药品说明书 INSTRUCTONS ——阅读、写作与翻译.

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1 药品说明书 INSTRUCTONS ——阅读、写作与翻译

2 第一节 《药品说明书》基本结构 《药品说明书》英文表达方式有： Instructions， Directions， Description
第一节 《药品说明书》基本结构 《药品说明书》英文表达方式有： Instructions， Directions， Description 现在多用Package Insert，或简称 Insert， 也有用Leaflet或Data Sheets

3 包括下列内容: 药品名称 (Drug name) 性状 (Description)
药理作用 (Pharmacological Actions ) 适应症 (Indication) 禁忌症 (Contraindication) 注意事项 (Precaution) 副作用 (Side effects) 剂量和用法 (Dosage and administration) 包装 (Packing) 有效期 (Expiry date) 出厂日期 (Manufacturing date) 参考文献 (References)

4 一．药品名称 (Drug Name) 通用名（ Generic Name） 化学名（Chemical Name）
药品名称有商品名(Trade name) 、 通用名（ Generic Name） 化学名（Chemical Name） 药品说明书上最常用的名称是商品名。 有时在商品名之下（或后）又列有通用名或化学名. 例如： Rulide（罗力得）之后 列有（Roxithromycin，罗红霉素）； Minipress（脉宁平）之后列有（Praxosin HCl，盐酸哌唑嗪）

5 1. 商品名(Trade name) 商品名是由生产厂家命名并向该国政府有关部门(国家食品药品管理局) 注册的药品名. 商品名右上角往往有一符号®, 意思是注册商标，是Register的缩写。 商品名因厂而异, 因国而异, 一种药物可以有几个,几十个商品名, 因此仅根据商品名很难确定该药为何种药物,需要查阅其化学结构. 药物说明书一开头,除了商品名外,还有时标有 “Issued to /for the medical profession only” 意思为 “仅供医学界专业参考”

6 2. 商品名译法 药品名称的中文翻译方法有多种，包括音译、意译、音意合译、谐音译以及按药理作用或药物成分翻译。
a. 音译 Penicilin 盘尼西林，Cediland (西地兰), Persantin(潘生丁), aspirin (阿司匹林) b. 意译 Chlorimycin 氯霉素；Tetracyclin 四环素；Cholic Acid 胆酸 c. 音意合译 Medemycin 麦迪霉素（－mycin 霉素） d. 谐音 Legalon利肝隆，Webilin胃必灵 e. 按药理作用或药物成分翻译

7 二．药品性状（Description） 除了用Description外，还常用Property/Properties;
药品性状：包括药品的外观、理化性质、成分、结构、特征等。 除了用Description外，还常用Property/Properties; Physical and chemical properties; Characteristics (性状)； 有些说明书介绍很简单，仅给出化学结构或成分，标题为： Chemical structure(化学结构); Composition (成分) Active ingredients (有效成分) 等

8 1．结构特点： 此部分结构差异较大，长短不一。 介绍药物多用被动语态。 除了普通性和描述性词汇外，还常涉及到化学化工词汇。 由于是对药物性质的一般描述，故多用一般式。

9 Example 1 Description Buflomedil Hydrochloride, the active ingredient of Ikelan, is a vasoactive and nerve protective drug. The empirical formular is C17H25NO4. HCl, representing a molecular weight of Each ampoule of Ikelan injection contains 50mg Buflomedil Hydrochloride. It is a clear, colorless or light yellow solution. Each film coated tablet for oral administration contains 150mg or 300mg of Buflomedil Hydrochloride. Each ml of the oral solution drops contains 150mg Buflomedil Hydrochloride.

10 Example 2 Properties This drug is an angiotensin converting enzyme inhibitor（ACEI）.
Description Kirin Sterile Powder contains spectinomycin hydrochloride which is an aminocyclitol antibiotics produced by a species of soil microorganism designated as Streptomyces spectabilis.

