英文药名：ZOSYN（Tazobactam/Piperacillin Hydrate） 中文药名：他唑巴坦/哌拉西林复方冻干粉注射剂 生产厂家：大鹏药业 ゾシン静注用2.25／ゾシン静注用4.5 治疗类别名称 β-内酰胺酶抑制剂抗生素配方配方 商標名 ZOSYN 他唑巴坦 一般名 タゾバクタム(Tazobactam) (略号：TAZ) 化学名 (2S,3S,5R)-3-Methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide 構造式 分子式 C10H12N4O5S 分子量 300.29 性状 白色至浅黄色结晶性粉末。二甲基亚砜或N，易溶于N-二甲基甲，水，甲醇或乙醇（99.5）微溶。溶于碳酸氢钠溶液（3→100）。 熔点 大约184℃（分解） 分配系数 1.5×10-3（1-辛醇/水，pH为7） 哌拉西林水合物 一般名 ピペラシリン 水和物(Piperacillin Hydrate) (略号：PIPC・H2O) 化学名 (2S,5R,6R)-6-{(2R)-2-[(4-Ethyl-2,3-dioxopiperazine-1-carbonyl)amino]-2-phenylacetylamino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid monohydrate 構造式 分子式 C23H27N5O7S・H2O 分子量 535.57 性状 它是一种白色结晶粉末。易溶于甲醇，乙醇（99.5），或二甲亚砜微溶于去，在极微溶于水。 熔点 150〜160℃（分解） 分配系数 7.1×10-2（1辛醇/水，pH为7） 条件批准 在建立药品风险管理计划的顶部，要正确实施。 药效药理 1. 抗菌作用 (1) 葡萄球菌等革兰氏阳性菌，具有广泛的抗菌谱的革兰氏阴性细菌和厌氧细菌绿脓杆菌等，作用杀菌。 (2) 对β-内酰胺酶生产哌拉西林抗性的革兰氏阳性和革兰氏阴性细菌具有较强的抗菌活性。 2. 作用机序 他唑巴坦的青霉素酶β-内酰胺酶，灭活强烈头孢菌素酶和底物特异性延伸，β-内酰胺酶，以及防御哌拉西林由这些酶水解，对耐哌拉西林细菌它显示了抗菌活性。此外，哌拉西林指示由细菌的细胞壁合成抑制的抗菌作用。 适应病症 <Adaptive species> 感性的金黄色葡萄球菌，链球菌，肺炎链球菌，肠球菌，的莫拉（Buranhamera）卡他莫拉菌，大肠埃希氏菌，柠檬酸杆菌，克雷伯菌属，肠杆菌属，沙雷菌属，变形杆菌属，普罗维登西亚，流感这种药物除了难辨梭状芽孢杆菌，类杆菌，普雷沃菌，铜绿假单胞菌，不动杆菌属，消化链球菌，梭状芽孢杆菌 <Indications> 败血症，肺炎，肾盂肾炎，复杂性膀胱炎，腹膜炎，腹腔内脓肿，胆囊炎，胆管炎 相关使用说明的效果或疗效 给药时，以验证此代理的易感性的原则，参与β-内酰胺酶，可以认为，给药的情况下其中中度或通过对本药敏感的致病菌感染。 用法和用量 1. 一般感染症 ・ 败血症，肺炎，腹膜炎，腹腔内脓肿，胆囊炎，胆管炎的情况下， 成年人，一次4.5克（效价）每日静脉滴注三次。肺炎，症状，可每天根据条件提高到4倍。如果需要的话，它也可以静脉注射慢。 通常，一旦112.5mg/kg的每日三次小儿静脉输注。需要的话，也可以静脉注射慢。此外，症状，可以适当根据条件减肥单剂量。然而，单剂量的上限应不超过4.5克，一次在成人 ・ 在肾盂肾炎和复杂性膀胱炎的情况下 成年人，一次4.5G，每日两次静滴。症状可以每天根据条件提高到3倍。如果需要的话，它也可以静脉注射慢。 通常，一旦112.5mg（效价/kg的静脉输注的儿童，每天两次。需要的话，可以静脉注射慢。此外，症状，可以适当根据条件减肥单剂量。此外，症状，可每天根据条件提高到3倍。然而，单剂量的上限应不超过4.5克（效价）一次在成人。 2. 中性粒细胞减少性发热 成年人，一次4.5克，一天四次静脉滴注。需要的话，可以静脉注射慢。 一般，一次90毫克/kg的每日四次小儿静脉输注。如果需要的话，也可以静脉注射慢。然而，单剂量的上限应不超过4.5克，一次在成人。 包装规格 静脉注射 2.25克×10瓶 4.5克×10瓶 制造和销售 大鹏药业有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/6139505F3020_1_09/ Notification of Adaptation for Adaptation of Pyrogenic Neutropenia for Zosyn (R) for Intravenous Antibiotic Preparation Containing β-Lactamase Inhibitor Taiho Pharmaceutical Co., Ltd. (Headquarters: Tokyo, President: Masayuki Kobayashi, hereinafter "Taiho Pharmaceutical") is an antibiotic formulation containing β-lactamase inhibitor "Zosyn® for intravenous injection 2.25, Zosyn (R) 4.5, Zosyn (R) infusion IV bag 4.5 "(generic name: tazobactam · piperacillin, hereafter" this drug ") has obtained approval to add indication for febrile neutropenia today I will inform you. Under the Ministry of Health, Labor and Welfare's "Medical Necessary Unapproved Drugs and Non-Adverse Drug Consideration Conference (* 1) (hereinafter referred to as" Review Conference "), Development request for acquisition of adaptation of "febrile neutropenia" was submitted from the related academic society, and the evaluation meeting gave the evaluation that medical necessity is high at the review meeting. As a result, the Ministry of Health, Labor and Welfare asked for development at Taiho Pharmaceutical in December 2010, and in response to this request, Phase III clinical trial for this indication was conducted, and on July 2, 2014, an adaptation addition application was made It was. This approval acquisition is based on Phase III clinical trials which examined the antipyretic effect, efficacy and safety of this drug for adults and children with pyrogenic neutropenia patients and the pharmacokinetics of this drug for pediatric