理*常见抗肿瘤药物储存配置使用注意事项荆文荣、,,杨春松、,,高山、,,王叶立、,,曹芝菡、,,周庆22,许群芬、宀(1.四川大学华西第二医院药学部/循证药学中心,四川成都619061;2.四川大学出生缺陷与相关妇儿疾病教育部重点实验室,四川成都619061-摘要:整理分析我院常见静脉用抗肿瘤药物,从药物储存、配置、使用角度阐述静脉用抗肿瘤药物的注意事项,确保疗效和用药安全,为临床安全用药提供依据,体现药学服务的价值。

SANTA FE 2018 Hyundai Getting Started说明书

SANTA FE 2018 Hyundai Getting Started说明书

2018 HyundaiSANTA FEGetting Started Audio, Connectivity, and NavigationPairing346913Table of ContentsGetting StartedAudio, Connectivity, and NavigationCameraNOTEand proceed.Connect a USB cable from your phone to the vehicle’s USB slot.Android Auto Android Auto Android AutoApple CarPlayApple CarPlayAllow permission from your phone to connectto your vehicle.Enjoy using the applications displayed on your vehicle’s head unit screen.1232018 SANTA FEAndroid Auto & Apple CarPlaySmartphone IntegrationPress the BLUETOOTH ® icon on the screen.Then press BLUETOOTH CONNECTION .Press ADD NEW .Then turn on your phone’s BLUETOOTH and select the device (Santa Fe) found by your phone.23NOTERefer to your phone’s owner’s manual or visit for more information.NOTEIf your phone is supported, your contact list may be transferred to your vehicle automatically. Depending on the phone make and model:• S ome phones may request approval to download contacts; this process will take a few minutesThe vehicle will confirm successfulphone pairing completion.5BEFORE YOU STARTinstructions on the previous pages.Press the PUSH TO TALKbutton on the steering wheel. You will hear a beep.After the beep, say the command “CALL ”followed by the name of the desired contact.Example:“CALL JOHN SMITH ”Select the number you would like to call by saying“1,” “2,” “WORK ,” or “HOME.”1 2 3NOTECompatibility and performance may vary based on your phone, the phone’s software, and your wireless carrier.To start voice command, press the PUSH TO TALK button on the steering wheel.HELP provides guidance oncommands that can be used within the Here are a few common voice commands to use after the phone has been paired:Say “CALL of the saved contact with whom you wish to speak. For example, “CALL JOHN SMITH .”“DIAL ” makes a call by dialing the spoken numbers. For example: “DIAL 1-800-633-5151.”“PHONE ” provides guidance on phone-related commands.“CALL HISTORY ” displays the phone’s call history screen.“CONTACTS ” displays the phone’s contacts screen.Press the PUSH TO TALKbutton on the steering wheel.You will hear a beep.1 This step will display the list of POI categoriesthat you can say. Say “RESTAURANTS .”A list of POI categories will be displayed. If youwould like to find coffee shops nearby, say “COFFEE SHOPS .”234After the beep, say a command:“FIND POI *.”*Point of InterestSelect the PUSH TOTALK button and say “CANCEL ROUTE ”after the prompt to stop navigation guidance.8Follow the prompt and say “YES ” to set as yourdestination.6Touch ADDRESS .2 The location will be pinned on the map.If the address is correct, press SET AS DESTINATION .4begin when you select START GUIDANCE .Press the PUSH TO TALK button and say “CANCEL ROUTE ” after the prompt to stop navigation guidance.6Press theDESTINATIONSEARCH button.When prompted, say “COFFEE ,” “ADDRESS ” or “POI NAME IN CITY .”A list of nearbydestinations matching your search criteria will be displayed.Select a destination from the list for a map view.PressSTART GUIDANCE to begin your route.123Destination SearchPowered by Google™Navigation Head Unit 2018 SANTA FE。