11 Example 4 Description Fluconazole is a bis- trizole: 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazole-1-yl)-2-propanol. It has the following structural formula: (omitted) Fluconazole is a white to off-white crystalline powder which is sparingly soluble in water and saline. It has a molecular weight of Fluconazole is available as gelatin capsule containing 50mg, an intravenous infusion containing Fluconazole 2mg/ ml in a saline solution.

12 叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。
 例1．Folic acid is a yellowish to orange， crystalline powder; odourless or almost odourless.     叶酸是淡黄色至橙色结晶粉沫，无臭或几乎无臭。      例2．Intralipos 10% is a white opaque fat emulsion for intravenous injection， containing 10 W/V % of purified soybean oil.     脂肪乳剂（10%）是白色，不透明，供静脉注射用的脂肪乳剂，含有10%（W/V）的精制大豆油。  例3．Ursosan Tablet 50mg is a white plain tablet which contains 50mg of ursodeoxycholic acid.      熊去氧胆酸片为白色素片，每片含50mg熊去氧胆酸。   

13 例4．Sterile pyrogen-free， orange red， freeze-dried powder in vials containing 10mg and 50mg of doxorubicin hydrochloride with lactose.     （本品）为小瓶装，灭菌无热原，桔红色冻干粉沫，每小瓶含有10mg盐酸阿霉素和50mg的乳糖。 例5．It occurs as a white to off-white， crystalline solid， poorly soluble in water， dilute acid and most organic solvents.     本品（炎痛息康）为白色至类白色结晶固体，难溶于水、稀酸及大多数有机溶剂中。

14 例6．Pamine， chemically known as epoxytropine tropate methylbromide， has the empirical formula C18H24NO4Br and the molecular weight     哌明的化学名称为环氧莨菪碱托品酸酯溴代甲烷，实验式为C18H24NO4Br，分子量为398.3。 例7．Kanendomycin is a very stable antibiotic， and its activity does not decrease when the powder is placed in an airtight container and kept at room temperatures for more than 2 years.     卡内多霉素是一种很稳定的抗生素，其粉沫置于密封容器中，在室温下保存二年以上，活性不减。

15 例8．This product is prepared from units of human plasma which have been tested and found nonreactive for hepatitis associated (Australia) antigen.     本品由人血浆制备，此血浆业经检验，并且证明对肝炎（澳大利亚）抗原无反应。

16 2. 常用词语 (1) 性状部分常用词语表达 color 颜色 taste 味道 tasteless 无味 colorless 无色
crystalline 结晶的 solubility 溶解度 yellowish 淡黄色 bitter 苦味 whitish 微白色的 odour 气味 greenish 淡绿色的 odourless 无嗅 sterile 灭菌，无菌的 orange red 桔红色的 pyrogen-free 无热原的 soluble 可容的 insoluble

17 brown 棕色 brownish 浅棕色的 transparent 透明的 opaque 不透明的 off-white 类白色 或 黄白色的 stable 稳定的 molecular formular injection liquid molecular weight solution powder chemical structure tablet solid

18 (2) 表示组成、来源、制备方法的常用表达 constituents 组成; prepare 制备, be derived from 由……衍生; be obtained from 由……制的; be prepared from 由……制备; obtained by 由……获得; consist of 由……组成; be composed of 由……组成; contain; have; possess 有（具有）

19 三. 药理作用 (Pharmacological Actions)
较详细的药品说明书一般要介绍药品的临床药理、体外实验、药效、药物代谢、毒性和毒理作用等。该部分常用的标题为： Pharmacological Actions 药理作用 Pharmacology 药理学 Pharmacological Properties 药理性质 Actions and properties 作用与性质 Mechanism of Action 作用机理 Mode of Action 作用方式 Clinical Experiments 临床实验 Pharmacology and toxicology 药理学与毒理学 Biological Activity 生物活性（若为抗生素类药品，常用之）

20 有时还列出小标题，例如： Clinical Pharmacology 临床药理学; Clinical effect/ use 临床效果/用途; Pharmacodynamics 药效学; Pharmacokinetics 药物代谢动力学。

