英文药品说明书写法(2)

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英文药品说明书写法(2)2007-02-02 13:34第六节 用量与用法


本项最常用的英语表示法有:

Dosage and Administration 用(剂)量与用法
Route of Administration 给药途径(用法)
Administration 用法
Direction for Use 用法
Method of (for) Administration 用法
Application and Dosage 用法与用(剂)量
Mode of Application 用法
Dosage 用(剂)量
How to Use 用法
Posology 剂量学

还可能有其他的表示方法。

本项也是阅读的重点,读者必须正确理解本项内容中的给药对象、给药方式、剂量及剂量单位、给药时间等。

1、常用表示剂量的术语

average dose 平均剂量 minimal (minimum) dose 最小有效量
daily dose 日剂量(一日量) multiple dose 多剂量
divided dose 分次剂量 overdose (overdose) 过量
fatal (lethal) dose 致死量 single dose 一次剂量
indicated dose 有效蛴量 standard dose 标准(合适)剂量
initial (beginning, starting) dose 首次量 suggested (recommended) dose 推荐剂量
maintenance dose 维持量 therapeutic dose 治疗剂量
maximum dose 最大剂量(极量) usual (normal) dose 常用剂量

2、常用的剂量单位表示法

g=gram 克 l=liter (litre) 升
mg=milligram 毫克 ml=milliliter 毫升
kg=kilogram 千克 c.c. 毫升
mcg=microgram 微克 I.U.=international unit 国际单位
ug 微克 body weight 体重
per square meter of body surface 每平方米体表面积

3、每次给药次数的表示方法

daily (per day, a day, every day ) 每日
every …hours 每隔…小时
intervats of … 每隔…
once (twice) daily (a day) 每日一(二)次
every other day 每隔一日
three times a day (daily) 每日三次
three times a week 每周三次
once (twice) a week (weekly) 每周一(二)次
Divided into … doses 分…次
in two or three divided doses 分为二或三次(个剂量)

例1 Unless other wise prescribed by the physician, the average daily dose is 1 capsule 3 times daily.
如果医生不另开处方,平均日剂量为每日3次、每次1个胶襄。

例2 The suggested dose is 10 to 15 mg per kg dody weight daily in 3-4 divided doses orally, taken with meets.
日剂量最好每公斤体重10-15mg,分3-4次口服,与食物共服。

例3 The initial dosage recommended is 1/2 tablet of Madopa 250 three times daily.
开始剂量最好为每日3次,每次半片美多巴250。

例4 Children: The usual dose is 50 to 100 mg/kg/day total, given in four equally divided and spaced doses.
儿童:常用总剂量为每日50-100mg/kg体重,均分为四等份,等间隔给药。

例5 The recommended starting dose is 20mg given as a single d
aily dose.
推荐的首剂量为每20mg,一次服用。

4、给药对象:最常见的用词有

adolescents 青少年 intant(s) 幼儿
adult(s) 成年人 male 男性
baby (babies) 婴儿 newborn baby (babies) 新生儿
children (child) 儿童 patient(s) 患者,病人
debilitated patients 体弱患者 pediatric 儿科的
elderly patient(s) 老年患者 pregnant women 孕妇
female 女性 senile patient(s) 老年患者(病人)

5、给药方式的表示法:多用副词成或介词短语表示,例如:

intra-arterially 静脉内给药 by mouth (OS) 口服
intragluteally 臀肌内给药 by phleboclysis 静脉输液
intramuscularly 肌内给药 by intramuscular (IM) injection 肌肉注射
intraperitoneally 腹(膜)腔内给药 by intravenous (IV) injection 静脉注射
intrapleurally 胸(膜)腔内给药 by the intra-articatar administration 关节内给药
intrathecally 鞘内给药 by the intramuscular administration (route) 肌内给药
intravenously 静脉内给药 by the intranasal route 鼻内给药
locally 局部给药 orally 口服给药
parenterally 肠道外给药 by the intraperitoneal administration 腹(膜)腔内给药
subconjuntivally 结膜下给药 by the intravenous infusion (perfusion) 静脉输注
subcutaneously 皮下给药 sublingually 舌下给药
submucously 粘膜下给药 by the intrathecal administration 鞘内给药
by aerosol 喷雾给药 by the subligual administration 舌下给药
by drip phleboclysis 点滴静脉输液 per rectum 直肠给药
by enema 灌肠 per vaginum 阴道给药
by lumbar 腰椎给药 pro recto 直肠给药

