拜科奇说明
卡莫齐产品使用说明说明书
Information for the use of Camozzi productsCATALOGUE >Release 8.5APPENDIX >Camozzi products/2.0101A P P E N D I XJust browsing through the pages of our website , you will have the possibility to download GSD files for the configuration of Valve Islands, all relative use and installation manuals and the configuration software of the product codes.Moreover, here you can find all 2D and 3D files in the most commonly used formats.a/2.0102a A P P E N DI XDouble-acting cylinder, fixed cushionsDouble-acting cylinder, cushionedDouble-acting cylinder, adjustable rear cushionDouble-acting cylinder, adjustable front cushionDouble-acting cylinder, through-rod, fixed cushionsDouble-acting cylinder, through-rod,adjustable front and rear cushion Double-acting cylinder, magneticDouble-acting cylinder, magnetic, fixed cushionsDouble-acting cylinder, magnetic, adjustable cushions in both directionsDouble-acting cylinder, magnetic, adjustable rear cushionDouble-acting cylinder, magnetic, adjustable front cushionDouble-acting cylinder, magnetic, through-rod, fixed cushionsDouble-acting cylinder, magnetic, through-rod, adjustable cushions in both directionsDouble-acting cylinder, magnetic, through-rodMagnetic twin rod cylindersMagnetic twin through-rod cylindersDouble-acting rotary cylinderDouble-acting rotary cylinder, magneticSingle-acting rotary cylinderMagnetic tandem cylinder, two stages, fixed cushionsMagnetic tandem cylinder, three stages, fixed cushionsMagnetic tandem cylinder, four stages, fixed cushionsMagnetic multi-position cylinder, fixed cushionsDouble-acting rodless cylinder, magneticCYLINDERSCYLINDERSSingle-acting cylinder, front springSingle-acting cylinder,non cushionedSingle-acting cylinder, through-rodSingle-acting cylinder, through-rod, adjustable cushionSingle-acting cylinder, magneticSingle-acting cylinder, front spring, adjustable rear cushionSingle-acting cylinder, rear spring, magneticSingle-acting cylinder, magnetic, front springSingle-acting cylinder, through-rodSingle-acting cylinder, through-rod, adjustable rear cushionSingle-acting cylinder, front spring, adjustable rear cushionSingle-acting cylinder, through-rod, adjustable rear cushionHydrocheck, regulated rod thrustHydrocheck, regulated rod return Hydrocheck, regulated rod thrust with stop valveHydrocheck, regulated rod return with stop valveHydrocheck, regulated rod thrust with skip valveHydrocheck, regulated rod return with skip valveHydrocheck, regulated rod thrust with skip and stop valveHydrocheck, regulated rod return with skip and stop valve Double-acting magnetic grippersRod lock deviceSOLENOID VALVESDirectly operated solenoid valve, 2/2 NCCD01CD02CD03CD04CD05CD06CD07CD08CD09CD10CD11CD12CD13CD14CD15CD16CD17CD18CD19CD2TCD3TCD4TCDPPCDSSCS03CS04CS05CS06CS07CS08CS09CS10CS11HI01HI02HI03HI04HI05HI06HI07HI08PNZ1RDLKEV01CATALOGUE >Release 8.5APPENDIX >Camozzi products Pneumatic symbols/2.0301A P P E N D I XSymbol TypeSymbol TypeCS13Symbol TypeSymbol TypeSOLENOID VALVESSOLENOID VALVESDirectly operated solenoid valve, 3/2 NCDirectly operated solenoid valve, 3/2 NC, monostable, with manual overrideDirectly operated solenoid valve, 3/2 NODirectly operated solenoid valve, 3/2 NO, monostable, with manual overrideSolenoid valve, 3/2 NC with quick exhaustDirectly operated solenoid valve, 3/2 NC, bistable, with manual overrideDirectly operated solenoid valve, 3/2 NO, bistable, with manual overrideSolenoid valve, 3/2 NC, monostable, with bistable manual overrideSolenoid valve, 3/2, monostable,solenoid pilot with separate air supply and bistable manual override Solenoid valve, 3/2 NO, monostable, with bistable manual overrideSolenoid valve, 3/2, monostable,solenoid pilot with separate air supply and bistable manual override Solenoid valve, 3/2, bistable, with manual override bistabileSolenoid valve, 3/2, bistable,solenoid pilot with separate air supply and bistable manual overrideSolenoid valve, 3/2 NC, monostable, (pneumatic spring) and bistable manual overrideSolenoid valve, 3/2 NO, monostable, (pneumatic spring) and bistable manual overrideSolenoid valve, 5/2, monostable, with bistable manual overrideSolenoid valve, 5/2, monostable,solenoid pilot with separate air supply and bistable manual overrideSolenoid valve, 5/2, monostable,(pneumatic spring) and manual