21 1．结构特点 该部分涉及到多学科的词汇，如 药理学（药效学，药物代谢动力学）、生理学、毒理学、化学与微生物学等专业的词汇，有时较难理解。
此外，在本部分还经常遇到一些医学缩略词，如：CNS（中枢神经系统）、EEG（脑电图）、LD50（半数致死量）、ED50（半数有效量）、t1/2 (半衰期)等。该项一般用陈述句，句子结构有时比较复杂。

22 Example 1.. Pharmacodynamic and Pharmacokinetic Properties Buflomedil is a weak, non-specific, calcium antagonist and α-adrenergic receptor inhibitor. It improves microcirculation by increasing erythrocyte flexibility, inhibiting platelet aggregation, decreasing vascular resistance. The drug also improves tissue oxygenation and increases ATP production. The absolute bioavailability of the drug ranges from 50% to 80% after the administration of a single oral dose. The degree of protein binding of Buflomedil changes according to the serum concentration. Protein binding is 81% at 0. 5 mg/L, 6l% at 5mg/L and 25% at 50 mg/L. The mean elimination half-life is 2 to 4 hours. 12% to 28% of a single ora1 or i. v. dose is eliminated unchanged in the urine over 48 hours, and an equal percentage as the para-demethyl metabolite.

23 Example 2 Clinical Pharmacology Spectinomycin hydrochloride is an inhibitor of protein synthesis in the bacterial cell; the site of action is the 30S ribosomal subunit. In vitro studies have shown spectinomycin hydrochloride to be active against most strains of Neisseria gonorrhoea (minimum inhibitory concentration ＜7. 5 to 20 mcg/ml ). Definitive in vitro studies have shown no cross-resistance of N. gonorrhea between spectinomycin hydrochloride and penicillin. The antibiotic is not significantly bound to plasma protein.

24 Example 3 Human Pharmacology Kirin Sterile Powder (spectinomycin hydrochloride) is rapidly absorbed after intramuscu1ar injection. A single, two gram injection produces peak serum concentrations (averaging about 100 mg/ml at one hour. Average serum concentrations of 15 mg/ml for the two gram dose was present eight hours after dosing. )

25 Example 4 Based on inspection of each patient’s pharmacokinetic curves, the distribution phase of WR2721’s removal from plasma predominates and is complete within 6 min after drug administration.

26 2．常用词语 （1）动词： Indicate 表明，提示； Maintain 维持； Demonstrate 显示；
exert (action on) 起一作用 Exhibit 显示；

27 Inhibit 抑制； Accumulate 积蓄（积累）； metabolize 代谢； Administer 给药； Excrete 排泄； Tolerate 耐受

28 （2）形容词： average／mean平均的； be effective against 对…有效； be related to与…有关；
（be）sensitive to 对…敏感； （be）resistant to对…有耐药

29 （3）名 词 Activity活性； Mechanism 机理； Absorption 吸收； Distribution 分布；
Elimination 清除； Excretion 排泄， Serum concentration 血清浓度； Tolerance 耐受性;

30 Clearance rate 廓清率； Toxicity 毒性； Plasma level 血浆浓度（水平）； Half life 半衰期； Effect on…对…的作用; In vitro体外； in vivo体内。

31 四．适应症 Indications 该项是药品说明书的重点，常用标题： Indications 适应症;
Indications and Usage 适应症与用途； Major／ Principal Indications 主要适应症； Uses 用途； Action and Use 作用与用途。

32 1．结构特点 一般说，该项仅列出疾病名称，或用短语表示该药能治疗的疾病。
较详细的说明书亦用完整的句子表述该药能治疗什么病，及对哪些细菌和微生物有效或无效。由于疾病和细菌、病毒名称太多，请查阅英汉医学词汇等工具书。

33 Example 1 Indications Prevention and long-term treatment of angina pectoris. Treatment of severe heart failure in combination with cardiac glycosides, preparations promoting secretion of urine, ACE inhibitors, drugs causing a dilation of the arterial blood vessels. High pressure in the pu1monary circulation.

