英文药品说明书中注意事项的写法
“注意事项”也是药品说明书中的重要内容之一。为了安全用药,厂商在本项中特别强调应注意的事项,其中主要包括:正确的剂量和用法,超过剂量时的应急措施,用药对象,可能出现的较严重的副作用及治疗方案,药物的配伍,药液的配制、使用及保管等、方面的注意事项。现就本项内容详细介绍如下:
1. 本项常用的英语表示法:
Precaution(s) 注意事项 Special note(caution, precaution)特别注意
Caution(s) 注意事项 N.B. 注意
Noto 注意 Warning(s) 警告
有时也用:
Important 重要事项 Important for the patients 患者须知
2. 本项中常见的检查项目:
blood count 血细胞汁数 Kidney (renal) function 肾功能
blood picture(hemogram) 血象 Liver(hepatic)function 肝功
blood level 血浓度 serum concentration 血清浓度
blood pressure 血压 serum creatinine test 血清肌酸酐检验
clotting time 凝血时间 urine routine(examination) 尿常规
creatinine clearance 肌酸酐清除率
3. 本项的特点是内容长短不一,有难有易;词汇量大,涉及面广,既有普通词汇,也有大量的专业词汇及编写词。许多词汇、结构和句型可在药理作用、适应症、禁忌症、剂量和用法、副作用,贮藏等项中见到。从英语结构上分析,句型变化较多,长句、难句也屡屡出现,是比较难读的一个项目。
例1 Warnings and precautions: Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweight the risk of possible CNS side-effects.
警告和注意事项:癫痫病人及有中枢神经系统病史的患者慎用环丙沙星,仅当认为疗效超过可能产生的中枢神经系统副作用的危险时才可使用。
例2 Ciprofloxacin could result in impainnent of the patients ability to drive or operate machinary, particularly in conjunction with alcohol.
环丙沙星能损害人们驾驶汽车或操纵机器的能力,尤其是在饮酒之后。
例3 Warnings: Vepeside should be administered under the supervision of a qualifiedphysicain experienced in the use of cancer chemotherapeutic agents.
警告:泛必治应该在使用治疗癌症的化疗制剂方面有经验、有资格的医生的监护下使用。
例4 The most serious risk associated with anticoagulant therapy with sodium warfarin are hemorrhage in any tissue or organ and less frequently, necrosis and/ or gangrene of skin and other tissues. The risk of hermorrhage is related to level of intensity and the duration of anticoagulant therapy.
用华注林钠进行抗凝治疗产生的最严重的危险就是组织或器官出血,以及不大常出现的皮肤和其他组织的坏死和(或)坏疽。出血的危险与抗凝治疗的药物浓度(水平)及疗程长短有关。
例5 The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts havesufficiently recovered.
血小板数低于s0,000/mm3 或绝对中性白细胞数低于500/mm3 ,表明不能继续使用本品治疗,待白细胞计教充分恢复后才能继续用药。
例6 Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation.
当怀疑华法林治疗引起坏死时,则须停止治疗,并且考虑使用肝素治疗。
例7 Dosage should be controlled by periodic determinations of prothrombin time(PT) or other suitable coagulation tests.
必须定期检查凝血酶原时间(PT),或做其他相应的凝血试验来控制剂量。
例8 Please note Cerebral convulsive disease is regarded as a relative contraindication for examinations in the subarachnoid space. If after careful consideration, these examinations are nevertheless performed, all equipment and medicines necessary to counter any convulsions may occur must be prepared ready for use beforehand.
请注意:脑惊厥被认为相对禁止进行蛛网膜下腔检查,如经谨慎考虑后、仍要进行这些检查时.必须事先备妥应付可能发生惊厥所需的所有设备与药品。
例9 Caution must be exercised in the case of hypersensitivity to iodinated contrast media, latent hyperthyroidism and bland nodular goitre.
对碘造影剂过敏、隐匿性甲状腺亢进和轻微甲状腺肿的病例,应慎重。
例10 Caution Alcohol intake may enhance nitrate effects and occasionally induce hypotension with subsequent impairment of reactivity. During the first three months ofpregnancy drugs should only be used on the express direction of the attendant physician. Isket spray should not be stored at temperatures above 25。C! Temperatures above 40 ℃ are to be be avoided, even for bried periods! Do not force canister open, even when empty!
注意:饮酒可增强硝酸盐的作用、偶尔引起低血压,继而损害反应力。妊娠三个月时,只有在监护医生明确指导下才可使用本品。异舒吉喷雾剂的贮存温度不应超过25℃!避免超过40℃。即使短时间也不可!不要用力开罐,即使空罐时也不可用力开!勿使儿童接触本品
例11 As with all new drugs, patients should be followed carefully so that any side-effects or unusual manifestations of drug idiosyncrasy may be detected. If any allergic reaction to Keflex occurs, the drug should be discontinued and the patient treated with the usual agents.
像使用所有新药一样,应细心地随访患者,以便观察任何副作用或药物特异反应。如果出现对头抱菌素IV的过敏反应,应停药,并用常规药物治疗患者。
例12 In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine. While this is usually reversible, It is important in such patients to pay careful attention to those factors which may lead to hypercalcemia.
对于肾功能正常的患者,慢性高钙血症可能与血清肌酸酐增多有关。这通常虽然是可逆的,然而对这样的病人,密切注意可能导致血钙过多的各种因素是很重要的。
例13 Precautions 一Avoid the concomitant use, in the absence of special monitoring laboratory of parameters, of anticoagulants or aspirin. 一Inform the attending physician in the event of bleeding or of the occurence of a hematoma.
注意事项:在无化验室参考指标的专门监测情况下,避免与抗凝剂或阿司匹林合用。如发生出血或出现血肿,应通知主治医生。
例14 Periodical examination of hepatic or renal function and blood picture is desirable since Kedacillin may increase SGOT. SGPT and BUN, and decrease erythrocyte and leucocyte.
磺苄青霉素钠可使血清谷-草转氨酶,血清谷-丙转氨酶和血液尿素氮增高,使红细胞和白细胞减少.所以最好要定期检查肝、肾功能和血象。
例15 N.B.Transference from insuline to Glutril may be attempted in case of maturity-onsetdiabetes with obesity;dosage is based upon the result of the necessarily frequent metablic tests.
注意:伴有肥胖症的成年型糖尿病患者,可试从胰岛素改用格路特利治疗,剂量应以必须经常进行的代谢试验为依据。