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Deltyba Tablets 20×50mg(delamanid,迪拉马尼,デルティバ錠)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 50毫克/片 20片/盒 
包装规格 50毫克/片 20片/盒 
计价单位: 盒 
生产厂家中文参考译名:
大冢制药
生产厂家英文名:
Otsuka
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/6222006F1029_1_04/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
DELTYBA(デルティバ錠)50mg/tablets 20tabs/box
原产地英文药品名:
delamanid
中文参考商品译名:
DELTYBA(デルティバ錠)50毫克/片 20片/盒
中文参考药品译名:
迪拉马尼
曾用名:
简介:

 

部份中文迪拉马尼处方资料(仅供参考)
英文名:delamanid
商品名:DELTYBA tablets
中文名:迪拉马尼片
生产商:大冢制药
药品简介
Deltyba(delamanid,デルティバ)是一种硝基二氢咪唑并嗯唑衍生物, 具有新型的作用机制。该药物可通过抑制分枝菌酸(结核分枝杆菌外部的蜡状外壳的一个重要组成部分,可帮助菌体抵抗青霉素及其他大部分抗生素)合成,干扰结核分枝杆菌(MTB)细胞壁代谢,进而抑制抗耐药菌株活性。
デルティバ錠50mg
治疗类别名称
结核病化疗药物
批准日期:2014年9月
商標名
DELTYBA tablets
一般名
デラマニド〔Delamanid(JAN)〕
化学名
(2R)-2-Methyl-6-nitro-2-[(4-{4-[4-(trifluoromethoxy)phenoxy]piperidin-1-yl}phenoxy)methyl]-2, 3-dihydroimidazo[2, 1-b]oxazole
構造式
分子式
C25H25F3N4O6
分子量
534.48
性 状
白色至是浅黄色的晶体或结晶粉末。N,N-二甲基乙酰胺是可溶的,并且是易溶略微四氢呋喃,略少溶于乙腈,略溶于甲醇,极微溶于乙醇(99.5),并且几乎不溶于水。
熔点
约195℃(分解)
审批条件
从在日本的施用经验已经非常有限的一段时间后,制造和销售,通过进行的所有的情况下的利用效果的调查,所以能够理解这种用药患者的背景资料,这种药物在安全性和有效性的早期收集的数据,采取必要的措施,正确使用此药。
薬効薬理
1. 薬理作用
(1) 抗菌作用
耐多药结核分枝杆菌,并显示在结核杆菌,包括耐药结核分枝杆菌的抗菌活性,也表现出对细胞内的结核杆菌和休眠结核杆菌厌氧条件下的抗菌活性。
(2) 治療効果
在小鼠慢性肺结核模型,剂量相关降低活菌通过口服给药的肺数观察,表明有治疗效果。另外,在免疫应答和免疫缺陷小鼠结核模型,表现出治疗效果相媲美。
(3) 抗结核药物联合作用
在小鼠和豚鼠慢性肺结核模型,观察治疗期间与现有抗结核药物联合用药的缩短。另外,在慢性结核病的豚鼠模型中,表明在厌氧环境对结核分枝杆菌的治疗作用。
2. 作用机序
抑制结核杆菌特异性霉菌酸生物合成。
3. 耐性
突变抵抗由具有结核杆菌辅酶F420相关基因获得。在体外试验中,Deramanido天然耐药菌出现频率高于利福平,它比得上异烟肼。然而,跨电阻与其它抗结核药是不允许。
疗效或作用
<适应的物种>
感性的结核杆菌对本药
<主治>
多耐药结核病
剂量和给药方法
成人一天两次,一次100毫克,早晨,晚上餐后口服给药。
包装规格
片剂
50毫克:[PTP] 20片(10片×2),60片(10片×6)
生产厂商
大冢制药有限公司
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/6222006F1029_1_05/
----------------------------------------------------------
Brand name : DELTYBA Tablets 50mg
 Active ingredient: Delamanid
 Dosage form: brownish-yellow tablet, diameter: 11.7 mm, thickness: 5.3 mm
 Print on wrapping: Front: デルティバ錠50mg, Otsuka; Back: デルティバ錠50mg, DELTYBA tab 50mg, 吸湿注意, Otsuka
Effects of this medicine
This medicine exerts its antibacterial activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids in M. tuberculosis.
It is usually used to treat pulmonary multidrug-resistant tuberculosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 2 tablets (100 mg of active ingredient) at a time, twice daily after breakfast and dinner. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•As periodic electrocardiographic monitoring and serum albumin concentration measurements are necessary while on this medicine, follow the instructions of your doctor.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include insomnia, headache, and somnolence. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•palpitations, chest discomfort, chest pain [QT prolongation]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•As this medicine is hygroscopic, tablets should be kept in the package sheet and not be removed until immediately before use.
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•If there is a remainder, this is to be discarded. Do not store it. Ask your pharmacist or medical institution about how to discard it.   

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