34 Example 2 Indications Timentin is indicated for a wide range of infections for which susceptible organisms have been detected or are suspected. Typical indications include: Severe infections, for example: Septicaemia，Bacteraemia，Peritonitis，intra-abdominal sepsis，Post-surgical infections, Bone and joint infections，Skin and soft tissue infections.

35 2．常用词语 疾病名称是适应症部分最常见的词汇．还涉及到微生物（尤其是各种致病菌）方面的词汇。例如： （1）名词和名词短语：
bacteria细菌；germs病菌；microbes，microorganisms 微生物; aerobes需氧菌； anaerobes厌氧菌； Gram-Positive bacteria革兰阳性菌； gram-negative bacteria革兰阴性菌； staphylococcus葡萄球菌： staph. Aureus 金黄色葡萄球菌；

36 streptococcus 链球菌; faecalis 粪链球菌； Escherichia coil 大肠杆菌 Pseudomonas aeruginosa 绿脓杆菌； Klebsiella pneumoniae 肺炎杆菌；Diplococcus pneumoniae肺炎双球菌； Cryptococcus隐球菌； virus病毒。

37 （2）形容词及词组： acid-fast 耐酸的； resistant to 耐受； susceptible to 对……敏感的；
be active against， be effective in／ for／ against对……有效; have (has ) …action against … 对…有作用； be used to， be used in/for，be employed to 用于； be of value of，be intended to，be indicated in／for 适用于; for／in the treatment of….. 用于治疗……； for／ in the management of…. 用于控制…….

38 Example (1) Cedilanid is used for the treatment of all forms of heart failure and cardiac arrythmia. 西地兰可用于治疗各类心力衰竭和心率不齐 (2) Hyminal is also used for the treatment of insomnia due to organic disorder. 海米那也可用于由器质性疾病引起的失眠症。 (3) The tablets are effective for the prevention of anginal attack. 本片剂对预防心绞痛发作有疗效 (4) Clinically Persantin has proved effective in the treatment of coronary disease and heart condition 临床证明“潘生丁”治疗冠心病和心脏病有效。 (5) The drug is effective against various kinds of bacteria resistant to other drugs. 本药对于抗其他药物的各种细菌有效。

39 (6) Kanamycin is effective both in vitro an in vivo against gram-positive and gram-negative bacteria as well as acid-fast bacteria. 卡那霉素在体内外对革兰氏阳性和革兰氏阴性菌以及耐酸菌均有效。 (7) This antibiotics has strong antibacterial action against gram-positive and gram-negative bacteria. 本抗菌素对革兰氏阳性和革兰氏阴性菌有强的抗菌作用。 (8) Vionactane has a specific tuberculostatic action against tubercle bacilli. “紫霉素”对结核杆菌具有特殊的抑菌作用。 (9) Possess…; manifests… ; show…… action against… displays…; exerts….

40 五．禁忌症 Contraindications
也可用 Restrictions on Use（用药限制） 在Restrictions on Use下面常列小标题， 如： Contraindications （禁忌症）； Precautions ／ Note（注意事项）； Warnings（警告）等。

41 1．结构特点 本部分段落较短，句子结构一般不复杂，常用省略句和祈使句。 Example 1： Contraindications 禁忌症
The use of Kirin Sterile Powder is contraindicated in patients previously found hypersensitive to it． （对本品过敏者禁用）

42 Example 2 ： Contraindications 禁忌症 Not to be used in patients with a history of hypersensitivity to β-lactame, e.g. penicillins and cephalosporins. Intradermal hypersensitivity test is advised prior to use: not to be used in patients giving a positive reaction.

43 Example 3 Contraindications（禁忌症） Systemic fungal infections． Known hypersensitivity to MEDROLTM Tablets or to methylprednisolone.