此外还有许多其他的表示法,不一一列举。

6、表示“投药”的常用动词

administer (或be administered、give、be given、indicate、be indicated) 给药、投药
use (或be used 、employ、be employed) 用药
recommend (be recommended、suggest、be suggested) 推荐给药

7、表示不同的用药方式的动词:

take 服用 inhale 吸入 apply to 用于、涂于、敷于
spray 喷雾 inject 注射 swallow 吞服

例6 …the recommended single dose is 1 ampoule, given subcutaneously, intramuscularly or intravenously.
建议一次剂量为1安瓶,皮下、肌肉或静脉注射给药。

例7 I.M injections should be administered in the amount of 25-50mg daily per kilo of body weight, subdivided into injections every 6-8-12 hours.
肌肉注射:每日每公斤体重给药25-50mg,每6-8-12小时一次。

例8 For adults give intramuscular injection of 400 to 600 mg per day in 2-3 divided doses. For intants give intramuscular injection of 10-20mg/kg per day in two divided doses.
成年人:肌肉注射,每日400-600mg,分2-3次注射;婴儿:肌肉注射,每日10-20
mg/kg体重,分2次注射。

例9 The tablets (or the syrup) are to be taken during or after a meal with a little liquid.
片剂(或糖浆)应于食间或饭后用少量液体送服。

例10 Apply the Nitro-Dur system firmly to the skin surface. The Nitro-Dur system may be applied to any convenient skin area, a recommended side of application is the arm or chest.
把护心贴片紧贴在皮肤表面,护心贴片可贴在任何方便的皮肤区域,最好是贴在手臂或胸部。

例11 In general 1 to 3 metered doses should should be inhaled or sprayed onto or under the tongue at the every oneset of anginal pain.
一般应在心绞痛开始发作时就吸入,或向舌上或舌下喷入1-3个规定的剂量。

8、其它的短语或句型,例如:

according to 根据 be adjusted 调整 depend on 依据 adapt to 适合,修改
on the basis of 在…基础上 vary from…to… 变化范围由…至…,因…而异
range from … to … 变化范围由…至…
it is advisable to (it is recommended to、it is suggested to ) 建议…

例子很多,不一一列举。

例12 Dosage should be adapted to patients individually, on the basis of periodic tests of glycosuria and blood sugar.
在周期性检验尿糖和血糖的基础上,调整剂量,使之适用于不同的患者。

例13 It si advisable to initiate therapy with massive doses: 3x2 tablets daily after meals over 2-4 days.
建议开始治疗时采用大剂量,每日剂量为3x2片,饭后服用,持续2-4日。

例14 In severs chronic cases, treatment is started with daily 1 to 2 ampoules of Bilocid and continused with one ampoule every other day, injected slowly by the intravenous route.
治疗严重的慢性疾病时,治疗从每日1-2支利胆素注射剂开始,继续治疗时每隔一日1安瓶缓慢静脉注射。

例15 The number of injections required may vary from from patient to patient.
所需注射次数因患者而异。

例16 The dosage of Glutril must be adjusted by the doctor according to the individual metabolic state.
格路特利的剂量需由医生根据每个患者的代谢状况调整。

例17 In such instance, it is recommended that the dose be reduced.
在这种情况下,建议减少剂量。

例18 The maintenance dosage is determined by response of the patient.
维持剂量视患者对药物的反应而定。

从上述例句可见,本项中英语的普通词汇较多,只要有一定的英语基础均可读懂,专业词汇多为医学词汇,可从英汉医学词典中查出。


第七节 不良反应


不良反应这一项中包括药物的副作用、症状及体征、毒性作用及耐受力、过敏反应、停药等。现分述如下:

1.“不良反应”的常用的英语表示法有
mended dosage side-effects e.g. venous irritatiion or hypersensitivity reactions (cutaneous and mucous reactions) are only observed in isolated cases.
用推荐剂量治疗时,仅见个别的静脉刺激或过敏反应(皮肤及粘膜反应)病例。

