楷莱说明书

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高危药品及抢救药品管理

高危药品及抢救药品管理

高危药品目录一、高浓度电解质制剂:1、10%氯化钾2、10%的氯化钠二、肌肉松弛剂:1、短效(5-10min):氯化琥珀胆碱(司克林);2、中效(20 -30min):维库溴铵(仙林针)、阿曲库铵、罗库溴铵,3、长效(45-100min):哌库溴铵(阿端)三、细胞毒化药物:1、作用于DNA化学结构的药物:阿霉素(脂质体:楷莱)、白消安、环磷酰胺、卡铂、顺铂(顺可达)、丝裂霉素、阿柔比星(阿克拉霉素)、奥沙利铂(艾恒、乐沙定)、白消安、苯丁酸氮芥(留可然)、吡柔比星、表柔比星(艾达生)、卡莫司汀(卡氮芥)、柔红霉素、异环磷酰胺(匹服平针)2、影响核酸合成的药物:阿糖胞苷、氟尿嘧啶、甲氨蝶呤、羟基脲、氟达拉滨(福达华)、吉西他滨(键择)、卡培他滨(希罗达)、巯嘌呤、脱氧氟尿苷(艾丰、氟铁龙)3、作用于核酸转录的药物:放线菌素D(更生霉素针)、平阳霉素(博莱)4、作用于DNA复制的拓扑异构酶I抑制剂:拓扑替康(金喜素)5、作用于微管蛋白合成的药物:长春新碱、高三尖杉酯碱、依托泊苷(威克)、长春地辛(托马克注射液)、长春瑞宾(艾克宁、盖诺、诺维本)、多西他赛(艾素、泰索帝)、三尖杉酯碱、替尼泊苷(邦莱、卫萌)、依托泊苷、紫杉醇(泰素、海王、福王)6、其他细胞毒药物:门冬酰胺酶(L-门冬酰胺酶)四、其他类秋水仙碱注射液胰岛素阿片类麻醉药静脉用抗凝药(肝素)发华林依前列醇注射液、胰岛素注射液、硫酸镁注射剂、甲氨蝶呤片(口服,非肿瘤用途)、阿片酊、缩宫素注射液、硝普钠注射剂、磷酸钾注射液、异丙嗪注射剂、100mL 或更大体积的灭菌注射用水(供注射、吸入或冲洗用)剑阁县人民医院高危药品管理制度1、高危险药品包括高浓度电解质制剂、肌肉松弛剂及细胞毒化药品等,具体品种见附录。

2、高危险药品应设置专门的存放药架,不得与其他药品混合存放。

3、高危险药品存放药架应标识醒目,设置黑色警示牌提示牌提醒药学人员注意。

4、高危险药品使用前要进行充分安全性论证,有确切适应症时才能使用。

IKONICS Chroma Stencil Remover 285 用户指南说明书

IKONICS Chroma Stencil Remover 285 用户指南说明书

An IKONICS Company | ISO 9001 Certifi ed | NASDAQ Listed: IKNX www.chromaline .com(800) 328-4261Follow us! WARNING: This product can expose you to chemicals including methanol, which is known in the State of California to cause birth defects or other reproductive harm. For more information go to C H R O M A L I N E S C RE E N C H E M I C A LCHOMA/STENCIL REMOVER™ 285Chroma/Stencil Remover™ 285 is a super concentratedliquid product formulated for the removal of all photosensi-tized emulsions. Especially suitable for automatic systems.APPLICATION Chroma/Stencil Remover 285 should be diluted with clean water, at a ratio of 1 part product to 20-40 parts water. Chroma/Stencil Remover 285 contains additives to aid in the complete removal of photosensitized emulsions from all types of screen mesh. CHARACTERISTICS Chroma/Stencil Remover 285 is a water-soluble colorlessliquid with no flash point. Product contains some acidsolutions and therefore is classified as corrosive. Chroma/Stencil Remover 285 quickly and easily dissolves allphotosensitized emulsions and rinses away completely.USEAGE INSTRUCTIONS For manual application, apply the Chroma/Stencil Remover285 solution to both sides of the wet screen. Allowsolution to dissolve the emulsion. Scrub the stencil area onboth sides to aid in a more complete removal of thestencil. Rinse with high pressure water. No degreasingusually required, except when applying capillary films.To ensure the safe and proper use of Chroma/Screen Chemical products, always refer to the products of SDS before use.180731FOR TECHNICAL SERVICE Call Toll Free: 1-800-328-4261Email: *******************(Outside North America Call +1-218-628-2217)。

楷莱说明书 附带图片

楷莱说明书 附带图片

【药品名称】通用名:楷莱注射液英文名:Caelyx【成分】盐酸多柔比星脂质体 doxorubicin HCl【药物分类】抗肿瘤抗生素类性状盐酸多柔比星的化学名称为:(1S,3S)-3-乙醇酰-1,2,3,4,6,11-六氧-3,5,12-三羟基-10-甲氧基-6,13-二氧并四苯-1-基-3-氨基-2,3,6-三去氧-α-L-来苏吡喃糖苷。

分子式:C27H29NO11 · HCl,分子量:579.99。

本品这种工艺被称作为空间稳定或隐匿,可以保护脂质体免受单核巨噬细胞系统(MPS)识别,从而延长其在血液循环中的时间。

本品为无菌、半透明的红色混悬液,每瓶10 mL,含盐酸多柔比星2 mg/mL,是用于单剂量静脉滴注给药的浓缩液。

本品的活性成分为盐酸多柔比星,是从一种波塞链霉菌表灰变种(strep tomyces peucetius var. caesius)培养液中提取得到的蒽环类细胞毒性抗生素。

药理作用概述多柔比星抗肿瘤的确切机理尚不清楚。

一般认为它具有抑制DNA、RNA 和蛋白合成的细胞毒作用。

这是由于这种蒽环类抗生素能嵌入DNA双螺旋的相邻碱基对之间,从而抑制其解链后再复制。

用本品对动物进行多剂量给药的研究中所显示的毒性与人体长期滴注盐酸多柔比星的结果相近。

本品是将盐酸多柔比星包封并隐匿于脂质体中,因而其毒性反应的程度有所不同。

心脏毒性兔的研究表明,合用本品的心脏毒性低于使用一般盐酸多柔比星制剂。

皮肤毒性在大鼠和狗进行的重复给药试验中,用相当于临床应用的剂量可见严重的皮肤炎症和溃疡形成。

在狗的研究中,降低给药剂量或者延长给药间隔可减少这些损伤的发生率和减轻严重程度。

在长期静脉滴注用药的病人中也可见近似的皮肤损害,如手掌-足底红斑性感觉迟钝。

过敏反应在狗的重复给药毒理研究中,给予脂质体(安慰剂)可见以下急性反应:低血压、粘膜苍白、流涎、呕吐和活动过多而后活动减少及嗜睡。

狗使用本品和多柔比星可见相似但不很严重的反应,预给抗组胺药可以减轻低血压反应。

盐酸多柔比星脂质体注射液说明书楷莱样本

盐酸多柔比星脂质体注射液说明书楷莱样本

盐酸多柔比星脂质体注射液说明书楷莱盐酸多柔比星脂质体注射液说明书【药品名称】通用名:盐酸多柔比星脂质体注射液商品名:楷莱英文名:Doxorubicin Hydrochloride Liposome Injection汉语拼音:Yan Suan Duo Ruo Bi Xing Zhi Zhi Ti Zhu She Ye【成份】本品主要成分及其化学名称为:盐酸多柔比星,(1S,3S)-3-乙醇酰-1,2,3,4,6,11-六氧-3,5,12-三羟基-10-甲氧基-6,13-二氧并四苯-1-基-3-氨基 -2,3,6-三去氧-α-L-来苏吡喃糖苷。

其结构式为:分子式:C27H29NO11.HCl分子量:579.99CAS No.:25316-40-9【性状】本品是一种脂质体制剂,系将盐酸多柔比星经过与甲氧基聚乙二醇的表面结合包封于脂质体中。

这种工艺被称作为空间稳定或隐匿,能够保护脂质体免受单核巨噬细胞系统(MPS)识别,从而延长其在血液循环中的时间。

本品为无菌、半透明的红色混悬液,每瓶10 mL,含盐酸多柔比星 2 mg/mL,是用于单剂量静脉滴注给药的浓缩液。

本品的活性成分为盐酸多柔比星,是从一种波塞链霉菌表灰变种(strep tomyces peucetius var. caesius)培养液中提取得到的蒽环类细胞毒性抗生素。

【适应症】本品可用于低CD4(<200 CD4淋巴细胞/mm3)及有广泛皮肤粘膜内脏疾病的与艾滋病相关的卡波氏肉瘤(AIDS-KS)病人。

本品可用作一线全身化疗药物,或者用作治疗病情有进展的AIDS-KS病人的二线化疗药物,也可用于不能耐受下述两种以上药物联合化疗的病人:长春新碱、博莱霉素和多柔比星(或其它蒽环类抗生素)。