44 2. 常用词语及句式： （1）禁用或慎用药物的疾病。例如： Cardiac failure 心力衰竭；
Cardiac insufficiency 心功能不全； renal insufficiency 肾功能不全; impairment of the kidney， impairment of renal funcion 肾功能损伤； insufficiency of the liver 肝功能不全； liver／ hepatic damage 肝损伤； functional disorder of liver 肝功能（异常）障碍； hypertension 高血压； severe hypotension 重度低血压； severe anemia 重度贫血； Diabetes 糖尿病.

45 （2）禁用或慎用药物的人群、病人和情况 例如： pregnant women 孕妇; Pregnancy 孕期，妊娠期；
the first/last／trimester /3 months of pregnancy 妊娠期的最初／后 3个月； Lactation 哺乳期； children under …years of age, …岁以下儿童； patient with… / who… …患者； breast –feeding 哺乳（的）; Hypersensitivity 过敏（性）; Allergic 过敏的； Anaphylactic 过敏的.

46 （3）常用句式 allergic/ hypertensive/ anaphylactic to … 对…过敏
hypersensitivity test 过敏实验； Contraindications are… 禁忌症是… … be contraindicated in / for … 对…禁忌，禁用于… … should not be used/ employed in … 不得用于… It is advisable to avoid the use of．…．建议不用于… … must not be administered / given to … 不得用于… … should be used with caution 应慎用… … be not recommended for… 最好不用于…

47 六．用法与剂量 应特别注意该部分中各种剂量单位的表示法、成人、儿童和孕妇的剂量差别、服药时间以及剂量用法。 常用的标题有：
Dosage and Administration 剂量与用法; Application and Dosage 用法与用量; Administration 用法； Direction for Use 用法； method of Administration 用法； How to use用法； Route of Administration 给药途径； Dosage 剂量，用量； Dosology 剂量学。

48 1．结构特点 用法与剂量是药品说明书不可缺少的内容，但祥略不一。
应特别注意本项中关于给药对象、给药方式、剂量、剂量单位、给药时间等用词的准确性，尤其是剂量单位，稍不小心，则差之千里。 本部分常用祈使句和省略句，句中谓语动词多用被动语态。

49 Example 1. Dosage Adults (including elderly patients):
The usual dosage is 1. 6 ~ 3. 2 g Timentin 6 ~ 8 hourly according to body weight. The maximum recommended dosage is 3. 2 g every 4 hours.

50 Dosage in renal impairment:
Mild impairment (Creatinine clearance > 30 ml/minute): 3. 2 g every 8 hours . Moderate impairment (Creatinine clearance l0~30 ml/minute): l. 6 g every 8 hours. Severe impairment (Creatinine clearance < 10 ml/minute): l. 6 g every 12 hours

51 Children: The usual dosage of Timentin for children is 80 mg/kg bodyweight given every 6-8 hours. For premature infants and full term infants during the perinatal period, the dosage is 80 mg/kg bodyweight every 12 hours, increasing to every 8 hours thereafter. Children with renal impairment: As with the adult dosage, similar reduction should be made for children.

52 Example 2：Dosage and Administration
Intramuscular administration: 3 ampoules (150 mg) daily, i. m. in 3 divided doses for a period up to 14 days. Intravenous administration: 50 to 400 mg daily (1 to 8 ampoules) in divided doses for a period up to 10 days, at regular time intervals. In case of slow intravenous infusion, Ikelan injectable solution should be dissolved in 500 ml isotonic solution of dextrose or Sodium Chloride. After dilution, it must be administered within 4 hours.

53 Oral administration: The mean daily dose is 300 to 600 mg daily in two divided doses. Dosage adjustment is not required in patients with renal failure or ill patients under hemodialysis. Ikelan drops do not contain sugar, thus it can be administered to diabetic patients.

