帮我翻译益患适说明书成中文
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发布时间:2009-03-20 13:42:44
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Brown, round, biconvex, film-coated tablet impressed with "IRESSA 250" on one side and plain on the ther .Each tablet contains 250 mg gefitinib.
Indications
IRESSA is indicated for the treatment of patinedts with locally advanced or metastatic Non Small Cell Lung cancer(NSCLC) who have preciously received chemotherapy.
Dosage And Administration
The recommended dose of IRESSA is one 250 mg tablet once a day, taken with or without food.
The tablet can slao be dispersed in half a glass of drinking water(non-carbonated).No other liquids should be used. Drop the tablet in the water, without crushing it, stir until the tablet is dispersed(approximately 10 minutes) and drink the liquid immediately. Rinse the glass with half a glass of water and drink. The liquid can also be administered through a naso-gastirc tube.
IRESSA is not recommended for use in children or adolescents as safety and effectiveness in these patient prpulations has not been studied.
No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity or renal function or patients with moderaty to severe hepatic impairment due to liver metastased(see Pharmacokinetic Properties' section).
Dosage adjustment: Patients with poorly tolerated diarrhoea or skin adverse drug reactions may be successfully managed by providing a brief(up to 14 days) therapy interruption folowed by reinstatement of the250 mg dose(see Pharmacokinetic Properties' section).
Contraindications
Known severe hypersensitivity to the active substance or to any of the excipients of this product.
Warnings and Precautions
Interstitial Lung Disease has been observed uncommonly in patients treated with Iressa. Patients typically have an acute onset of dyspnoea associated with cough, low grade fecer, respiratory distress and arterial oxygen desaturation. Symproms may become severe within a short time and fatal outcomes have been reported. Radionlogical investigations frequently show pulmonary infiltrates or interstitial shadowing with ground glass appearance. Patients with concurrent Idopathic Pulmonary Fibrosis/Interstitial Pneumonia/pneumoconiosis/radiation pneumonia/ drug-induced pneumonia have been observed to have an increased rate of mortality from this condition.
If patients present with worsening of respiratory symptoms. Iressa Should be interrupted and prompt investigation initiated. If Interstitial Lung Disease is confirmed, Iressa should be discontinued and the patient treated appropriately.
Asymptomatic increases in liver transaminases have been observed( see Pharmacokinetic Properties' section). Therefore periodic liver function testing is recommended Iressa should be used cautiously in the presence of mild to moderate increases of liver transaminases. Discontunuation should be considered if changes are severe.
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>>>>>>>>休闲养生网回答:使用说明
布朗轮, biconvex ,薄膜包衣片的印象“易瑞沙250 ”一方和平原的存在。每片含有250毫克吉非替尼。
有迹象表明
易瑞沙是用于治疗局部晚期或转移性非小细胞肺癌( NSCLC )中谁拥有昂贵地接受化疗。
剂量和管理
建议剂量的易瑞沙是250毫克片剂每天一次,采取带或不带食物。
片剂可以被分散了一半玻璃的饮用水(非碳酸) 。没有其他液体应使用。下降的片水,它没有破碎,搅拌,直到片分散(约10分钟)和饮料的液体立即。清洗玻璃的一半一杯水和饮料。液体也可以通过管理鼻管。
易瑞沙不推荐用于儿童或青少年的安全性和有效性在这些病人还没有研究。
无剂量调整要求的基础上,患者年龄,体重,性别,种族或肾功能或患者严重肝损害由于肝脏转移(见药代动力学特性'节) 。
剂量调整:患者的耐受性很差腹泻或皮肤药物不良反应可能会成功地管理提供了一个简短的(最多14天)治疗中断的恢复the250毫克剂量(见药代动力学特性'节) 。
禁忌
已知的严重过敏反应的活性物质或任何辅料的产品。
警告和预防措施
间质性肺疾病已观察到异常的患者易瑞沙。患者通常有急性发作的呼吸困难与咳嗽,低度,呼吸窘迫和动脉血氧饱和。 可能成为严重的很短的时间内和致命的结果的报告。 调查显示经常性肺间质浸润阴影或与地面的玻璃外观。患者并发特发性肺纤维化/间质性肺炎/肺尘埃沉着病/放射性肺炎/药物诱导性肺炎已观察到有增加死亡率从这个条件。
如果病人有恶化的呼吸道症状。易瑞沙应中断并迅速展开调查。如果间质性肺疾病得到证实,易瑞沙应该停止,病人适当处理。
无症状增加肝转氨酶已观察(见药代动力学特性'节) 。因此,定期肝功能测试是易瑞沙建议应慎重使用中存在的轻度至中度增加肝转氨酶。应该考虑是否改变是严重的。
楼主参考。
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