医疗说明书中英翻译
整理：人工翻译平台
医疗说明书中英翻译特别重要，因为中文的说明书样式繁多，相对而言，英文的说明书格式比较固定，这也反映了欧美药品管理的规范，尤其是fda和ema，值得仔细阅读和学习。
原文（中文）
译文（英文）
请仔细阅读说明书并在医师指导下使用
please read the package insert carefully and use under the direction of the physician.
[核准日期]
[approval date]
[药品名称]
[drug name]
通用名称
generic name
商品名称
trade name
[成份]
[ingerdients]
本品主要成份
active ingredients
化学名称
chemical name
化学结构式
chemical structural formula
分子式
molecular formula
分子量
molecular weight
游离碱
free base
[性状]
[description]
[适应症]
[indications]
[规格]
[strenths]
[用法用量]
[dosage and administration]
本品推荐剂量为每次150 mg.每日两次，给药间隔大约为12小时。
recommended dosage: 150 mg twice daily approximately 12 hours apart.
本品应与食物同服，用水送服整粒胶囊。
b should be taken with food and swallowed whole with liquid.
不应超过推荐的每日最大剂量300 mg。
do not exceed the recommended maximum daily dosage of 300 mg.
特殊人群
special populations
儿童人群
paediatric use
尚未在临床试验中研究本品在儿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岁）
geriatric use (≥65 years)
与年龄小于65岁的患者相比，未在老年患者中观察到安全性和有效性的总体差异。
no overall differences in safety and effectiveness were observed between subjects who were 65 and over and younger patients.
无需根据患者年龄调整起始剂量（参见【药代动力学】）。
no dose adjustment is necessary according to patient age (see [pharmacokinetics]).
年龄、体重和性别
age, body weight and gender
肾损伤
renal impairment:
无需对轻度至中度肾损伤患者的起始剂量进行调整。
adjustment of the starting dose in patients with mild to moderate renal impairment is not required.
肝损伤
hepatic impairment
尚未在分类为child pugh b和c级的肝损伤患者中进行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，不建议使用本品对中度（child pugh b）和重度（child pugh c）肝损伤患者进行治疗（参见【药代动力学】）。
therefore, treatment of patients with moderate (child pugh b) and severe (child pugh c) hepatic impairment with b is not recommended (see [pharmacokinetics]).
吸烟者
smokers
【不良反应】
[adverse reactions]
1.安全性概要
1 overview of safety
与使用b相关的最常见不良事件包括腹泻、恶心和呕吐、腹痛、食欲减退、体重下降和肝酶升高。
the most common adverse events associated with b were diarrhea, nausea and vomiting, belly ache, decreased appetite, weight decreased and hepatic enzyme increased.
相应的不良反应的管理请参见【注意事项】。
for relevant management of adverse reactions, see [warnings and precautions].
2.在主要临床试验中不良反应的发生情况
2. occurrence of adverse reactions in major clinical trials
【禁忌】
[contraindications]
本品禁用于已知对b、花生、大豆或任何本品辅料过敏的患者。
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）肝损伤患者禁用本品。
patients with moderate (child pugh b) or severe (child pugh c) hepatic impairment.
妊娠期间禁用本品（参见【孕妇及哺乳期妇女用药】以及【药理毒理】）。
pregnant women [see pregnancy and lactation] and [pharmacology and toxicology].
【注意事项】
[warnings and precautions]
胃肠道疾病
gastrointestinal disorders
肝功能
hepatic function
如果任何肝功能检测指标升高伴有肝损伤的临床体征或症状，例如黄疸，则应永久性停止本品治疗。
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-胎儿毒性
embryofoetal toxicity
根据动物研究结果及其作用机制，妊娠女性给药后，本品会对胎儿造成危害。
according to the results of animal studies and its mechanism, b may cause harm to the fetus after being administered to pregnant women.
接受本品给药前，要检查妊娠状态。
pregnancy testing must be conducted prior to treatment with b.
高血压
hypertension
伤口愈合并发症
wound healing complications
qt间期影响
effect on qt interval
大豆卵磷脂
soybean lecithin
对驾驶和操纵机器能力的影响
effects on ability to drive and use machines
【孕妇及哺乳期妇女用药】
[pregnancy and lactation]
有生育能力的妇女以及避孕
women of childbearing potential and contraception
妊娠
pregnancy
哺乳
breast feeding
尚无b及其代谢产物在人类乳汁中排泄的资料。
there is no information on the excretion of b and its metabolites in human milk.
无法排除本品对新生儿/婴儿的风险。
a risk to the newborns/infants cannot be excluded.
使用本品治疗期间应停止哺乳。
breast-feeding should be discontinued during treatment with b.
生育力
fertility
基于临床前研究，尚无男性生育能力受损的证据。
based on preclinical investigations there is no evidence for impairment of male fertility.
医疗说明书中英翻译
【儿童用药】
[pediatric use]
【老年用药】
[geriatric use]
【药物相互作用】
[interactions]
【药物过量】
[overdosage]
在药物过量的情况下，应中断治疗，并根据需要启动常规支持性措施。
in case of overdose, interrupt treatment and initiate general supportive measures as appropriate.
【药理毒理】
[pharmacology and toxicology]
药理作用
pharmacology
毒理研究
toxicological study
遗传毒性
genetic toxicity
生殖毒性
reproduction toxicity
致癌性
carcinogenicity
医疗说明书中英翻译
【药代动力学】
[pharmacokinetics]
吸收
absorption
分布
distribution
代谢
metabolism
消除
elimination
转运
transport
暴露-应答关系
exposure - response relationship
特殊人群中的群体药代动力学分析
population pharmocokinetic analysis in special populations
年龄
age
体重
body weight
体重与b的暴露量呈负相关。
an inverse correlation between body weight and exposure to b was observed.
人种
race
肾损伤
renal impairment
肝损伤
hepatic impairment
联合治疗
concomitant treatment
【贮藏】
[storage]
【包装】
[package]
【有效期】
[shelf life]
【执行标准】
[specifications]
【批准文号】
[license number]
【生产企业】
[manufacturer]
国内联系单位
contact
生产日期
manufacturing date
产品批号
product lot number
有效期至
expiry date
仅在使用前开启
open only before use
b：药品名。
备注：文章整理自“jec医学信息与编译”微信公众号。
医疗说明书中英翻译
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