54 2. 常用词语 (1) 表示剂量 average／ maintenance dose 平均／维持／剂量
minimal／minimum dose 最小剂量； daily dosage 日剂量； multiple doses 多剂量； divided doses 分次剂量； overal dose / overdosage 过量； fatal/ lethal dose 致死量； single dose 一次剂量；

55 individual dose 单次剂量； indicated dose 有效剂量； standard dose 标准剂量 initial／starting / beginning dose 首次剂量； suggested/ recommended dose 推荐剂量； therapeutic dose 治疗剂量； maximum dosage 最大剂量； usual／ normal dose 常用／普通剂量； total dose 总剂量

56 （2）表示剂量单位 g = gram 克； mg = milligram 毫克； kg = kilogram 千克； mcg = microgram 微克； μg微克; L = liter／litre 升; ml = milliliter 毫升； I．U．= international unit 国际单位

57 （3）表示给药次数 daily／ per day／ a day／ every day 每日； at intervals of… 每隔…;
every…….hours 每隔……小时; once（twice）a day 每日一（二）次； three times a day 每日三次； every other day 隔日； every two（three） days 每隔2（3）日； once（twice）a week 每周1（2）次； three times a week 每周三次; divided into…dose 分…次（服用／给药）； in two or three divided doses 分二或三次服用.

58 （4）表示给药对象 newborn babies 新生儿； Baby 婴儿； Infants 幼儿； Adolescents 青少年； Children 儿童； debilitated patients 体弱患者； elderly patients 老年患者； senile patients 老年病人

59 （5）表示给药方式 ①副词： intra-arterially 动脉内给药； intravenously 静注；
Intragluteally 臀肌内给药； intrasmuscularly 肌注； intraperitoneally 腹（膜）腔内给药； intrapleurally 胸（膜）腔内给药； Intrathecally 鞘内给药；

60 Locally 局部给药； Topically 局部外敷； orally 口服； parenterally 肠道外给药； subconjunctivally 结膜下给药； Subcutaneously 皮下给药； Sublingually 舌下给药； Submucously 粘膜下给药

61 ②介词短语： by aerosol 喷雾给药； by drip phleboclysis 点滴静脉输液； by enema 灌肠；
by lumbar 腰椎给药; by phleboclysis静脉输液; by intramuscular injection（i.m.）肌肉注射； by intravenous injection （i.v.）静脉注射； by intra-articular administration关节内给药； by the intramuscular administration（route）肌内给药；

62 by the intranasal route鼻内给药；
by the Intraperitoneal administration 腹（膜）腔内给药; by the intravenous infusion（perfusion）静脉输液; by the intrathecal administration 鞘内给药； by the sublingual administration 舌下给药； per os (by mouth) 经口； per rectum直肠给药； per recto直肠给药； per viginum 阴道给药

63 ③ 动词： Take 服用, inhale（be inhaled）吸人; apply to 涂于，敷于; spray 喷雾; Swallow 吞服； Administer 给药，投药； give给药；use 用药；employ 用药； recommend／suggest 推荐给药； Suggest 推荐给药

64 七．不良反应与副作用 本项主要指明药品的副作用、毒性作用、耐受、过敏反应及停药等。常用的标题有： Adverse Reaction（s），
Unwanted／ Untoward Reaction（s） 不良反应； Side effect（s）， Unwanted／Undesirable effects， Side Reaction（s）， By-Effects; After-Effects．

65 1. 结构特点 陈述句。 Example 1 Adverse reactions
句子结构一般不复杂，常用短语或省略句，有时也用 陈述句。 Example 1 Adverse reactions FLUID AND ELECTROLYTE DISTURBANCE Sodium retention，congestive heart failure in susceptible patients，hypertension，fluid retention; potassium loss and hypokalemic alkalosis(低钾血症性碱中毒) ．

66 MUSCULOSKELETAL Sodium myopathy，muscle weakness，osteoporosis，pathologic fracture，vertebral compression fractures and aseptic necrosis， GASTROINTESTINAL Peptic ulceration with possible perforation and hemorrhage， gastric hemorrhage，pancreatitis , esophagitis and perforation of the bowel.