overrideSolenoid valve, 5/2, monostable,(pneumatic spring) and bistable manual overrideSolenoid valve, 5/2, monostable, solenoid pilot with separate air supply, pneumatic spring and bistable manual override Solenoid valve, 5/2, bistable, with bistable manual overrideSolenoid valve, 5/2, bistable, with manual overrideSolenoid valve, 5/2, bistable,solenoid pilot with separate air supply and bistable manual overrideSolenoid valve, 5/3 CC,with bistable manual overrideSolenoid valve, 5/3, solenoid pilot with separate air supply and bistable manual overrideSolenoid valve, 5/3, solenoid pilot with separate air supply and bistable manual override Solenoid valve, 5/3 CO, with manual overrideSolenoid valve, 5/3 CO,with bistable manual overrideSolenoid valve, 5/3 CO,solenoid pilot with separate air supply and bistable manual overrideSolenoid valve, 5/3 CO,solenoid pilot with separate air supply and bistable manual override Solenoid valve, 5/3 CP , with manual overrideSolenoid valve, 5/3 CP ,with bistable manual overrideSolenoid valve, 5/3 CP , solenoid pilot with separate air supply and bistable manual override Solenoid valve, 5/3 CP , solenoid pilot with separate air supply and bistable manual overrideDouble solenoid valve, 3/2 NC,monostable, with bistable manual overrideDouble solenoid valve, 3/2, monostable, solenoid pilot with separate air supply and bistable manual overrideDouble solenoid valve, 3/2 NO,monostable, with bistable manual overrideDouble solenoid valve, 3/2, monostable, solenoid pilot with separate air supply and bistable manual overrideDouble solenoid valve, 3/2 NC, NO,monostable, with bistable manual overrideDouble solenoid valve, 3/2, monostable, solenoid pilot with separate air supply and bistable manual overrideDirectly operated solenoid valve, 3/2,possible universal use, reversed printed ports 1 and 2 on the bodyIndirectly operated solenoid valve, 2/2 NODirectly operated solenoid valve, 2/2 NC, with linked diaphragmIndirectly operated solenoid valve, 2/2 NCPNEUMATICALLY OPERATED VALVES Pneumatically operated valve,3/2, monostable, mechanical spring Pneumatically operated valve, 3/2, bistableEV05EV06EV07EV08EV09EV10EV11EV12EV13EV14EV15EV16EV17EV18EV19EV20EV21EV22EV23EV24EV25EV26EV48EV47EV46EV43EV42EV45EV44EV41EV40EV39EV38EV37EV36EV35EV30EV31EV32EV33EV34APPENDIX >Camozzi productsCATALOGUE >Release 8.5/2.0302aA P P E N D I XEV04EV03EV29EV28CATALOGUE >Release 8.5APPENDIX >Camozzi productsa /2.0303A P P E N D I XVN01VN02VN03VN04VN05VN06VN07VN08VN09VN10VN11VN12VN13VN14VN15VN16VN17VN18VN19VN20VN21VN22VN23VN24VN25Symbol TypeSymbol TypePNEUMATICALLY OPERATED VALVES MECHANICALLY OPERATED VALVES Pneumatically operated valve, 5/2, preferentialPneumatically operated valve, 5/2, bistablePneumatically operated valve, 5/2, monostable, pneumatic spring Pneumatically operated valve, 5/3 CCPneumatically operated valve, 5/3 COPneumatically operated valve, 5/3 CPPneumatically operated double valve, 3/2, monostablePneumatically operated double valve, 3/2, monostablePneumatically operated double valve, 3/2, monostableMECHANICALLY OPERATED VALVES Mechanically operated valve, plunger actuation, 3/2 NC, monostable, mechanical spring Mechanically operated valve, plunger actuation, 3/2, monostable, mechanical springMechanically operated valve, plunger actuation, 3/2 NO, monostable, mechanical spring Mechanically operated valve,lever/roller actuation, 3/2 NC, monostable,mechanical springMechanically operated valve,lever/roller actuation, 3/2, monostable, mechanical springMechanically operated valve,lever/roller actuation, 3/2 NO, monostabile,mechanical springMechanically operated valve, unidirectional lever actuation, 3/2 NC, monostable, mechanical springMechanically operated valve, unidirectional lever actuation,3/2 monostable, mechanical springMechanically operated valve, plunger actuation, 5/2, monostable, mechanical springMechanically operated valve, plunger actuation, 5/2, monostable, mechanical springMechanically operated valve, lever/rolleractuation, 5/2, monostable, mechanical spring Mechanically operated valve, lever/rolleractuation, 5/2, monostable, mechanical spring Mechanically operated valve,unidirectional lever actuation, 5/2, monostable, mechanical spring Mechanically operated sensor valve, 3/2 NO, monostable, mechanical spring