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当前位置:药品说明书与价格首页 >> 抗感染类 >> 药品目录 >> 抗生素类 >> 头孢菌素类 >> Zeftera Intravenous for injection(头孢托罗注射剂)

Zeftera Intravenous for injection(头孢托罗注射剂)

2016-02-21 07:53:21  作者:新特药房  来源:互联网  浏览次数:0  文字大小:【】【】【
简介: 英文药名:Zeftera(ceftobiprole medocaril) 中文药名:头孢托罗注射剂 生产厂家:扬森-Cilag 药品介绍商品名:ZEFTERA™药理作用:新的头孢菌素给药途径:静脉注射适应症:18岁及以上年龄患者 ...

英文药名:Zeftera(ceftobiprole medocaril)

中文药名:头孢托罗注射剂

生产厂家:扬森-Cilag
药品介绍
商品名:ZEFTERA™
药理作用:新的头孢菌素
给药途径:静脉注射
适应症:
18岁及以上年龄患者,有疑似或确认由MRSA所致的皮肤感染,包括糖尿病患者所致的足部感染。

新类广谱抗生素Zevtera的第一个头孢托罗注射剂获加拿大批准上市,用于治疗包括糖尿病脚感染在内的复杂性皮肤和皮肤软组织感染。
本品上市是包括抗由MRSA在内的潜在致死菌引起感染的一重大进步。本品是一新颖的广谱抗生素,在检测出引起感染的确切细菌前即可作为一线治疗药使用。
头孢托罗专门设计结合于许多革兰阳性球菌类上的耐青霉素(造成细菌活性转向MRSA和耐青霉素的肺炎链球菌)靶点。头孢托罗作为单一静脉注射剂显示对其它许多常常发生在社区和医院传染的革兰阳性菌和革兰阴性菌有广谱抗菌活性。加拿大卫生部批准头孢托罗用于治疗18岁及以上的微生物可疑菌感染:复杂性皮肤和皮肤软组织感染。包括不威胁肢体的糖尿病脚感染(无同时患有阴沟肠杆菌、大肠杆菌、肺炎克雷伯杆菌、奇异变形杆菌、包括耐甲氧西林在内的金黄色葡球菌和化脓链球菌引起的骨髓炎)。
Zevtera(TM) (ceftobiprole medocaril), the novel anti-MRSA broad-spectrum antibiotic
Zeftera (Ceftobiprole Medocaril)
Trade name of the product:
Zeftera
Pharmaceutical active ingredients:
Ceftobiprole Medocaril
Available forms, composition and doses of Zeftera:
Injectable; Injection; Ceftobiprole Medocaril 500 mg
Medical categories:
Human:
Cephalosporins fourth-generation
Indications and usages, anatomical therapeutic chemical and diseases classification codes:
J01DI01 - Ceftobiprole Medocaril
Pharmaceutical companies: manufacturers, researchers, developers, local distributors and suppliers:
Janssen
New Drugs Online Report for ceftobiprole
Information
Generic Name: ceftobiprole  
Trade Name: Zevtera (EU), Zeftera (US) 
Entry Type: New molecular entity  
Development and Regulatory status
UK: Launched 
EU: Launched 
US: None 
UK launch Plans: Available only to registered users
Actual UK launch date: May 2015 
Comments
May 15: Launched in the UK [15].
21/05/2015 09:35:20 
Jan 15: UK launch planned for 2015 but no exact dates known yet [14].
27/01/2015 15:02:25 
Jun 14: Basilea are currently focused on preparing the launch of ceftobiprole for treatment of community and hospital-acquired pneumonia in Europe with a pharmaceutical distributor or contract sales organisation. They anticipate that ceftobiprole will be available in the first key EU markets in 2H 2014 [13].
26/06/2014 10:21:14 
Jun 14: Basilea confirm they have no current plans to file in the US, as they will not launch a new PIII study without a US partner [13].
26/06/2014 10:20:01 
Oct 13: Approved in the EU for the treatment of hospital-acquired pneumonia (excluding ventilator-associated pneumonia) and community-acquired pneumonia in adults [12].
24/10/2013 09:32:47 
Aug 13: The FDA has indicated that their current guidelines mandating two pivotal trials per indication are still valid which will delay approval in the US [11]
22/08/2013 11:12:01 
Jul 12: Filed in EU under the decentralized procedure for the treatment of pneumonia in hospitals. The submission is supported by 2 PIII studies of first- line empiric ceftobiprole vs single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired (nosocomial) pneumonia [10].
31/07/2012 21:38:15 
Jan 12: There are no further development plans for ceftobiprole in community-acquired pneumonia [8]. 
24/04/2012 11:44:50 
Jan 12: Basilea will finalise filing plans for the US upon additional discussions with the FDA [7].
24/04/2012 11:38:34 
Jan 12: Plan to file in EU in 2H 2012 for treatment of pneumonia in the hospital setting [5].
07/01/2012 21:57:58 
