第十一节 其他项目

上述10项是绝大多数英文药品说明书中必备项目，但是许多说明书中还常常出现其他一些项目。例如：

1、特点（Characteristics），

2、性质（Properties），

3、药代动力学（Phamacokinetics），

4、用药过量（Overdosage），

5、相互作用（Interactions），

6、有效期（Validity），

7、其他可能出现的项目。

现将各项简要分述如下：

1、Characteristics（特点）或Features（特点）的主要内容是药物的药理作用特点、疗效、剂量及药物代谢等。所以本项内的英语词汇及结构特点与“药理学”、“剂量”等项内容相似。

例1 Characteristics:

1）Asverin Is an entirely new and patented cough medicine developed by Tanabe's rocess.

2）Asverin being a non-narcotic, can be used as a common medicine.

3）Antitussive effect of Asverin is equal to or more powerful than that of codeine.

4）Asverin is provided with an expectoranting action which has been never found in any conventional antitussitive agents so far available in the market.

5）Asverin can be administered safely for a long duration without any sideeffect.

特点1）安嗽灵是一种全新的、获有专利的用塔那勃氏方法研制的镇咳药。

2）安嗽灵属非麻醉药，可作为常用药使用。

3）安嗽灵的镇咳作用相当于或强于可待因。

4）安嗽灵的祛痰作用是迄今市场上可买到的常用镇咳药中前所未有的。

5）安嗽灵可长期服用，既安全又无副作用。

2. Properties（Property）（性质）：本项内容与Characteristics 基本相同。

例2 Methotrexate （MTX） is an antimetabolite of folic acid which has been used for a long time in thechemotherapy of tumours.

氨甲叶酸（简称MTX）为甲酰四氢叶酸的抗代谢物，长期以来一直用作治疗肿瘤的化疗药物。

例3 Unlike nitroglycerine, it is not rapidly inactivated in the liver and a reliable clinical effect can be expected. Toxicity is low-effects are minimal with Motazomin.

脉心导敏与硝酸甘油不同，在肝脏不能迅速失活，因而可望具有可靠的临床效果，本品毒性小，副作用极为轻微。

例4 Urgenin acts as an anti-inflammatory, reducing the swelling in the prostatic bladder region caused by general obstruction. It also stimulates the blood circulation in this area and the body's natural defence mechanism.

护前列腺素具有抗炎作用，能减轻前列腺膀胱区因一般性梗阻引起的肿胀，本品能刺激上述部位的血液循环，并增加机体的自然防御机制。

例5 Medomin induces restorative sleep lasting 6-8 hours. Because it is rapidly and completely broken down in the body, it is unlikely to produce morning hangover and does not cumulate. It retains its full activity even when used repeatedly.

美多眠可使消除疲劳的睡眠持续6～8小时；由于本品在体内能迅速和完全分解，因而不会产生清晨的“残留作用．也没有积蓄作用。即使经常服用，本品仍能保持充分的活性。

3．Pharmacokinetics（药物代谢动力学） 的内容王要是代谢（metabolism），吸收（absorption），分布与排泄（distribution and elimination）等：

例6 Ampicillin is stable in the presence of gastic acid and is well absorbed from the gastrointestinal tract （30-60% of a dose being absorbed by this route）. Its absorpt-ion, however, is diminished when it is taken fogether with food.

氨苄青霉素在胃酸中稳定．而且易被胃肠道吸收（30～60％的一次剂量经此途径吸收）然而与食物共服，其吸收减少。

例7 The absolute bioavailability of Miacalic fouowing intramuscular or subcutaneous injection is approximately 70％. Its peak plasma concentration is attained within one hour and it has half-life of elimination of 70－90 minutes.Up to 95% of the dose is excreted via the kidneys, 2% as unchanged drug. The apparent volume of distribution is 0.15～0.31／kg and protein binding 30～40％.

肌注或者下注射后．密钙息的绝对生物利用率约为70％。1小时内其血药浓度可达高峰，其半衰期为 70～90分钟。高达95％的剂量经由肾脏排出，2％以其不变的药物原型排出。表观分布容积为0.15～0.31/kg、蛋白质结合率为 30～4C％。

例8 Midazolam is completely metabolized in the body. The primary metabolite is a-hydroxy-midazolam, which can be traced in the plasma. Immediately after its formation, this active metabolite is conjugated with glucuronic acid（inactlvation）and then eliminated by the kidneys.

速眠安在体内代谢完全，主要的代谢产物为a-羟基速眠安，可在血浆中查出。代谢产物形成后，此活性代谢物便立即与葡萄糖醛酸结合（失活），然后由肾脏排出。

4. Overdosage（超剂量，药物过量）主要介绍用药过量所产生的后果（effect），症状（signs and symptoms）及处理（treatment）方法。其英语词汇和结构等与“剂量与用法”，“副作用”，“注意事项”等项目中的词汇和结构相似。

例9 Overdosage may give rise to the following signs and symptoms: tremor, xcitation, convulsions, changes in blood pressure impairment of consciousness, and coma. EEG and ECG changes may also occur.

Treatment: Measures to monitor and safeguard vital functions. Administration of diazepam wherenecessary.

超剂量可能引起下列体征和症状：震颤、兴奋、痉挛、血压改变、意识损害及昏迷。心电图和脑电图也可能发生改变。

治疗：采取措施监护重要器官的功能。必要时给予安定。

例10 Manifestations of Halcion overdosage include extensions of its pharmacological activity, namely somnolence and hypnosis. As in all cases of drug overdosage, respiration, pulse, and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. Intravenous fluids should be administered and an adequate airway maintained.

好尔睡服用过量的表现是其药理活性的扩展，即嗜睡和催眠。像处理所有药物过量的病例一样，必须对呼吸、脉搏和血压进行监测，必要时采用通用措施，应立即洗胃、静脉输液，并保持呼吸道畅通。