【规格】20mg/ml/支【用法用量】本品应为每2-3周静脉内给药20 mg/m2,给药间隔不宜少于10天,因为不能排除药物蓄积和毒性增强的可能。

病人应持续治疗2-3个月以产生疗效。

楷莱说明书

楷莱说明书

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DOXIL safely and effectively. See full prescribing information for DOXIL. DOXIL ® (doxorubicin HCl liposome injection) for intravenous infusion Initial U.S. Approval: 1995WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, SUBSTITUTION See full prescribing information for complete boxed warning. • Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m . Cardiac toxicity may also occur at lower cumulative doses with mediastinal irradiation or concurrent cardiotoxic agents (5.1). • Acute inf 2usion-related reactions, sometimes reversible uponterminating or slowing infusion, occurred in up to 10% of patients. Serious and sometimes fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use (5.2). • Severe myelosuppression may occur (5.3) • Reduce dosage in patients with impaired hepatic function (2.6). • Accidental substitution of DOXIL resulted in severe side effects. Do not substitute on mg per mg basis with doxorubicin HCl (2.1). ----------------------------RECENT MAJOR CHANGES--------------------------Indications and Usage, AIDS-related Kaposi’s Sarcoma (1.2) 6/2008 ----------------------------INDICATIONS AND USAGE----------------------------DOXIL is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer (1.1)After failure of platinum-based chemotherapy. • AIDS-related Kaposi’s Sarcoma (1.2)After failure of prior systemic chemotherapy or intolerance to such therapy. •Multiple Myeloma (1.3) In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy. -----------------------DOSAGE AND ADMINISTRATION-----------------------Administer DOXIL at an initial rate of 1 mg/min to minimize the risk ofinfusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolusinjection or undiluted solution (2.1). • Ovarian cancer: 50 mg/m 2 IV every 4 weeks for 4 courses minimum (2.2) • AIDS-related Kaposi’s Sarcoma: 20 mg/m 2IV every 3 weeks (2.3) • Multiple Myeloma: 30 mg/m 2IV on day 4 following bortezomib which is administered at 1.3 mg/m 2 bolus on days 1, 4, 8 and 11, every 3 weeks (2.4) --------------------DOSAGE FORMS AND STRENGTHS---------------------- Single dose vial: 20 mg/10 mL and 50 mg/30 mL (3) -------------------------------CONTRAINDICATIONS------------------------------- • Hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL (4, 5.2) • Nursing mothers (4, 8.3) ---------------------------WARNINGS AND PRECAUTIONS-------------------- • Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required (5.4) • Radiation recall reaction may occur (5.5) ------------------------------ADVERSE REACTIONS------------------------------ Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand and foot syndrome, rash, neutropenia, thrombocytopenia and anemia (6). To report SUSPECTED ADVERSE REACTIONS contact Ortho Biotech Products, LP at (888) 227-5624 or FDA at 1-800-FDA-1088 or /medwatch. ---------------------------------DRUG INTERACTIONS---------------------------- • DOXIL may interact with drugs known to interact with conventional formulations of Doxorubicin HCl. (7) -----------------------USE IN SPECIFIC POPULATIONS----------------------- • DOXIL can cause fetal harm when used during pregnancy. (5.6, 8.1) See 17 for PATIENT COUNSELING INFORMATION. Revised: 06/2008FULL PRESCRIBING INFORMATION: CONTENTS*WARNING-- INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION 1 INDICATIONS AND USAGE 1.1 Ovarian Cancer 1.2 AIDS-Related Kaposi’s Sarcoma 1.3 Multiple Myeloma 2 DOSAGE AND ADMINISTRATION2.1 Usage and Administration Precautions 2.2 Patients With Ovarian Cancer 2.3 Patients With AIDS-Related Kaposi’s Sarcoma 2.4 Patients With Multiple Myeloma 2.5 Dose Modification Guidelines 2.6 Patients With Impaired Hepatic Function 2.7 Preparation for Intravenous Administration 2.8 Procedure for Proper Handling and Disposal 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Cardiac Toxicity 5.2 Infusion Reactions 5.3 Myelosuppression 5.4 Hand-Foot Syndrome (HFS) 5.5 Radiation Recall Reaction 5.6 Fetal Mortality 5.7 Toxicity Potentiation 5.8 Monitoring: Laboratory Tests 6 ADVERSE REACTIONS 6.1 Overall Adverse Reactions Profile 6.2 Adverse Reactions in Clinical Trials 6.3 Post Marketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NON-CLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, and Impairment ofFertility 14 CLINICAL STUDIES 14.1 Ovarian Cancer 14.2 AIDS-Related Kaposi’s Sarcoma 14.3 Multiple Myeloma 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listedFULL PRESCRIBING INFORMATIONWARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION1. The use of DOXIL (doxorubicin HCl liposome injection) may lead to cardiac toxicity.Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL at a starting dose of50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m2or between 500-550 mg/m2, the risk of cardiac toxicity for patients treated with DOXIL was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see Warnings and Precautions (5.1)].2. Acute infusion-related reactions including, but not limited to, flushing, shortness ofbreath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with DOXIL. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. DOXIL should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see Warnings and Precautions (5.2)].3. Severe myelosuppression may occur [see Warnings and Precautions (5.3)].4. Dosage should be reduced in patients with impaired hepatic function [see Dosage andAdministration (2.6) and Use in Specific Populations (8.6)].5. Accidental substitution of DOXIL for doxorubicin HCl has resulted in severe sideeffects. DOXIL should not be substituted for doxorubicin HCl on a mg per mg basis [see Dosage and Administration (2.1)].1 INDICATIONS AND USAGE1.1 Ovarian CancerDOXIL (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.1.2 AIDS-Related Kaposi’s SarcomaDOXIL is indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.1.3 Multiple MyelomaDOXIL in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.2 DOSAGE AND ADMINISTRATION2.1 Usage and Administration PrecautionsLiposomal encapsulation can substantially affect a drug’s functional properties relative to those of the unencapsulated drug. Therefore DO NOT SUBSTITUTE one drug for the other.Do not administer as a bolus injection or an undiluted solution. Rapid infusion may increase the risk of infusion-related reactions [see Warnings and Precautions (5.2)]. DOXIL must not be given by the intramuscular or subcutaneous route.Until specific compatibility data are available, it is not recommended that DOXIL be mixed with other drugs.DOXIL should be considered an irritant and precautions should be taken to avoid extravasation. With intravenous administration of DOXIL, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the infusion should be immediately terminated and restarted in another vein. The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.2.2 Patients With Ovarian CancerDOXIL (doxorubicin HCl liposome injection) should be administered intravenously at a dose of 50 mg/m2 (doxorubicin HCl equivalent) at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion-related adverse reactions are observed, the rate of infusion can be increased to complete administration of the drug over one hour. The patient should be dosed once every 4 weeks, for as long as the patient does not progress, shows no evidence of cardiotoxicity [see Warnings and Precautions (5.1)], and continues to tolerate treatment. A minimum of 4 courses is recommended because median time to response in clinical trials was 4 months. To manage adverse reactions such as hand-foot syndrome (HFS), stomatitis, or hematologic toxicity the doses may be delayed or reduced [see Dosage and Administration (2.5)]. Pretreatment with or concomitant use of antiemetics should be considered.2.3 Patients With AIDS-Related Kaposi’s SarcomaDOXIL (doxorubicin HCl liposome injection) should be administered intravenously at a dose of 20 mg/m2 (doxorubicin HCl equivalent). An initial rate of 1 mg/min should be used tominimize the risk of infusion-related reactions. If no infusion-related adverse reactions are observed, the infusion rate should be increased to complete the administration of the drug over one hour. The dose should be repeated once every three weeks, for as long as patients respond satisfactorily and tolerate treatment.2.4 Patients With Multiple MyelomaBortezomib is administered at a dose of 1.3 mg/m2 as intravenous bolus on days 1, 4 , 8 and 11, every three weeks. DOXIL 30 mg/m2 should be administered as a 1-hr intravenous infusion on day 4 following bortezomib. With the first DOXIL dose, an initial rate of 1 mg/min should be used to minimize the risk of infusion-related reactions. If no infusion-related adverse reactions are observed, the infusion rate should be increased to complete the administration of the drug over one hour. Patients may be treated for up to 8 cycles until disease progression or the occurrence of unacceptable toxicity.2.5 Dose Modification GuidelinesDOXIL exhibits nonlinear pharmacokinetics at 50 mg/m2; therefore, dose adjustments may result in a non-proportional greater change in plasma concentration and exposure to the drug [see Clinical Pharmacology (12.3)].Patients should be carefully monitored for toxicity. Adverse reactions, such as HFS, hematologic toxicities, and stomatitis may be managed by dose delays and adjustments. Following the first appearance of a Grade 2 or higher adverse reactions, the dosing should be adjusted or delayed as described in the following tables. Once the dose has been reduced, it should not be increased at a later time.Recommended Dose Modification GuidelinesTable 1: Hand-Foot Syndrome (HFS)Toxicity Grade Dose Adjustment1 Redose unless patient has experienced previous Grade 3 or 4 HFS. If(mild erythema, swelling, so, delay up to 2 weeks and decrease dose by 25%. Return to original or desquamation not dose interval.interfering with dailyactivities)2 Delay dosing up to 2 weeks or until resolved to Grade 0-1. If after(erythema, desquamation, 2 weeks there is no resolution, DOXIL should be discontinued. Ifor swelling interfering resolved to Grade 0-1 within 2 weeks, and there are no prior Grade 3-4 with, but not precluding HFS, continue treatment at previous dose and return to original dosenormal physical interval. I f patient experienced previous Grade 3-4 toxicity, continueactivities; small blisters treatment with a 25% dose reduction and return to original dose interval.or ulcerations less than2 cm in diameter)3 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease(blistering, ulceration, or dose by 25% and return to original dose interval. If after 2 weeks there is swelling interfering with no resolution, DOXIL should be discontinued.walking or normal dailyactivities; cannot wearregular clothing)4 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease(diffuse or local process dose by 25% and return to original dose interval. If after 2 weeks there is causing infectious no resolution, DOXIL should be discontinued.complications, or a bedridden state orhospitalization)Table 2: Hematological ToxicityGrade ANC Platelets Modification1 1,500 – 1,900 75,000 - 150,000 Resume treatment with n o dosereduction2 1,000 - <1,500 50,000 - <75,000 Wait until ANC > 1,500 and platelets> 75,000; redose with no dose reduction3 500 – 999 25,000 - <50,000 Wait until ANC > 1,500 and platelets> 75,000; redose with no dose reduction4 <500 <25,000 Wait until ANC > 1,500 and platelets> 75,000; redose at 25% dose reductionor continue full dose with cytokinesupportTable 3: StomatitisToxicity Grade Dose Adjustment1 Redose unless patient has experienced previous Grade 3 or 4(painless ulcers, toxicity. If so, delay up to 2 weeks and decrease dose by 25%. Return toerythema, or mild original dose interval.soreness)2 Delay dosing up to 2 weeks or until resolved to Grade 0-1. If after(painful erythema, 2 weeks there is no resolution, DOXIL should be discontinued. Ifedema, or ulcers, but can resolved to Grade 0-1 within 2 weeks and there was no prior Grade 3-4eat) stomatitis, continue treatment at previous dose and return to originaldose interval. If patient experienced previous Grade 3-4 toxicity,continue treatment with a 25% dose reduction and return to original doseinterval.3 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease(painful erythema, dose by 25% and return to original dose interval. If after 2 weeks there isedema, or ulcers, and no resolution, DOXIL should be discontinued.cannot eat)4 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease(requires parenteral or dose by 25% and return to DOXIL original dose interval. If afterenteral support) 2 weeks there is no resolution, DOXIL should be discontinued.Multiple MyelomaFor patients treated with DOXIL in combination with bortezomib who experience hand-foot syndrome or stomatitis, the DOXIL dose should be modified as described in Tables 1 and 3 above. Table 4 describes dosage adjustments for DOXIL and bortezomib combination therapy. For bortezomib dosing and dosage adjustments, see manufacturer’s prescribing information.Table 4: Dosage adjustments for DOXIL + bortezomib combination therapyPatient status DOXIL bortezomibFever ≥38°C and Do not dose this cycle if before Reduce next dose by 25%3ANC <1,000/mm Day 4; if after Day 4, reducenext dose by 25%.On any day of drug Do not dose this cycle if before Do not dose; if 2 or more doses are not administration after Day 1 of Day 4; if after Day 4 reduce next given in a cycle, reduce dose by 25% in each cycle: dose by 25% in the following following cycles.3Platelet count <25,000/mm cycles if bortezomib is reducedHemoglobin <8g/dL for hematologic toxicity.3ANC <500/mmGrade 3 or 4 non-hematologic Do not dose until recovered to Do not dose until recovered to Grade <2 drug related toxicity Grade <2 and reduce dose by and reduce dose by 25% for all25% for all subsequent doses. subsequent doses.Neuropathic pain or peripheral No dosage adjustments. See bortezomib manufacturer’s neuropathy prescribing information for dosageadjustments in patients with neuropathicpain.2.6 Patients With Impaired Hepatic FunctionLimited clinical experience exists in treating patients with hepatic impairment with DOXIL. Based on experience with doxorubicin HCl, it is recommended that the DOXIL dosage be reduced if the bilirubin is elevated as follows: serum bilirubin 1.2 to 3.0 mg/dL - give ½ normal dose; serum bilirubin > 3 mg/dL - give ¼ normal dose.No information, including dosage adjustments, is available for patients with multiple myeloma with hepatic impairment.2.7 Preparation for Intravenous AdministrationEach 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.DOXIL doses up to 90 mg must be diluted in 250 mL of 5% Dextrose Injection, USP prior to administration. Doses exceeding 90 mg should be diluted in 500 mL of 5% Dextrose Injection, USP prior to administration. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in DOXIL. Diluted DOXIL should be refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 24 hours.Do not use with in-line filters.Do not mix with other drugs.Do not use with any diluent other than 5% Dextrose Injection.Do not use any bacteriostatic agent, such as benzyl alcohol.DOXIL is not a clear solution but a translucent, red liposomal dispersion.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.Rapid flushing of the infusion line should be avoided.2.8 Procedure for Proper Handling and DisposalCaution should be exercised in the handling and preparation of DOXIL.The use of gloves is required.If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.DOXIL should be considered an irritant and precautions should be taken to avoid extravasation. With intravenous administration of DOXIL, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the infusion should be immediately terminated and restarted in another vein. DOXIL must not be given by the intramuscular or subcutaneous route.DOXIL should be handled and disposed of in a manner consistent with other anticancer drugs. Several guidelines on this subject exist [see References (15)].3 DOSAGE FORMS AND STRENGTHS•20 mg/10 mL single use vial•50 mg/30 mL single use vial4 CONTRAINDICATIONSDOXIL (doxorubicin HCl liposome injection) is contraindicated in patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of DOXIL [see Warnings and Precautions (5.2)].DOXIL is contraindicated in nursing mothers [see Use in Specific Populations (8.3)].5 WARNINGS AND PRECAUTIONS5.1 Cardiac ToxicitySpecial attention must be given to the risk of myocardial damage from cumulative doses of doxorubicin HCl. Acute left ventricular failure may occur with doxorubicin, particularly in patients who have received a total cumulative dosage of doxorubicin exceeding the currently recommended limit of 550 mg/m2. Lower (400 mg/m2) doses appear to cause heart failure in patients who have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide.Prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage. Congestive heart failure or cardiomyopathy may be encountered after discontinuation of anthracycline therapy. Patients with a history of cardiovascular disease should be administered DOXIL only when the potential benefit of treatment outweighs the risk.Cardiac function should be carefully monitored in patients treated with DOXIL. The most definitive test for anthracycline myocardial injury is endomyocardial biopsy. Other methods, such as echocardiography or multigated radionuclide scans, have been used to monitor cardiac function during anthracycline therapy. Any of these methods should be employed to monitor potential cardiac toxicity in patients treated with DOXIL. If these test results indicate possible cardiac injury associated with DOXIL therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.In a clinical study in patients with advanced breast cancer, 250 patients received DOXIL at starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m2, or between 500–550 mg/m2, the risk of cardiac toxicity for patients treated with DOXIL was 11%. In this study, cardiotoxicity was defined as a decrease of >20% from baseline if the resting left ventricular ejection fraction (LVEF) remained in the normal range, or a decrease of >10% if the resting LVEF became abnormal (less than the institutional lower limit of normal). The data on left ventricular ejection fraction (LVEF) defined cardiotoxicity and congestive heart failure (CHF) are in the table below.Table 5: Number of Patients With Advanced Breast CancerDOXIL (n=250) Patients who Developed Cardiotoxicity (LVEF Defined) 10Cardiotoxicity (With Signs & Symptoms of CHF) 0Cardiotoxicity (no Signs & Symptoms of CHF) 10Patients With Signs and Symptoms of CHF Only 2In the randomized multiple myeloma study, the incidence of heart failure events (ventricular dysfunction, cardiac failure, right ventricular failure, congestive cardiac failure, chronic cardiacfailure, acute pulmonary edema and pulmonary edema) was similar in the DOXIL+bortezomib group and the bortezomib monotherapy group, 3% in each group. LVEF decrease was defined as an absolute decrease of ≥15% over baseline or a ≥5% decrease below the institutional lower limit of normal. Based on this definition, 25 patients in the bortezomib arm (8%) and 42 patients in the DOXIL + bortezomib arm (13%) experienced a reduction in LVEF.5.2 Infusion ReactionsAcute infusion-related reactions were reported in 7.1% of patients treated with DOXIL in the randomized ovarian cancer study. These reactions were characterized by one or more of the following symptoms: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction resolved when the rate of infusion was slowed. In this study, two patients treated with DOXIL (0.8%) discontinued due to infusion-related reactions. In clinical studies, six patients with AIDS-related Kaposi’s sarcoma (0.9%) and 13 (1.7%) solid tumor patients discontinued DOXIL therapy because of infusion-related reactions.Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.The majority of infusion-related events occurred during the first infusion. Similar reactions have not been reported with conventional doxorubicin and they presumably represent a reaction to the DOXIL liposomes or one of its surface components.The initial rate of infusion should be 1 mg/min to help minimize the risk of infusion reactions [see Dosage and Administration (2)].5.3 MyelosuppressionBecause of the potential for bone marrow suppression, careful hematologic monitoring is required during use of DOXIL, including white blood cell, neutrophil, platelet counts, and Hgb/Hct. With the recommended dosage schedule, leukopenia is usually transient. Hematologic toxicity may require dose reduction or delay or suspension of DOXIL therapy. Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage. Development of sepsis in the setting of neutropenia has resulted in discontinuation of treatment and, in rare cases, death.DOXIL may potentiate the toxicity of other anticancer therapies. In particular, hematologic toxicity may be more severe when DOXIL is administered in combination with other agents that cause bone marrow suppression.In patients with relapsed ovarian cancer, myelosuppression was generally moderate and reversible. In the three single-arm studies, anemia was the most common hematologic adverse reaction (52.6%), followed by leukopenia (WBC< 4,000 mm3; 42.2%), thrombocytopenia (24.2%), and neutropenia (ANC <1,000; 19.0%). In the randomized study, anemia was the most common hematologic adverse reaction (40.2%), followed by leukopenia (WBC <4,000 mm3;36.8%), neutropenia (ANC <1,000; 35.1%), and thrombocytopenia (13.0%) [see Adverse Reactions (6.2)].In patients with relapsed ovarian cancer, 4.6% received G-CSF (or GM-CSF) to support their blood counts [see Dosage and Administrations (2.5)].For patients with AIDS-related Kaposi’s sarcoma who often present with baseline myelosuppression due to such factors as their HIV disease or concomitant medications, myelosuppression appears to be the dose-limiting adverse reaction at the recommended dose of 20 mg/m2 [see Adverse Reactions (6.2)]. Leukopenia is the most common adverse reaction experienced in this population; anemia and thrombocytopenia can also be expected. Sepsis occurred in 5% of patients; for 0.7% of patients the event was considered possibly or probably related to DOXIL. Eleven patients (1.6%) discontinued study because of bone marrow suppression or neutropenia.Table 10 presents data on myelosuppression in patients with multiple myeloma receiving DOXIL and bortezomib in combination [see Adverse Reactions (6.2)].5.4 Hand-Foot Syndrome (HFS)In the randomized ovarian cancer study, 50.6% of patients treated with DOXIL at 50 mg/m2 every 4 weeks experienced HFS (developed palmar-plantar skin eruptions characterized by swelling, pain, erythema and, for some patients, desquamation of the skin on the hands and the feet), with 23.8% of the patients reporting HFS Grade 3 or 4 events. Ten subjects (4.2%) discontinued treatment due to HFS or other skin toxicity. HFS toxicity grades are described above [see definitions of HFS grades in Dosage and Administration (2.5)].Among 705 patients with AIDS-related Kaposi’s sarcoma treated with DOXIL at 20 mg/m2 every 2 weeks, 24 (3.4%) developed HFS, with 3 (0.9%) discontinuing.In the randomized multiple myeloma study, 19% of patients treated with DOXIL at 30 mg/m2 every three weeks experienced HFS.。