Sep 10: Basilea says that its soon-to-be ex-partner J&J is to discontinue sales of ceftobiprole for the treatment of complicated skin and soft tissue infections in Switzerland following problems it has had elsewhere in getting the drug approved; Swissmedic has been asked by J&J to withdraw its sales licence based on "the unfavorable assessments of the marketing authorisation applications" in the US and EU. J&J has also put in requests for withdrawals of marketing applications in Russia, Ukraine and Azerbaijan, the remaining countries in which ceftobiprole is currently approved. Basilea said that the decision to discontinue sales of the drug in the Swiss market "does not preclude the submission of a new application for marketing authorisation in the future" [4].
12/09/2010 13:53:40 
Feb 10: Johnson & Johnson has terminated its agreement with Basilea to develop & co-promote ceftobiprole (2). Basilea claims that J & J breached the licence agreement & had submitted a Request for Arbitration in Feb 09. The arbitration decision is anticipated before the end of 2010 (3).
10/06/2010 15:41:47 
Phase III in EU and US (1)
22/04/2009 17:00:04 
Trial or other data
Jun 15: Basilea Pharmaceutica has launched its new broad-spectrum antibiotic cephalosporin Zevtera across the UK for the first-line treatment of serious bacterial pneumonia. In clinical trials, Zevtera showed non-inferiority to currently used antibiotics for community-acquired and hospital-acquired pneumonia, and post-hoc-analyses of the data also show an early clinical response for Zevtera compared to a standard combination of antibiotics. On the safety side, Zevtera was also found to be well-tolerated, the most common side effects (reported by 3% or more patients) being nausea, vomiting, diarrhoea, infusion site reactions, hypersensitivity and taste impairment [16]. 
03/07/2015 10:08:59
Oct 07: Basilea announce top-line results from a PIII trial (NCT00210964) involving 781 pts. Ceftobiprole medocaril was non-inferior to combination therapy with ceftazidime and linezolid for the treatment of nosocomial pneumonia. In the clinically evaluable population, clinical cure was achieved by 69% of ceftobiprole medocaril recipients & 72% of ceftazidime plus linezolid recipients; non-inferiority of ceftobiprole medocaril was also established in the intent-to-treat population analysis. When pts with ventilator-associated pneumonia (VAP) were excluded, the cure rates in the clinically evaluable population were 77% & 76% in the ceftobiprole & combination groups, respectively. However, cure rates with ceftobiprole medocaril were lower in pts with VAP & noninferiority could not be established. Sub-group analyses indicated that certain pts characteristics influenced patient outcomes in VAP pts. The largest difference in cure rates occurred in pts below the age of 45 years & with increased renal function. In the ceftobiprole group, there were more male pts with underlying conditions, including severe head trauma [8,9].
24/04/2012 11:52:12
Evidence Based Evaluations
SMC 
References  
Available only to registered users
 Category
BNF Category: Cephalosporins, carbapenems and other beta-lactams (05.01.02)
Pharmacology: Novel cephalosporin  
Epidemiology: Hospital-acquired pneumonia is defined as a new infection of lung parenchyma appearing more than 48 hours after admission to hospital. It occurs mostly in pts who are severely debilitated, immunocompromised or mechanically ventilated; mortality rate for pneumonia in hospitalised pts is 6-12% [6].  
Indication: Bacterial infections 
Additional Details: hospital-acquired/hospitalised community-acquired pneumonia 
Method(s) of Administration  
Intravenous 
Company Information
Name: Basilea 
US Name: Basilea 
Further Information
Anticipated commissioning route (England) CCG 
High cost drug list? No
Tariff In tariff
Implications Available only to registered users

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