patients Based on the results of. This study confirmed that this drug can be administered effectively and safely in the same way as drugs already approved in Japanese fever neutropenia patients. Taiho Pharmaceutical will continue to make efforts to further contribute to patients and medical staff in the treatment of infectious diseases. About Zosyn (R) This drug is produced by Taiho Pharmaceutical Co., Ltd. Tazobactam, which is a β-lactamase inhibitor, and piperacillin, a penicillin antibiotic created by Toyama Chemical Industry Co., Ltd. (Head office: Tokyo, President and CEO: Masuji Sugata) It is an antibiotic preparation for injection mixed at a ratio of 1: 8. Taisho Toyama Pharmaceutical Co., Ltd. (Head Office: Tokyo, Representative Director: Kenichi Fujita) sells Taiho Pharmaceutical in the domestic market. This drug was approved as an indication for septicemia, pneumonia, pyelonephritis and complicated cystitis in adults and children in July 2008, and in September 2012 adaptation of peritonitis, peritoneal abscess, cholecystitis and cholangitis Sickness has been approved. Overseas, it has been approved in 112 countries (* 2). It is also recommended as one of the first-line drugs in clinical practice guidelines on the treatment of various infectious diseases such as Europe and the United States, and it is highly appreciated as a global standard drug. About febrile neutropenia Various chemotherapy and radiotherapy, etc. are applied to patients with hematopoietic diseases such as acute leukemia and solid cancer. Fever Neutropenia is a feverish disease that develops during neutropenia associated with bone marrow suppression resulting from these treatments. It is also known to be a disease with a high risk of rapidly becoming severe and leading to death, but it is known to improve by administration of broad spectrum antimicrobials. ※ 1: Although it is approved for use in Europe and the US, in addition to evaluating the medical necessity for unapproved medicines and indications in the country, it is necessary to evaluate the necessity of medical treatment, the necessity for additionally necessary tests Meeting established for the purpose of contributing to the promotion of development of unapproved drugs and non-applicable drugs by pharmaceutical companies by confirming the validity of the drug. ※ 2: As of August 2014 (latest) <Product overview> product name Zosyn (R) for intravenous injection 2.25, Zosyn (R) for intravenous injection 4.5, Zosyn (R) combination IV infusion bag 4.5 common name Tazobactam·piperacillin Indication 1. General infectious diseases <Adaptive fungal species> This drug is susceptible to Staphylococcus, Streptococcus, Streptococcus, Streptococcus, Enterococci, Moraxella (Blanchamellaria), Catharalis, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Providencia, Influenza Bacteria, Pseudomonas aeruginosa, Acinetobacter, Peptostreptococcus, Clostridium (except Clostridium difficile), Bacteroides, Prevotella <Indication> Septicemia, pneumonia, pyelonephritis, complex cystitis, peritonitis, abdominal abscess, cholecystitis, cholangitis 2. Pyrogenic neutropenia Dosage/Dose Dosage regimen/dose of "Zosyn (R) for intravenous injection 2.25, Zosyn (R) for intravenous injection 4.5" 1. General infectious diseases · In the case of sepsis, pneumonia, peritonitis, abdominal abscess, cholecystitis and