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核准日期:2006年11月 修改日期:2008年1月 2009年3月多西他赛注射液说明书请仔细阅读说明书并在医师指导下使用【药品名称】通用名称:多西他赛注射液商品名称:泰索帝® TAXOTERE ® 英文名称:DOCETAXEL INJECTION 汉语拼音:DUO XI TA SAI ZHUSHEYE【成份】化学名称: (2R,3S)-N-羧基-3-苯基异丝氨酸,N-叔丁基酯,13-酯链上5β-20-环氧 -1,2α, 4,7β,10β, 13α-六羟紫杉醇-11-烯-9-酮4-乙酸2-苯甲酸酯三水合物泰索帝® 0.5ml:20mg –每支0.5ml:20mg 注射液为将相当于20mg 多西他赛(无水)的多西他赛三羟化合物,溶解于0.5ml 吐温80中而制成。

泰索帝® 2.0ml:80mg –每支2.0ml:80mg 注射液为将相当于80mg 多西他赛(无水)的多西他赛三羟化合物,溶解于2.0ml 吐温80中而制成。

每毫升泰索帝®注射液含有40 mg 无水多西他赛。

泰索帝®溶剂-浓度为13% w/w 的注射用乙醇(以95%计)水溶液。

化学结构式:•3H 2O分子式:C 43H 53NO 14•3H 2O 分子量:861.9本注射剂的全部辅料为:浓溶液:吐温80和氮气;溶剂:95%乙醇和注射用水。

【性状】黄至棕黄色的粘稠液体,配有溶剂。

几乎不溶于水,高脂溶性。

【适应症】多西他赛的适应症如下:乳腺癌1. 适用于局部晚期或转移性乳腺癌的治疗。

2.泰索帝(多西他赛)联合曲妥珠单抗,用于HER2基因过度表达的转移性乳腺癌患者的治疗,此类患者先期未接受过转移性癌症的化疗。

3. 泰索帝(多西他赛)联合阿霉素及环磷酰胺用于淋巴结阳性的乳腺癌患者的术后辅助化疗。

非小细胞肺癌适用于局部晚期或转移性非小细胞肺癌的治疗,即使是在以顺铂为主的化疗失败后。

【规格】(1)0.5ml:20mg;(2)2.0ml:80mg【用法用量】多西他赛只能用于静脉滴注。

推荐剂量:一般性多西他赛的推荐剂量为每三周75mg/m2滴注一小时。

为减轻体液潴留,除有禁忌外,所有病人在接受多西他赛治疗前均必须预服药物。

此类药物只能包括口服糖皮质激素类,如地塞米松,在多西他赛滴注一天前服用,每天16mg(例如:每日2次,每次8mg),持续3天。

只有医生才能修改治疗方案。

多西他赛不能用于中性粒细胞数目低于1500/mm3的病人。

多西他赛治疗期间,如果病人发生发热性中性粒细胞减少且中性粒细胞数目持续一周以上低于500/mm3,出现严重或蓄积性皮肤反应或外周神经症状,多西他赛的剂量应酌情递减。

乳腺癌在可以手术的淋巴结阳性的乳腺癌辅助化疗中,推荐剂量为:给予阿霉素50mg/m2及环磷酰胺500mg/m2一小时后,给予多西他赛75mg/m2,每三周一次,进行6个周期(见治疗中调整剂量)。

