手機(jī)版
前面所述10項(xiàng)是絕大多數(shù)英文藥品說(shuō)明書(shū)中必備項(xiàng)目，但是許多說(shuō)明書(shū)中還常常出現(xiàn)其他一些項(xiàng)目。例如：
1、特點(diǎn)（Characteristics），
2、性質(zhì)（Properties），
3、藥代動(dòng)力學(xué)（Pharmacokinetics），
4、用藥過(guò)量（Overdosage），
5、相互作用（Interactions），
6、有效期（Validity），
7、其他可能出現(xiàn)的項(xiàng)目。
現(xiàn)將各項(xiàng)簡(jiǎn)要分述如下：
1、Characteristics（特點(diǎn)）或Features（特點(diǎn)）的主要內(nèi)容是藥物的藥理作用特點(diǎn)、療效、劑量及藥物代謝等。所以本項(xiàng)內(nèi)的英語(yǔ)詞匯及結(jié)構(gòu)特點(diǎn)與“藥理學(xué)”、“劑量”等項(xiàng)內(nèi)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.
特點(diǎn)1）安嗽靈是一種全新的、獲有專利的用塔那勃氏方法研制的鎮(zhèn)咳藥。
2）安嗽靈屬非麻醉藥，可作為常用藥使用。
3）安嗽靈的鎮(zhèn)咳作用相當(dāng)于或強(qiáng)于可待因。
4）安嗽靈的祛痰作用是迄今市場(chǎng)上可買到的常用鎮(zhèn)咳藥中前所未有的。
5）安嗽靈可長(zhǎng)期服用，既安全又無(wú)副作用。
2、 Properties (Property)（性質(zhì)）：本項(xiàng)內(nèi)容與Characteristics 基本相同。
例2 Methotrexate (MTX) is an antimetabolite of folic acid which has been used for a long time in the chemotherapy of tumours.
氨甲葉酸（簡(jiǎn)稱MTX）為甲酰四氫葉酸的抗代謝物，長(zhǎng)期以來(lái)一直用作治療腫瘤的化療藥物。
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.
脈心導(dǎo)敏與硝酸甘油不同，在肝臟不能迅速失活，因而可望具有可靠的臨床效果，本品毒性小，副作用極為輕微。
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.
護(hù)前列腺素具有抗炎作用，能減輕前列腺膀胱區(qū)因一般性梗阻引起的腫脹，本品能刺激上述部位的血液循環(huán)，并增加機(jī)體的自然防御機(jī)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.
美多眠可使消除疲勞的睡眠持續(xù)6～8小時(shí)；由于本品在體內(nèi)能迅速和完全分解，因而不會(huì)產(chǎn)生清晨的“殘留作用．也沒(méi)有積蓄作用。即使經(jīng)常服用，本品仍能保持充分的活性。
3、Pharmacokinetics（藥物代謝動(dòng)力學(xué)） 的內(nèi)容王要是代謝（metabolism），吸收（absorption），分布與排泄（distribution and elimination）等：
例6 Ampicillin is stable in the presence of gastric acid and is well absorbed from the gastrointestinal tract (30-60% of a dose being absorbed by this route). Its absorption, however, is diminished when it is taken together with food.
氨芐青霉素在胃酸中穩(wěn)定．而且易被胃腸道吸收（30～60％的一次劑量經(jīng)此途徑吸收）然而與食物共服，其吸收減少。
例7 The absolute bioavailability of Miacalic following 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，密鈣息的絕對(duì)生物利用率約為70％。1小時(shí)內(nèi)其血藥濃度可達(dá)高峰，其半衰期為 70～90分鐘。高達(dá)95％的劑量經(jīng)由腎臟排出，2％以其不變的藥物原型排出。表觀分布容積為0.15～0.31/kg、蛋白質(zhì)結(jié)合率為 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（inactivation）and then eliminated by the kidneys.
速眠安在體內(nèi)代謝完全，主要的代謝產(chǎn)物為a-羥基速眠安，可在血漿中查出。代謝產(chǎn)物形成后，此活性代謝物便立即與葡萄糖醛酸結(jié)合（失活），然后由腎臟排出。
4、 Overdosage（超劑量，藥物過(guò)量）主要介紹用藥過(guò)量所產(chǎn)生的后果（effect），癥狀（signs and symptoms）及處理（treatment）方法。其英語(yǔ)詞匯和結(jié)構(gòu)等與“劑量與用法”，“副作用”，“注意事項(xiàng)”等項(xiàng)目中的詞匯和結(jié)構(gòu)相似。
例9 Overdosage may give rise to the following signs and symptoms: tremor, excitation, 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 where necessary.
