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入门指南MedDRA 17.1 版MSSO-DI-6003-17.1.02014 年9 月致读者致读者本《入门指南》以中文编写，仅供中文版MedDRA 使用。
其他支持非中文用户的《入门指南》也已编写完毕，并附有各自译本。
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具体版本的更改或文件中的更改在《新增内容》文档中提供。
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MedDRA 术语集通过ISO 9001:2008 注册质量管理体系来维护。
为了帮助读者更方便地找到本《SMQ 入门指南》的新增和更改内容，以下列出了MedDRA 17.1 版的重大更改部分。
附录B：MedDRA 概念描述：修订以下描述词：药物转移用药过量用药剂量不足上消化道新增以下描述词：产品剂型混乱产品标示混乱产品名称混乱产品包装混淆_________________________________________________________________________________致谢MedDRA 商标归代表ICH 的IFPMA 所有。
《精神疾病诊断与统计手册第四版》(DSM-IV) (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition ) Copyright 1994 American Psychiatric Association。
《国际疾病分类编码第九版临床修正版》(ICD-9-CM) (International Classification of Diseases, Ninth Revision, Clinical Modification) Copyright 1998 Medicode, Inc.。
药物说明书概言药品说明书，是指药品生产企业印制并提供的，包含药理学、毒理学、药效学、医学等药品安全性、有效性重要科学数据和结论的，用以指导临床正确使用药品的技术性资料。
说明书内容要求说明书必须包括以下内容：药品名称、成分、适应症或者功能主治、用法、用量、不良反应、禁忌、注意事项、规格、有效期、批准文号和生产企业。
药品说明书还必须包括孕妇及哺乳期妇女用药、药物相互作用，缺乏可靠的实验或者文献依据而无法表述的，说明书保留该项标题并应当注明“尚不明确”。
药品说明书还应当包括临床研究、儿童用药、老年用药和药物过量、药理毒理和药代动力学。
缺乏可靠的实验或者文献依据而无法表述的，说明书不再保留该项标题。
化学药品、治疗用生物制品、中药、预防用生物制品说明书书写的具体内容和格式按照《化学药品及治疗用生物制品说明书规范细则》、《中药说明书规范细则》、《预防用生物制品说明书规范细则》的规定执行化学药品及治疗用物制品说明书规范细则说明书格式特殊药品、外用药品、非处方药品标识X X X说明书处方药在此标注“请仔细阅读说明书并在医生指导下使用”。
非处方在此标注“请仔细阅读说明书并按说明书使用或在药师指导下购买使用。
”警示语【药品名称】通用名称：商品名称：英文名称：汉语拼音：拉丁名称：【成份】【性状】【处方组成】【作用类别】【临床研究】【适应症】【用法、用量】【不良反应】【禁忌】【注意事项】【孕妇及哺乳期妇女用药】【儿童用药】【老年患者用药】【药物相互作用】【药物过量】【药理毒理】【药代动力学】【规格】【贮藏】【包装】【有效期】【批准文号】【生产企业】企业名称：生产地址：邮政编码：电话号码：传真号码：网址：【发布日期】说明书各项内容书写要求说明书标题“XXX说明书”中的“XXX”是指该药品的通用名称。
警示语是指对药品严重不良反应及其潜在的安全性问题的警告，还可以包括药品禁忌、注意事项及剂量过量等需提示用药人群特别注意的事项。
依托孕烯植入剂使用效果的临床分析王萍;乌守恒;曾晓峰;周颖;林卫【期刊名称】《中国计划生育学杂志》【年(卷),期】2018(026)001【总页数】3页(P50-52)【作者】王萍;乌守恒;曾晓峰;周颖;林卫【作者单位】四川大学华西妇产儿童医院成都,610041;四川大学华西妇产儿童医院成都,610041;四川大学华西妇产儿童医院成都,610041;四川大学华西妇产儿童医院成都,610041;四川大学华西妇产儿童医院成都,610041【正文语种】中文依托孕烯植入剂是一种高效、长效、可逆的单孕激素皮下埋植避孕系统，适用于有长期避孕需求的育龄期女性，并且大量临床经验证实能有效缓解痛经和治疗月经量多。
同时，也有文献报道使用依托孕烯植入剂可能出现阴道出血模式改变、体重增加、面部痤疮、孕激素相关副作用等不良反应。
现对本院近2年内使用依托孕烯植入剂时间>1年的女性进行随访研究，为我国更广泛使用或研究依托孕烯植入剂提供参考依据。
1 对象与方法1.1 研究对象2014年6月11日-2016年5月26日在本院行依托孕烯植入剂皮下埋植的女性。
依托孕烯植入剂单根型(荷兰欧加农公司生产)，每支含68 mg依托孕烯，所有妇女在植入药剂前，均排除禁忌证，并签署知情同书。
2017年4月3日-2017年6月1日进行电话随访。
1.2 研究内容研究内容包括：①基本资料，年龄、文化程度、职业、生育史、埋植原因、植入前月经情况；②使用效果，避孕效果、痛经和月经量多的治疗作用；③副作用，阴道出血模式改变、体重增加、面部痤疮、卵巢囊肿、皮下埋植部位早期红肿、疼痛等，孕激素相关副作用；④其他，满意度、续用率、取出原因等。
根据视觉模糊评分法(VRS)将痛经进行分度[1]。
采用国际妇产科联盟(FIGO)2014年月经新分类系统[2-3]对月经模式进行评价，了解研究对象月经模式改变情况。
1.3 统计学方法采用统计学软件SPSS 24.0对数据资料进行分析，计量资料数据用均数±标准差表示，计数资料用率表示。
1.IDENTIFICATION OF THE SUBSTRANCE/PREPARATION AND THECOMPANY/UNDERTAKINGPOSITION/INFORMATION ON INGREDIENTS3.HAZARDS IDENTIFICATIONMaterial Safety Data SheetRevision Date:February 23,2018Product code QP020Product name RNAzol®RT RNA Isolation ReagentContact manufacturer GeneCopoeia,Inc.9620Medical Center Drive,Suite 101Rockville,MD 20850USAPhone:301-762-0888Toll free:1-866-360-9531Fax:301-762-3888Chemical Name CAS-No Weight %Phenol108-95-230-60Guanidine isothiocyanate 593-84-015-40Ammonium thiocyanate1762-95-47-13Contact with acids or bleach liberates toxic gases.DO NOT ADD acids or bleach to any liquid wastes containing this product.We recommend handling all chemicals with caution.GHS –Classification Signal Word DANGERHealth HazardsAcute oral toxicity Category 4Acute dermal toxicityCategory 