高危药品及抢救药品的管理

高危药品及抢救药品的管理

高危药品目录一、高浓度电解质制剂:1、10%氯化钾2、10%的氯化钠二、肌肉松弛剂:1、短效(5-10min):氯化琥珀胆碱(司克林);2、中效(20 -30min):维库溴铵(仙林针)、阿曲库铵、罗库溴铵,3、长效(45-100min):哌库溴铵(阿端)三、细胞毒化药物:1、作用于DNA化学结构的药物:阿霉素(脂质体:楷莱)、白消安、环磷酰胺、卡铂、顺铂(顺可达)、丝裂霉素、阿柔比星(阿克拉霉素)、奥沙利铂(艾恒、乐沙定)、白消安、苯丁酸氮芥(留可然)、吡柔比星、表柔比星(艾达生)、卡莫司汀(卡氮芥)、柔红霉素、异环磷酰胺(匹服平针)2、影响核酸合成的药物:阿糖胞苷、氟尿嘧啶、甲氨蝶呤、羟基脲、氟达拉滨(福达华)、吉西他滨(键择)、卡培他滨(希罗达)、巯嘌呤、脱氧氟尿苷(艾丰、氟铁龙)3、作用于核酸转录的药物:放线菌素D(更生霉素针)、平阳霉素(博莱)4、作用于DNA复制的拓扑异构酶I抑制剂:拓扑替康(金喜素)5、作用于微管蛋白合成的药物:长春新碱、高三尖杉酯碱、依托泊苷(威克)、长春地辛(托马克注射液)、长春瑞宾(艾克宁、盖诺、诺维本)、多西他赛(艾素、泰索帝)、三尖杉酯碱、替尼泊苷(邦莱、卫萌)、依托泊苷、紫杉醇(泰素、海王、福王)6、其他细胞毒药物:门冬酰胺酶(L-门冬酰胺酶)四、其他类(肝素)发华林依前列醇注射液、胰岛素注射液、硫酸镁注射剂、甲氨蝶呤片(口服,非肿瘤用途)、阿片酊、缩宫素注射液、硝普钠注射剂、磷酸钾注射液、异丙嗪注射剂、100mL 或更大体积的灭菌注射用水(供注射、吸入或冲洗用)剑阁县人民医院高危药品管理制度1、高危险药品包括高浓度电解质制剂、肌肉松弛剂及细胞毒化药品等,具体品种见附录。