超劑量可能引起下列體征和癥狀：震顫、興奮、痙攣、血壓改變、意識(shí)損害及昏迷。心電圖和腦電圖也可能發(fā)生改變。
治療：采取措施監(jiān)護(hù)重要器官的功能。必要時(shí)給予安定。
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.
好爾睡服用過(guò)量的表現(xiàn)是其藥理活性的擴(kuò)展，即嗜睡和催眠。像處理所有藥物過(guò)量的病例一樣，必須對(duì)呼吸、脈搏和血壓進(jìn)行監(jiān)測(cè)，必要時(shí)采用通用措施，應(yīng)立即洗胃、靜脈輸液，并保持呼吸道暢通。
5、Interactions或drug Interactions（相互作用，或藥物的交互作用）：本項(xiàng)內(nèi)容主要是介紹藥物合用時(shí)的注意事項(xiàng)。
例11 Temaril tablets should not be administered with 4 hours of medications containing magnesium，aluminum or iron salts as interference with absorption may occur.
在使用了含鎂、鋁或鐵鹽的藥物之后的4小時(shí)內(nèi)不應(yīng)使用環(huán)丙沙星片劑，因?yàn)榭赡苡绊懳铡?br />
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 with simultaneous administration of blood-pressure-lowering medicaments the effect of the latter can be potentiated.
同時(shí)飲酒可能損害反應(yīng)時(shí)間，例如駕駛車輛或操縱機(jī)器期間。大量服用單硝酸異山梨醇的同時(shí)服用降血壓藥物，可能會(huì)增強(qiáng)后者的藥效。
例13 Dormicum can enhance the central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing drugs, analgesics and anesthetics.
速眠安能增強(qiáng)神經(jīng)安定劑、鎮(zhèn)定劑、抗抑郁劑、催眠藥、止痛藥和麻醉劑的中樞神經(jīng)鎮(zhèn)靜作用。
例14 Concomitant treatment with other vasodilators, calcium antagonists, beta-blockers, 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.
與其他藥物，例如：血管擴(kuò)張藥、鈣拮抗劑、β-受體阻斷劑、利尿劑、抗高血壓藥、三環(huán)抗抑郁藥、強(qiáng)鎮(zhèn)靜劑及二氫麥角胺合用，以及飲酒等，可加強(qiáng)硝酸甘油護(hù)心貼膏的降血壓作用。
6、Validity（有效期）：藥品的有效期或失效期有以下幾種表示方法：
validity 有效期
storage life 貯存期
Expiry (Exp.) date 失效（日）期
Shelf life 貯存期（貯藏期限）
Expiring 失效期
Stability 穩(wěn)定性
Expiration date 失效（日）期
例15 Expiry: 18 months (Expiry date is printed on the vial label.)
有效期：18個(gè)月（失效日期印在瓶簽上）。
例16 Validity and storage: The solution will keep for five years if stored at a temperature below +20℃
有效期及貯存法：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.
穩(wěn)定性：頭孢哌酮存于5～25℃溫度下的穩(wěn)定性至少可達(dá)24小時(shí)。木品粉劑的藥效實(shí)際上可保持到包裝上規(guī)定的失效日期。
例18 Stability: See expiry date on the outside of the pack.
穩(wěn)定性；見(jiàn)外包裝上的失效日期
例19 Shelf-life: The drug should not be used after the expiry date(=Exp) printed on pack.
本品超過(guò)包裝上印刷的有效期后不得使用，
7、其他可能出現(xiàn)的項(xiàng)目：
1） References 參考文獻(xiàn) Literature 參考文獻(xiàn)
2） Clinical data 臨床數(shù)據(jù)
3） Formula (Formulation) 分子式
4） Recommendations 建議
5） Remark(s) 注意 Attention 注意
6） Tolerance 耐受性
7） Information for the patients 患者須知
8） Further information 補(bǔ)充資料
9） Batch No 批號(hào)
10）Made in 由……制造 Produced by 由…生產(chǎn)Manufactured by 由…制造
11）Pharmaceutical Precautions 藥品的注意事項(xiàng)
還可能有其他項(xiàng)目．這里不再列舉。
