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本刊讯根据药品不良反应评估结果,为控制药品使用风险,决定对独一味口服制剂说明书进行修订,具体修订要求如下:1.不良反应项应当包括:(1)消化系统:胃(脘)不适、腹痛、腹胀、腹泻、恶心、呕吐、口干等,有肝生化指标异常病例报告。(2)全身性反应:疼痛、水肿、乏力、潮红、过敏反应等。(3)皮肤:皮疹、瘙痒等。(4)神经系统:头晕、头痛等。(5)心血管系统:心悸、胸闷等。(6)其他:有鼻衄、黑便、紫癜病例报告。
According to the results of ADR evaluation, in order to control the risk of drug use, we decided to amend the specification of Duluth Oral Preparation. The specific revision requirements are as follows: 1. Adverse reactions should include: (1) digestive system: stomach , Abdominal pain, abdominal distension, diarrhea, nausea, vomiting, dry mouth, liver biochemical abnormalities have reported cases. (2) systemic reactions: pain, edema, fatigue, flushing, allergic reactions. (3) skin: rash, itching and so on. (4) nervous system: dizziness, headache and so on. (5) cardiovascular system: heart palpitations, chest tightness and so on. (6) Other: a nosebleed, melena, purpura cases report.