10、注射用阿尼芬净.docx

阿尼芬净注射液（Anidulafungin/Eraxis）——FDA批准阿尼芬净治疗念珠菌感染关键字：阿尼芬净注射液（Anidulafungin/Eraxis）FDA批准了Eraxis?(通用名：阿尼芬净[anidulafungin])用于治疗假丝酵母（Candida）引起的某些感染。Candida是一种能在就医病人或免疫系统受损的病人中引起严重感染的类似酵母的真菌。“该产品为与假丝酵母相关的几种感染提供了一种新的可选疗法”，FDA的药品评价与研究中心主任Steven Galson博士称。“它是现有用于治疗这些潜在的严重真菌病症的抗菌药物的有益补充。”一种从未在美国上市的新分子实体Eraxis，是一种静脉注射的抗真菌药物，并被用于治疗食道（念珠菌病）、血液（念珠菌血症）中的假丝酵母感染以及其他类型的假丝酵母感染，包括腹部脓肿和腹膜炎（腹腔内壁发炎）。临床研究评价了Eraxis的安全性和有效性，并且显示Eraxis在食道念珠菌病、念珠菌血症（candidemia）以及其他包括腹部脓肿和腹膜炎在内的假丝酵母感染的治疗中是安全且有效的。Eraxis在临床研究中普遍很耐受。最常见报告的不良事件是：轻度腹泻，肝酶的实验室测试水平轻微上升，以及头痛。一些病人经历了与输液相关的反应，其中多数为轻度。在具有重大的潜在医学状况的且正伴服多重药物的少数病人中，有严重肝异常的报道。Eraxis由纽约州的Pfizer公司生产。ERAXIS - anidulafungin?injection, powder, lyophilized, for solution??Roerig?ERAXIS? (anidulafungin) FOR INJECTION?[INTRAVENOUS INFUSION, DILUTED WITH STERILE WATER FOR INJECTION] (not for IV Bolus Injection)DESCRIPTIONERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of?Aspergillusnidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4-(pentyloxy)[1,1:4,1-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B.?Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients:50 mg/vial?- fructose (50 mg), mannitol (250 mg), polysorbate 80 (125 mg), tartaric acid (5.6 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.100 mg/vial?- fructose (100 mg), mannitol (500 mg), polysorbate 80 (250 mg), tartaric acid (11.2 mg), and sodium hydroxide and/or hydrochloric acid for pH adjustment.The empirical formula of anidulafungin is C58H73N7O17?and the formula weight is 1140.3.Th