2、高危险药品应设置专门的存放药架,不得与其他药品混合存放。

3、高危险药品存放药架应标识醒目,设置黑色警示牌提示牌提醒药学人员注意。

4、高危险药品使用前要进行充分安全性论证,有确切适应症时才能使用。

flat-jack产品说明书

flat-jack产品说明书

flat-jack products GmbH Innstrasse 885640 PutzbrunnFon +49 89 454577 - 150 Fax +49 89 454577 - 155*****************www.flat-jack.deCongratulations and thank you for choosing flat-jack®!flat-jack ® avoids flat spots on the tires of your automobile. These flat spots arisethrough pressure load during long standing times and can therefore badly reduce your driving pleasure. flat-jack® guarantees the perfect adaption to every shape of tire./// flat-jack®flat-jack® retains the actual condition of the tires over long periods of standing still of your automotive treasures. Please read the instructions and safety guidelines of this manual carefully to guarantee safe and secure operation of the flat-jack® ./// Disclaimer of liabilityIf the flat-jack® is used differently than described in this instruction manual damage of the product, vehicle or even people may occur. The manufacturer takes no liability for damage arising from incorrect handling./// The advantages of• Complete decoupling from the ground.• Best thermic insolation by means of air.• Unique concept with high contact area.• Effective and even pressure distribution over the whole contact area.• Reduction and compensation of lateral forces on the entire chassis.• Simple to use (roll on, roll off).• By means of air: 100% effectiveness.• High quality materials.• High load capacity up to 2,5t per air pillow.• Can be individually combined.• Light weight (0,6 kg), easy to store.•Design serves as centering aids./// flat-jack is not only an air pillow®Membrane conceptflat-jack® is constructed double-walled. The inner membranes guarantee optimal density and the outer cover is responsible for longevity and stabilisation of the shape.Chamber conceptThe special inner chamber structure with special par-tition walls does not only allow an optimal adaption to each tire shape but also distributes the pressure effectively by enlarging the contact area. The uni-queness of flat-jack® also results from reduction and compensation of lateral forces and tensions on the entire chassis./// flat-jack® model overview1 set contains one pair of flat-jack®• Size S: up to tire width 195mm/7,68 inch Art Nr.: 426032833001 2• Size M: up to tire width 255mm/10,04 inch A rt Nr.: 426032833002 9• Size L: up to tire width 345mm/13,58 inch Art Nr.: 426032833003 6/// Getting startedIncorrect handling of this product may result in injury. Check the flat-jack® always before usage. Make sure it is not damaged and that the valves are also correctly functioning. Please read the flat-jack®safety guidelines carefully before use.flat-jack products GmbH Innstrasse 885640 PutzbrunnFon +49 89 454577 - 150 Fax +49 89 454577 - 155*****************www.flat-jack.deMade in Germany Patent pending World noveltyflat-jack®Owner‘s manualOwner‘s manual/// Imortant instructionsThe selected materials for the production of flat-jack® fulfil the highest quality material standards. The construction of a flexible body filled with air is subject to a certain material expansion. As a result there is a minimal loss of pressure after the first inflation with air. Use of the valve caps increases the density. High temperature variation has a negative influence on the density of the valves. For optimal use of flat-jack® it is mandatory to:• Use the valve caps.• Check pressure levels after 3 days.• Additionally check pressure levels at regular • periods.• Avoid temperature variation (use in garagesor closed areas is recommended).Before emptying the flat-jack® make sure that:There are no people directly in front or behind the vehicle. Parking brake is applied. Manual transmission: first gear is engaged. Automatic transmission: “P” is selected (park gear). Slowly and carefully empty the flat-jack at the drain valve./// Technical specificationInside material: PU/PUR membraneOutside material: PU/PUR braid-reinforced Valve: German high quality productOperating pressure: 0.4-0.8 bar/5.8-11.6 psi Maximum pressure: 1.0 bar/14.5 psiMaximum load: verified up to 2,5t per tire air pillowStyle of construction: double-walled high frequency welded/// Storage and cleaningStore flat-jack® pressure-free in a dryenvironment. Use solvent-free detergents for cleaning. Our recommendation: Use a moist cloth and dishwashing liquid./// Returning the flat-jack®In case of returning the flat-jack® please usethe original packaging material to avoid transport damages. The manufacturer does not take any liability for damages caused during transport due to incorrect packaging./// Safety instructionsflat-jack® size has to correspond with tire size.• Size S: up to tire width 195mm/7,68 inch Art Nr.: 426032833001 2• Size M: up to tire width 255mm/10,04 inch A rt Nr.: 426032833002 9• Size L: up to tire width 345mm/13,58 inch Art Nr.: 426032833003 6• Before use a clean and level base is necessary.• Secure the vehicle against rolling away by applying parking brake/placing in gear.• Never use flat-jack® in duplex garages.• In inflating manufacturer’s instructions must be followed.• Inflate flat-jack® axle by axle.•to 11.60 psi•Maximum pressure: 1.0 bar/14.25 psiExcessive pressure prevents transverse movement of the vehicle and therefore eliminates the advantage of reducing chassis strain.• flat-jack® is not a lifting bag and shall not beused to lift heavy loads other than specified in the flat-jack® manual.• flat-jack® is not a swimming aid./// Use of flat-jack®A level base is necessary. Secure the vehicle against rolling away: Parking brake/ placing in gear.2Place empty flat-jack® directly to tires. Lay in front or behind all tires.3Ensure centred tire position. Valves (*) must be accessible from outside.4Carefully roll vehicle on to flat-jack®. Centre tires. Apply parking brake. Manual transmission: Engage first gear. Automatic transmission: Select …P“ (park gear).5Carefully fill flat jack at the inflation valve until vehicle …hovers“ above groud using operating pressures given. Check pressure constantly. Operating pressure variesbetween 0.4 and 0.8 bar according to vehicle weight. Respect maximum pressure of 1.0 bar!67/// To empty the flat-jack®at the vehicleinstructionsMount valve caps.。

盐酸多柔比星脂质体注射液说明书

盐酸多柔比星脂质体注射液说明书

氨基-2,3,6-三去氧-α-L-来苏吡喃糖苷
化学结构式:
分子式:C27H29NO11 · HCl 分子量:579.99 辅料:全氢化卵磷脂(HSPC), MPEG-DSPE,胆固醇,硫酸铵,组氨酸,蔗糖,盐酸,氢氧 化钠,注射用水。
CCDS 更新 2013-03-08
1
【性状】 本品是一种脂质体制剂,系将盐酸多柔比星通过与甲氧基聚乙二醇的表面结合包封于脂质体
CCDS 更新 2013-03-08
3
AIDS-KS 患者中,输液相关反应的特点是面部潮红、气喘、面部水肿、头痛、寒颤、背痛、胸
闷、喉咙憋胀和/或低血压,报告比例为 5%~10%。输液反应中惊厥非常罕见。所有患者的这些反应
核准日期:2007 年 05 月 26 日 修改日期:2010 年 05 月 21 日
2011 年 04 月 26 日 2012 年 02 月 21 日 2013 年 07 月 18 日
盐酸多柔比星脂质体注射液说明书
【药品名称】
请仔细阅读说明书并在医师指导下使用
通用名称:盐酸多柔比星脂质体注射液 商品名称:楷莱 CAELYX
中。这种工艺被称作为空间稳定或隐匿,可以保护脂质体免受单核巨噬细胞系统(MPS)识别,从 而延长其在血液循环中的时间。
本品为红色半透明混悬液,每瓶 10ml,含盐酸多柔比星 2mg/ml,是用于单剂量静脉滴注给药 的浓缩液。本品的活性成分为盐酸多柔比星,是从一种波塞链霉菌表灰变种(strep tomyces peucetius var. caesius)培养液中提取得到的蒽环类细胞毒性抗生素。 【适应症】
10ml:20mg 【用法用量】
本品应为每 2~3 周静脉内给药 20mg/m2,给药间隔不宜少于 10 天,因为不能排除药物蓄积和 毒性增强的可能。病人应持续治疗 2~3 个月以产生疗效。为保持一定的疗效,在需要时继续给药。 本品用 250 毫升 5%葡萄糖注射液稀释,静脉滴注 30 分钟以上。禁止大剂量注射或给用未经稀释的 药液。建议本品滴注管与 5%葡萄糖滴注管相连接以进一步稀释并最大限度地减少血栓形成和外渗 危险。

卡莱菲472控制头说明书

卡莱菲472控制头说明书

FunctionTechnical speci cations Fit valves:The 472 control head can be coupled to the following valves:-220, 221, 338, 339 and 676 seriesControl adjustment scale, 472 seriesProduct RangeThermostatic control head with remote adjusting knob472 series472000The 472 thermostatic c ontrol head with remote adjusting knob is used on thermostati c radiator valve bodies for automati ontrol of room temperature when the position of the valve does not allow for easy a c c ess to adjust the temperature setting.Scale of adjustment:0 - 5Setting temperature range: 43 - 82˚ F (6 - 28˚ C)Frost protection cut-in: 43˚ F (6˚ C)Accuracy:± 0.7˚ F (0.4˚ C)Max. sensor temperature: 120˚ F (50˚ C)Length of capillary:78” (2 m)*1234532°F 43°F 54°F 61°F 68°F 75°F 82°F 0°C6°C12°C16°C20°C24°C28°CDuring long periods of absence during winter months, set the adjustment to temperature reference number * on the dial to ensure the temperature is not less than 40° F (5° C).InstallationLegendtemperature reference number 3temperature reference number 2cover stop clip base plate adjustment pointSetting the upper temperature limitTemperature range limitations1234The 472 remote controller provides thermostaticradiator valve control from a distance when the valve is not easy to access.The c ontrol knob c omes standard with two stop c lips, mounted on top of the knob to the right near the temperature reference number 5 and on the left hand side next to the temperature referenc e number 0. This allows adjustment within a high and low range of c hoic e and be locked and hidden.Adjust the c ontrol knob to the desired temperature pointing to the adjustment point, example here is to temperature reference number 3, 68°F (20°C), (figure 1). Lift the c over from the base plate using a sc rewdriver (figure 3). Remove the stop c lip found near temperature referenc e number 5 and push it on the degree s c ale near the temperature reference number 3 (figure 5).Setting the lower temperature limit Locking a xed temperature setting56789Press the cover with the adjustment pointmark fac ing up bac k onto the base plateuntil it snaps into position (figure 8). At thispoint temperature adjustments cmade for any desired temperature up to thetemperature referenc(20°C). No temperature setting can now bemade above the temperature referenc enumber 3, whic h is loc ked in as the hightemperature limit setting.Adjust the c ontrol knob to the desiredtemperature pointing to the adjustmentreference number 2, 61°F (16°C), (figure 2).Lift the cover from the base plate using ascrewdriver (figure 4). Remove the stop clipfound near temperature reference number0 and push it on the degree scale near thetemperature reference number 2 (figure 6).Press the cover with the adjustment pointmark fac ing up bac k onto the base plateuntil it snaps into position (figure 9). At thispoint temperature adjustments cmade for any desired temperature abovethe temperature reference number 2, 61°F(16°C). No temperature setting can now bemade below the temperature referenc enumber 2, whic h is loc ked in as the lowtemperature limit setting.Adjust the control knob to the desired temperature pointing to the adjustment point, example here is to temperature reference number 3, 68°F (20°C), (figure 1). Lift the cover from the base plate using a screwdriver (figure 3). Remove the stop clip found near temperature reference number 0 and also the stop clip found near temperature reference number 5 and push both of them on the degree scale near the temperature reference number 3 (figure 7). Press the cover with the adjust-ment point mark facing up back onto the base plate until it snaps into position (figure 8). At this point no temperature adjustments c an be made at all for any other temperature and it is now locked on the desired temperature reference number 3, 68°F (20°C).Security InstructionAll work mu st be performed by qu ali ed personnel trained in the proper application, installation, and maintenance of systems in accordance with all applicable codes and ordinances. 11-12-2018。

