Naloxone_hydrochloride_LCMS_16933_MedChemExpress

Naglazyme® (galsulfase)(Intravenous)Document Number: MH-0084 Last Review Date: 02/01/2022Date of Origin: 11/28/2011Dates Reviewed: 12/2011, 02/2013, 02/2014, 12/2014, 10/2015, 10/2016, 10/2017, 10/2018, 02/2019,02/2020, 02/2021, 02/2022I.Length of AuthorizationCoverage will be provided for 12 months and may be renewed.II.Dosing LimitsA.Quantity Limit (max daily dose) [NDC Unit]:•Naglazyme 5 mg vial: 23 vials per 7 daysB.Max Units (per dose and over time) [HCPCS Unit]:•115 billable units every 7 daysIII.Initial Approval Criteria 1Coverage is provided in the following conditions:•Patient is at least 5 years of age; AND•Documented baseline 12-minute walk test (12-MWT), 3-minute stair climb test (3-MSCT), and/or pulmonary function tests (e.g., FEV1, etc.); AND•Documented baseline value for urinary glycosaminoglycan (uGAG); ANDMucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome) † Ф1,4,5•Patient has a definitive diagnosis of MPS VI as confirmed by the following:o Detection of pathogenic mutations in the ARSB gene by molecular genetic testing; ORo Arylsulfatase B (ASB) enzyme activity of <10% of the lower limit of normal in cultured fibroblasts or isolated leukocytes; AND▪Patient has normal enzyme activity of a different sulfatase (excluding patients with Multiple Sulfatase Deficiency [MSD]); AND▪Patient has an elevated urinary glycosaminoglycan (uGAG) level (i.e. dermatan sulfate or chondroitin sulfate) defined as being above the upper limit of normal bythe reference laboratory†FDA-approved indication(s); ‡Compendia recommended indication(s); ФOrphan DrugIV.Renewal Criteria 1,4,5Coverage can be renewed based on the following criteria:•Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified insection III; AND•Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: anaphylaxis and hypersensitivity reactions, immune-mediated reactions, acute respiratorycomplications associated with administration, acute cardiorespiratory failure, severeinfusion reactions, spinal or cervical cord compression, etc.; AND•Disease response with treatment as defined by improvement or stability from pre-treatment baseline by the following:o Reduction in uGAG levels; AND▪Improvement in or stability of 12-minute walk test compared (12-MWT); OR▪Improvement in or stability of 3-minute stair climb test (3-MSCT); OR▪Improvement in or stability of pulmonary function testing (e.g., FEV1, etc.)V.Dosage/Administration 1Indication DoseMucopolysaccharidosis VI(MPS VI, Maroteaux-Lamy Syndrome) 1 mg/kg administered as an intravenous (IV) infusion oncea weekVI.Billing Code/Availability InformationHCPCS Code:•J1458 – Injection, galsulfase, 1 mg; 1 billable unit = 1 mgNDC:•Naglazyme 5 mg per 5 mL solution; single-use vial: 68135-0020-xxVII.References1.Naglazyme [package insert]. Novato, CA; BioMarin Pharmaceutical Inc.; December 2019.Accessed January 2022.2.Giugliani R, Harmatz P, Wraith JE. Management guidelines for mucopolysaccharidosis VI.Pediatrics. 2007 Aug;120(2):405-18.3.Giugliani R, Federhen A, Rojas MV, et al. Mucopolysaccharidosis I, II, and VI: Brief reviewand guidelines for treatment. Genet Mol Biol. 2010 Oct;33(4):589-604. Epub 2010 Dec 1.4.Vairo F, Federhen A, Baldo G, et al. Diagnostic and treatment strategies inmucopolysaccharidosis VI. Appl Clin Genet. 2015 Oct 30;8:245-55.5.Valaannopoulos V, Nicely H, Harmatz P, et al. Mucopolysaccharidosis VI. Orphanet J RareDis. 2010; 5: 5.6.Harmatz P, Giugliani R, Schwartz I, et al. Enzyme replacement therapy formucopolysaccharidosis VI: a phase 3, randomized, double-blind, placebo-controlled,multinational study of recombinant human N-acetylgalactosamine 4-sulfatase(recombinant human arylsulfatase B or rhASB) and follow-on, open-label extension study. JPediatr. 2006 Apr;148(4):533-539.Appendix 1 – Covered Diagnosis CodesICD-10 ICD-10 DescriptionE76.29 Other mucopolysaccharidosesAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National CoverageDetermination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/AMedicare Part B Administrative Contractor (MAC) JurisdictionsJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。