67 Example 2 Side－effects Side-effects are uncommon and typical of other injectable penicillins 副作用：该药副作用不常见，与其它注射青霉素类有相似的副作用

68 2. 常用词语 （1）不良反应、副作用所导致的症状和体征
allergic ／ hypersensitive／ anaphylactic reaction（s）过敏反应; allergy/ hypersensitivity过敏； dizziness眩晕； local reaction（s）局部反应； systematic reaction 全身反应； toxicity reaction 毒性反应； double infections 双重感染； flush潮红；nausea恶心；vomiting 呕吐; anorexia厌食 skin reaction 皮肤反应; pruritus 瘙痒；rash皮疹； lethargy 嗜睡；spasm痉挛；coma昏迷； tiredness疲倦；diarrhea腹泻； loss of appetite 食欲减退； thirst口渴; restlessness不安；dyspepsia消化不良；

69 （2）表示停药的词语 abandon停（药）; cessation／ stop停药，停止治疗； discontinue／ discontinuance， discontinuation停药，中断治疗; suspend暂停（用药）; withdraw 停药，撤药； terminate 停（药）

70 （3）其它常见词汇 tolerance耐受； tolerability耐受性； （ir）reversible（不）可逆的；temporary暂时性的； transient一过性的，短暂的； spontaneously自行（性）地。

71 八．注意事项 该部分也是说明书的重要内容之一，主要强调用药应注意的事项，以免引起副作用。如：药物单独和合并使用的注意事项及其主要缺点；药物配伍、给药及保存的注意事项等。常见标题有： Precautions 注意事项； Caution注意事项； Special notes/ Caution／ Precaution特别注意 ； Note注意 ; Warnings警告; 重要事项 Important for the patient（s）患者须知。

72 1. 结构特点 该项内容常涉及许多专业词汇及缩写词，其中一些词汇、结构和句型也用于药理作用、适应症、禁忌症、剂量和用法、副作用等项, 句型变化多，多用长句和难句，结构比较复杂

73 EXAMPLE 1 Precautions Animal studies with Timentin have shown no teratogenic effects. However. there is no experience of Timentin in human pregnancy, therefore its use in pregnancy cannot be recommended. Changes in liver function testes have been observed in some patients receiving Timentin. The clinical significance of these changes is uncertain but Timentin should be used with care in patients with evidence of severe hepatic dysfunction.

74 In patients with moderate or severe renal impairment Timentin dosage should be adjusted as recommended in the "dosage" section. In rare cases, bleeding manifestations have been reported following high dosage of ticarcillin. If bleeding manifestations occur with Timentin, treatment should be discontinued and appropriate therapy instituted unless, in the opinions of the physician, no alternative is available.

75 2. 常用句式 … should be used with caution in…应慎用…
... could result in... … 可能导致… ... should be administered under the supervision of the doctor / physician ... 应遵医嘱用药 The most serious risk associated with... is... 使用…最严重的危险是…. ... therapy should be discontinued when... 当…时，应终止…治疗 Dosage should be controlled by... 应通过…来控制剂量 Caution must be exercised in the case of hypersensitivity to... 对…过敏时须慎用 Caution should be exercised in the administration of... 用…应谨慎

76 ... shou1d be kept out of the reach of children. …勿使儿童接近
A close watch is kept on 要密切注意… Care must be taken of (or to do... )... 对…（或做…）须谨慎 Attention should be paid to 应注意… Caution is called for... 对…须谨慎 It is suggested / recommended that... 最好… It is important / essential / imperative that... 重要（必要）的是…

77 九．包装 该部分的常用标题为 Pack，Package和Supply。 下列标题亦经常使用： Packing(s) 包装；
How Supplied包装方式； Method of Supply包装方式； Packing for hospital 医院用包装； Hospital packs 医院用包装； Packaging 包装; presentation 包装; availability 包装; Mode / Form of Issue包装; package quality 包装量; trade packs ／packagings 商品包装； Dispensing包装

78 1. 结构特点 该部分内容比较简单，常用祈使句和省略句，有时仅列出包装方式、容器及包装量。 2. Example： Packaging 500 mg lyophilisate vials: 5 via1s + 5 solvent ampoules (for intramuscular and intravenous use). 500 mg enteric coated tablets: 10 tablets.