例4 When adverse reactions occur, they are usually reversible and disappear when the hormone is discontinued.
当不良反应发生时,它们往往是可逆的,停用激素后副作用即消失。

例5 The most serious side-effect is damage to the bone marrow. Because of this, the white blood cell count should be controlled often enough druing the treatment.
最严重的副作用是骨髓损害,因此在治疗期间,要经常监测白细胞计数。

例6 These unwanted effects usually disappear spontaneously after 7-14 days or following a temporary reduction in the dosage.
这些副作用通常在7-14日之后,或者暂时降低剂量便自行消失。

例7 With high dosage continuous infusion (more than 200mg/m2/day) over 5 to 7 days, the gastrointestinal complications are more pronounced and can on occasion lead to ileus. All side effects are reversible after cessation of therapy.
大剂量连续输注超过 5~7日(超过 200mg/m2/日),胃肠道并发症更为明显,偶尔可导致肠梗阻。停药后副作用皆可逆转。

例 8 In some patients nausea, dizziness,and vomiting may occur in the first days of treatment but the treatment need not be discontinued for that. In rare cases a decrease of blood pressure may appear for which a blood pressure check-up is recommended in out-patients before the treatment is initiated. If side-effects persist, lower doses should be administered.
服用本品的头几天,有些病人可能会出现恶心、头晕和呕吐,但不必停药。偶有血压下降的病例,为此,在治疗开始前建议对门诊患者检测血压。若副作用持续不消失,应减少服用剂量。

例9 Major adverse reactions (much less common than the minor adverse reactions) include inhibition of myelopoiesis, drug fever and hepatitis.
较重的不良反应(远不及轻度不良反应常见)包括抑制骨髓细胞生成,药物热及肝炎。

例10 Side-effects: Loss of appetite and nausea occur in most cases, sometimes with vomiting. These symptoms are usually confined to the first few days of treatment and then tend to disappear.
副作用:多数病例出现食欲减退、恶心,有时呕吐。这些症状通常发生在治疗的最初几天,以后逐渐消失。

第八节 注意事项


“注意事项”也是药品说明书中的重要内容之一。为了安全用药,厂商在本项中特别强调应注意的事项,其中主要包括:正确的剂量和用法,超过剂量时的应急措 施,用药对象,可能出现的较严重的副作用及治疗方案,药物的配伍,药
液的配制、使用及保管等、方面的注意事项。现就本项内容详细介绍如下:

1. 本项常用的英语表示法:
Precaution(s) 注意事项 Special note(caution, precaution)特别注意
Caution(s) 注意事项 N.B. 注意
Noto 注意 Warning(s) 警告
有时也用:
Important 重要事项 Important for the patients 患者须知

2. 本项中常见的检查项目:
blood count 血细胞汁数 Kidney (renal) function 肾功能
blood picture(hemogram) 血象 Liver(hepatic)function 肝功
blood level 血浓度 serum concentration 血清浓度
blood pressure 血压 serum creatinine test 血清肌酸酐检验
clotting time 凝血时间 urine routine(examination) 尿常规
creatinine clearance 肌酸酐清除率

3. 本项的特点是内容长短不一,有难有易;词汇量大,涉及面广,既有普通词汇,也有大量的专业词汇及编写词。许多词汇、结构和句型可在药理作用、适应症、禁忌 症、剂量和用法、副作用,贮藏等项中见到。从英语结构上分析,句型变化较多,长句、难句也屡屡出现,是比较难读的一个项目。

例1 Warnings and precautions: Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweight the risk of possible CNS side-effects.
警告和注意事项:癫痫病人及有中枢神经系统病史的患者慎用环丙沙星,仅当认为疗效超过可能产生的中枢神经系统副作用的危险时才可使用。

例2 Ciprofloxacin could result in impainnent of the patients ability to drive or operate machinary, particularly in conjunction with alcohol.
环丙沙星能损害人们驾驶汽车或操纵机器的能力,尤其是在饮酒之后。