cholangitis Usually, adults intravenously infused intravenously as tazobactam / piperacillin once, 4.5 g (potency) once a day. In the case of pneumonia, it can be increased to 4 times a day depending on symptoms and pathology. Incidentally, it is also possible to slowly inject intravenously if necessary. Usually, infants should be infused intravenously with 112.5 mg (titer)/kg once a day three times a day. Incidentally, it is also possible to slowly inject intravenously if necessary. Also, one dose can be reduced according to symptoms and pathology. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. ·Cases of pyelonephritis and complicated cystitis Usually, adults receive intravenous infusion of tazobactam/ piperacillin once a day 4.5 g (titer) twice a day. It can be increased to three times a day depending on symptoms and pathology. Incidentally, it is also possible to slowly inject intravenously if necessary. Usually, infants should be infused intravenously twice daily with 112.5 mg (titer)/kg for children. Incidentally, it is also possible to slowly inject intravenously if necessary. Also, one dose can be reduced according to symptoms and pathology. Furthermore, it can be increased to three times a day depending on symptoms and pathological conditions. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. 2. Pyrogenic neutropenia Usually, adults receive intravenous drip infusion of 4.5 g (titer) once a day as tazobactam/piperacillin once a day. Incidentally, it is also possible to slowly inject intravenously if necessary. Usually, infants intravenously infusate 90 mg (titer) / kg once a day four times a day for children. Incidentally, it is also possible to slowly inject intravenously if necessary. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. Dosage regimen/dosage of "Zosyn(R)Injection Infusion IV Bag 4.5" 1. General infectious diseases · In the case of sepsis, pneumonia, peritonitis, abdominal abscess, cholecystitis and cholangitis Usually, adults receive intravenous drip infusion of 4.5 g (titer) once a day as tazobactam/piperacillin once. In the case of pneumonia, it can be increased to 4 times a day depending on symptoms and pathology. Usually, infants should be infused intravenously with 112.5 mg (titer)/kg once a day three times a day. The dose can be reduced as appropriate according to symptoms and pathology. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. · Cases of pyelonephritis and complicated cystitis Usually, adults receive intravenous infusion of tazobactam/ piperacillin once a day 4.5 g (titer) twice a day. Incidentally, it can be increased to three times a day depending on symptoms and pathology. Usually, infants should be infused intravenously twice daily with 112.5 mg (titer)/kg for children. The dose can be reduced as appropriate according to symptoms and pathology. It can also be increased to three times a day depending on symptoms and pathology. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. 2. Pyrogenic neutropenia Usually, adults receive intravenous drip infusion of 4.5 g (titer) once a day as tazobactam·piperacillin once a day. Usually, infants intravenously infusate 90 mg (titer)/kg once a day four times a day for children. However, the upper limit of a single dose should not exceed 4.5 g (titer) once in adults. This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895