Ordering Information Cat. No. Product ***********MagNA Lyser Instrument (230 Volt)***********MagNA Lyser Instrument (110 Volt)(Instruments supplied with rotor and rotor cooling block)***********MagNA Lyser Green Beads (100 tubes)Related Products Cat. No. Product***********MagNA Pure LC DNA Isolation Kit II (Tissue)***********MagNA Pure LC mRNA Isolation Kit II (Tissue)03 330 591 001MagNA Pure LC RNA Isolation Kit III (Tissue)***********MagNA Pure LC DNA Isolation Kit III (Bacteria, Fungi)***********MagNA Pure LC RNA Isolation Tissue Lysis Buffer – Refill (70 ml)System DescriptionHomogenize up to 16 samples in just a few seconds.Save valuable lab space with a small benchtop instrument.Reduce hands-on time by replacing the mortar and pestle and other manual methods.Integrate your workflow with the automated nucleic acid isolation of the MagNA Pure LC Instrument.Perform consistent and reproducible sample disruption.Process many different sample types.Prevent nucleic acid degradation with the benchtop cooling unit.Ease your setup with a removable rotor and prefilled disposable vials.Automate with an easy-to-use instrumentVersatile, efficient, and rapid pre-preparationFigure 71. Add your sample and lysis buffer to the MagNA Lyser Green Beads.2. Homogenize with the MagNA Lyser Instrument.3. Centrifuge to pellet the debris.4. Proceeed with the supernatant to prepare nucleic acids or proteins.For detailed information,visit or contact your local representative.Trademarks:MagNA Pure, MagNA Lyser, LightCycler, and the MagNA Pure Logo are trademarks of a member of the Roche Group.The technology used for the LightCycler System is licensed from Idaho Technology Inc., Salt Lake City, UT, USA.Fully automated sample preparationon the PCR Workflow SystemRoche Diagnostics GmbH Roche Applied Science Nonnenwald 282372 Penzberg Germany0000Roche Applied Science Part of Roche DiagnosticsMagNA Lyser InstrumentStart the Ball Rollingwith Automated Tissue HomogenizationᕤᕣᕢᕡFigure 6Components of the system.The MagNA Lyser InstrumentAutomated tissue homogenizationProcessing conditionsRefer to the following tables for guidelines on setting up your homogenizationSample material(10 mg)*Time settings(seconds)Cooling(between the runs)Speed Average yield(µg)***Average purity(OD 280/260 nm)***Spleen 2 x 25 906,00030–40 1.9Liver 25-6,00016–18 1.8Lung 2 x 25906,00025 1.8Kidney25-6,000201.8Maize leaves **20-5,00010n.d.Maize polenta **20-5,0008n.d.Tortilla chips **20-5,0001n.d.*Aliqout containing 10 mg sample material (here mouse and food samples) was taken for the DNA purificationusing the MagNA Pure LC DNA Isolation Kit II (Tissue), (see pack insert)**Centrifugation after the homogenization for 5 minutes at 2,200 x g*** Yield and purity strongly depend on the condition of the sample material n.d.not determinedData kindly provided by Dr. Peterhänsel, RWTH Aachen, GermanyFigure 1Gel electrophoresis from genomic DNA isolated from tissue homogenized with the MagNA LyserInstrument, using the MagNA Pure LC DNA Kit II (Tissue).Marker: DNA Marker III*Aliquot containing 10 mg sample material (here mouse and human research samples) was taken to purify RNAeither with the MagNA Pure LC RNA Isolation Kit III (Tissue) or the MagNA Pure LC mRNA Isolation Kit II (Tissue) homogenized with the MagNA Lyser Instrument.** Yield and purity strongly depend on the condition of the sample material. The yield for mRNA was not determined.Sample material(10 mg)*Time settings(cycles/seconds)Cooling(between/afterthe runs in seconds)SpeedAverage yield (mg)(total RNA)**Average purity(OD 280/260 nm)**RNA/mRNARarely expressed targets in small numbers of target cells,as seen in experiments about minimalresidual diseases,are difficult to detect.Increasing the cell number can improve sensitivity and lead to accurate results.Without the MagNA Lyser pre-processing,the MagNA Pure mRNA HS Kit can efficiently obtain mRNA from a maximum of 1 x 107white blood cells (WBCs),as shown in research studies with human samples.However,using greater cell numbers results in a saturation effect with quantitative assays (Figure 3).Homogenization of the lysate with the MagNA Lyser Instrument prior to the purification eliminatesthe amplification saturation at 1 x 107cells and allows the use of up to 2.5 x 107WBCs (Figure 4 and 5),enhancing the analytical sensitivity of the assay.Eliminate sensitivity barriers with increased sample inputFigure 3mRNA was purified from different amounts of human white blood cells with the MagNA Pure mRNA HS Kit. G6PDH was amplified using the LightCycler t(9;22) Quantification Kit (see text beside).Figure 4mRNA was purified from different amounts of human white blood cells with the MagNA Pure mRNA HS Kit. The lysates from 2.5 x 107cells and 5 x 107cells were homogenized with the MagNA Lyser Instrument (2x50 seconds with 90 seconds cooling in between) prior to the mRNA purification. G6PDH was amplified using the LightCycler t(9;22) Quantification Kit (see text beside).Figure 5Scalability from 1 x 106cells to 2.5 x 107cells is represented in the graph and the table of the relationship between crossing points and cell numbers. The limitation of cell input is indicated by no change in crossing point with increased cell number (see text beside).Cell number 5 x 1072.5 x 1071 x 1075 x 1061 x 106Log (cell number)7.77.47.06.76.0Crossing point 20.320.321.822.424.4crossingpointLog(cell number)252423222120195.86.36.87.37.8Figure 2Gel electrophoresis from total RNA isolated from tissue homogenized with the MagNA Lyser Instrument, using the MagNA Pure LC RNA Kit III (Tissue).Ma r k e rS p l e e nL i v e rL u n gK i d n e yM a r k e rMa i z e l e a v e sMa i z e l e a v e sS p l e e nL i v e r11 kb5 kb5 kb28 S rRNA 18 S rRNASpleen 2 x 50 90 6,500–7,000 30–40 1.9Liver 50 - 6,500–7,000 13–17 2.0Thymoid tissue60906,500n.d.n.d.Heart 60 90 6,500 n.d. n.d.Abdominal fat 60 90 6,500 n.d. n.d.Aorta 60 90 6,500 n.d. n.d. Other samples1+n x 50 90 6,500–7,000- -1 x 105 x 101 x 10- 5 x 101 x 105 x 105 x 10- 5 x 102.5 x 10 5 x 10。

