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醫(yī)療說(shuō)明書(shū)中英翻譯
整理：人工翻譯平臺(tái)
醫(yī)療說(shuō)明書(shū)中英翻譯特別重要，因?yàn)橹形牡恼f(shuō)明書(shū)樣式繁多，相對(duì)而言，英文的說(shuō)明書(shū)格式比較固定，這也反映了歐美藥品管理的規(guī)范，尤其是FDA和EMA，值得仔細(xì)閱讀和學(xué)習(xí)。
原文（中文）
譯文（英文）
請(qǐng)仔細(xì)閱讀說(shuō)明書(shū)并在醫(yī)師指導(dǎo)下使用
Please read the package insert carefully and use under the direction of the Physician.
[核準(zhǔn)日期]
[APPROVAL DATE]
[藥品名稱(chēng)]
[DRUG NAME]
通用名稱(chēng)
Generic Name
商品名稱(chēng)
Trade Name
[成份]
[INGERDIENTS]
本品主要成份
Active Ingredients
化學(xué)名稱(chēng)
Chemical Name
化學(xué)結(jié)構(gòu)式
Chemical Structural Formula
分子式
Molecular Formula
分子量
Molecular Weight
游離堿
free base
[性狀]
[DESCRIPTION]
[適應(yīng)癥]
[INDICATIONS]
[規(guī)格]
[STRENTHS]
[用法用量]
[DOSAGE AND ADMINISTRATION]
本品推薦劑量為每次150 mg.每日兩次，給藥間隔大約為12小時(shí)。
Recommended dosage: 150 mg twice daily approximately 12 hours apart.
本品應(yīng)與食物同服，用水送服整粒膠囊。
B should be taken with food and swallowed whole with liquid.
不應(yīng)超過(guò)推薦的每日最大劑量300 mg。
Do not exceed the recommended maximum daily dosage of 300 mg.
特殊人群
Special Populations
兒童人群
Paediatric Use
尚未在臨床試驗(yàn)中研究本品在兒童患者中的安全性和有效性。
The safety and effectiveness of B have not been established in pediatric patients in clinical trials.
老年患者（≥65歲）
Geriatric Use (≥65 years)
與年齡小于65歲的患者相比，未在老年患者中觀察到安全性和有效性的總體差異。
No overall differences in safety and effectiveness were observed between subjects who were 65 and over and younger patients.
無(wú)需根據(jù)患者年齡調(diào)整起始劑量（參見(jiàn)【藥代動(dòng)力學(xué)】）。
No dose adjustment is necessary according to patient age (see [PHARMACOKINETICS]).
年齡、體重和性別
Age, Body Weight and Gender
腎損傷
Renal Impairment:
無(wú)需對(duì)輕度至中度腎損傷患者的起始劑量進(jìn)行調(diào)整。
Adjustment of the starting dose in patients with mild to moderate renal impairment is not required.
肝損傷
Hepatic Impairment
尚未在分類(lèi)為Child Pugh B和C級(jí)的肝損傷患者中進(jìn)行B的安全性和有效性的研究。
The safety and effectiveness studies of B have not been conducted in patients with Child Pugh B and Child Pugh C hepatic impairment.
因此，不建議使用本品對(duì)中度（Child Pugh B）和重度（Child Pugh C）肝損傷患者進(jìn)行治療（參見(jiàn)【藥代動(dòng)力學(xué)】）。
Therefore, treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with B is not recommended (see [PHARMACOKINETICS]).
吸煙者
Smokers
【不良反應(yīng)】
[ADVERSE REACTIONS]
1.安全性概要
1 Overview of Safety
與使用B相關(guān)的最常見(jiàn)不良事件包括腹瀉、惡心和嘔吐、腹痛、食欲減退、體重下降和肝酶升高。
The most common adverse events associated with B were diarrhea, nausea and vomiting, belly ache, decreased appetite, weight decreased and hepatic enzyme increased.
相應(yīng)的不良反應(yīng)的管理請(qǐng)參見(jiàn)【注意事項(xiàng)】。
For relevant management of adverse reactions, see [WARNINGS AND PRECAUTIONS].
2.在主要臨床試驗(yàn)中不良反應(yīng)的發(fā)生情況
2. Occurrence of Adverse Reactions in Major Clinical Trials
【禁忌】
[CONTRAINDICATIONS]
本品禁用于已知對(duì)B、花生、大豆或任何本品輔料過(guò)敏的患者。
Patients with known hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients of B.
