第十一節(jié) 其他項目
上述10項是絕大多數(shù)英文藥品說明書中必備項目,但是許多說明書中還常常出現(xiàn)其他一些項目。例如:
1、特點(Characteristics)
2、性質(Properties)
3、藥代動力學(Phamacokinetics)
4、用藥過量(Overdosage)
5、相互作用(Interactions)
6、有效期(Validity)
7、其他可能出現(xiàn)的項目。
現(xiàn)將各項簡要分述如下:
1、Characteristics(特點)或Features(特點)的主要內容是藥物的藥理作用特點、療效、劑量及藥物代謝等。所以本項內的英語詞匯及結構特點與“藥理學”、“劑量”等項內容相似。
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)咳作用相當于或強于可待因。
4)安嗽靈的祛痰作用是迄今市場上可買到的常用鎮(zhèn)咳藥中前所未有的。
5)安嗽靈可長期服用,既安全又無副作用。
2. Properties(Property)(性質):本項內容與Characteristics 基本相同。
例2 Methotrexate (MTX) is an antimetabolite of folic acid which has been used for a long time in thechemotherapy of tumours.
氨甲葉酸(簡稱MTX)為甲酰四氫葉酸的抗代謝物,長期以來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),并增加機體的自然防御機制。
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;由于本品在體內能迅速和完全分解,因而不會產(chǎn)生清晨的“殘留作用。也沒有積蓄作用。即使經(jīng)常服用,本品仍能保持充分的活性。
3.Pharmacokinetics(藥物代謝動力學) 的內容王要是代謝(metabolism),吸收(absorption),分布與排泄(distribution and elimination)等:
例6 Ampicillin is stable in the presence of 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 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。密鈣息的絕對生物利用率約為70%。1小時內其血藥濃度可達高峰,其半衰期為 70~90分鐘。高達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、蛋白質結合率為 30~40%。 醫(yī).學教育網(wǎng)整理飛例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.
速眠安在體內代謝完全,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合(失活),然后由腎臟排出。
4. Overdosage(超劑量,藥物過量)主要介紹用藥過量所產(chǎn)生的后果(effect),癥狀(signs and symptoms)及處理(treatment)方法。其英語詞匯和結構等與“劑量與用法”,“副作用”,“注意事項”等項目中的詞匯和結構相似。
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)護重要器官的功能。必要時給予安定。
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.
好爾睡服用過量的表現(xiàn)是其藥理活性的擴展,即嗜睡和催眠。像處理所有藥物過量的病例一樣,必須對呼吸、脈搏和血壓進行監(jiān)測,必要時采用通用措施,應立即洗胃、靜脈輸液,并保持呼吸道暢通。
英文藥品說明書的寫法(一)
英文藥品說明書的寫法(二)
英文藥品說明書的寫法(三)
英文藥品說明書的寫法(四)
英文藥品說明書的寫法(五)
英文藥品說明書的寫法(六)
英文藥品說明書的寫法(七)
英文藥品說明書的寫法(八)
英文藥品說明書的寫法(九)
英文藥品說明書的寫法(十)
英文藥品說明書的寫法(十二)