英文药名: Diflucan Dry Syrup(fluconazole)
中文药名: 氟康唑口服悬浮液(福司氟康唑)
生产厂家: 辉瑞公司
ジフルカンドライシロップ350mg/ジフルカンドライシロップ1400mg
药品治疗分类 深部真菌病的治疗剂 批准上市日期:2012年6月 商標名 Diflucan Dry Syrup 一般名 フルコナゾール(fluconazole) 略号 FLCZ 化学名 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol 分子式 C13H12F2N6O 分子量 306.27 融点 137~141℃ 構造式
性状 氟康唑是一种白色结晶粉末淡黄白色。易微溶于乙醇(99.5),和微溶于水。余溶于稀盐酸。 药理作用 本品为新型三唑类抗真菌药,是真菌甾醇合成的强效特异性抑制剂,对真菌细胞色素P-450依赖酶的抑制作用具有高度选择性。口服和静脉注射对各种动物真菌感染模型有效。 适应病症 念珠菌引起的和隐球菌感染之后 真菌血症,呼吸道真菌病,胃肠道真菌病,泌尿道霉菌病,Makinzuimakuen 深部真菌疾病的预防中的造血干细胞移植的患者 用法与用量 成人 ・ 念珠菌 每日一次,每次50-100毫克口服给药 ・ 隐球菌病 每日一次,每次50-100毫克口服给药。 在严重的或顽固性真菌感染的情况下,可以被增加至400毫克作为一个单一的每日剂量。 ・ 深部真菌疾病的预防中的造血干细胞移植的患者 每日一次,每次400毫克口服给药 小児 ・ 念珠菌 每日一次,每次3毫克/公斤口服 ・ 隐球菌病 每日一次,3-6毫克/公斤至每天口服给药。在严重的或顽固性真菌感染的情况下,可以增加高达12毫克/公斤作为每日剂量。 ・ 深部真菌疾病的预防中的造血干细胞移植的患者 孩子,口服给药一天一次为12mg/kg。 应当指出的是,要根据患者的状况减肥适当。 然而,这不超过400毫克作为每日剂量。 新生児 新生儿至14日龄,施用相同剂量作为子在每72小时为氟康唑。 随后的15天龄的新生,施用相同剂量作为子在每48小时为氟康唑。 任何疑问,请遵医嘱! 包装规格: 干糖浆 350毫克*1瓶 1400mg*1瓶
生产商: 辉瑞日本公司 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/6290002R1027_1_06/ New dosage form of Diflucan®, a therapeutic agent for deep-seated mycoses "Diflucan® Dry Syrup 350mg/1400mg" New Release June 22, 2012 Pfizer Inc. Pfizer Inc. (Headquarters: Shibuya-ku, Tokyo; President: Ichiro Umeda) announced that from the Established Pharmaceuticals Division, a new form of Diflucan® (generic name: fluconazole), a therapeutic agent for deep fungal diseases, ® Dry Syrup 350 mg / 1400 mg "will be released on Friday, June 29, 2012. Diflucan Dry Syrup 350 mg/1400 mg, a therapeutic agent for deep mycosis, was approved for manufacture and marketing on February 14 (Tue) this year and was listed in the drug price standard today. Diflucan has been used for treatment of various fungal diseases caused by Candida and Cryptococcus in adults and children, and for prevention of fungal infections in hematopoietic stem cell transplant patients. As an internal medicine, capsules have been approved in 1989, but in response to the results of the examination at "unapproved drugs for high medical necessity/non-indication drug review meeting *", about addition of suspension agents 2010 On May 21, 2009, the Ministry of Health, Labor and Welfare asked Pfizer Inc. for development. Due to the new release this time, suspension drugs (dry syrup) already on the market will be added overseas for infants who are difficult to take capsules and adults with dysphagia disorder. Pfizer established the Established Pharmaceutical Business Division in September 2009 in order to deliver "long-used standard treatment medicine", dealing with long-listed items and generic drugs including diflukan. Pfizer will continue to contribute to medical treatment in Japan by delivering products that meet Pfizer's standards without changing either new drugs or Established drugs. ※ "Medically unnecessary drugs that are highly unlikely to be approved" and "Adaptation medicine review committee" are approved for use in Europe and the United States but are not approved domestically, unapproved drugs by pharmaceutical companies · drugs not approved Meeting established for the purpose of promoting the development of the conference. It is organized by the Ministry of Health, Labor and Welfare and consists of medical and pharmaceutical academic experts. Overview of Diflucan® Dry Syrup product name Diflucan® Dry Syrup 350 mg (Diflucan® Dry Syrup 350 mg) Diflucan® Dry Syrup 1400 mg (Diflucan® Dry Syrup 1400 mg) common name Fluconazole Indication Candida and Cryptococcus infections Fungal bacteremia, respiratory mycoses, gut fungal disease, urinary tract infection, fungal meningitis Prevention of deep fungal infections in hematopoietic stem cell transplant patients * For the diflucan capsule 50 mg/100 mg and the diflucan intravenous solution 50 mg/100 mg/200 mg, in addition to the addition of the indication and effect of "prevention of deep mycosis in hematopoietic stem cell transplant patients" in November last year and "dosage regimen for children" We have obtained additional approval of.
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