WIKA压力天平CPB5800操作说明书

WIKA压力天平CPB5800操作说明书

Pressure Balance压力天平CPB5800Pressure Balance CPB5800 CPB5800 压力天平Operating Instructions Pressure Balance Page 4 - 37 压力天平操作说明书第 38 - 72 页InformationThis symbol provides you with information, notes and tips.Warning!This symbol warns you against actions that can cause injury to people or damage to the instrument.C o n t e n t s1. General (5)1.1 General Instructions (5)1.2 Safety Instructions (6)2. Product Description (7)2.1 General Product Information (7)2.2 Basic principle of the Pressure Balance (8)2.3 Environmental factors (9)2.3.1 Local fluctuations in gravity-value (9)2.3.2 Temperature (Piston/Cylinder) (10)2.3.3 Ambient conditions (10)2.3.4 How the cross-sectional area responds to pressure (11)2.4 Arrangement of control elements (11)2.4.1 Standard hydraulic base (12)2.4.2 High-pressure hydraulic base (13)3. Commissioning and Operation (14)3.1 Preparation (14)3.1.1 Setting up the Device (14)3.1.2 Hydraulic pressure media used (14)3.1.3 Installing the piston-cylinder system (15)3.1.3.1 Connection for piston-cylinder system with G3/4 B (male) thread (16)3.1.3.2 Connection for piston-cylinder system with ConTect quick connector (17)3.1.3 Connecting the device under test (18)3.1.4 Venting the System (18)3.2 Operation (19)3.2.1 Procedure for single-range piston-cylinder system 1,600 psi or 120 bar (19)3.2.1.1 Mass loading (19)3.2.1.2 Approaching the pressure value (19)3.2.1.3 Pressure stable (19)3.2.2 Procedure for single-range piston-cylinder system 4,000 psi or 300 bar (20)3.2.2.1 Mass load (20)3.2.2.2 Approaching the pressure value (20)3.2.2.3 Pressure stable (20)3.2.3 Procedure for all dual-range piston-cylinder systems (21)3.2.3.1 Mass load (21)3.2.3.2 Approaching the pressure value (21)3.2.3.3 Pressure stable (21)3.2.4 Next pressure level (22)3.2.5 Releasing pressure (22)3.3 Disassembly (23)4. Troubleshooting measures (24)5. Maintenance and Care (25)5.1 Cleaning (25)5.1.1 Piston-cylinder system (25)5.1.1.1 Procedure for single-range piston-cylinder system 1,600 psi or 120 bar (26)5.1.1.2 Procedure for single-range piston-cylinder system 4,000 psi or 300 bar (27)5.1.1.3 Procedure for all dual-range piston-cylinder systems (28)5.1.2 Mass set (29)5.2 Consumable Parts (29)5.3 Changing the hydraulic pressure medium (29)5.3.1 Removing hydraulic pressure medium (29)5.3.2 Filling in of hydraulic pressure medium (29)5.3.3 Venting of the System (after Complete Filling only) (30)5.4 Recalibration (30)6. Specifications (31)7. Tables of masses (34)8. Accessories (36)1.General1.1 General InstructionsIn the following chapters detailed information on the CPB5800 pressure balance and its proper use can be found.Should you require further information, or should there be problems which are not dealt within detail in the operating instructions, please contact the address below:DH-BudenbergA Division of WIKA Instruments Ltd.10 Huntsman Drive, Northbank Ind. Est.Irlam, Manchester • M44 5EG United KingdomTel.: (+44) 844 406 0086Fax: (+44) 844 406 0087E-Mail:*********************.ukWIKA Alexander Wiegand SE & Co. KGAlexander Wiegand StrasseD-63911 KlingenbergTel.: (+49) 9372/132-0Fax: (+49) 9372/132-406E-Mail:*************If nothing to the contrary is agreed, the pressure balance is calibrated in compliance with the currently valid body of international regulations and can be referred directly to a national standard.The warranty period for the pressure balance is 24 months according to the general terms of supply of ZVEI.The guarantee is void if the appliance is put to improper use or if the operating instructions are not observed or if an attempt is made to open the appliance or to release attachment parts or the tubing. We also point out that the content of these operating instructions neither forms part of an earlier or existing agreement, assurance or legal relationship nor is meant to change these. All obligations of WIKA Alexander Wiegand SE & Co. KG result from the respective sales contract and the general business terms of WIKA Alexander Wiegand SE & Co. KG.WIKA is a registered trade mark of WIKA Alexander Wiegand SE & Co. KG.Names of companies or products mentioned in this handbook are registered trade marks of the manufacturer.The devices described in this manual represent the latest state of the art in terms of their design, dimension and materials. We reserve the right to make changes to or replace materials without any obligation to give immediate notification.Duplication of this manual in whole or in part is prohibited.© 2012 Copyright WIKA Alexander Wiegand SE & Co. KG. All rights reserved.1.2 Safety InstructionsRead these operating instructions carefully prior to operating the pressurebalance CPB5800. Its trouble-free operation and reliability cannot be guaranteed unless the safety advice given in this manual is followed when using the device.1. The system must only be operated by trained and authorised personnel who understand the manual and can work according to it.2. Trouble-free operation and reliability of the device can only be guaranteed so long as the conditions stated under "Setting up the device" are taken into consideration.3. The CPB5800 always has to be handled with the care required for any precision instrument (protect from humidity, impacts and extreme temperatures). The device, the piston-cylinder-system and the mass-set must be handled with care (don't throw, hit, etc.) and protected from contamination. By no means apply any force to the operating elements of the CPB5800.4. If the device is moved from a cold to a warm environment, you should therefore ensure the device temperature has adjusted to the ambient temperature before operational use.5. If the equipment is damaged and operates no longer safely, then it should be taken out of service and securely marked in such a way so that it is not used until repaired. Operator safety may be at risk if:■ There is visible damage to the device ■ The device is not working as specified■ The device has been stored under unsuitable conditions for an extended period of time.If there is any doubt, please return the device to the manufacturer for repair or servicing.6. Customers must not attempt to alter or repair the device themselves. If the instrument is opened or attachment parts or the tubing are released, its trouble-free operation and reliability is impaired and may endanger the operator. Please return the device to the manufacturer for any repair or maintenance work.7. Only original type or OEM specified seals should be used in this instrument.8. Any procedure not included in the following instructions or outside of the manual must not be attempted.2Product Description2.1 General Product Information■ApplicationPressure balances are the most accurate instruments for the calibration of electronic or mechanical pressure measuring instruments. The direct measurement of pressure, according to its definition as a quotient of force and area, and the use of high-quality materials result in small uncertainties of measurement and an excellent long-term stability.For these reasons pressure balances have already been used in calibration laboratories of industry, national institutes and research labs for many years. Due to the integrated pressure generation and the purely mechanical measuring principle the CPB5800 is also ideally suited for on-site use as well as service and maintenance purposes.■Piston-cylinder measuring systemPressure is defined as a quotient of force and area. Correspondingly, the core of the CPB5800 is a very precisely manufactured piston/cylinder system. The piston and cylinder are manufactured from hardened steel and tungsten carbide, respectively, and are very well protected in a solid stainlesssteel/hardened tool steel housing against impacts or contamination from outside.As a standard the connection of the piston-cylinder system is a G3/4 female thread. The patented ConTect quick connector is available as an option. This enables the piston-cylinder system to be changed quickly and safely without any tools.The CPS5800 piston-cylinder systems are available in two fundamentally different designs, depending on measuring range.■Single-range piston-cylinder systems (for measuring ranges 120 bar and 300 bar or 1,600 psi and 4,000 psi respectively)■Dual-range piston-cylinder systems (for measuring ranges 700 bar, 1,200 bar and 1,400 bar or 10,000 psi, 16,000 psi and 20,000 psi respectively)The accuracy is 0.015 % as a standard (optional also to 0.006 %) of reading.The dual-range piston-cylinder system offers two measuring ranges in one housing with automatic measuring range switching from low-pressure to high-pressure pistons. This provides the user with an extremely flexible measuring instrument that can cover a wide measuring range with high accuracy, with only one piston-cylinder unit and one set of masses. Additionally two test points can automatically be achieved by the operator loading the masses only once (low pressure – high pressure area utilisation).The entire construction design of the piston-cylinder unit and the very precise manufacturing of the piston and the cylinder stand for excellent operating characteristics with a long free rotation time and low fall rates and for a very high long term stability. Therefore the recommended re-calibration interval is 2 up to 5 years depending on the conditions of usage.■ FunctioningDepending on the measuring range of the device under test the operator can fit the instrument base with the corresponding system. In order to generate the individual test points, the piston-cylindersystem is loaded with masses. The weight applied is proportional to the desired pressure and provided by using optimally graduated weights. These weights are manufactured to standard gravity (9.80665 m/s²) although they can be adjusted for customers specific location/gravity value.The integrated priming pump and the 250 ml tank enable large test volumes to be easily filled and pressurised. For further pressure increases and fine adjustment, a very precisely-controllable spindle pump is fitted, which is self-contained with in the pump body when in use.As soon as the measuring system reaches equilibrium, there is a balance of forces between the pressure and mass load applied.The excellent quality of the system ensures that this pressure remains stable over several minutes, so that the pressure value for comparative measurements can be read without any problems, or also so that more complex adjustments can be carried out on the device under test.CPS5800 single-range piston-cylinder systemCPS5800 dual-range piston-cylinder systemPressure pHigh-pressure pistonLow-pressure piston =High-pressure cylinderForce FForce FCross-sectional area APressure p2.2 Basic principle of the Pressure BalanceTheir operating principle is based on the physical definition of pressure, the quotient of force and area.ForcePr essure =AreaThe key element of the pressure balance is a precision-manufactured piston-cylinder system with a precisely measured cross-sectional area.To apply a pressure charge to the system, the piston is placed under a load with (calibrated) masses.Each mass from the set of masses is identified by a nominal weight, which generates a pressure value in the system (assuming standard reference conditions). Each mass has a number and in thecalibration certificate describing the mass value to each mass with its resultant pressure value. The masses are chosen according to the desired pressure value.After that, the integrated spindle pump increases the pressure until the masses are in a floating state.2.3 Environmental factorsThe piston pressure gauge is calibrated to standard reference conditions when it leaves the factory (depending on customer specifications).If there are significant deviations between the application conditions and the defined reference conditions, appropriate corrections must be made.Following are the main factors that enter into play and must be considered.These corrections can be made automatically with the Calibrator Unit CPU6000 (see accessories point 8)!2.3.1 Local fluctuations in gravity-valueThe local force of gravity is subject to major fluctuations caused by geographical variation.The value may differ from one place on earth to another by as much as 0.5 %. Since this value has a direct effect on the measurement, it is essential that it be taken into consideration.The masses can even be adjusted during manufacturing to match the location where they will be used. Another option, especially if the device will be used at multiple locations, is to perform a calibration to the standard gravity,"Standard-g = 9.80665 m/s 2".Then a correction must be performed for each measurement according to the formula below:g - Application siteTrue pressure = Nominal value ⋅S tandard - gExample:Local gravity set during manufacturing: 9.806650 m/s 2Locale gravity at application site: 9.811053 m/s 2Nominal pressure: 100 bar g Local9.81105 True pressure: p = p Nominal= 100bar= 100.0449barg Standard9.80665Without the correction, measurements would differ from the nominal applied pressure by 0.05%.2.3.2 Temperature (Piston-cylinder)The effective area of the piston-cylinder system is influenced by temperature.The effect depends on the material used and is described by the temperature coefficient (TK).In the event of deviations from standard reference conditions (typically 20°C), the following formula must be used to make a correction:1True pressure = Nominal value ⋅(1 + (t Appl - t Reference)⋅TK)Example:Reference temperature: 20°CTemperature during use: 23°CTK: 0.0022%1True pressure = 100bar ⋅= 99.99340bar(1 + (23 - 20)⋅ 2.2-5)Without the correction, measurements would differ from the nominal applied pressure by 0.007%.2.3.3 Ambient conditionsThe