盐酸阿考替胺及制剂一、化合物大体信息英文名AcotiamideHydrochloride HydrateAcotiamidehydrochlorideAcotiamide产品名称阿考替胺盐酸盐三水合物阿考替胺盐酸盐阿考替胺分子结构分子式分子量CAS 登录号773092-05-0二、产品信息【药品名称】盐酸阿考替胺【英文名称】acotiamide hydrochloride hydrate【商品名】Acofide【中文化学名】：N-[2-(二异丙基氨基)乙基]-2-[(2-羟基-4,5-二甲氧基苯甲酰)氨基]-1,3-噻唑-4-羧酸胺盐酸盐三水合物【英文化学名】：N-{2-[Bis(1-methylethyl)amino]ethyl}-2-[(2-hydroxy-4,5-dimethoxybenzoyl)amino]thiazole-4-carboxamidemonohydrochloride trihydrate【化学结构】：【分子式】：【分子量】：【CAS】：773092-05-0【性状】白色或类白色结晶性粉末【熔点】154℃-156℃【溶解度】本品在DMF中溶解，甲醇中略溶，乙醇和水中微溶，丙酮中极微溶，乙酸乙酯中不溶。

【pka】[药理作用及特点] 阿考替胺最先由日本Zeria新药工业株式会社研发，后由Astellas 制药与Zeria药业在日本一路推出。

阿考替胺口服片剂在消化道主如果通过抑制乙酰胆碱酯的机制起作用，可增进胃动力、改善胃容纳障碍、增强胃底扩张。

最新数据显示，西方国家普通人群消化不良症状已接近40%，并显著降低了生活质量。

其中小部份人群由胃溃疡引发，可通过根治幽门螺杆菌进行医治，约20%的有症状人群属于胃食道逆流疾病，可通过质子泵抑制剂有效医治，但大多数消化不良人群属于FD，对于FD的医治目前仍具有挑战性。

【注册分类】化药3+3类【剂型规格】100mg【制剂】片剂【适应症】用于医治功能性消化不良（FD）【用法用量】一天三次，一次100mg，饭前服用。

L-半胱氨酸盐酸盐一水物详细说明书
英文名称：L-Cysteine.HCI.H2O；L-Cysteine hydrochloride；L(+)-β-Mercaptoalanine hydrochloride；(R)-2-Amino-3-mercaptopropionic acid hydrochloride；L(+)-α-Amino-β-thiopropionic acid hydrochloride；L(+)-Amino-α-mercaptopropionic acid hydrochloride
其他名称：L-半胱氨酸盐酸盐；L（+）-β-盐酸硫氢代丙氨酸；（R）-2-氨基-3-巯基丙酸盐酸盐；L-盐酸半胱氨酸一水物；L(+)-盐酸半膀胱氨基酸；L-氢氯半胱氨酸一水物
CAS号：7048-04-6
C3H8ClNO2S·H2O=175.63
级别：BR
含量：≥99.0%
比旋光度：+5.5º～+7.0º
PH：1.5～2.0
氯化物：19.89～20.29%
铵盐：≤0.02%
硫酸盐：≤0.02%
重金属：≤10ppm
砷盐：≤1ppm
铁盐：≤10ppm
干燥失重：8.5～12.0%
性状：白色结晶或结晶性粉末，有吸湿性。

在空气中缓慢氧化和分解。

溶于水、乙醇和丙酮。

水溶液呈酸性。

熔点175～178℃(分解)。

半数致死量(小鼠，腹腔)1250mg/kg
用途：生化研究。

钢铁原材料中的钙、镁测定。

测定溶血素的还原剂。

厌氧菌的生长培养和计数
保存：RT，避光。