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Outline
What is the generic name?
MICAFUNGIN
What is the Trade Name for MICAFUNGIN?
Micafungin
What are the Indications for MICAFUNGIN?
- 1 INDICATIONS AND USAGE Micafungin for injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.1 ) and Use in Specific Populations ( 8.4 )] Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations ( 8.4 )] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies ( 14.2 )] . Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies ( 14.3 )]. Limitations of Use The safety and effectiveness of micafungin for injection has not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations ( 8.4 )]. Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida. The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established. Micafungin for injection is an echinocandin indicated in adult and pediatric patients for ( 1 ): Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adults and pediatric patients 4 months of age and older. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older. Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT). Limitations of Use The safety and effectiveness of micafungin for injection has not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed. ( 1 , 2.3 , 8.4 ) Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. ( 1 ) The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established. ( 1 )
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