4Acute Inhalation Toxicity -Vapors Category 4Skin corrosion/irritationCategory 1B Serious eye damage/eye irritationCategory 1Specific target organ systemic toxicity (single exposure)Category 3Specific target organ systemic toxicity (repeated exposure)Category 3Health Hazards(continued)Mutagenicity Mutagenic category2Physical hazardsNot hazardousHazard StatementsH314-Causes severe skin burns and eye damageH341-Suspected of causing genetic defectsH373-May cause damage to organs through prolonged or repeated exposureH412-Harmful to aquatic life with long lasting effectsH302-Harmful if swallowedH312-Harmful in contact with skinH332-Harmful if inhaledH335-May cause respiratory irritationPrecautionary StatementsP301+P312-IF SWALLOWED:Call a POISON CENTER or doctor/physician if you feel unwellP304+P340-IF INHALED:Remove victim to fresh air and keep at rest in a position comfortable for breathingP301+P330+P331-IF SWALLOWED:rinse mouth.Do NOT induce vomitingP303+P361+P353-IF ON SKIN(or hair):Remove/Take off immediately all contaminated clothing.Rinse skin withwater/showerP305+P351+P338-IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses,if present and easy to do.Continue rinsingP310-Immediately call a POISON CENTER or doctor/physicianP308+P313-IF exposed or concerned:Get medical advice/attentionP273-Avoid release to the environmentP280-Wear protective gloves/protective clothing/eye protection/face protectionPrinciple Routes of ExposurePotential Health EffectsEyes Causes burns.Risk of serious damage to eyes.Corrosive to the eyesand may cause severe damage including blindness.Skin Causes burns.Possible risk of irreversible effects.Harmful in contactwith skin.Irritating to skin and mucous membranes.Inhalation Harmful by inhalation.Ingestion Harmful if swallowed.Ingestion causes burns of the upper digestive andrespiratory tracts.Ingestion may cause gastrointestinal irritation,nausea,vomiting and diarrhea.Specific effectsCarcinogenic effects Phenol has been classified by the International Agency for Research onCancer(IARC)as not classifiable as to carcinogenicity to humans(Group3).Mutagenic effects Not ApplicableReproductive toxicity Not ApplicableSensitization Not ApplicableTarget Organ Effects SkinLungsLiverSpleen4.FIRST AID MEASURES5.FIRE-FIGHTING MEASURES6.ACCIDENTAL RELEASE MEASURES7.HANDLING AND STORAGEKidneyHMISHealth 3*Chronic HazardFlammability 1ReactivitySkin contact Wash off immediately with soap and plenty of water while removing all contaminated clothes and shoes.Call a physician immediately.Eye contactIF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses,if present and easy to do.Continue rinsing.Rinseimmediately with plenty of water,also under the eyelids,for at least 15minutes.Call a physician immediately.Ingestion Call a physician or poison control center immediately.Rinse mouth.Do not induce vomiting without medical advice.Never give anything by mouth to an unconscious person.InhalationRemove to fresh air.Call a physician or poison control center immediately.Notes to physicianTreat symptomatically.Suitable extinguishing media Dry chemical.Carbon dioxide (CO2).Water spray.Foam.Special protective equipment for firefightersWear self-contained breathing apparatus and protective suit.Australia HazChem Code2XPersonal precautionsELIMINATE all ignition sources (no