effects of ambient conditions■air pressure■room temperature■relative humidityshould always be taken into consideration if the highest level of accuracy is required. Fluctuations in ambient conditions change air density.The air density affects the pressure through the buoyancy of the masses:Air densityWeight = Nominal weight⋅ 1 -Weight densityThe air density is typically 1.2 kg/m3The density of the masses (non-magnetic steel) is 7900 kg/m3A fluctuation of 5% in the relative humidity causes an additional uncertainty in the measurement of about 0.001%.2.3.4 How the effective area responds to pressureAt higher pressures, the effective cross-sectional surface changes due to the pressure load.The ratio of the cross-section and prevailing pressure is linear within an initial approximation. It is represented by the coefficient of expansion caused by pressure distortion (λ).Nominal pressureTrue pressure =1 + λ ⋅ Nominal pressureExample:Measuring point: 1000 barSystem with distortion coefficient: 10 -7 1/bar:1000True pressure =bar = 999.90bar1 +1⋅10-7⋅1000Without the correction, measurements would differ from the nominal applied pressure by 0.01%.2.4 Arrangement of control elementsThe CPB5800 instrument bases are available in 2 variants:■Standard hydraulic base- up to max 1,200 bar / 16,000 psi- with integrated pressure generation through priming pump and spindle pump- tubing made of stainless steel (1.4404), 6 x 2 mm- Standard pressure transmission medium: mineral oilOptional: Sebacate oil, brake fluid, Skydrol or Fomblin oil■High-pressure hydraulic base- up to max 1,400 bar / 20,000 psi- with integrated pressure generation through priming pump and spindle pump- tubing made of stainless steel (1.4404), 6 x 2 mm- Pressure transmission medium: mineral oil or Sebacate oilAs a standard both instruments bases are fitted with a connection for the piston-cylinder system with G3/4 B (male) thread.The patented ConTect quick connector can be installed as an option allowing a quick and safe change of the piston-cylinder system without the need for tools (not available for the hydraulic high-pressure version!).The connection of the test item is made without tools using a quick-connection. Via the freely-rotating knurled nut, the test item can be oriented as required. As standard, a threaded insert with a G1/2 female thread is provided. Other threaded inserts are available to connect the most common pressure measuring instruments.2.4.1 Standard hydraulic base■ View from above■ Front view■ Rear viewRotating foot studs for levelling base Interface to piston temperature sensor(optional and in combination with CPU6000 only)Interface to float position sensor(optional and in combination with CPU6000 only)Outlet valvePriming pumpTest item connectionOil reservoir sealing screw Connector for piston-cylinder system(optional ConTect quick connection)Level Screwpress2.4.2 High-pressure hydraulic base■ View from above■ Front view■ Rear viewInterface to piston temperature sensor(optional and in combination with CPU6000 only)Rotating foot studs for levelling baseInterface to float position sensor(optional and in combination with CPU6000 only)Outlet valveScrewpressPriming pumpOil reservoir sealing screwConnector for piston-cylinder system G3/4 B (male) thread Level3. Commissioning and Operation3.1 Preparation3.1.1 Setting up the Device■ Set up the pressure balance on a solid surface. If it is not resting on a solid foundation or is subject to vibrations, measurements and safety could be affected. This should be avoided.■ If no temperature control system is present, the device should at least not be placed near a heat element or window. This will reduce drafts and warm air flows as much as possible.■ The spirit level should be used to level the assembly. At this time, rough levelling can be performed without the piston-cylinder system. Using the rotating foot studs, position the device so that it is horizontal. For uppermost accuracy, the spirit level should be put on top of the fitted piston and its level adjusted to the horizontal.■ Place the star handle with knobs onto the spindle pump. Ensure that the spring-loaded thrust pad engages into the star handle bushing.■ We recommend unscrewing the spindle pump completely when you start to record measurement values, (turning anticlockwise) to allow enough swept displacement for measurements. The outlet valve must be opened during this process.■ The oil container may need to be filled, or refilled (volume 250 ml). For this purpose, the lockingscrew with the oil filling symbol on top of the basement must be opened. Special oil must be used for refilling (1 litre supplied, or available as accessory). The system must be vented before initial filling, or after a complete oil change. For this purpose, please proceed according to section 5.3.3.■ The protection film on the screwed drain plug of the oil container need to be removed before operating (coverage of the ventilation hole during transportation).3.1.2 Hydraulic pressure media usedMineral oil based hydraulic fluidAn hydraulic mineral oil with a viscosity grade VG22 is used as standard.Certain customers may wish to use the piston unit on other hydraulic fluids. Before attempting this, the following should be checked:Pressure medium is compatible with bronze, hardened tool steel, tungsten carbide and with o-rings/composite seals used in the assembly. Special seal kits are available for certain pressure media.The new pressure medium being used will have inherent physical properties (density, surface tension) that may affect the uppermost accuracy of the unit. Units that have been manufactured for a non-standard pressure medium will have had its calibrated mass adjusted for the fluids buoyancy and surface tension components. If the piston unit has not been specially calibrated, the accuracy of the unit will be reduced, and this should be taken into account.Skydrol 500BThe instrument base is also available for use on Skydrol 500B or any other phosphate ester based fire resistant liquid. This base is fitted with Ethylene Polypropylene (EP) seals. The operating characteristics of the piston-cylinder system should be tested on Skydrol. EP seals are not suitable for mineral oils.Note that continual immersion of the instrument housing in Skydrol will cause deterioration. Spillage should be wiped off the housing / cover immediately.Brake fluidsThe instrument base for use on non-petroleum based brake fluids should be ordered fitted with EP seals and the operating characteristics of the piston-cylinder system should be tested on the liquid. This liquid is known by the following names:FMVSS No.116, DOT3 or DOT4, SAE J 1 703, BS AU 174:Part 2, IS04925.Other fluidsThe instrument base can be used on silicone based fluids, sebacate based fluids, or inertperfluorinatedpolyethers such as Fluorolube, Fomblin, Halocarbon, which are of the viscosity as the standard mineral oil based hydraulic fluid mentioned above and are chemically inert, being suitable for contact with metals and with the nitrile seals which are standard on the base.3.1.3 Installing the piston-cylinder system■ The piston-cylinder system that is used depends on the device to be tested. You should select a system with a comparable or higher measuring range.■ The connection for the piston-cylinder system in the instrument base is available in 2 different versions:- Connection for piston-cylinder system with G3/4 B (male) thread (see section 3.1.3.1)- Connection for piston-cylinder system with ConTect quick connector, not for the 1,400 bar-version (see section 3.1.3.2)3.1.3.1 Connection for piston-cylinder system with G3/4 B (male) threadBefore removing the transit plug on the connector for the piston-cylinder system, make sure the system is not under pressure (open the outlet valve).■ The piston-cylinder system is connected vertically onto the thread of the piston receptacle, and tightened by hand. Excess force is not required to achieve an effective seal. An O-ring seal is already fitted, so no additional sealing material is required.Ensure that the sealing surface of the piston-cylinder system is clean.Check the o-ring in the piston stand is correctly seated and for any sign of wear. Replace, if necessary.■ For an exact alignment of the device, the spirit level may be removed from the base plate and placed on the top of the fitted piston-cylinder system. This will ensure the most accurate levelling of the piston-cylinder system.Oil collecting trayTemperature sensor, optional3.1.3.2 Connection for piston-cylinder system with ConTect quick connectorBefore releasing the transit plug in the ConTect quick-release mechanism, make sure the system is not under pressure (open the outlet valve).■ Place the piston-cylinder system vertically in the quick connector.Ensure that the sealing surface of the piston-cylinder system is clean.Check the o-ring in the ConTect stand is correctly seated and for any sign of Replace, if necessary.■ Turning the butterfly screw about one and a half turn clockwise (as far as it will go) is enough to screw the system in place with an automatic seal (finger-tight).■ For an exact alignment of the device, the spirit level may be removed from the base plate and placed on the top of the fitted piston-cylinder system. This will ensure the most accurate levelling of the piston-cylinder system.1.4.2. 3.Put spirit level on top of pistonO-ring 4 x 2.2(see accessories section 8.)3.1.3 Connecting the device under test■ Place the device to be calibrated/verified in the quick connector with the knurled nut. It can be freely positioned. Hand-tightening will suffice for effective sealing.■ To calibrate instruments with rear/back entry connections, use the 90° a ngle connection(see accessories section 8).Check the o-ring in the test stand is correctly seated and for any sign of wear. Replace, if necessary.Please see to it, that each instrument mounted to the pressure balance must be clean inside.■ The quick connector comes equipped with a G 1/2 threaded insert in the standard delivery package.When you are calibrating devices with different connection threads, the threaded inserts can be changed as appropriate (see accessories "Adapter Set"). For short connection threads an additional sealing insert (order no. 2011514 resp. content of the adapter set) can be mounted onto the existing sealing surface in the knurled nut.3.1.4 Venting the systemAfter installing the piston-cylinder system and the device under test, air may be trapped in the system. The system may be vented before beginning the calibration using the following procedure:■ The piston-cylinder system and the device under test must be clamped, and the complete mass set must be loaded on the piston-cylinder system.■ Generate a pressure of approximately 50 bar using the priming pump■ Increase the pressure with the spindle pump until just below the final value of the measuring range of the piston-cylinder system, or of the device under test (the smaller pressure range is the decisive factor).Important: The piston-cylinder system must remain in its lower position for this operation, i.e. not yet moving into equilibrium.■ Open the outlet valve slowly, any trapped air will escape into the tankThis procedure may need to be repeated 1 to 2 times in order to remove all trapped air. The device is now ready to use.Threaded insert Knurled nutO-ring 8 x 2(see accessories section 8.)3.2 Operation3.2.1 Procedure for single-range piston-cylinder system 1,600 psi or 120 bar3.2.1.1 Mass loading■ Load the piston head with masses equivalent to the required pressure calibration point required. Ensure the masses are correctly located in its respective spigot/recess.Each mass has the following markings: -Pressure Value -Piston Area-Mass set numberFor high accuracy calibration, an additional marking (letter or letter/number combination) is marked on the mass. This is to identify masses of similar nominal pressure values, and thus obtain the actual mass value (grams) of said item.■ This piston-cylinder unit has a basic head mass equivalent to 10 psi. If calibration is required in another pressure unit, the first mass applied to the piston head should be the make-up mass (small mass with ‘+PISTON’ marking).3.2.1.2 Approaching the pressure value■The system must first be filled with oil and pre-compressed. ■ For this the outlet valve must be closed.■ Operate the priming pump for several strokes. The pressure increases to a maximum of about 50 bar (depending on the volume of the connected test specimen).■ After that, increase the pressure by turning the built-in spindle pump clockwise.■ Just before the generated pressure reaches the actual calibration point, the masses should be rotated by hand (approx 30-40 RPM) to ensure that the piston is in free-rotation. Care should be applied when rotating the masses that no un-necessary transverse loads are applied to the piston.Never rotate the piston-cylinder unit, if the piston is in the lower or upper block position.3.2.1.3 Pressure stable■ Continue generating pressure until the system is in a state of equilibrium.■ As the pressure calibration point is achieved, the piston will begin to move in an upward direction to its ‘FLOATING’ position. The ‘FLOATING’ (free ro tation) position is between 1-7mm above the cylinder. To confirm this, the operator can press down lightly (use index finger) onto the top of the masses applied. If the piston and masses appear to bounce (move freely up and down) the piston unit is at pressure value of masses applied.As there is only a small pressure change required between the piston floating/not floating we recommend turning the pump spindle slowly and evenly clockwise.■ The piston and thus the test pressure as well now remain stable for several minutes.。