中度（Child Pugh B）或重度（Child Pugh C）肝損傷患者禁用本品。
Patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
妊娠期間禁用本品（參見(jiàn)【孕婦及哺乳期婦女用藥】以及【藥理毒理】）。
Pregnant women [see Pregnancy and lactation] and [PHARMACOLOGY AND TOXICOLOGY].
【注意事項(xiàng)】
[WARNINGS AND PRECAUTIONS]
胃腸道疾病
Gastrointestinal Disorders
肝功能
Hepatic Function
如果任何肝功能檢測(cè)指標(biāo)升高伴有肝損傷的臨床體征或癥狀，例如黃疸，則應(yīng)永久性停止本品治療。
If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with B should be permanently discontinued.
胚胎-胎兒毒性
Embryofoetal Toxicity
根據(jù)動(dòng)物研究結(jié)果及其作用機(jī)制，妊娠女性給藥后，本品會(huì)對(duì)胎兒造成危害。
According to the results of animal studies and its mechanism, B may cause harm to the fetus after being administered to pregnant women.
接受本品給藥前，要檢查妊娠狀態(tài)。
Pregnancy testing must be conducted prior to treatment with B.
高血壓
Hypertension
傷口愈合并發(fā)癥
Wound Healing Complications
QT間期影響
Effect on QT Interval
大豆卵磷脂
Soybean Lecithin
對(duì)駕駛和操縱機(jī)器能力的影響
Effects on Ability to Drive and Use Machines
【孕婦及哺乳期婦女用藥】
[PREGNANCY and LACTATION]
有生育能力的婦女以及避孕
Women of childbearing potential and Contraception
妊娠
Pregnancy
哺乳
Breast Feeding
尚無(wú)B及其代謝產(chǎn)物在人類(lèi)乳汁中排泄的資料。
There is no information on the excretion of B and its metabolites in human milk.
無(wú)法排除本品對(duì)新生兒/嬰兒的風(fēng)險(xiǎn)。
A risk to the newborns/infants cannot be excluded.
使用本品治療期間應(yīng)停止哺乳。
Breast-feeding should be discontinued during treatment with B.
生育力
Fertility
基于臨床前研究，尚無(wú)男性生育能力受損的證據(jù)。
Based on preclinical investigations there is no evidence for impairment of male fertility.
醫(yī)療說(shuō)明書(shū)中英翻譯
【兒童用藥】
[PEDIATRIC USE]
【老年用藥】
[GERIATRIC USE]
【藥物相互作用】
[INTERACTIONS]
【藥物過(guò)量】
[OVERDOSAGE]
在藥物過(guò)量的情況下，應(yīng)中斷治療，并根據(jù)需要啟動(dòng)常規(guī)支持性措施。
In case of overdose, interrupt treatment and initiate general supportive measures as appropriate.
【藥理毒理】
[PHARMACOLOGY AND TOXICOLOGY]
藥理作用
Pharmacology
毒理研究
Toxicological Study
遺傳毒性
Genetic Toxicity
生殖毒性
Reproduction Toxicity
致癌性
Carcinogenicity
醫(yī)療說(shuō)明書(shū)中英翻譯
【藥代動(dòng)力學(xué)】
[PHARMACOKINETICS]
吸收
Absorption
分布
Distribution
代謝
Metabolism
消除
Elimination
轉(zhuǎn)運(yùn)
Transport
暴露-應(yīng)答關(guān)系
Exposure - Response Relationship
特殊人群中的群體藥代動(dòng)力學(xué)分析
Population Pharmocokinetic Analysis in Special Populations
年齡
Age
體重
Body Weight
體重與B的暴露量呈負(fù)相關(guān)。
An inverse correlation between body weight and exposure to B was observed.
人種
Race
腎損傷
Renal Impairment
肝損傷
Hepatic Impairment
聯(lián)合治療
Concomitant Treatment
【貯藏】
[STORAGE]
【包裝】
[PACKAGE]
【有效期】
[SHELF LIFE]
【執(zhí)行標(biāo)準(zhǔn)】
[SPECIFICATIONS]
【批準(zhǔn)文號(hào)】
[LICENSE NUMBER]
【生產(chǎn)企業(yè)】
[MANUFACTURER]
國(guó)內(nèi)聯(lián)系單位
Contact
生產(chǎn)日期
Manufacturing Date
產(chǎn)品批號(hào)
Product Lot Number
有效期至
Expiry Date
僅在使用前開(kāi)啟
Open only before use
B：藥品名。
備注：文章整理自“JEC醫(yī)學(xué)信息與編譯”微信公眾號(hào)。
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