例3 Warnings: Vepeside should be administered under the supervision of a qualified physicain experienced in the use of cancer chemotherapeutic agents.
警告:泛必治应该在使用治疗癌症的化疗制剂方面有经验、有资格的医生的监护下使用。

例4 The most serious risk associated with anticoagulant therapy with sodium warfarin are hemorrhage in any tissue or organ and less frequently, necrosis and/ or gangrene of skin and other tissues. The risk of hermorrhage is related to level of intensity and the duration of anticoagulant therapy.
用华注林钠进行抗凝治疗产生的最严重的危险就是组织或器官出血,以及不大常出现的皮肤和其他组织的坏死和(或)坏疽。出血的危险与抗凝治疗的药物浓度(水平)及疗程长短有关。

例5 The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.

血小板数低于s0,000/mm3 或绝对中性白细胞数低于500/mm3 ,表明不能继续使用本品治疗,待白细胞计教充分恢复后才能继续用药。

例6 Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation.
当怀疑华法林治疗引起坏死时,则须停止治疗,并且考虑使用肝素治疗。

例7 Dosage should be controlled by periodic determinations of prothrombin time(PT) or other suitable coagulation tests.
必须定期检查凝血酶原时间(PT),或做其他相应的凝血试验来控制剂量。

例8 Please note Cerebral convulsive disease is regarded as a relative contraindication for examinations in the subarachnoid space. If after careful consideration, these examinations are nevertheless performed, all equipment and medicines necessary to counter any convulsions may occur must be prepared ready for use beforehand.
请注意:脑惊厥被认为相对禁止进行蛛网膜下腔检查,如经谨慎考虑后、仍要进行这些检查时.必须事先备妥应付可能发生惊厥所需的所有设备与药品。

例9 Caution must be exercised in the case of hypersensitivity to iodinated contrast media, latent hyperthyroidism and bland nodular goitre.
对碘造影剂过敏、隐匿性甲状腺亢进和轻微甲状腺肿的病例,应慎重。

例10 Caution Alcohol intake may enhance nitrate effects and occasionally induce hypotension with subsequent impairment of reactivity. During the first three months of pregnancy drugs should only be used on the express direction of the attendant physician. Isket spray should not be stored at temperatures above 25。C! Temperatures above 40 ℃ are to be be avoided, even for bried periods! Do not force canister open, even when empty!
注意:饮酒可增强硝酸盐的作用、偶尔引起低血压,继而损害反应力。妊娠三个月时,只有在监护医生明确指导下才可使用本品。异舒吉喷雾剂的贮存温度不应超过25℃!避免超过40℃。即使短时间也不可!不要用力开罐,即使空罐时也不可用力开!勿使儿童接触本品

例11 As with all new drugs, patients should be followed carefully so that any side-effects or unusual manifestations of drug idiosyncrasy may be detected. If any allergic reaction to Keflex occurs, the drug should be discontinued and the patient treated with the usual agents.
像使用所有新药一样,应细心地随访患者,以便观察任何副作用或药物特异反应。如果出现对头抱菌素IV的过敏反应,应停药,并用常规药物治疗患者。

例12 In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine. While this is usually reversible, It is important in such patients t
o pay careful attention to those factors which may lead to hypercalcemia.
对于肾功能正常的患者,慢性高钙血症可能与血清肌酸酐增多有关。这通常虽然是可逆的,然而对这样的病人,密切注意可能导致血钙过多的各种因素是很重要的。

例13 Precautions 一Avoid the concomitant use, in the absence of special monitoring laboratory of parameters, of anticoagulants or aspirin. 一Inform the attending physician in the event of bleeding or of the occurence of a hematoma.
注意事项:在无化验室参考指标的专门监测情况下,避免与抗凝剂或阿司匹林合用。如发生出血或出现血肿,应通知主治医生。

例14 Periodical examination of hepatic or renal function and blood picture is desirable since Kedacillin may increase SGOT. SGPT and BUN, and decrease erythrocyte and leucocyte.
磺苄青霉素钠可使血清谷-草转氨酶,血清谷-丙转氨酶和血液尿素氮增高,使红细胞和白细胞减少.所以最好要定期检查肝、肾功能和血象。