盐酸多柔比星脂质体注射液说明书--楷莱

盐酸多柔比星脂质体注射液说明书--楷莱

盐酸多柔比星脂质体注射液说明书--楷莱(总5页)-CAL-FENGHAI.-(YICAI)-Company One1-CAL-本页仅作为文档封面,使用请直接删除盐酸多柔比星脂质体注射液说明书【药品名称】通用名:盐酸多柔比星脂质体注射液商品名:楷莱英文名:Doxorubicin Hydrochloride Liposome Injection汉语拼音:Yan Suan Duo Ruo Bi Xing Zhi Zhi Ti Zhu She Ye【成份】本品主要成分及其化学名称为:盐酸多柔比星,(1S,3S)-3-乙醇酰-1,2,3,4,6,11-六氧-3,5,12-三羟基-10-甲氧基-6,13-二氧并四苯-1-基-3-氨基-2,3,6-三去氧-α-L-来苏吡喃糖苷。

其结构式为:分子式:C27H29NO11.HCl分子量:579.99CAS No.:25316-40-9【性状】本品是一种脂质体制剂,系将盐酸多柔比星通过与甲氧基聚乙二醇的表面结合包封于脂质体中。

这种工艺被称作为空间稳定或隐匿,可以保护脂质体免受单核巨噬细胞系统(MPS)识别,从而延长其在血液循环中的时间。

本品为无菌、半透明的红色混悬液,每瓶10 mL,含盐酸多柔比星2mg/mL,是用于单剂量静脉滴注给药的浓缩液。

本品的活性成分为盐酸多柔比星,是从一种波塞链霉菌表灰变种(strep tomyces peucetius var. caesius)培养液中提取得到的蒽环类细胞毒性抗生素。

【适应症】本品可用于低CD4(<200 CD4淋巴细胞/mm3)及有广泛皮肤粘膜内脏疾病的与艾滋病相关的卡波氏肉瘤(AIDS-KS)病人。

本品可用作一线全身化疗药物,或者用作治疗病情有进展的AIDS-KS病人的二线化疗药物,也可用于不能耐受下述两种以上药物联合化疗的病人:长春新碱、博莱霉素和多柔比星(或其他蒽环类抗生素)。

【规格】20mg/ml/支【用法用量】本品应为每2-3周静脉内给药20 mg/m2,给药间隔不宜少于10天,因为不能排除药物蓄积和毒性增强的可能。

细胞毒性药物配制方法及使用时注意事项

细胞毒性药物配制方法及使用时注意事项

抗肿瘤药物的用药顺序及溶媒选择原则(1)药物相互作用原则? ?有的化疗药物之间会发生相互作用,从而改变药物的体内过程,可能影响疗效或毒性。

如顺铂影响紫杉醇的清除率,先用紫杉醇再用顺铂。

(2)刺激性原则? ?使用非顺序依赖性化疗药物时,应先用对组织刺激性较强的药物,后用刺激性小的药物。

由于治疗开始时静脉尚未损伤,结构稳定性好,药业渗出机会少,药物对静脉引起的不良反应较小如长春瑞滨和顺铂合用时,长春瑞滨刺激性强,宜先给药。

(3)细胞动力学原则? ? 生长较慢的实体瘤处于增殖期的细胞较少,G0期细胞较多,先用周期非特异性药物杀灭一部分肿瘤细胞,使肿瘤细胞进入增殖期再用周期特异性药物。

顺铂和依托泊苷合用时,先用顺铂后用VP-16。

? ? 生长快的肿瘤先用周期特异性药物大量杀灭处于增殖周期的细胞,减少肿瘤负荷,随后用周期非特异性药物杀灭残存的肿瘤细胞。

用药顺序1、联用顺铂化疗化疗方案? ? ? ???联用药物? ? ? ? 用药顺序? ? ? ? 原因GP? ? ? ? 吉西他滨? ? ? ? 先用GEM? ? ? ? 顺铂会影响吉西他滨的体内过程,加重骨髓抑制。

TP? ? ? ???紫杉醇? ? ? ? 先用PTX? ? ? ? 顺铂对细胞色素P450酶有调节作用,可使PTX清除率大约降低33%,产生更为严重的骨髓抑制FP ? ? ? ? 5-FU? ? ? ? 先用DDP? ? ? ? 小剂量DDP能够增加细胞内蛋氨酸, 使细胞内活性叶酸生成增加, 从而增加5-FU的抗肿瘤作用。

PP? ?? ?? ?培美曲塞? ? ? ? 先用Alimta,30min后用顺铂? ? ? ? 说明书2、联合长春新碱化疗化疗方案? ? ? ???联用药物? ? ? ???用药顺序? ? ? ?? ?? ?? ?? ?? ?? ?? ? 原因CHOP? ? ? ? 环磷酰胺? ? ? ? 先用VCR,6-8小时后在给CTX? ? ? ?? ?? ?VCR具有同步化作用,使细胞停滞在M期,约6~8h后细胞同步进入G1期,再用CTX可增效VCM? ? ? ???甲氨蝶呤? ? ? ???先用VCR? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ???VCR阻止甲氨蝶呤从细胞内渗出而提高细胞内浓度VDLP ? ? ? ? 门冬酰胺酶? ? ? ? 先用VCR? ? ? ?? ?? ?? ?? ?? ?? ?? ?合用加重神经系统血液系统毒性,先于门冬12~24小时给药3、甲氨蝶呤化疗方案? ? ? ???联用药物? ? ? ???用药顺序? ? ? ?? ?? ?? ?? ?? ?? ? 原因CMF? ? ? ? 5-FU? ? ? ? 用MTX4~6h后用5-FU? ? ? ? 序贯抑制 MTX----二氢叶酸还原酶抑制剂 5-FU-----胸腺嘧啶合成酶抑制剂VCM? ? ? ???甲氨蝶呤? ? ? ???先用VCR? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?阻止甲氨蝶呤从细胞内渗出而提高细胞内浓度,先注射VCR? ? ? ? 门冬酰胺酶??使用门冬酰胺酶10日后使用本品或者使用本品24小时后给予门冬酰胺酶? ? ? ? 门冬酰胺酶能抑制蛋白质的合成,使细胞停止于G 1 期,不能进入S期,从而降低其对MTX的敏感性。