Mechanically operated sensor valve, 3/2 NC, monostable, mechanical spring Mechanically operated sensor valve, plunger actuation, 5/2, monostable, mechanical springMechanically operated sensor valve, plunger actuation, 5/2, bistable Valvola a comando meccanico frontale sensibile 5/2, bistabile Mechanically operated sensor valve, lever/roller actuation, 5/2, bistableMANUALLY OPERATED VALVES Manually operated valve, 3/2, bistableManually operated valve, 3/2, bistable, lockable in two positions Manually operated valve, 3/2, bistableManually operated valve, 3/2 NC, monostable, mechanical spring Manually operated valve, 3/2 NO, monostable, mechanical spring Manually operated valve, 3/2, monostable, mechanical spring Manually operated lever valve, 3/2, bistableManually operated lever valve, 3/2, bistableManually operated lever valve, 3/2 NC, monostable, mechanical spring Manually operated lever valve, 3/2, bistableManually operated lever valve, 3/2, monostable, mechanical spring Pedal operated valve, 3/2 NC, monostable, mechanical spring Manually operated valve, 5/2, bistableManually operated valve, 5/2, monostable, mechanical spring Manually operated lever valve, 5/2, bistableManually operated lever valve, 5/2, bistableManually operated lever valve, 5/2, monostable, mechanical spring Pedal operated valve, 5/2, bistablePedal operated valve, 5/2, monostable bistableManually operated lever valve, 5/3 CC, stableManually operated lever valve, 5/3 CC, monostableManually operated lever valve, 5/3 CO, stableManually operated lever valve, 5/3 CO, stableManually operated lever valve, 5/3 CO, monostableManually operated lever valve, JoystikVP06APPENDIX >Camozzi productsCATALOGUE >Release8.5/2.0304aA P P E N D I XFT01FT02FT03FA01FA02FA03FC01PR01PR02PR03PR04PR05PR06LU0FR01FR02AMP1VMP1CATALOGUE >Release 8.5APPENDIX >Technical information about productsSpring loads cylinders/3.0101A P P E N D I XAPPENDIX >Technical information about productsCATALOGUE >Release8.5a /3.0102aA P P E N D IX* F = spring forceFlow and speed cylindersCATALOGUE >Release 8.5APPENDIX >Technical information about products/3.0201A P P E N D IXAPPENDIX >Technical information about productsCATALOGUE >Release8.5/3.0301aA P P E N D I XOutput forces double-acting cylindersThrust sideValues in NewtonTraction sideValues in NewtonTraction sideValues in Newtona /3.03A P P E N D I Xa P E N D I X Table showing air consumption of double-acting cylindersThrust side Values in NL for each 10 mm of stroke Traction side Values in NL for each 10 mm of stroke/3.04A P P E N D I X Traction sideValues in NL for each 10 mm of strokea P E N D I X Dimensioning guide for Shock Absorbers Series SAa /3.05A P P E N D IX Calculation:a P E N D I X = 600 cycles/h ω= 100 cycles/h To ensure the lifetime of the shock absorber, the movement of the impact bodymust be perpendicular to the shock absorbers axial centre.Note : The maximum allowable eccentricity θ≤ 2,5° (0,044 rad).Perpendicularity of the loadωL o a d7. Vacuum switch6. Solenoid valves5. Vacuum generator4. Vacuum hose3. Mounting elements2. Suction pads1. Calculation of the forcesFlowchart for system design Example of Vacuum calculationa /3.07A P P E N D I XComparison:A comparison of the figures for load cases I and II results, in this example, in a maximum value for FTH =1822 N in load case II,and this value is therefore used for further design calculations.a P E N D I X/3.07A P P E N D I Xa P E N DI XCATALOGUE >Release 8.5APPENDIX >Technical information about productsTechnical information about suction padsWhen designing a vacuum circuit and selecting suitable suction pads it is necessary to follow certain calculations toselect each individual component in a correct way.Listed below is a summary of the most common data to take into consideration./3.0801A P P E N D I XAPPENDIX >Technical information about productsCATALOGUE >Release8.5a /3.0802aA P P E N D I X。
伊伐布雷定说明书
核准日期：2015年4月29日盐酸伊伐布雷定片说明书请仔细阅读说明书并在医师指导下使用【药物名称】通用名称：盐酸伊伐布雷定片商品名称：可兰特®/CORLENTOR®英文名称：Ivabradine Hydrochloride Tablets汉语拼音：Yansuan Yifabuleiding Pian【成份】本品活性成份为盐酸伊伐布雷定。
化学名称：3-(3-{[((7S)-3,4-二甲氧基双环[4.2.0]辛-1,3,5-三烯-7-基)甲基]甲氨基}丙基)-1,3,4,5-四氢-7,8-二甲氧基-2H-3-苯并氮杂卓-2-酮，盐酸盐化学结构式：分子式：C27H36N2O5•HCl分子量：505.1【性状】本品为橙色薄膜衣片，5mg片剂为椭圆形，7.5mg片剂为三角形，除去包衣显白色。
【适应症】适用于窦性心律且心率≥75次/分钟、伴有心脏收缩功能障碍的NYHAⅡ～Ⅳ级慢性心力衰竭患者，与标准治疗包括β-受体阻滞剂联合用药，或者用于禁忌或不能耐受β-受体阻滞剂治疗时。