治疗局部晚期或转移性乳腺癌患者时,多西他赛单一用药的推荐剂量为100mg/m2。

一线用药时,多西他赛75mg/m2联合阿霉素(50mg/m2)(见安全处置建议)。

与曲妥珠单抗联合用药时,多西他赛推荐剂量为:100mg/m2,每三周一次,曲妥珠单抗每周一次。

在一项关键临床研究中,多西他赛首次静脉给药应于曲妥珠单抗第一次用药后一天。

如果患者对前次曲妥珠单抗剂量耐受良好,多西他赛以后的用药应紧随曲妥珠单抗静脉输注之后给药。

曲妥珠单抗的用法及用量,见其产品说明书。

非小细胞肺癌治疗非小细胞肺癌时,对于前期未经治疗的患者治疗非小细胞肺癌推荐剂量为多西他赛75mg/m2并立即给予顺铂75mg/m2静脉输注30-60分钟。

对于前期铂类治疗失败的患者,多西他赛推荐剂量为单一用药75mg/m2。

治疗中调整剂量:一般性:多西他赛应用于中性粒细胞计数≥1500/mm3的患者。

多西他赛治疗期间,如果患者发生发热性中性粒细胞减少且中性粒细胞数目持续一周以上<500/mm3,出现重度或蓄积性皮肤反应或重度外周神经症状,多西他赛的剂量应由100mg/m2减至75mg/m2,及/或由75mg/m2减至60mg/m2。

若患者在60mg/m2剂量时仍然出现以上症状,应停止治疗。

乳腺癌辅助化疗在关键的临床研究中,接受乳腺癌辅助化疗的患者,出现并发性中性粒细胞减少(包括中性粒细胞减少发生时间延长,发热性中性粒细胞减少,或感染),在所有以后的用药周期中,推荐预防使用G-CSF(如:第4天至第11天)。

若患者持续出现以上反应,应坚持使用G-CSF,并将多西他赛剂量减少至60mg/m2。

然而,临床发生中性粒细胞减少时间较早。

因此应权衡患者中性粒细胞减少的危险及当前使用的推荐剂量而使用G-CSF。

如果未使用G-CSF,多西他赛剂量应由75减至60mg/ m2,发生3级或4级口腔炎的患者应将剂量减至60mg/m2。

联合顺铂治疗对于起始剂量为多西他赛75mg/m2联合顺铂的患者,且前期疗程中曾出现血小板最低值<25000/mm3 , 或曾出现发热性中性粒细胞减少,或曾出现严重的非血液学毒性,下一疗程的多西他赛剂量应减为65mg/m2。

顺铂剂量调整,见其产品介绍。

对于曲妥珠单抗剂量调整,见其产品说明书。

特殊人群:肝功能有损害的患者:根据100mg/m2多西他赛单一用药的药代动力学数据,ALT 和/或AST超过正常值上限1.5 倍同时碱性磷酸酶超过正常值上限2.5倍的患者,多西他赛的推荐剂量为75mg/m2(见《注意事项》及《药代动力学》)。

对于血清胆红素超过正常值上限和/或ALT及AST超过正常值上限3.5倍并伴有碱性磷酸酶超过正常值上限6倍的患者,除非有严格的使用指征,否则不应使用,也无减量使用建议。

无肝功能有损害患者接受泰索帝联合治疗的数据。

【不良反应】从以下单一用药及联合用药的患者中,收集了与多西他赛很可能或可能相关的不良反应:. 1312名患者接受100mg/m2以及121名患者接受75mg/m2多西他赛单药治疗。

. 258名患者接受75mg/m2多西他赛联合阿霉素50mg/m2治疗。

. 406名患者接受75mg/m2多西他赛联合顺铂75mg/m2治疗。

. 92名患者接受多西他赛联合曲妥珠单抗治疗。

. 744名患者接受多西他赛与阿霉素及环磷酰胺联合治疗(与临床重要的治疗相关的不良反应将描述如下)。

根据NCI通用毒性标准(3级=G3,3-4级=G3/4;4级=G4)及COSTART术语来描述反应。

频度定义为:非常常见(>1/10),常见(>1/100,<1/10);不常见(>1/1000,<1/100);少见(>1/10000,<1/1000);罕见(<1/10000)。

在每个频度组按严重程度由高到低的顺序列出不良反应。

多西他赛单药治疗最常见报告的不良反应为:中性粒细胞减少[可逆转且不蓄积(见《用法用量》及《注意事项》);减少至最低点的中位时间为7天,发生重度中性粒细胞减少(<500/mm3) 持续的中位时间为7天],贫血、脱发、恶心、呕吐、口腔炎、腹泻和虚弱。