Rockwell SCALANCE X204-2LD 产品说明书

Rockwell SCALANCE X204-2LD 产品说明书

Product data sheet6GK5204-2BC10-2AA3 Product-type designation SCALANCE X204-2LDSCALANCE X204-2LD, MANAGED IE SWITCH,4 X 10/100MBIT/S RJ45 PORTS,2 X 100MBIT/S SINGLEMODE BFOC,ERROR SIGNAL CONTACT WITH SET BUTTON,REDUNDANT POWER SUPPLY,PROFINET-IO DEVICE,NETWORK MANAGEMENT,INTEGRATED REDUNDANCY MANAGER ANDELECTRONIC MANUAL ON CD,C-PLUG OPTIONALTransfer rate / 110 Mbit/sTransfer rate / 2100 Mbit/sNumber of electrical/optical connections• for network components or terminal equipment / maximum6Number of electrical connections• for network components and terminal equipment4• for signaling contact1• for power supply1• for redundant power supply1Design of the electrical connection• for network components and terminal equipment RJ45 port• for signaling contact2-pole terminal block• for power supply4-pole terminal blockNumber of optical interfaces / for optical waveguide / at 100 Mbit/s2Design of optical interface / for optical waveguide / at 100 Mbit/s BFOC port (singlemode up to 26 km)Connectable optical power relative to 1 mW• of the transmitter output-15 … -7 dBOptical sensitivity relative to 1 mW / of the receiver input / minimum-34 dBAttenuation / of fiber-optic cable transmission link / minimum0 dBnecessaryRange / at the optical interface / depending on the optical fiber used0 … 26 kmdesign of the removable storage / C-PLUG YesOperating voltage / of signaling contacts / at DC / rated value24 VOperating current / of signaling contacts / at DC / maximum0.1 AType of / supply voltage DCSupply voltage / external24 V• minimum18 V• maximum32 VProduct component / fusing at power supply input YesType of fusing / at input for supply voltage0,6 A / 60 VConsumed current / maximum0.265 AActive power loss / at 24 V / for DC 6.36 WAmbient temperature• during operating-40 … +60 °C• during storage-40 … +70 °C• during transport-40 … +70 °CRelative humidity / at 25 °C / without condensation / during operating95 %/ maximumProtection class IP IP30Design compactWidth60 mmHeight125 mmDepth124 mmNet weight0.78 kgMounting type• 35 mm DIN rail mounting Yes• wall mounting Yes• S7-300 rail mounting Yes50Cascading in the case of a redundant ring / at reconfiguration time of<\~0.3\~sCascading in cases of star structuring Any (depending only on signal propagation time) Product function• CLI Yes• web-based management Yes • MIB support Yes • TRAPs via email Yes • Configuration with STEP 7Yes • Port mirroring Yes • for IRT / PROFINET IO switch No • PROFINET IO diagnosis Yes • switch-managed Yes Protocol / is supported• Telnet Yes • HTTP Yes • HTTPS Yes • TFTP Yes • FTP Yes • BOOTP No • SNMP v1Yes • SNMP v2Yes • SNMP v3Yes • DCP Yes • LLDP Yes Identification & maintenance function• I&M0 - device-specific information Yes • I&M1 – higher level designation/location designation YesProduct function• Port diagnostics Yes • Statistics Packet Size Yes • Statistics packet type Yes • Error statistics YesProduct function / DHCP client YesProduct function• Ring redundancy Yes • Redundancy manager Yes • Standby redundancy No • High Speed Redundancy Protocol (HRP)Yes • Media Redundancy Protocol (MRP)Yes • Parallel Redundancy Protocol (PRP)No• Passive listening YesProtocol / is supported / PRP YesProtocol / is supported / SSH YesProduct function / SICLOCK support YesProtocol / is supported• NTP No• SNTP YesStandard• for EMC / from FM FM3611: Class 1, Division 2, Group A, B, C, D / T4, CL.1, Zone 2,GP. IIC, T4• for hazardous zone EN 60079-0 : 2006, EN 60079-15: 2005, II 3 G Ex nA II T4 KEMA 07ATEX 0145X• for safety / of CSA and UL UL 60950-1, CSA C22.2 No. 60950-1• for hazardous area / of CSA and UL ANSI / ISA 12.12.01, CSA C22.2 No. 213-M1987, CL. 1 / Div. 2 /GP. A, B, C, D T4, CL. 1 / Zone 2 / GP. IIC, T4• for emitted interference EN 61000-6-4 (Class A)• for interference immunity EN 61000-6-2Verification of suitability EN 61000-6-2, EN 61000-6-4• CE mark Yes• C-Tick Yes• KC approval Yes• Railway application in accordance with EN 50155No• Railway application in accordance with EN 50124-1NoMarine classification association• American Bureau of Shipping Europe Ltd. (ABS)Yes• Bureau Veritas (BV)Yes• Det Norske Veritas (DNV)Yes• Germanische Lloyd (GL)Yes• Lloyds Register of Shipping (LRS)Yes• Nippon Kaiji Kyokai (NK)Yes• Polski Rejestr Statkow (PRS)YesInternet-Link• to website: Industry Mall /industrial-controls/mall• to website: Industrial communication /simatic-net• to website: Information and Download Center /automation/net/catalog• to website: Image database /bilddb• to website: CAx Download Manager /cax• to website: Industry Online Support letzte Änderung:Aug 6, 2014。

Accel 2 click 商品说明说明书

Accel 2 click 商品说明说明书

23clickBOARD™2. Soldering the headers3. Plugging the board inOnce you have soldered the headers your board is ready to be placed into the desired mikroBUS ™ socket. Make sure to align the cut in the lower-right part of the board with themarkings on the silkscreen at themikroBUS ™ socket. If all the pins are aligned correctly, push the board all the way into the socket.Turn the board upward again. Make sure to align the headers so that they are perpendicular to the board, then solder the pins carefully.Turn the board upside down so that the bottom side is facing you upwards. Place shorter pins of the header into the appropriate soldering pads.Before using your click board ™, make sure to solder 1x8 male headers to both left and right side of the board. Two 1x8 male headers are included with the board in the package.4. Essential featuresAccel 2 click , with its embedded state machines, is especially suited for designing motion control user interfaces. It allows you to implement gesture recognition. User-defined programs can distinguish movement patterns like shake and double shake, face up and face down, turn and double turn, and activate an interrupt upon their execution. An integrated FIFO buffer, with multiple operating modes, enables you to optimize between performance and power consumption.1Accel 2 click carries ST’s LIS3DSH IC , a low-power factory-calibrated three-axis accelerometer which embeds a FIFO buffer and two programmable state machines. The board communicates with the target board MCU through either SPI (CS#, SCK, SDO, SDI) or I2C (SCL, SDA) interfaces. It also has an interrupt pin (INT) which can be programmed to respond to user defined movement patterns.Accel 2 click1. IntroductionAccel 2 click manualver 1.000100000079133VCC-3.3R510KCS#SCK SDO SDIVCC-3.3R12K2LD1INT AN RST CS SCK MOSI MISO +3.3V GND PWM INT RX TX SCL SDA +5V GNDINT29RES 10INT1/DRDY11GND12GND 13V D D14R E S 15G N D 16VDDIO 1NC3GND 5SCL/SPC 4NC 2S D A /S D I 6S E L/S D O 7C S8U1LIS3DSHVCC-3.3J3J1R210KJ2SDI/SDASDO/ADDR310KVCC-3.3SCK SCL SPI SPI SPI I2CI2CI2CSDI SDO SDA SCK/SCLJ4VCC-3.3ADD1ADD0SCK/SCLS D I /S D A S D O /A D D C S #R4100KINTSCL SDAC1100nF C2100nFVCC-3.38. Code examplesMikroElektronika offers free tech support (/support) until the end of the product’s lifetime, so if something goes wrong, we’re ready and willing to help!Once you have done all the necessary preparations, it’s time to get your click board ™ up and running. We have provided examples for mikroC ™, mikroBasic ™ and mikroPascal ™ compilers on our Libstock website. Just download them and you are ready to start..com6. DimensionsMikroElektronika assumes no responsibility or liability for any errors or inaccuracies that may appear in the present document. Specification and information contained in the present schematic are subject to change at any time without notice.Copyright © 2015 MikroElektronika.All rights reserved.mmmils LENGTH 28.61125WIDTH 25.41000HEIGHT*3.31305. Schematic7. SMD jumpers10. Disclaimer9. Support25.4 m m / 1000 m i l s28.6 mm / 1125 milsAccel 2 click features two sets of jumpers. The three SEL. COMM. jumpers are for switching between SPI and I 2C interfaces (soldered in I 2C by default). I 2C ADD is for specifying the I2C address.* without headers。

RYOHIN KEIKAKU CO., LTD MJ-DCLA2GL 产品说明书

RYOHIN KEIKAKU CO., LTD MJ-DCLA2GL 产品说明书

If the battery is leaking, remove the battery and wipe off the liquid thoroughly with a cloth or paper. If it comes in contact with the eyes or skin, it may cause blindness, inflammation, or other injuries.
of volume. And light used 30 seconds a day. Alarm at the time set ±0 second to the displayed time Electric sound, Sound changes in 4 levels Changeable, Maximum volume approx. 100 dB (above speaker) Provided Provided From year 2014 to 2099 Interchangeable in AM/PM 12 hours or 24 hour time LED light used for LCD display part -9.9 to +50 °C(+14.1 to +122 °F) ±2 °C(±3.6 °F), between display available range 20 to 95 %RH (%RH means Relative Humidity) ±10 %RH, between display available range Every 1 minute W148 x D64 x H59mm (W5.83 x D2.52 x H2.32 in) 230 g (0.51 lb) (include batteries) Case ABS/ LCD Display Glass None

抗肿瘤药物多柔比星脂质体

抗肿瘤药物多柔比星脂质体

药学与临床研究Pharmaceutical and Clinical Research 2010多柔比星(Doxorubicin )是1969年从松链丝菌浅灰色变株(Str.peucetius var.caesius )中提取分离到的蒽环类抗生素,具有很强的抗癌活性,化疗指数较高,临床上单独使用或与其他抗癌药物联合使用可有效治疗各种恶性肿瘤。

多柔比星属于细胞周期非特异性药物,它主要通过嵌入DNA 碱基对之间并与DNA 紧密结合,从而阻止DNA 的复制,抑制DNA 依赖性多聚酶的作用,干扰RNA 转录过程。

这种阻止细胞分裂的作用,并不能选择性地区分肿瘤细胞和正常细胞,因此与大多数化疗药物一样,多柔比星的不良反应很多。

除呕吐、恶心、脱发等常见副作用外,还由于阿霉素类化合物与心肌的亲和力明显高于其他组织,并能通过半醌代谢物损害心肌细胞,从而带来严重的剂量依赖性心脏毒性,使其临床应用受到极大限制[1]。

虽然通过减少累积给药剂量可以一定程度上缓解阿霉素类抗肿瘤药物的心脏毒性,但同时会降低对肿瘤的控制效果。

近年来,脂质体作为一种新型的靶向药物载体,可以增加药物疗效,减少毒副作用,在肿瘤药物开发中备受重视[2]。

大量研究表明,脂质体技术对克服阿霉素心脏毒性尤为有效,阿霉素脂质体因此迅速成为各大制药公司开发的热点,先后有多个药物上市,进入临床应用,其中以多柔比星脂质体为最多。

1脂质体制剂脂质体(liposome)是一种具有类似生物膜结构的磷脂双分子层小囊泡。

最初是在1965年由英国科学家Bangham 和Standish 等发现的。

他们用电镜观察到磷脂分散在水中自然形成多层囊泡,每层由厚度约为4纳米的双分子层组成,囊泡中央和各层之间被水相隔开[3]。

1971年Ryman 等人提出将脂质体用于药物载体,以提高药物靶向性和降低药物的副作用,此后对其研究日益深入,并逐渐在临床上得到广泛应用。

脂质体作为药物载体,与传统剂型相比,具有许多独特的优点[4]。

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