【规格】按C27H36N2O5计：（1）5mg ；（2）7.5mg 。
【用法用量】口服，一日两次，早、晚进餐时服用（见【药代动力学】）。
本品起始治疗仅限于稳定性心力衰竭患者。
建议在有慢性心力衰竭治疗经验的医生指导下使用。
通常推荐的起始剂量为5mg，一日两次。
治疗2周后，如果患者的静息心率持续高于60次/分钟，将剂量增加至7.5mg，一日两次；如果患者的静息心率持续低于50次/分钟或出现与心动过缓有关的症状，例如头晕、疲劳或低血压，应将剂量下调至2.5mg（半片5mg片剂），一日两次；如果患者的心率在50和60次/分钟之间，应维持5mg，一日两次。
治疗期间，如果患者的静息心率持续低于50次/分钟，或者出现与心动过缓有关的症状，应将7.5mg或5mg一日两次的剂量下调至下一个较低的剂量。
如果患者的静息心率持续高于60次/分钟，应将2.5mg或5mg一日两次的剂量上调至上一个较高的剂量。
Ibrance中文说明书
【药物名】Palbociclib【商品名】Ibrance【美国上市时间】乳腺癌，2015年2月【类别】抑制剂【靶点】CDK4,CDK6【分子结构】分子式：C24H29N7O2化学名：6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one结构式为：分子量：447.54 Da【生产公司】Pfizer 辉瑞公司【购买地】美国【剂型和规格】口服胶囊，规格为：125 mg、100 mg和75 mg。
125mg胶囊：不透明硬明胶胶囊，大小0，在胶囊的焦糖帽上用白墨汁印有“Pfizer”，在浅橙色体上印有“PBC 125”。
100mg胶囊：不透明硬明胶胶囊，大小1，在胶囊的焦糖帽上用白墨汁印有“Pfizer”，在浅橙色胶囊体上印有“PBC 100”。
75mg胶囊：不透明硬明胶胶囊，大小2，在浅橙色胶囊帽上用白墨汁印有“Pfizer”，在浅橙色胶囊体上印有“PBC 75”。
【处方】Palbociclib是一种黄色至橙色粉有pKa为7.4(第二哌嗪氮)和3.9(吡啶氮)。
在或低于pH 4，Palbociclib行为如同高溶解度化合物。
高于pH 4，药物物质溶解度显著减低。
无活性成分：微晶纤维素，一水乳糖，羟基乙酸淀粉钠，胶体二氧化硅，硬脂酸镁，和硬明胶胶囊壳。
浅橙色，浅橙色/焦糖和焦糖不透明胶囊壳含明胶，红色氧化钛，黄色氧化铁，和二氧化钛；和印刷油墨含虫胶，二氧化钛，氢氧化铵，丙二醇和二甲基硅油。
【作用机理】Palbociclib是一种周期蛋白-依赖激酶(CDK)4和6的抑制剂。
周期蛋白D1和CDK4/6是导致细胞增殖信号通路的下游。
在体外，Palbociclib雌激素受体(ER)-阳性乳癌细胞株通过阻断细胞从细胞周期G1进入S期的进展减低细胞增殖。
用palbociclib和抗雌激素的联合处理与单独各个药物处理比较，乳癌细胞株导致视网膜母细胞瘤蛋白(Rb)磷酸化的减低导致减低E2F表达和信号和阻止增加生长。
重组人凝血因子Ⅷ药品安全性及体内药学特性评价
重组人凝血因子Ⅷ药品安全性及体内药学特性评价霍记平;赵志刚【摘要】血友病A是凝血因子Ⅷ缺乏引起的出血性疾病,重组人凝血因子Ⅷ(重组FⅧ)因能大大降低病原体感染风险,被多数指南推荐使用.本文根据中国药品综合评价指南,对我国上市的4种重组FⅧ制剂的药品安全性和体内药学特性从两方面进行比较,以促进临床安全合理用药.这4种产品均可用于A型血友病出血的控制和预防,但4种药品在半衰期方面存在一定差异,在抑制物发生率差异方面尚需在临床实践中进一步验证.临床用药应结合患者个体情况,优先选择半衰期较长的药品,以使患者达到最佳治疗效果.【期刊名称】《药品评价》【年(卷),期】2019(016)010【总页数】5页(P3-6,37)【关键词】血友病A;重组FⅧ;安全性;体内药学特性【作者】霍记平;赵志刚【作者单位】首都医科大学附属北京天坛医院药学部,北京 100070;首都医科大学附属北京天坛医院药学部,北京 100070【正文语种】中文【中图分类】R969.1血友病是一种由凝血因子基因突变引起的X染色体连锁的隐性遗传性出血性疾病，主要分为血友病A(凝血因子Ⅷ缺乏)和血友病B(凝血因子Ⅸ缺乏)，分别约占所有血友病患者的80%～85%和15%～20%。
目前我国血友病的患病率为2.73/10万人口。
血友病患者严重出血时如不及时治疗可危及生命[1]。
凝血因子替代治疗是目前血友病有效的治疗措施，替代治疗药物主要包括重组人凝血因子Ⅷ(重组FⅧ)和血源性人凝血因子Ⅷ(血源FⅧ)[1]。
使用不含任何血液成分的基因重组因子能大大降低已知和未知病原体感染风险，多数指南推荐重组FⅧ治疗[2,3]。
由于不同品牌的药品质量差异较大，加上血友病患者需要终生治疗，这就给患者和医生选择药品带来很大压力[4]。
2018年发表在药品评价的《凝血因子Ⅷ药品综合评价》对中国上市的4种血源FⅧ和3种重组FⅧ进行了综合评价。
2018年新型重组FⅧ科跃奇®上市，为使不同重组FⅧ制剂综合评价更加全面，本文拟依据中国药品综合评价指南从药品安全性和体内药学特性两方面对目前国内市售的4种重组FⅧ制剂进行比较，以期为临床合理用药提供参考。
拜科奇产品手册
目录
.1 . . . . . .1 .1.1 .1. .1. .1. .1. . ..1 .. .1 . . . . . . . 10 11
拜科奇的产品特性 ......................................................................................................... 质量保证........................................................................................................................ 产品纯度........................................................................................................................ 耐受性和安全性的临床前证据 ....................................................................................... 临床前免疫原性模型...................................................................................................... 临床前疗效研究............................................................................................................. 拜科奇临床前研究小结 .................................................................................................. 临床研究........................................................................................................................ 对既往接受过治疗的患者（PTPs）的研究.................................................................... 0 药代动力学 .................................................................................................................... 0 疗效............................................................................................................................... 临床免疫原性 ................................................................................................................ 外科手术中的应用 ......................................................................................................... 安全性 ........................................................................................................................... 对既往未接受过治疗（PUPs）或仅接受过最低限度治疗（MTPs）的患者的研究 ....... 拜科奇用于治疗PUPs/MTPs的安全性及疗效 ................................................................ PUPs/MTPs中抑制物的产生率...................................................................................... 重组人凝血因子VIII抑制物的形成.................................................................................. 