例15 erence from insuline to Glutril may be attempted in case of maturity-onset diabetes with obesity;dosage is based upon the result of the necessarily frequent metablic tests.
注意:伴有肥胖症的成年型糖尿病患者,可试从胰岛素改用格路特利治疗,剂量应以必须经常进行的代谢试验为依据。

第九节 包 装


1“包装”在英文药品说明书中的表示法有许多,最常用的是Pack(Package)和Supply,例如:
Pack(s) (Packing(s)) 包装 Supplys(Supplied) 包装
Package(s) 包装 How Supplied 包装方式
Packing for Hospital 医院用包装 Method of Supply 包装方式
Package Quantitiess( Quantity)包装量
此外还有,
Presentation 包装 Hospital (Size) Packs 医院用包装
Availability 包装 Trade Packs(Packings) 商品包装
Mode(Form)of Issue 包装

2 常见的包装单位(工具)的英语表示法:
ampoule(s) 安瓿 carton 纸盒
blister pack(package) 铝塑包装(水泡眼包装)
pack 包
blister strip 铝塑条状包装(水泡眼条包装)
sheet 张
bottle 瓶
strip 条
box 盒
tube 管
canist 罐
vial 玻璃小瓶

3 药物的常见剂型的英语表示法:
aerosol (spray, inhaler) 气雾剂 ampoule 针剂
capsules 胶囊 oral solution 口服液
coated(-)tablets 包衣片 pill 丸剂
cream 乳膏 powder 粉剂
derm TTS 皮肤贴膏 retard capsules (tablets) 缓释胶囊(片)
dregees 糖衣丸 scored-tablets 刻(划)痕片
drops 滴剂 solution 溶液剂
emulsion 乳剂栓剂 sugar-coated tablets 糖衣片
film-coated tablets 薄膜片。膜衣片
suppositories 栓剂
granule 颗粒 suspension 悬浮剂,混悬剂
injection 注射
剂,针剂
sustainedrelease tablets 恒(缓)释片
liniment 搽剂 syrup 糖浆
liquid 液剂 tablets 片剂
ointment 软膏

4 本项的结构特点;内容结构简单,多为不完全句,或仅仅列出包装工具、剂型、装量等,词汇量容易阅读。

例1 Presentation 30 capsules.
包装:30粒胶囊装。

例2 Packages:Box containing one 100 mg bottle
包装:盒装,每盒1瓶,每瓶100 mg。

例3 Packing Bottle of 12 capsules 250 mg and 500 mg.Bxo of 12 capsules 250 mg in blister.
Bottle for pediatri use (granulated): 20 gm granulated contain 1 gm ampicillin, The content of the spoon included in the packing corresponds to 100 mg ampicillin.
包装瓶装12粒胶囊,每粒含量250或500mg。盒装12粒胶囊(水泡眼包装),每粒含量250mg。瓶装儿童用颗粒剂:20克颗粒剂每瓶含有 1 g 氨苄青霉素。附在包装内的一匙的量,相当于1O0 mg 氨苄青霉素。

例4 Mode of issue Ceopran Is issued in vials containing 250 mg, 500 mg and 1 gram of cephaloridine.
包装方式本品小瓶包装,内装 250mg、500mg及 1 g 头抱菌素II。

例5 Trade packs Trade packs containing 50 and 100 sugar coated tablets.
商品包装 50 及 100 糖衣片包装。

例6 Packs(Madopar)250: Cross-scrored tablets each containing 200mg levodopa+50 mg benserazide.
包装 美多巴”250”刻痕片,每片含200mg左族多巴50mg羟苄丝肼。

例7 Method of supply Tablets in tubes, each containing 30 tablets. Paint in glass bottles of 24 nine is supplied only on prescription.
包装方式 管装片剂.每管30片。玻璃瓶装搽剂,每瓶24ml。敏白灵只按处方供药。

例8 Availability Syrup: Orbenin syrup is available in bottles containing reconstitutable powder for preparing an aqueous solution. When dispensed each 5 ml teaspoonful contains 125mg cloxacillin as the sodium salt.
包装 糖浆:全霉林糖浆为瓶装,内含可供再配制水溶液的粉末。配制后的每茶匙5ml药液中含125ml 邻氯青霉素钠盐,