smoking,flares,sparks or flames in immediate area).Use personal protection equipment.Avoid contact with skin,eyes or clothing.Ensure adequate ventilation.Keep people away from and upwind of spill/leak.Evacuate personnel to safe areas.Methods for cleaning upPrevent product from entering drains.Soak up with inert absorbentmaterial.Neutralize spill with slaked lime,sodium bicarbonate or crushed limestone.Collect powdered material and deposit in sealed containers and dispose of phenol as hazardous waste.Isolate area and deny entry.Environmental precautionsPrevent further leakage or spillage if safe to do so.Prevent product from entering drains.Do not allow material to contaminate ground water system.See Section 12for more information8.EXPOSURE CONTROLS /PERSONAL PROTECTIONHandling Always wear recommended Personal Protective Equipment.Avoid contact with skin,eyes or clothing.Remove all sources of ignition.StorageKeep containers tightly closed in a cool,well-ventilated place.Keep away from heat,sparks,flame and other sources of ignition (i.e.,pilot lights,electric motors and static electricity).Protect from sunlight.Exposure limitsChemical name OSHA PELOSHA PEL (Ceiling)ACGIH OEL (TWA)ACGIH OEL (STEL)Phenol5ppm 19mg/m 3None 5ppm None Guanidine isothiocyanate None None None None Ammonium thiocyanate5mg/m 3NoneNoneNoneEngineering measures Use in a chemical fume hoodPersonal protective equipmentPersonal Protective Equipment requirements are dependent on the user institution's risk assessment and are specific to the risk assessment for each laboratory where this material may be used.Respiratory protection In case of insufficient ventilation wear suitable respiratory equipment RespiratorUp to 50ppmRecommendations,National Institute of Occupational Safety and Health,U.S.(APF =10)Any air-purifying half-mask respirator with organic vaporcartridge(s)in combination with an N95,R95,or P95filter.The following filters may also be used:N99,R99,P99,N100,R100,P100.(APF =10)Any supplied-air respirator Up to 125ppm:(APF =25)Any supplied-air respirator operated in a continuous-flow mode.(APF =25)Any powered air-purifying respirator with an organic vapor cartridge in combination with a high-efficiency particulate filter.Up to 250ppm:(APF =50)Any air-purifying full-facepiece respirator equipped with organic vapor cartridge(s)in combination with an N100,R100,or P100filter.(APF =50)Any air-purifying,full-facepiece respirator (gas mask)with a chin-style,front-or back-mounted organic vapor canister having an N100,R100,or P100filter.(APF =50)Any powered,air-purifying respirator with a tight-fitting facepiece and organic vapor cartridge(s)in combination with a high-efficiency particulate filter.(APF =50)Any self-contained breathing apparatus with a full facepiece.(APF =50)Any supplied-air respirator with a full facepiece.Emergency or planned entry into unknown concentrations or IDLH conditions:(APF =10,000)Any self-contained breathing apparatus that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode.9.PHYSICAL AND CHEMICAL PROPERTIES10.STABILITY AND REACTIVITY11.TOXICOLOGICAL INFORMATION(APF =10,000)Any supplied-air respirator that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode in combination with an auxiliary self-contained positive-pressure breathing apparatus.Escape:(APF =50)Any air-purifying,full-facepiece