1 抑制物形成的潜在标志物 .............................................................................................. 1 抑制物形成的发生率...................................................................................................... 抑制物分子 ................................................................................................................... 抑制物的特异性............................................................................................................. 对PTPs的临床免疫原性研究 ......................................................................................... PUPs/MTPs中抑制物发生率的比较 ............................................................................. 抑制物产生的累积风险 .................................................................................................. 0 小结：拜科奇与凝血因子VIII抑制物 .............................................................................. 1 免疫耐受诱导 (ITI) ........................................................................................................ 长期预防........................................................................................................................ 产品亮点总结 ................................................................................................................ 0 参考文献........................................................................................................................
Oxlumo (Lumasiran) 用药指南说明书
UnitedHealthcare ® Community PlanOxlumo ® (Lumasiran)Policy Number : CS2023D0102H Effective Date : December 1, 2023 Instructions for UseTable of Contents Page Application ..................................................................................... 1 Coverage Rationale ....................................................................... 1 Applicable Codes .......................................................................... 2 Background .................................................................................... 2 Clinical Evidence ........................................................................... 3 U.S. Food and Drug Administration ............................................. 3 References ..................................................................................... 3 Policy History/Revision Information ............................................. 4 Instructions for Use ....................................................................... 4 This Medical Benefit Drug Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted: StatePolicy/Guideline FloridaRefer to the state's Medicaid clinical policy IndianaOxlumo ® (Lumasiran) (for Indiana Only) KansasNone LouisianaOxlumo ® (Lumasiran) (for Louisiana Only) North CarolinaNone OhioOxlumo ® (Lumasiran) (for Ohio Only)TexasRefer to drug specific criteria found within the Texas Medicaid Provider Procedures ManualOxlumo is proven and medically necessary for the treatment of PH1 when all of the following criteria are met:For initial therapy , all of the following: o Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1; ando Confirmation of the PH1 diagnosis based on both of the following: ▪ Metabolic testing demonstrating one of the following:Increased urinary oxalate excretion [e.g., greater than 1 mmol/1.73 m 2 per day (90 mg/1.73 m 2 per day),increased urinary oxalate: creatinine ratio relative to normative values for age]; orIncreased plasma oxalate and glyoxylate concentrations and▪ Genetic testing has confirmed a mutation in the alanine: glyoxylate aminotransferase (AGT or AGXT) geneand o Patient has not received a liver transplant; andCommercial Policy • Oxlumo ® (Lumasiran)o Oxlumo is prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1; ando Oxlumo dosing is in accordance with the United States Food and Drug Administration approved labeling; ando Initial authorization will be for no more than 6 monthsFor continuation of therapy, all of the following:o Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); ando Patient has not received a liver transplant; ando Oxlumo is prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1; ando Oxlumo dosing is in accordance with the United States Food and Drug Administration approved labeling; ando Reauthorization will be for no more than 12 monthsThe following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.HCPCS Code DescriptionJ0224 