País: Taiwán
Idioma: chino
Fuente: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
POSACONAZOLE, MICRONIZED
美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)
J02AC04
口服懸液劑
POSACONAZOLE, MICRONIZED (0812204720) MG
玻璃瓶裝
製 劑
須由醫師處方使用
Cenexi HSC 2, RUE LOUIS PASTEUR, 14200 HEROUVILLE SAINT CLAIR, FRANCE FR
posaconazole
1.對amphotericin B或itraconazole或voriconazole治療無效或不能忍受之成人侵入性麴菌病(invasive aspergillosis)的第二線用藥。(無效的定義是先前用有效抗黴菌劑的治療劑量至少7天,感染惡化或未改善)2.對itraconazole或fluconazole治療無效或不能忍受之成人口咽念珠菌感染(oropharyngeal candidiasis)的第二線用藥。(無效的定義是先前用有效抗黴菌劑的治療劑量至少治療一段時間:持續性黴菌血症3天,非黴菌血症型感染7天,食道念珠菌病14天,感染惡化或未改善)3.適用於13歲以上高危險病人,用來預防侵入性黴菌感染,包括造血幹細胞移植接受者因為植體宿主反應,而接受高劑量免疫抑制劑治療,及acute myelogenous leukemia或高危險myelodysplastic syndrome病人接受誘導化學治療,而引起長期嗜中性白血球減少症。
註銷日期: 2018/09/12; 註銷理由: 自請註銷; 有效日期: 2020/10/06; 英文品名: Posanol 40 mg/ml oral suspension
已註銷
2010-10-06
1 POSANOL S-CCDS-MK5592-OS-T-112016 MK5592-TWN-2016-013980 1. NAME OF THE MEDICINAL PRODUCT Posanol 40 mg/ml oral suspension 2. DESCRIPTION AND Q UALITATIVE COMPOSITION Posanol ® (posaconazole) is a triazole antifungal agent available as a suspension for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3_R_,5_R_)-5- (2,4-difluorophenyl)tetrahydro-5- (1_H_-1,2,4-triazol-1-y lm ethy l)-3-furanyl]methoxy]phenyl]-1-piperaziny l]phenyl]-2-[(1S,2S)- 1-ethyl-2-hydroxypropyl]-2,4-dihydro-3_H_-1,2,4-triazol-3-one with an empirical formula of C 37 H 42 F 2 N 8 O 4 and a molecular weight of 700.8. The structural formula is: Posaconazole is a white powder and is insoluble in water. POSANOL Oral Suspension is a white, cherry -flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavor, and purified water. 3. PHARMACEUTICAL FORM ORAL SUSPENSION WHITE SUSPENSION 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Second-line treatment for invasive aspergillosis in adults with disease that is refractory to amphotericin B, itraconazole or voriconazole, or in adults who are intolerant of these medicinal products. (Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.)_ _ 2. Second-line treatment for oropharyngeal candidiasis in adults with disease that is refractory to itraconazole and fluconazole. (Refractoriness is defined as progression of infection or failure to improve after a minimum treatment period: persistent fungemia: 3 days; non-fungemic infections: 7 days; esophageal candidiasis: 14 days of prior therapeutic doses of effective antifungal therapy.) 3. Posanol is also indicated for prophylaxis of invasive fungal infections in the following patient pop Leer el documento completo