——FDA批准首个语音指导的肾上腺素自动注射笔 近日,美国食品与药物管理局(FDA)批准使用首个语音指导的肾上腺素自动注射笔(Auvi-Q)将于今年11月15日后上市。该注射笔适用于摄入鸡蛋、坚果等变应原以及虫咬和虫螫等引起的威胁生命变态反应的急救治疗。
据该装置的制造商介绍,这是首个能够同时通过语音和视觉指导患者完成注射过程的装置。
Auvi-Q大小相当于信用卡,厚度相当于一部手机,带有可收缩注射针装置,以免注射完毕后发生针头误伤。该装置一共有2中不同的剂量:0.3mg适用于体重为66磅以上的患者,0.15mg适用于体重33至66磅患者,该装置并未在体重小于33磅患者中进行研究。
Indication Auvi-Q™ (epinephrine injection, USP) is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic and exercise-induced anaphylaxis. Auvi-Q is intended for individuals with a history of anaphylaxis or who are at risk for anaphylactic reactions.
Important Safety Information Auvi-Q should ONLY be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY.
Epinephrine should be administered with caution to patients with certain heart diseases, and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
Auvi-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical or hospital care. |