Injection, lumasiran, 0.5 mgDiagnosis Code DescriptionE72.53 Primary hyperoxaluriaPrimary hyperoxaluria (PH) is a rare inborn error of glyoxylate metabolism characterized by the overproduction of oxalate, which is deposited as calcium oxalate in various organs. In particular, the kidney is a prime target for oxalate deposition, as excessive urinary excretion of oxalate may lead to end-stage renal disease (ESRD). PH is primarily caused by autosomal recessive enzymatic defects in pathways of glyoxylate metabolism that result in enhanced oxalate production. PH type 1 (approximately 80 percent of cases) is due to mutations of hepatic peroxisomal enzyme alanine: glyoxylate aminotransferase (AGT). Glycolate oxidase (GO) is an enzyme responsible for the metabolism of glycolate to glyoxylate and glyoxylate to oxalate. Lumasiran reduces levels of GO enzyme by targeting the hydroxy acid oxidase 1 (HAO1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. As the GO enzyme is upstream of the deficient alanine: glyoxylate aminotransferase (AGT) enzyme that causes PH1, the mechanism of action of lumasiran is independent of the underlying AGXT gene mutation. Lumasiran is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3) because its mechanism of action does not affect the metabolic pathways causing hyperoxaluria in PH2 and PH3.In patients with PH, the increased urinary excretion of oxalate results in an oversaturated urine for calcium oxalate, which leads to urolithiasis and nephrocalcinosis. Recurrent stones and progressive nephrocalcinosis cause renal parenchymal inflammation and fibrosis, and if persistent, may progress to ESRD. As renal function deteriorates, plasma oxalate exceeds 30 micromol/L (the plasma supersaturation threshold for calcium oxalate), because of reduced urinary oxalate excretion. This leads to calcium oxalate deposition into nonrenal tissues including the retina, myocardium, vessel walls, skin, bone, and the central nervous system (systemic oxalosis). Liver transplantation is the only curative intervention for PH type 1 as it corrects the underlying enzymatic defect due to mutations of the AGXT gene.The efficacy of lumasiran was established in a pivotal placebo-controlled and open-label clinical studies (ILLUMINATE-A, ILLUMINATE-B, and a phase 1/2 study) in 77 patients with PH1 (including 56 pediatric patients). Patients ranged in age from 4 months to 61 years at first dose. The median duration of exposure was 9.1 months (range 1.9 to 21.7 months). Overall, 58 patients were treated for at least 6 months, and 18 patients for at least 12 months.A phase 1/2 study evaluated lumasiran at multiple doses in a single blind, randomized, placebo-controlled trial in 20 patients with PH1. Patients were randomized 3:1 to receive lumasiran and all patients received lumasiran in the open-label extension phase. After a median of 7 months on lumasiran, patients experienced a 66% mean reduction of urinary oxalate content from baseline. Among patients receiving 3.0 mg/kg monthly or quarterly doses of lumasiran, 10/12 (83%) achieved urinary oxalate levels within the normal range.ILLUMINATE-A was a randomized, double-blind trial comparing lumasiran and placebo in 39 patients ≥ 6 years of age with PH1 and an eGFR ≥ 30 mL/min/1.73 m2 (ILLUMINATE-A; NCT03681184). Patients received 3 loading doses of 3 mg/kg lumasiran (n = 26) or placebo (n = 13) administered once monthly, followed by quarterly maintenance doses of 3 mg/kg lumasiran or placebo. The primary endpoint from ILLUMINATE A was the percent reduction from baseline in 24-hour urinary oxalate excretion corrected for BSA averaged over months 3 through 6. The LS mean percent change from baseline in 24-hour urinary oxalate in the lumasiran group was -65% (95% CI: -71, -59) compared with -12% (95% CI: -20, -4) in the placebo group, resulting in a between-group LS mean difference of 53% (95% CI: 45, 62; p < 0.0001). By Month 6, 52% (95% CI: 31, 72) of patients treated with lumasiran achieved a normal 24-hour urinary oxalate corrected for BSA (≤ 0.514 mmol/24 hr/1.73 m2) compared to 0% (95% CI: 0, 25) placebo-treated patients (p = 0.001).ILLUMINATE-B was a single-arm study in 18 patients < 6 years of age with PH1 and an eGFR > 45 mL/min/1.73 m2 for patients ≥ 12 months of age or a normal