respirator (gas mask)with a chin-style,front-or back-mounted organic vapor canister having an N100,R100,or P100filter./Any appropriate escape-type,self-contained breathing apparatus.Hand protectionImpervious gloves.S24-Avoid contact with skin.S36-Wear suitable protective clothing.Eye protectionTight sealing safety goggles.Skin and body protection Impervious clothing.Hygiene measuresContaminated work clothing should not be allowed out of the workplace.Avoid contact with skin,eyes or clothing.Handle in accordance with good industrial hygiene and safety practice.Environmental exposure ControlsPrevent product from entering drains.General information FormLiquid.Appearance Red,maroon.OdorMedicinal,sweet,tar-like.Boiling point/range °C No data available °F No data available Melting point/range °C No data available °F No data available Flash point°C No data available °F No data available Autoignition temperature °C No data available °F No data availableOxidizing properties No information available Water solubilitySolubleStabilityStable under normal conditions.Materials to avoidStrong oxidizing agents.Strong acids.Isocyanates.Heat.Nitriles,Nitrides.Alkaline earth metals.Strong oxidizers,alkali metals and alkaline earth metals may cause fires or explosions.Hazardous decomposition Toxic gas.Sulphur oxides.Hydrogen cyanide (hydrocyanic acid).Carbon oxides,ProductsNitrogen Oxides.PolymerizationHazardous polymerization does not occur.Acute toxicityChemical name LD50(oral,rat/mouse)LD50(dermal,rat/rabbit)LC50(inhalation,rat/mouse)Phenol=317mg/kg (Rat)No data available =316mg/m3(Rat)Guanidine isothiocyanate571mg/kg2000mg/kg5.319mg/L (4H)12.ECOLOGICAL INFORMATION13.DISPOSAL CONSIDERATIONS14.TRANSPORT INFORMATIONAmmonium thiocyanate =500mg/kg (Rat)No data available No data availablePrinciple Routes of Exposure Potential Health Effects Eyes Causes burns.Risk of serious damage to eyes Corrosive to the eyes and may cause severe damage including blindness.Skin Causes burns.Possible risk of irreversible effects Harmful in contact with skin.Irritating to skin and mucous membranes.Inhalation Harmful by inhalationIngestionHarmful if swallowed Ingestion causes burns of the upper digestive and respiratory tracts Ingestion may cause gastrointestinal irritation,nausea,vomiting and diarrheaCarcinogenic effects Phenol has been classified by the International Agency for Research on Cancer (IARC)as not classifiable as to carcinogenicity to humans (Group 3).Mutagenic effects No information available.Reproductive toxicity No information available.SensitizationNo information available.Target organ effectsSkin.Lungs.Liver.Spleen.Kidney.EcotoxicityHarmful to aquatic organisms,may cause long-term adverse effects in the aquatic environment.Chronic aquatic toxicity Category 3MobilitySee log PowBiodegradation Inherently biodegradable Bioaccumulation No information availableChemical name Freshwater algae data Water flea data Freshwater fish species dataMicrotox dataLog Pow PhenolDesmodesmusDaphnia magna =316mg/m3(Rat)logPow1.subspicatus EC50187EC5047-279mg/L (72h) 4.24-10.7mg/L Pseudokirchneriella (48subcapitata EC50h)Daphnia 46.42mg/L (96h)magnaEC5010.2-15.5mg/L (48h)Dispose of contents/containers in accordance with local regulations.IATA15.REGULATARY INFORMATIONProper shipping name Corrosive liquid,n.o.s.