当多西他赛与其它化疗药物联合使用时可增加多西他赛不良事件的严重程度。

在联合曲妥珠单抗治疗中,列出≥10%的不良事件(所有级别)报告。

在曲妥珠单抗联合组对比多西他赛单药组,SAE发生率(40%比30%)及4级AE(34%比23%)的发生率增高。

泰索帝常见不良反应如下:免疫系统异常过敏反应大多发生在多西他赛开始输注的最初几分钟内,通常是轻度至中度的。

最常报告的症状是伴或不伴有搔痒的红斑及皮疹,胸闷,背痛,呼吸困难及药物性发热或寒颤。

重度反应包括, 低血压和/或支气管痉挛或全身皮疹/红斑,停止输注并进行对症治疗后即可恢复(见《注意事项》)。

神经系统异常当出现重度外周神经毒性症状时,应减少多西他赛的剂量(见《用法用量》及《注意事项》)。

轻至中度感觉神经症状包括感觉异常,感觉障碍或疼痛包括烧灼痛。

运动神经事件主要表现为虚弱。

皮肤及皮下组织异常观察到通常是轻至中度可逆转的皮肤反应,常表现为皮疹,包括主要见于手、足(包括严重的手-足综合征),或发生在臂部,脸部及胸部的局部皮疹,常伴有搔痒。

皮疹多发生于输注多西他赛后一周内。

较少见的重度症状如:极少导致干扰或中断多西他赛治疗的皮疹继而脱皮的报导(见《用法用量》及《注意事项》)。

重度的指甲病变,以色素沉着或色素减退为特点,有时发生疼痛和指甲脱落。

在有些病例中,可能是多种因素造成了以上这些结果,例如:患者伴随的感染,伴随的其他药物以及潜在的疾病。

全身及注射部位异常注射部位一般为轻度反应,包括色素沉着,炎症,皮肤发红或发干,静脉炎或渗出及肿胀。

体液潴留包括如外周水肿,也有少数报道发生胸膜腔积液,心包积液,腹水及体重增加。

外周水肿通常开始于下肢并可能发展至全身伴体重增加3kg或以上。

体液潴留的发生率及程度是可蓄积的(见《注意事项》)。

多西他赛100mg/m2单一用药:血液及淋巴系统异常少见:出血事件合并G3/4血小板减少症。

神经系统异常数据表明多西他赛100mg/m2单一用药后,35.3%具有神经毒反应患者是可逆转的。

在3个月之内自行恢复。

心脏异常不常见:心衰(0.5%)。

胃肠道不适不常见:食道炎(1%,重度0.4%)。

皮肤及皮下组织异常非常少见:一例脱发,在研究结束时未逆转。

73%皮肤反应在21天之内逆转。

全身及注射部位异常至治疗中断的中位累积剂量为超过1,000mg/m2 ,至体液潴留恢复的中位时间为16.4周(范围0-42周)。

发生中度及重度体液潴留的起始时间,预防用药患者(中位累积剂量:818.9mg/m2)比未预防用药患者(中位累积剂量:489.7mg/m2)延迟;然而,有报导在某些患者中,在治疗早期发生体液潴留。

肝脏系统在接受多西他赛单药(100 mg/m²)治疗的患者中,观察到有低于5%的患者出现了血清转氨酶-AST, ALT, 胆红素和碱性磷酸酶水平的升高,并超过正常值上限的2.5倍。

多西他赛75mg/m2单一用药:多西他赛75mg/m2联合阿霉素:总之,接受多西他赛单药治疗的患者与接受多西他赛联合阿霉素治疗的患者相比,发生的不良反应是相似的。

多西他赛75mg/m2联合顺铂:临床上重要的治疗相关性不良事件显示如下。

下面这张表中的安全数据,来自于在一项随机,开放,3种方案对照的临床试验。

在该临床试验中,807例不能切除的IIIB或者IV 期非小细胞肺癌患者,接受了多西他赛的联合治疗,这些患者以前没有接受过化疗。

采用美国的国立癌症研究所制订的常见毒性标准,对这些不良反应进行了描述。

除血液系统毒性或者另行注明以外,这些不良反应被认为可能或很可能与治疗有关。

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