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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->感冒
处方药:处方药
包装规格: 6毫克/毫升 60毫升/瓶
计价单位:
  点击放大  
生产厂家英文名:
Genentech, Inc.
该药品相关信息网址1:
http://www.Tamiflu.com/
该药品相关信息网址2:
http://www.drugs.com/tamiflu.html
原产地英文商品名:
TAMIFLU Oral SUSPENSION 6MG/ML 60ML/BOTTLE
原产地英文药品名:
OSELTAMIVIR PHOSPHATE
中文参考商品译名:
达菲悬口服浮液液 6毫克/毫升 60毫升/瓶
中文参考药品译名:
磷酸奥司他韦
原产地国家批准上市年份:
2000/12/14
英文适应病症1:
Influenza
英文适应病症2:
Prevention of Influenza
临床试验期:
完成
中文适应病症参考翻译1:
流感
中文适应病症参考翻译2:
预防流行性感冒
药品信息:

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 详细处方信息以本药内容附件PDF文件(200943004100640.pdf)的“原文Priscribing Information”为准
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部分中文Tamiflu处方资料(仅供参考)

流行性感冒病毒分为A,B,C三型,其中A型病毒所造成的感染疫情严重,B型次之,C型则罕见而不构成威胁。在目前的流感治疗 药物中,Amantadine及Rimantadine只能用于治疗A型流感,而且具有容易产生抗药性及发生中枢神经毒性的缺点。

Tamiflu 是第一个经FDA核准可以同时用于治疗、预防A型及B型流感的口服药物,而且不具上列病毒药物缺点的新药。作用机转 Tamiflu 是流行性感冒病毒神经胺苺(neuraminidase)之强力选择性抑制剂的前驱药(prodrug),病毒的神安酸莓是帮助新成的病毒颗粒从感染细胞释出及更进一步散播传染病毒的必要物。

这活性代谢物利用抑制剂传染病毒从感染细胞的释出,来降低流行性感冒A 型及B型 病毒的散播。

药物动力学:
吸收--Tamiflu口服后,可迅速被消化道吸收,在30分钟内可测到活性代谢物的血中浓度,且在口服2-3小时到达最高血中浓度。    
分布 --?膍s显示,口服Tamiflu之后,具抗病毒浓度的活性代谢物可在肺、支气管与肺泡灌洗、鼻黏膜、中耳和气管中测得。  
代谢及排除--Tamiflu主要利用位于肝脏的酯酉每(esterase)转变成活性代 物。大于90%的Tamiflu是利用转化换成活性代谢物而被排除,活性代谢物并不会被 更进一步的代谢,且主要是经由尿液排泄。 

临床应用:
1 治疗A 型及B型流行性感冒: 
甲、 适用对象:12岁以上之儿童及及成人,感冒症状出现48小时内 。
乙、用法、用量:口服剂量为一颗75mg胶囊,每天2次,共5天。
丙、疗效:在两次包含1355位病患随机、双盲的第三期临床试验中,病患于出现感冒症状40小时之内,以oseltamivir治疗可缩短流行幸感冒证症状的病程达32小时,其疾病的严重性也减轻38%。再者,oseltamivir可减少因流行性感冒并发症而使用抗生素治疗用量约50%,这些并发症包括支气管炎、肺炎、鼻窦炎和中耳炎。

2.预防A型及B型流行性感冒:
Oseltamivir以完成包括季节性预防及 家成员感染后之预房两种临床试验。在针对季节性预防效果的试验中,在流感盛行季节针对1559人给予oseltamivir75mg,每日一次,连续 6周,预防流感比例为 82%。在针对家庭成员感染流感后之预防试验,每日一次给予oseltamivir75mg,连续7天,预防流感比例92%,目前FDA已核准oseltamivir用于家庭成员感染后之预防。

TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. TAMIFLU is indicated for prophylaxis of influenza in patients 1 year and older. TAMIFLU is not a substitute for early and annual influenza vaccination.
•Millions of patients in the U.S. have been prescribed TAMIFLU 12
•Generally well tolerated in children (≥1 year of age), adults, and the elderly (>65 years of age) 1
•In vitro studies showed no interference with the cytochrome P450 pathway 1
•Co-administration with amoxicillin does not alter plasma levels of either drug 1

Safety Information
There is no evidence for efficacy against any illness caused by agents other than influenza types A and B.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization.

Efficacy of TAMIFLU has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving TAMIFLU. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on TAMIFLU usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of TAMIFLU to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with TAMIFLU.

The most common adverse events reported >1% of patients treated with TAMIFLU and more commonly than in patients treated with placebo are:
•Treatment of adult and pediatric patients – nausea, vomiting.
•Prophylaxis of adult and pediatric patients – nausea, vomiting, abdominal pain.

Vaccination is considered the first line of defense against influenza.

TAMIFLU for Prevention of Influenza
Protect Family Members – Take Action Immediately
TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days. TAMIFLU is indicated for prophylaxis of influenza in patients 1 year and older. TAMIFLU is not a substitute for early and annual influenza vaccination. 1
•Vaccination is the first line of defense against influenza. According to the CDC, antiviral medications can be effective for the prevention of influenza. 3
Protect Adults from Influenza Infection
TAMIFLU Helps Prevent Flu Transmission in Adults 1
 
Number of household contacts aged ≥12 years=405
•The primary efficacy endpoint was the proportion of contacts of an influenza-positive index case with laboratory-confirmed clinical influenza 11
A cluster-randomized, double-blind, placebo-controlled study conducted at 76 centers in North America and Europe during the winter of 1998-1999 that involved 377 index cases: 43% with laboratory-confirmed influenza infection. 11

Protect Children from Influenza Infection
TAMIFLU Provides Protective Efficacy Against Flu in Children 1 to 12 Years Old 1
•Primary efficacy variable was the percentage of households with at least 1 secondary case of laboratory-confirmed influenza illness during the 10-day period after the start of treatment in the index case(s) 8
A prospective, open-label, randomized, parallel-group trial conducted in Europe and North America during the 2000-2001 influenza season with a total of 812 participants aged ≥1 year. Household contacts of index cases received postexposure prophylaxis with oseltamivir for 10 days or treatment at the time of developing illness (expectant treatment) during the postexposure period. All index cases received oseltamivir treatment for 5 days. 8

TAMIFLU is indicated for prophylaxis of influenza patients 1 year and older. TAMIFLU is not a substitute for early and annual vaccination.

Track the flu. Help protect your patients by knowing when influenza is in your area.

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 详细处方信息以本药内容附件PDF文件(200943004100640.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-30
附件:




200943004100640.pdf    

 
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