(guanidine thiocyanate-phenol solution).Hazard Class 8Subsidiary class None Packing group II UN-No 1760ERG Code 153ComponentTSCA Phenol,108-95-2(30-60)Listed Guanidine isothiocyanate,593-84-0(15-40)Listed Ammonium thiocyanate 1762-95-4(7-13)ListedUS Federal Regulations SARA 313This product contains the following toxic chemical(s)subject to the notification requirements of section 313of Title III of the Superfund Amendments and Reauthorization Act of 1986.This law requires certain manufacturers to report on annual emissions of specified chemicals and chemical categories.Please note that if you repackage,or otherwise redistribute,this product to industrial customers,a notice similar to this one should be sent to those customers:Chemical name CAS-No.Weight %SARA 313-Threshold values Phenol108-95-230-60 1.0Ammonium thiocyanate1762-95-47-131.0Clean Air Act,Section 112Hazardous Air Pollutants (HAPs)(see 40CFR 61)This product contains the following HAPs:Component CAS-No.Weight %HAPS data Phenol108-95-230-60PresentAmmonium thiocyanate1762-95-47-13Present (XCN where X=H or any other group where a formal dissociation may occur.For example KCN or Ca[CN]2)US state regulations Chemical name Massachusetts -RTK New Jersey-RTK Pennsylvania-RTK Illinois-RTK Rhode Island-RTK PhenolListed Listed Listed Listed Listed Guanidine isothiocyanate -----Ammonium thiocyanateListed-ListedListedListedCalifornia Proposition 65This product does not contain any Proposition 65chemicals.WHMIS Hazard Class D1A -Very toxic materials E -Corrosive material16.OTHER INFORMATIONThis product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR)and the MSDS contains all the information required by the CPR.Reason for revision Not Applicable.SDS sections updated.For research use only."The above information was acquired by diligent search and/or investigation and the recommendations are based on prudent application of professional judgment.The information shall not be taken as being all inclusive and is to be used only as a guide.All materials and mixtures may present unknown hazards and should be used withcaution.Since the Company cannot control the actual methods,volumes,or conditions of use,the Company shall not be held liable for any damages or losses resulting from the handling or from contact with the product as described herein.THE INFORMATION IN THIS SDS DOES NOT CONSTITUTE A WARRENTY,EXPRESSED OR IMPLIED,INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PUPOSE"End of Safety Data Sheet。
依奇珠单抗注射液Ixekizumab 英文名：Ixekizumab Injection汉语拼音：yi qi zhu dan kang zhu she ye【成份】活性成份：依奇珠单抗(由CHO细胞生产的重组人源化单克隆抗体)辅料:枸橼酸钠、无水枸橄酸、氯化钠、聚山梨酯80、注射用水【性状】本品为澄清至乳光，无色至微黄色至微棕色溶液，基本无可见颗粒。
【适应症】本品用于治疗适合系统治疗或光疗的中度至重度斑块型银屑病成人患者。
【规格】80mg/mL(自动注射器)【用法用量】本品应在具有诊断和治疗本品适应症经验的医师指导和监督下使用。
剂量:推荐剂量为在第0周皮下注射160mg(80mg注射两次)，之后分别在第2、4、6、8、10和12周各注射80mg(注射一次)，然后维持剂量为80mg(注射一次)每4周一次。
老年患者(≥65岁)无需调整剂量(参见[药代动力学])。
年龄≥75岁受试者的信息有限。
肾脏或肝脏损害：本品尚未在这些患者群体中开展研究。
无法提出剂量建议。
儿童：对于6至18岁的儿童和青少年，本品用于治疗中度至重度斑块型银屑病的安全性和有效性尚未建立。
尚无数据。
在6岁以下儿童中没有使用本品治疗中度至重度斑块型银屑病的经验。
给药方法：皮下给药。
本品用于皮下注射。
应轮换使用注射部位。
如果可能，应避免将银屑病受累皮肤作为注射部位。
不得剧烈摇晃溶液/自动注射器。
经过适当的皮下注射技术培训后，如果医护人员确定适当的话，患者可以自行注射依奇珠单抗。
但是，医师应确保对患者进行适当的随访。
包装说明书中包含全面的使用说明。
【不良反应】安全性摘要报告频率最高的药物不良反应(ADR)是注射部位反应和上呼吸道感染(鼻咽炎最为常见)。
不良反应列表：按MedDRA系统器官分类列出来自临床研究和上市报告（表1）的ADR。
在每个系统器官类别中，按发生频率排序ADR，发生频率最高的排列在前。
在同一排列组中，按严重程度降序排列药物不良反应。
