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,
2、性质,
3、药代动力学,
4、用药过量,
5、相互作用,
6、有效期,
7、其他可能出现的项目。
现将各项简要分述如下:
1、Characteristics或Features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 Tanabes 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:本项内容与Characteristics 基本相同。
例2 Methotrexate is an antimetabolite of folic acid which has been used for a long time in thechemotherapy of tumours.
氨甲叶酸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 bodys 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 的内容王要是代谢,吸收,分布与排泄等:
例6 Ampicillin is stable in the presence of gastic acid and is well absorbed from the gastrointestinal tract . 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 acidand 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,然后由肾脏排出。
4. Overdosage主要介绍用药过量所产生的后果,症状及处理方法。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。
5. Interactions或drug Interactions:本项内容主要是介绍药物合用时的注意事项。
例11 Temaril tablets should not be administered with 4 hours of medications containing mgnesium,aluminium or iron salts as interference with absorption may occur.
在使用了含镁、铝或铁盐的药物之后的4小时内不应使用环丙沙星片剂,因为可能影响吸收。
例12 Simultaneous consumption of alcohol can impair reaction time. e.g. in traffic or during operation of machines. At higher dosage of Elantan 20 wlth simultaneous administration of blood-pressure-lowering medicaments the effect of the latter can be potentiated.
同时饮酒可能损害反应时间,例如驾驶车辆或操纵机器期间。大量服用单硝酸异山梨醇的同时服用降血压药物,可能会增强后者的药效。
例13 Dormicum can enhance the central sedative effect of neuroleptics, tranquitizers, antidepressants, sleep-inducing drugs, analgesics and anesthetics.
速眠安能增强神经抑制剂、安定剂、抗抑郁剂、催眠、镇静剂和麻醉剂的中枢神经镇静作用。
例14 Concomitant treatment with other vasodilators, calcium antagonists, betablockers, diuretics, antihypertensives, tricyclic antidepressants, major tranquilizers, and dihydroergotamine, as well as the consumption of alcohol, may potentiate the blood pressure lowering effect of Nitroderm TTS.
与其他药物,例如:血管扩张药、钙桔抗剂、B-受体阻断剂、利尿剂、抗高血压药、三环抗抑郁药、
强镇静剂及二氢麦角胺合用,以及饮酒等,可加强硝酸甘油护心贴膏的降血压作用。
6。Validity:药品的有效期或失效期有以下几种表示方法:
validity 有效期 storage life 贮存期
Expiry date 失效期 Shelf life 贮存期
Expiring 失效期 Stability 稳定性
Expiration date 失效期
例15 Expiry: 18 months
有效期:18个月。
例16 Validity and storage: The solution will keep for five years if stored at a temperature below +20℃
有效期及贮存法:于20℃以下可保存5年。
例17 Stability: Cefoperazone is stable at least 24 hours in aqueous solutions, stored at temperature which ranges from 5 to 25℃.The powder form is really effective till the expiry date indicated on packings.
稳定性:头孢哌酮存于5~25℃温度下的稳定性至少可达24小时。木品粉剂的药效实际上可保持到包装上规定的失效日期。
例18 Stability: See expiry date on the outside of the pack.
稳定性;见外包装上的失效日期
例19 Shelf-life: The drug should not be used after the expiry date printed on pack.
木品超过包装上印刷的有效期后不得使用,
7. 其他可能出现的项目:
1) References 参考文献 Literature 参考文献
2) Clinical dtaa 临床数据
3) Formula 分子式
4) Recommendations 建议
5) Remark 注意 Attention 注意
6) Tolerance 耐受性
7) Intormation for the patients 患者须知
8) Further information 补充资料
9) Batch No 批号
10)Made in 由制造 Produced by 由生产
Manufacturedby 由制造
11)Pharmaceuticala Precautions 药品的注意事项
还可能有其他项目.这里不再列举。
以上是英文药品说明书中的主要项目的英文标题,不同的表示方法,结构特点,常用词,短语及句型等。掌握这些内容有助于了解英文说明书的脉络,但要完全理解说明书的全部内容还需要经过一番努力。
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