例9 How supplied Tablets: Coumadin (crystalline Wartarin Sodium USP), For oral use, single scored imprinted numericallyand Packaged in bottles with potencies and colors as follows:
包装 片剂:香豆定(结晶华法林钢一美国药典标准)。供口服。药片上有一条划痕,印有数字。瓶装,效价及颜色如下:

例10 Also available in Hospital Unit-Dose blister package of 100.
也提供医院用的单位剂量的铝塑包装,(每包〕100片装。

例11 Temaril 250:white, film-coated tablets marked on one side with 250, each tablet containing 291.5mg ciprofloxacin hydrochloride monohydrate (equivalent 50 250mg ciprofoxacin).
替马利尔25U:白色有刻痕标记的薄膜片,一面刻有“250mg
”字样、每片含 291.5mg 盐酸环丙沙星-水合物(相当于250mg环丙沙星)。

例12 Packs Standard packs of 20 dregees Hospital packs of 100,500 and 1000 dregees.
包装 标准包装为20粒糖衣九。医院用包装为100,500及1000粒糖衣丸。

例13 Package ouantities Beconase Nasal Spray is a metered-dose aerosolsol with a specially designed nasal applicator. Each canister provides 200 sprays.
包装 喷雾剂是一种气雾剂.配有专门设计可供鼻用的喷雾器,每罐可喷雾 200次。

第十节 贮存


“贮存”的英语常用表示法是Storage。本项中常用的一些短语有:

store (keep) in a cool and dry place 存于于阴凉干燥处
away from light 避光
away from children 勿让儿童接触
protect from light (heat) 避光(热)
out of (the) reach of children 勿让儿童触及
prevent moisture 防潮

本项的句子较简单多为一简单句,其中多为祈使句;用词也不多。

例1 store medicines carefully. Keep away from children.
注意保存.勿让儿童接触。

例2 Stroe below 25℃ protecting from freezing and light.
存于25℃以下,防冻,避光。

例3 Validity and storage. The solution will keep for five years if stored at a emperature below +20℃.
有效期及贮法:放置于20℃以下可保存5年。

例4 Storage instructions: Protect from heat and light.
贮存方法;避光及防热贮存。

例5 To be stored in a dry place at a temperature not above 25℃.
存于不高于25℃的干燥之处。

例6 Do not store the suppositories over 25℃.
本栓剂不得存于25℃以上的温度。

例7 store at below 25℃ and protect from moisture,
存于25℃以下,防潮。

例8 The solution should be prepared immediately prior to use, but can be stored at 4℃ or up to one week.
药液应在配制后立即使用,但在4℃下可贮存一周。

有时也有较复杂的结构,或较多的内容,如:

例9 Ampoules and unopened nasal spray bottles should should be stored in a refrigerator (2—8℃). Onceopened the nasal spray bottle must be kept at room temperature; it should be kept in the upright position and used for a maximum of 4 weeks. Like all drugs,Miacalcic should be kept out of reach of children.
安瓿或未开启的喷雾剂瓶应存于冰箱(2-8℃)中。喷雾剂瓶一旦开启。就应于室温下保存、药瓶应直立存放,使用时间最多为4周。与其他药物一样,密钙息应妥善保存,勿让儿童接触。

例10 Protect from light. Store in carton until contents have been used. Store at controlled room temperature(59一86F, 15℃一30℃). Dispense in al tight, light-resistant container as defined in the U.S.P.
避光保存。药片在使
用前于纸盒中保存。在恒温室温(59~86F,15℃一30℃)下保存。调剂时,使用美国药典规定的密闭,避光容器。

例11 Fungizone intravenous in powder form should be stored in the refrigerator, protected against exposure to light. The concentrate may be stored in the dark, at room temperature for 24 hours, or at refrigeratortemperatures for one week with minimal loss of potency and clarity. Any unused material should then be discarded.
两性霉素B粉剂应避光存于冰箱中。浓缩液可存于暗处,室温下可保存Z4小时,或可在冰箱 温度下保存一周,其效价及澄明度变化极小。那以后一切尚未用的药物就应弃之。


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