serum creatinine for patients < 12 months of age (ILLUMINATE-B; NCT03905694). The median age was 47 months (range 4 to 74 months). The primary endpoint was the percent reduction from baseline in spot urinary oxalate: creatinine ratio averaged over months 3 through 6. Patients treated with lumasiran achieved a reduction in spot urinary oxalate: creatinine ratio from baseline of 71% (95% CI: 65, 77).The approval of lumasiran for the expanded indication to include lowering of plasma oxalate levels was based on ILLUMINATE-C, a single-arm study in 21 patients with PH1, including patients on hemodialysis. Cohort A included 6 patients who did not require dialysis at the time of study enrollment. Cohort B included 15 patients who were on a stable regimen of hemodialysis. The primary endpoint was the percent change in plasma oxalate from baseline to month 6 for Cohort A and the percent change in pre-dialysis plasma oxalate from baseline to month 6 for Cohort B. The percent change from baseline to month 6 in plasma oxalate levels in Cohort A was a least-squares (LS) mean difference of -33% (95% CI: -82, 15) and in Cohort B it was -42% (95% CI: -51, -34).This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.1.Oxlumo [package insert] Cambridge MA, Alnylam Pharmaceuticals, Inc. September 2023.2.Cochat P, Hulton SA, Acquaviva C, et al. Primary Hyperoxaluria Type 1: Indications for Screening and Guidance forDiagnosis and Treatment. Nephrol Dial Transplant 2012; 27:1729.3.Hoppe B, Beck BB, Milliner DS. The primary hyperoxalurias. Kidney Int 2009; 75:1264.4.Niaudet P. Primary Hyperoxaluria. In: UpToDate, Mattoo TK, Kim MS, (Ed), UpToDate, Waltham, MA, 2020.5. A Phase 1/2 Trial of Lumasiran (ALN-GO1), An Investigational RNA Interference (RNAi) Therapeutic, For PrimaryHyperoxaluria Type 1. ESPN Annual Meeting. Antalya, Turkey. 4 October 2018.6. A Study to Evaluate Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 (ILLUMINATE-A). website: https:///ct2/show/NCT03681184?term=lumasiran&draw=2&rank=4. Accessed December 1, 2020.7. A Study of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1 (ILLUMINATE-B). website: https:///ct2/show/NCT03905694?term=lumasiran&draw=2&rank=2. Accessed December 1, 2020.8. A Study to Evaluate Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (ILLUMINATE-C). website: https:///ct2/show/NCT04152200?term=lumasiran&draw=2&rank=1. Accessed October 11, 2022.Date Summary of Changes12/01/2023 Supporting InformationUpdated References section to reflect the most current informationArchived previous policy version CS2023D0102GThis Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage, the federal, state or contractual requirements for benefit plan coverage must be referenced as the terms of the federal, state or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event of a conflict, the federal, state or contractual requirements for benefit plan coverage govern. Before using this policy, please check the federal, state or contractual requirements for benefit plan coverage. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. The UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.。
A型血友病儿童患者的常规预防
本品可用于儿童患者的常规预防，即对既往没有关节损伤的儿童患者常规预防，以降低出血发生频率和降低发生关节 损伤的风险。
本品不适用于血管性血友病。
【规格】 250 IU/瓶 500 IU/瓶 1000 IU/瓶
【用法用量】 配制后仅用于静脉注射 本品首次使用，应在具有治疗 A 型血友病经验的医生的指导下进行。 在标签上，本品均以国际单位（IU）标示重组人凝血因子Ⅷ的效价。 治疗的剂量和持续时间决定于Ⅷ因子缺乏的严重程度，出血的部位和范围以及患者的临床状况。 在大型手术和
1. 在无菌条件下配制本品。 2. 在手中对未开启的药瓶和注射器加温，使其达到舒适温度（切勿超过 37°C 或 99°F）。 3. 将保护盖从药瓶上取下（A）。使用酒精消毒橡胶塞，注意不要手持橡胶塞。 4. 将药瓶放在一个牢固、防滑的表面上。撕下药瓶适配器塑料外罩上的纸质标签 。不要从塑料外罩上取下适配器。
手术类型
小型手术 包括拔牙
治疗所需的Ⅷ因子水平（IU/dL 维持治疗效果的血浆水平所必
或正常水平的%）
须的剂量和给药频率
30～60
15～30IU/kg
每12～24小时重复给药，直到 出血得到控制
2 / 12
大型手术
围手术剂量50IU/kg。术前确定
包括扁桃体切除术、腹股沟疝 切开术、滑膜切除术、全膝关
出血类型
治疗所需的Ⅷ因子水平 维持治疗效果的血浆水平所必须
（IU/dL 或正常水平的%）
的剂量和给药频率
轻度出血
20～40
10～20IU/kg
早期关节积血、小范围的肌肉 或口腔出血
如存在进一步出血的证据，重复给 药。
中度出血
30～60
BEKOMAT 系列蒸汽吸收器产品说明书
Condensate technology | BEKOMAT ® 31U | 32U | 33U | 33U CODuring compressed air generation and processing, the optimum quality for the application should be achieved. It is important to remove contaminants and humidity from the compressed air as these can lead to quality problems, failures or loss of production. Condensate discharge without compressed air lossThe BEKOMAT® drains off condensate withoutloss of compressed air, thus reducing energy costs and CO2emissions. This is made possible by the integrated capacitive sensor,smart electronics for volume-controlled condensate dischargeand the proven pilot-controlled solenoid valve.The BEKOMAT® designed for quick and cost-effective servicing The innovative design of the BEKOMAT® 31U, 32U, 33U and 33U CO models is optimised for easy handling, installation and maintenance. The devices consist of no more than three assemblies joined together with quick-release connectors. Once installed, the control and sensorunit stays in place as only theservice unit (including all wearand pressure parts) needs to beexchanged.This sturdy condensate drain issuitable for both oil-contaminatedand oil-free, aggressivecondensate. ›No loss of compressed air during draining ›Low operating costs›Outstanding reliability›Durable and resistant to dirt›Large valve diameters prevent the formationof emulsions›No delicate mechanical components›Suitable for temperatures up to +70 °C› Easy to install and virtuallymaintenance-free›Versatile connection options›Easy exchange of service unit, even wherespace is confirmed with even in small areas›Servicing requires no installation work›Automated operationand monitoring›Ready for integration into modern systemmonitoring installations›Automatic start of self-cleaning processbased on dirt particle load›Service indicator warns operators in advancewhen the service unit needs to be replacedThe quickest route to efficiency: the BEKOMAT ® with service unitDimensions in mmDepth: 65Dimensions in mm* For more information on climate zones ( | | ) see reverse** Short-term peak volume can only be achieved if the device is correctly installed according to the operating manual. If in doubt, a install venting line.Depth: 73BEKO TECHNOLOGIES Ltd Unit 11-12 Moons Park Burnt Meadow Road North Moons Moat Redditch, B98 9PAPhone + 44 (0) 1527 575778 *************************.uk carbon neutral | DE-077-457728print production78-00073e.g. Northern Europe, Canada, Northern USA, Central Asia e.g. Central and Southern Europe, Central Americae.g. South-East Asian coastal regions, Oceania, Amazon and Congo regionsTemperature range: 1 to + 60 °CClimate – a key factorThe general climate and the ambient temperature are important factors for the formation of condensate in compressed air systems. That is why we quote separate performance data of our BEKOMAT ® models for three climate zones:Like all high-performance devices, the BEKOMAT ® needs to be serviced from time to time. This is done with our service unit containing all the necessary wearing parts. If you require assistance, contact our service technicians, who are also qualified to examine and assess your entire compressed air system for further optimisation.Service unitSubject to technical changes without prior notice. Errors and omissions excepted.Visit us atDo you have questions about the best way of processing your compressed air?We have the answers! We offer efficient solutions for any type of processing chain. Please contact us with all your queries. We would be delighted to tell you more about our condensate treatment, filtration, drying, measuring and process technology, and our comprehensive services.。
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拜科奇说明书
【批准文号】
S2*******
【中文名称】
注射用重组人凝血因子VIII
【产品英文名称】
Recombinant Coagulation FactorVIII for Injection
【生产企业】
Bayer HealthCare AG
【功效主治】
用于血浆凝血因子VⅢ(FVⅢ)缺乏的甲型血友病治疗。
在纠正或预防出血、急诊或择期手术中，本品起到暂时代替缺失的凝血因子的作用。
【化学成分】
重组人凝血因子VIII，加入了蔗糖、甘氨酸组氨酸等。
【药理作用】
人凝血因子VIII是正常血浆的组成成分，在血液凝固过程中起着必不可少的作用。
拜科奇对纠正和预防因因子VIII缺乏而致的严重出血有疗效。
输用每公斤体重1个单位的人凝血因子VIII可使循环血液中的因子VIII水平增加2%到25%。
对血友病患者的临床研究显示因子VIII的生物半衰期在6-14小时之间。
用TNBP和Tween 80进行的有机溶剂清洁剂(SD)灭活病毒处理对人类致病病毒如HIV-1、HBV、HCV等有高度的灭活作用，同时又不影响因子VIII和其他血浆蛋白的活性。
SD处理灭活病毒的效果经用指示病毒如疱疹性口炎病毒，Sindbis病毒和乙脑病毒，以及艾滋病毒(HIV)得到验证。
【药物相互作用】
【不良反应】
罕见严重的不良反应，但有异常情况时，请与医生联系。
极少的情况下可能会出现出血、皮疹和发烧。
【禁忌症】
【产品规格】
250 IU/瓶
【用法用量】
体内FVIII水平升高的百分比可用本品剂量(IU/kg)乘以每公斤体重每个单位的2 %(2%/IU/kg)计算而得。
计算方法依据血浆FVIII和重组AHF 在临床使用的剂量：预计的FVIII升高值(%) = #注射单位
×2%/IU/kg<246>体重(kg)。
【贮藏方法】
本品需冷藏(2-8°C)，遮光保存，禁止冷冻。
【注意事项】
使用本品前，如有下列情况，请告知医生：
-刚做过外科手术;
-患有挤压性损伤;
-患有血栓形成性疾病或进行性动脉粥样硬化性疾病;
-患有败血症。
重度出血者须到医院注射本药。
轻度或中度出血者可在家里注射重组人凝血因子VIIa(NovoSeven)，应立即向医生或医院汇报重组人凝血因子Ⅶa的使用剂量和效果(如：电
话联系)。
必要时与血液科专家保持密切联系。
如果用药24小时后，出血未得到控制，则不能再继续在家治疗，应到医院就诊。
将本品置于远离儿童的地方。